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Sample records for clinical oncology chemotherapy

  1. Principles and major agents in clinical oncology chemotherapy

    SciTech Connect

    Weller, R.E.

    1991-10-01

    This paper provides a brief classification of drugs available for veterinary chemotherapy, as well as justifications for their use. Some common neoplasia and the drugs of choice for their treatment are described. A listing by class of systemic chemotherapeutic agents, their mode of action, tumors responsive to the drugs, precautions and common adverse effects and mode of administration is provided. 2 tabs. (MHB)

  2. American Society of Clinical Oncology Clinical Practice Guideline Update on Chemotherapy for Stage IV Non–Small-Cell Lung Cancer

    PubMed Central

    Azzoli, Christopher G.; Baker, Sherman; Temin, Sarah; Pao, William; Aliff, Timothy; Brahmer, Julie; Johnson, David H.; Laskin, Janessa L.; Masters, Gregory; Milton, Daniel; Nordquist, Luke; Pfister, David G.; Piantadosi, Steven; Schiller, Joan H.; Smith, Reily; Smith, Thomas J.; Strawn, John R.; Trent, David; Giaccone, Giuseppe

    2009-01-01

    The purpose of this article is to provide updated recommendations for the treatment of patients with stage IV non–small-cell lung cancer. A literature search identified relevant randomized trials published since 2002. The scope of the guideline was narrowed to chemotherapy and biologic therapy. An Update Committee reviewed the literature and made updated recommendations. One hundred sixty-two publications met the inclusion criteria. Recommendations were based on treatment strategies that improve overall survival. Treatments that improve only progression-free survival prompted scrutiny of toxicity and quality of life. For first-line therapy in patients with performance status of 0 or 1, a platinum-based two-drug combination of cytotoxic drugs is recommended. Nonplatinum cytotoxic doublets are acceptable for patients with contraindications to platinum therapy. For patients with performance status of 2, a single cytotoxic drug is sufficient. Stop first-line cytotoxic chemotherapy at disease progression or after four cycles in patients who are not responding to treatment. Stop two-drug cytotoxic chemotherapy at six cycles even in patients who are responding to therapy. The first-line use of gefitinib may be recommended for patients with known epidermal growth factor receptor (EGFR) mutation; for negative or unknown EGFR mutation status, cytotoxic chemotherapy is preferred. Bevacizumab is recommended with carboplatin-paclitaxel, except for patients with certain clinical characteristics. Cetuximab is recommended with cisplatin-vinorelbine for patients with EGFR-positive tumors by immunohistochemistry. Docetaxel, erlotinib, gefitinib, or pemetrexed is recommended as second-line therapy. Erlotinib is recommended as third-line therapy for patients who have not received prior erlotinib or gefitinib. Data are insufficient to recommend the routine third-line use of cytotoxic drugs. Data are insufficient to recommend routine use of molecular markers to select chemotherapy

  3. Guidelines for timely initiation of chemotherapy: a proposed framework for access to medical oncology and haematology cancer clinics and chemotherapy services.

    PubMed

    Alexander, M; Beattie-Manning, R; Blum, R; Byrne, J; Hornby, C; Kearny, C; Love, N; McGlashan, J; McKiernan, S; Milar, J L; Murray, D; Opat, S; Parente, P; Thomas, J; Tweddle, N; Underhill, C; Whitfield, K; Kirsa, S; Rischin, D

    2016-08-01

    These guidelines, informed by the best available evidence and consensus expert opinion, provide a framework to guide the timely initiation of chemotherapy for treating cancer. They sit at the intersection of patient experience, state-of-the-art disease management and rational efficient service provision for these patients at a system level. Internationally, cancer waiting times are routinely measured and publicly reported. In Australia, there are existing policies and guidelines relating to the timeliness of cancer care for surgery and radiation therapy; however, until now, equivalent guidance for chemotherapy was lacking. Timeliness of care should be informed, where available, by evidence for improved patient outcomes. Independent of this, it should be recognised that shorter waiting periods are likely to reduce patient anxiety. While these guidelines were developed as part of a proposed framework for consideration by the Victorian Department of Health, they are clinically relevant to national and international cancer services. They are intended to be used by clinical and administrative staff within cancer services. Adoption of these guidelines, which are for the timely triage, review and treatment of cancer patients receiving systemic chemotherapy, aims to ensure that patients receive care within a timeframe that will maximise health outcomes, and that access to care is consistent and equitable across cancer services. Local monitoring of performance against this guideline will enable cancer service providers to manage proactively future service demand. PMID:27553996

  4. A prospective observational study to evaluate G-CSF usage in patients with solid tumors receiving myelosuppressive chemotherapy in Italian clinical oncology practice.

    PubMed

    Barni, S; Lorusso, V; Giordano, M; Sogno, G; Gamucci, T; Santoro, A; Passalacqua, R; Iaffaioli, V; Zilembo, N; Mencoboni, M; Roselli, M; Pappagallo, G; Pronzato, P

    2014-01-01

    Febrile neutropenia (FN) is a severe dose-limiting side effect of myelosuppressive chemotherapy in patients with solid tumors. Clinical practice guidelines recommend primary prophylaxis with G-CSF in patients with an overall ≥ 20 % risk of FN. AIOM Italian guidelines recommend starting G-CSF within 24-72 h after chemotherapy; for daily G-CSF, administration should continue until the absolute neutrophil count (ANC) is 1 × 10(9)/L post-nadir and should not be terminated after ANC increase in the early days of administration. The aim of this study was to assess guideline adherence in oncology practice in Italy. In this multicenter, prospective, observational study, patients were enrolled at the first G-CSF use in any cycle and were followed for two subsequent cycles (or until the end of chemotherapy if less than two additional cycles). Primary objective was to explore G-CSF use in Italian clinical practice; therefore, data were collected on the G-CSF type, timing of administration, and number of doses. 512 eligible patients were enrolled (median age, 62). The most common tumor types were breast (36 %), lung (18 %), and colorectal (13 %). A total of 1,164 G-CSF cycles (daily G-CSF, 718; pegfilgrastim, 446) were observed. Daily G-CSF was administered later than 72 h after chemotherapy in 42 % of cycles, and the median [range] number of doses was four [1, 10]. Pegfilgrastim was administered later than 72 h in 8 % of cycles. G-CSF prophylaxis in Italy is frequently administered in a manner which is not supported by evidence-based guidelines. As this practice may lead to poor outcomes, educational initiatives are recommended. PMID:24307348

  5. Chemotherapy drug shortages in pediatric oncology: a consensus statement.

    PubMed

    Decamp, Matthew; Joffe, Steven; Fernandez, Conrad V; Faden, Ruth R; Unguru, Yoram

    2014-03-01

    Shortages of essential drugs, including critical chemotherapy drugs, have become commonplace. Drug shortages cost significant time and financial resources, lead to adverse patient outcomes, delay clinical trials, and pose significant ethical challenges. Pediatric oncology is particularly susceptible to drug shortages, presenting an opportunity to examine these ethical issues and provide recommendations for preventing and alleviating shortages. We convened the Working Group on Chemotherapy Drug Shortages in Pediatric Oncology (WG) and developed consensus on the core ethical values and practical actions necessary for a coordinated response to the problem of shortages by institutions, agencies, and other stakeholders. The interdisciplinary and multiinstitutional WG included practicing pediatric hematologist-oncologists, nurses, hospital pharmacists, bioethicists, experts in emergency management and public policy, legal scholars, patient/family advocates, and leaders of relevant professional societies and organizations. The WG endorsed 2 core ethical values: maximizing the potential benefits of effective drugs and ensuring equitable access. From these, we developed 6 recommendations: (1) supporting national polices to prevent shortages, (2) optimizing use of drug supplies, (3) giving equal priority to evidence-based uses of drugs whether they occur within or outside clinical trials, (4) developing an improved clearinghouse for sharing drug shortage information, (5) exploring the sharing of drug supplies among institutions, and (6) developing proactive stakeholder engagement strategies to facilitate prevention and management of shortages. Each recommendation includes an ethical rationale, action items, and barriers that must be overcome. Implemented together, they provide a blueprint for effective and ethical management of drug shortages in pediatric oncology and beyond. PMID:24488741

  6. Chemotherapy Drug Shortages in Pediatric Oncology: A Consensus Statement

    PubMed Central

    DeCamp, Matthew; Joffe, Steven; Fernandez, Conrad V.; Faden, Ruth R.

    2014-01-01

    Shortages of essential drugs, including critical chemotherapy drugs, have become commonplace. Drug shortages cost significant time and financial resources, lead to adverse patient outcomes, delay clinical trials, and pose significant ethical challenges. Pediatric oncology is particularly susceptible to drug shortages, presenting an opportunity to examine these ethical issues and provide recommendations for preventing and alleviating shortages. We convened the Working Group on Chemotherapy Drug Shortages in Pediatric Oncology (WG) and developed consensus on the core ethical values and practical actions necessary for a coordinated response to the problem of shortages by institutions, agencies, and other stakeholders. The interdisciplinary and multiinstitutional WG included practicing pediatric hematologist-oncologists, nurses, hospital pharmacists, bioethicists, experts in emergency management and public policy, legal scholars, patient/family advocates, and leaders of relevant professional societies and organizations. The WG endorsed 2 core ethical values: maximizing the potential benefits of effective drugs and ensuring equitable access. From these, we developed 6 recommendations: (1) supporting national polices to prevent shortages, (2) optimizing use of drug supplies, (3) giving equal priority to evidence-based uses of drugs whether they occur within or outside clinical trials, (4) developing an improved clearinghouse for sharing drug shortage information, (5) exploring the sharing of drug supplies among institutions, and (6) developing proactive stakeholder engagement strategies to facilitate prevention and management of shortages. Each recommendation includes an ethical rationale, action items, and barriers that must be overcome. Implemented together, they provide a blueprint for effective and ethical management of drug shortages in pediatric oncology and beyond. PMID:24488741

  7. Clinical radiation oncology

    SciTech Connect

    Wang, C.C.

    1988-01-01

    This book presents current concepts of radiation oncology in the management of various malignant diseases. Recent advances such as the use of linear accelerators and recently increased knowledge concerning radiation biology have been incorporated into the text.

  8. Implementation of the american college of surgeons oncology group z1071 trial data in clinical practice: is there a way forward for sentinel lymph node dissection in clinically node-positive breast cancer patients treated with neoadjuvant chemotherapy?

    PubMed

    Mittendorf, Elizabeth A; Caudle, Abigail S; Yang, Wei; Krishnamurthy, Savitri; Shaitelman, Simona; Chavez-MacGregor, Mariana; Woodward, Wendy A; Bedrosian, Isabelle; Kuerer, Henry M; Hunt, Kelly K

    2014-08-01

    For clinically node-positive breast cancer patients receiving neoadjuvant chemotherapy, approximately 40 % will be found to be pathologically node negative. The American College of Surgeons Oncology Group Z1071 trial was therefore conducted to evaluate sentinel lymph node dissection (SLND) in these patients. The trial's primary end point was to determine the false-negative rate (FNR) among patients with clinical N1 disease in whom at least 2 sentinel lymph nodes (SLNs) were identified. The FNR was 12.6 %, which exceeded the prespecified end point of 10.0 %. After data publication, our multidisciplinary team discussed the trial results and how we may incorporate the findings into clinical practice. Patient selection and surgical technique are critical. As an example, when dual tracer technique was used, the FNR was 10.8 %. Data from the trial presented at the San Antonio Breast Cancer Symposium suggested that the FNR could be improved if a clip was placed in the biopsy-proven positive lymph node and removal of that node during SLND was confirmed. Taking this into consideration, we have proposed an approach to surgical management of the axilla in clinically node-positive patients receiving neoadjuvant chemotherapy termed targeted axillary dissection (TAD). TAD involves placing a clip at the time a lymph node is determined to be positive. After completion of neoadjuvant chemotherapy, the clipped node is localized by using a wire or radioactive seed, and during the SLND procedure, all SLNs and the clipped node are removed. We are currently evaluating the efficacy of TAD in axillary staging after neoadjuvant chemotherapy. PMID:24841348

  9. Tissue Microarrays in Clinical Oncology

    PubMed Central

    Voduc, David; Kenney, Challayne; Nielsen, Torsten O.

    2008-01-01

    The tissue microarray is a recently-implemented, high-throughput technology for the analysis of molecular markers in oncology. This research tool permits the rapid assessment of a biomarker in thousands of tumor samples, using commonly available laboratory assays such as immunohistochemistry and in-situ hybridization. Although introduced less than a decade ago, the TMA has proven to be invaluable in the study of tumor biology, the development of diagnostic tests, and the investigation of oncological biomarkers. This review describes the impact of TMA-based research in clinical oncology and its potential future applications. Technical aspects of TMA construction, and the advantages and disadvantages inherent to this technology are also discussed. PMID:18314063

  10. Medical Oncology Pharmacy: A New Role for the Clinical Pharmacist

    ERIC Educational Resources Information Center

    Morris, Carl R.; Hickman, Mary Johne

    1977-01-01

    The University of Tennessee has established a training program for clinical pharmacists dealing with cancer chemotherapy patients. Health-care settings are described in which these individuals can contribute as unique health-care team members in oncology. (Author/LBH)

  11. Sedation in clinical oncology.

    PubMed

    González Barón, Manuel; Gómez Raposo, César; Pinto Marín, Alvaro

    2005-08-01

    The clinical status of terminal cancer patients is very complex and is affected by several severe symptoms, of extended duration, changing with time and of multifactorial origin. When there are no reasonable cancer treatments specifically able to modify the natural history of the disease, symptom control acquires priority and favours the possible better adaptation to the general inexorable deterioration related to the neoplasic progression. Despite the important advances in Palliative Medicine, symptoms are frequently observed that are intolerable for the patient and which do not respond to usual palliative measures. This situation, characterised by rapid deterioration of the patient, very often heralds, implicitly or explicitly, approaching death. The intolerable nature and being refractory to treatment indicates to the health-care team, on many occasions, the need for sedation of the patient. The requirement for sedation of the cancer patient is a situation that does not allow for an attitude of doubt regarding maintenance of the patient in unnecessary suffering for more than a reasonable time. Given the undoubted clinical difficulty in its indication, it is important to have explored at an earlier stage all usual treatments possible and the grade of response, commensurate with the patient's values and desires. Sedation consists of the deliberate administration of drugs in minimum doses and combinations required not only to reduce the consciousness of the patients but also to achieve adequate alleviation of one or more refractory symptoms, and with the prior consent given by the patient explicitly, or implicitly or delegated. Sedation is accepted as ethically warranted when considering the imperative of palliation and its administration and, whenever contemplated, the arguments that justify them are clear recorded in the clinical history. It is not an easy decision for the physician since, traditionally, the training has been "for the fight to save life

  12. Limited Chemotherapy and Shrinking Field Radiotherapy for Osteolymphoma (Primary Bone Lymphoma): Results From the Trans-Tasman Radiation Oncology Group 99.04 and Australasian Leukaemia and Lymphoma Group LY02 Prospective Trial;Bone; Lymphoma; Radiotherapy; Chemotherapy; Clinical trial

    SciTech Connect

    Christie, David; Dear, Keith; Le, Thai; Barton, Michael; Wirth, Andrew; Porter, David; Roos, Daniel; Pratt, Gary

    2011-07-15

    Purpose: To establish benchmark outcomes for combined modality treatment to be used in future prospective studies of osteolymphoma (primary bone lymphoma). Methods and Materials: In 1999, the Trans-Tasman Radiation Oncology Group (TROG) invited the Australasian Leukemia and Lymphoma Group (ALLG) to collaborate on a prospective study of limited chemotherapy and radiotherapy for osteolymphoma. The treatment was designed to maintain efficacy but limit the risk of subsequent pathological fractures. Patient assessment included both functional imaging and isotope bone scanning. Treatment included three cycles of CHOP chemotherapy and radiation to a dose of 45 Gy in 25 fractions using a shrinking field technique. Results: The trial closed because of slow accrual after 33 patients had been entered. Accrual was noted to slow down after Rituximab became readily available in Australia. After a median follow-up of 4.3 years, the five-year overall survival and local control rates are estimated at 90% and 72% respectively. Three patients had fractures at presentation that persisted after treatment, one with recurrent lymphoma. Conclusions: Relatively high rates of survival were achieved but the number of local failures suggests that the dose of radiotherapy should remain higher than it is for other types of lymphoma. Disability after treatment due to pathological fracture was not seen.

  13. Introduction to veterinary clinical oncology

    SciTech Connect

    Weller, R.E.

    1991-10-01

    Veterinary clinical oncology involves a multidisciplinary approach to the recognition and management of spontaneously occurring neoplasms of domestic animals. This requires some knowledge of the causes, incidence, and natural course of malignant disease as it occurs in domestic species. The purpose of this course is to acquaint you with the more common neoplastic problems you will encounter in practice, so that you can offer your clients an informed opinion regarding prognosis and possible therapeutic modalities. A major thrust will be directed toward discussing and encouraging treatment/management of malignant disease. Multimodality therapy will be stressed. 10 refs., 3 tabs.

  14. Trajectories of Evening Fatigue in Oncology Outpatients Receiving Chemotherapy

    PubMed Central

    Wright, Fay; Melkus, Gail D’Eramo; Hammer, Marilyn; Schmidt, Brian L.; Knobf, M. Tish; Paul, Steven M.; Cartwright, Frances; Mastick, Judy; Cooper, Bruce A.; Chen, Lee-May; Melisko, Michelle; Levine, Jon D.; Kober, Kord; Aouizerat, Bradley E.; Miaskowski, Christine

    2015-01-01

    Context Fatigue is a distressing, persistent sense of physical tiredness that is not proportional to a person’s recent activity. Fatigue impacts patients’ treatment decisions and can limit their self-care activities. While significant interindividual variability in fatigue severity has been noted, little is known about predictors of interindividual variability in initial levels and trajectories of evening fatigue severity in oncology patients receiving chemotherapy (CTX). Objectives To determine whether demographic, clinical, and symptom characteristics were associated with initial levels as well as the trajectories of evening fatigue. Methods A sample of outpatients with breast, gastrointestinal, gynecological, and lung cancer (N=586) completed demographic and symptom questionnaires a total of six times over two cycles of CTX. Fatigue severity was evaluated using the Lee Fatigue Scale. Hierarchical linear modeling (HLM) was used to answer the study objectives. Results A large amount of interindividual variability was found in the evening fatigue trajectories. A piecewise model fit the data best. Patients who were White, diagnosed with breast, gynecological, or lung cancer, and who had more years of education, child care responsibilities, lower functional status, and higher levels of sleep disturbance and depression reported higher levels of evening fatigue at enrollment. Conclusion This study identified both non-modifiable (e.g., ethnicity) and modifiable (e.g., child care responsibilities, depressive symptoms, sleep disturbance) risk factors for more severe evening fatigue. Using this information, clinicians can identify patients at higher risk for more severe evening fatigue, provide individualized patient education, and tailor interventions to address the modifiable risk factors. PMID:25828560

  15. Clinical Oncology Assistantship Program for Medical Students.

    ERIC Educational Resources Information Center

    Neilan, Barbara A.; And Others

    1985-01-01

    The Clinical Oncology Assistantship Program at the University of Arkansas for Medical Sciences is described, along with student reactions to the program. The summer elective program involves cancer lectures (one week) and clinical exposure (nine weeks) in medical, surgical, and pediatric oncology services, as well as self-directed learning…

  16. Monitoring cancer stem cells: insights into clinical oncology

    PubMed Central

    Lin, ShuChen; Xu, YingChun; Gan, ZhiHua; Han, Kun; Hu, HaiYan; Yao, Yang; Huang, MingZhu; Min, DaLiu

    2016-01-01

    Cancer stem cells (CSCs) are a small, characteristically distinctive subset of tumor cells responsible for tumor initiation and progression. Several treatment modalities, such as surgery, glycolytic inhibition, driving CSC proliferation, immunotherapy, and hypofractionated radiotherapy, may have the potential to eradicate CSCs. We propose that monitoring CSCs is important in clinical oncology as CSC populations may reflect true treatment response and assist with managing treatment strategies, such as defining optimal chemotherapy cycles, permitting pretreatment cancer surveillance, conducting a comprehensive treatment plan, modifying radiation treatment, and deploying rechallenge chemotherapy. Then, we describe methods for monitoring CSCs. PMID:26929644

  17. Risk factors for readmission in patients with ovarian, fallopian tube, and primary peritoneal carcinoma who are receiving front-line chemotherapy on a clinical trial (GOG 218): an NRG oncology/gynecologic oncology group study (ADS-1236)☆

    PubMed Central

    Duska, Linda R.; Java, James J.; Cohn, David E.; Burger, Robert A.

    2015-01-01

    Background Readmission within 30 days is a measure of care quality. Ovarian cancer patients are at high risk for readmission, but specific risk factors are not defined. This study was designed to determine risk factors in patients with ovarian cancer receiving upfront surgery and chemotherapy. Methods The study population was enrolled to GOG 0218. Factors predictive of admission within 30 days of a previous admission or 40 days of cytoreductive surgery were investigated. Categorical variables were compared by Pearson chi-square test, continuous variables by Wilcoxon–Mann–Whitney test. A logistic regression model was used to evaluate independent prognostic factors and to estimate covariate-adjusted odds. All tests were two-tailed, α = 0.05. Results Of 1873 patients, 197 (10.5%) were readmitted, with 59 experiencing >1 readmission. One-hundred-forty-four (73%) readmissions were post-operative (readmission rate 7.7%). Significant risk factors include: disease stage (stage 3 vs 4, p = 0.008), suboptimal cytoreduction (36% vs 64%, p = 0.001), ascites, (p = 0.018), BMI (25.4 vs 27.6, p < 0.001), poor PS (p < 0.001), and higher baseline CA 125 (p = 0.017). Patients readmitted within 40 days of surgery had a significantly shorter interval from surgery to chemotherapy initiation (22 versus 32 days, p < 0.0001). Patients treated with bevacizumab had higher readmission rates in the case of patients with >1 readmission. On multivariate analysis, the odds of re-hospitalization increased with doubling of BMI (OR = 1.81, 95% CI: 1.07–3.07) and PS of 2 (OR = 2.05, 95% CI 1.21–3.48). Conclusion Significant risk factors for readmission in ovarian cancer patients undergoing primary surgery and chemotherapy include stage, residual disease, ascites, high BMI and poor PS. Readmissions are most likely after the initial surgical procedure, a discrete period to target with a prospective intervention. PMID:26335594

  18. American Society of Clinical Oncology Policy Statement on Clinical Pathways in Oncology.

    PubMed

    Zon, Robin T; Frame, James N; Neuss, Michael N; Page, Ray D; Wollins, Dana S; Stranne, Steven; Bosserman, Linda D

    2016-03-01

    The use of clinical pathways in oncology care is increasingly important to patients and oncology providers as a tool for enhancing both quality and value. However, with increasing adoption of pathways into oncology practice, concerns have been raised by ASCO members and other stakeholders. These include the process being used for pathway development, the administrative burdens on oncology practices of reporting on pathway adherence, and understanding the true impact of pathway use on patient health outcomes. To address these concerns, ASCO's Board of Directors established a Task Force on Clinical Pathways, charged with articulating a set of recommendations to improve the development of oncology pathways and processes, allowing the demonstration of pathway concordance in a manner that promotes evidence-based, high-value care respecting input from patients, payers, and providers. These recommendations have been approved and adopted by ASCO's Board of Directors on August 12, 2015, and are presented herein. PMID:26759491

  19. Antiemetics: American Society of Clinical Oncology Clinical Practice Guideline Update

    PubMed Central

    Basch, Ethan; Prestrud, Ann Alexis; Hesketh, Paul J.; Kris, Mark G.; Feyer, Petra C.; Somerfield, Mark R.; Chesney, Maurice; Clark-Snow, Rebecca Anne; Flaherty, Anne Marie; Freundlich, Barbara; Morrow, Gary; Rao, Kamakshi V.; Schwartz,, Rowena N.; Lyman, Gary H.

    2011-01-01

    Purpose To update the American Society of Clinical Oncology (ASCO) guideline for antiemetics in oncology. Methods A systematic review of the medical literature was completed to inform this update. MEDLINE, the Cochrane Collaboration Library, and meeting materials from ASCO and the Multinational Association for Supportive Care in Cancer were all searched. Primary outcomes of interest were complete response and rates of any vomiting or nausea. Results Thirty-seven trials met prespecified inclusion and exclusion criteria for this systematic review. Two systematic reviews from the Cochrane Collaboration were identified; one surveyed the pediatric literature. The other compared the relative efficacy of the 5-hydroxytryptamine-3 (5-HT3) receptor antagonists. Recommendations Combined anthracycline and cyclophosphamide regimens were reclassified as highly emetic. Patients who receive this combination or any highly emetic agents should receive a 5-HT3 receptor antagonist, dexamethasone, and a neurokinin 1 (NK1) receptor antagonist. A large trial validated the equivalency of fosaprepitant, a single-day intravenous formulation, with aprepitant; either therapy is appropriate. Preferential use of palonosetron is recommended for moderate emetic risk regimens, combined with dexamethasone. For low-risk agents, patients can be offered dexamethasone before the first dose of chemotherapy. Patients undergoing high emetic risk radiation therapy should receive a 5-HT3 receptor antagonist before each fraction and for 24 hours after treatment and may receive a 5-day course of dexamethasone during fractions 1 to 5. The Update Committee noted the importance of continued symptom monitoring throughout therapy. Clinicians underestimate the incidence of nausea, which is not as well controlled as emesis. PMID:21947834

  20. American Society of Clinical Oncology

    MedlinePlus

    ... Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial aiming to describe the performance of ... Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial aiming to describe the performance of ...

  1. Current Views on Clinical Oncology Training from the 2015 Oncology Registrars' Forum Survey.

    PubMed

    Kosmin, M; Brown, S; Hague, C; Said, J; Wells, L; Wilson, C

    2016-09-01

    The major role of the Oncology Registrars' Forum (ORF) of the Royal College of Radiologists is to voice the opinions of the clinical oncology trainee body and work towards improving all aspects of clinical oncology training in the UK. In order to provide data to support these efforts, the ORF undertakes a biennial survey of all trainees. As with the previous surveys, this year's ORF survey produced data that highlight areas of good training as well as new and ongoing areas of concern. This summary highlights the key survey results and provides recommendations for improving the delivery of clinical oncology training in the UK. PMID:27184941

  2. Lessons learned from radiation oncology clinical trials.

    PubMed

    Liu, Fei-Fei; Okunieff, Paul; Bernhard, Eric J; Stone, Helen B; Yoo, Stephen; Coleman, C Norman; Vikram, Bhadrasain; Brown, Martin; Buatti, John; Guha, Chandan

    2013-11-15

    A workshop entitled "Lessons Learned from Radiation Oncology Trials" was held on December 7-8, 2011, in Bethesda, MD, to present and discuss some of the recently conducted radiation oncology clinical trials with a focus on those that failed to refute the null hypothesis. The objectives of this workshop were to summarize and examine the questions that these trials provoked, to assess the quality and limitations of the preclinical data that supported the hypotheses underlying these trials, and to consider possible solutions to these challenges for the design of future clinical trials. Several themes emerged from the discussions: (i) opportunities to learn from null-hypothesis trials through tissue and imaging studies; (ii) value of preclinical data supporting the design of combinatorial therapies; (iii) significance of validated biomarkers; (iv) necessity of quality assurance in radiotherapy delivery; (v) conduct of sufficiently powered studies to address the central hypotheses; and (vi) importance of publishing results of the trials regardless of the outcome. The fact that well-designed hypothesis-driven clinical trials produce null or negative results is expected given the limitations of trial design and complexities of cancer biology. It is important to understand the reasons underlying such null results, however, to effectively merge the technologic innovations with the rapidly evolving biology for maximal patient benefit through the design of future clinical trials. PMID:24043463

  3. Clinical applications of PET in oncology.

    PubMed

    Rohren, Eric M; Turkington, Timothy G; Coleman, R Edward

    2004-05-01

    Positron emission tomography (PET) provides metabolic information that has been documented to be useful in patient care. The properties of positron decay permit accurate imaging of the distribution of positron-emitting radiopharmaceuticals. The wide array of positron-emitting radiopharmaceuticals has been used to characterize multiple physiologic and pathologic states. PET is used for characterizing brain disorders such as Alzheimer disease and epilepsy and cardiac disorders such as coronary artery disease and myocardial viability. The neurologic and cardiac applications of PET are not covered in this review. The major utilization of PET clinically is in oncology and consists of imaging the distribution of fluorine 18 fluorodeoxyglucose (FDG). FDG, an analogue of glucose, accumulates in most tumors in a greater amount than it does in normal tissue. FDG PET is being used in diagnosis and follow-up of several malignancies, and the list of articles supporting its use continues to grow. In this review, the physics and instrumentation aspects of PET are described. Many of the clinical applications in oncology are mature and readily covered by third-party payers. Other applications are being used clinically but have not been as carefully evaluated in the literature, and these applications may not be covered by third-party payers. The developing applications of PET are included in this review. PMID:15044750

  4. Adaptive clinical trial designs in oncology

    PubMed Central

    Zang, Yong; Lee, J. Jack

    2015-01-01

    Adaptive designs have become popular in clinical trial and drug development. Unlike traditional trial designs, adaptive designs use accumulating data to modify the ongoing trial without undermining the integrity and validity of the trial. As a result, adaptive designs provide a flexible and effective way to conduct clinical trials. The designs have potential advantages of improving the study power, reducing sample size and total cost, treating more patients with more effective treatments, identifying efficacious drugs for specific subgroups of patients based on their biomarker profiles, and shortening the time for drug development. In this article, we review adaptive designs commonly used in clinical trials and investigate several aspects of the designs, including the dose-finding scheme, interim analysis, adaptive randomization, biomarker-guided randomization, and seamless designs. For illustration, we provide examples of real trials conducted with adaptive designs. We also discuss practical issues from the perspective of using adaptive designs in oncology trials. PMID:25811018

  5. Electronic patient-reported outcome systems in oncology clinical practice.

    PubMed

    Bennett, Antonia V; Jensen, Roxanne E; Basch, Ethan

    2012-01-01

    Patient-reported outcome (PRO) questionnaires assess topics a patient can report about his or her own health. This includes symptoms (eg, nausea, fatigue, diarrhea, pain, or frequent urination), physical functioning (eg, difficulty climbing stairs or difficulty fastening buttons), and mental health (eg, anxiety, fear, or worry). Electronic PRO (ePRO) systems are used in oncology clinical care because of 1) their ability to enhance clinical care by flagging important symptoms and saving clinicians time; 2) the availability of standardized methods for creating and implementing PROs in clinics; and 3) the existence of user-friendly platforms for patient self-reporting like tablet computers and automated telephone surveys. Many ePRO systems can provide actionable links to clinical care such as summary reports in a patient's electronic medical record and real-time e-mail alerts to providers when patients report acute needs. This review presents 5 examples of ePRO systems currently in use in oncology practice. These systems support multiple clinical activities, including assessment of symptoms and toxicities related to chemotherapy and radiation, postoperative surveillance, and symptom management during palliative care and hospice. Patient self-reporting is possible both at clinical visits and between visits over the Internet or by telephone. The implementation of an ePRO system requires significant resources and expertise, as well as user training. ePRO systems enable regular monitoring of patient symptoms, function, and needs, and can enhance the efficiency and quality of care as well as communication with patients. PMID:22811342

  6. Chemotherapy for neuroendocrine tumors: the Beatson Oncology Centre experience.

    PubMed

    Hatton, M Q; Reed, N S

    1997-01-01

    The role of chemotherapy in malignant neuroendocrine tumours is difficult to assess because of their rarity and variation in biological behaviour. We present a retrospective review of chemotherapy given to 18 patients with metastatic and one with locally advanced neuroendocrine tumours. There were eight poorly differentiated neuroendocrine tumours, six thyroid medullary carcinomas, two phaeochromocytomas, two pancreatic islet cell tumours and one undifferentiated neuroblastoma. Four patients were given 3-weekly dacarbazine, vincristine and cyclophosphamide (DOC) chemotherapy. In eight patients, this regimen was modified by substituting the dacarbazine and cisplatin and etoposide (OPEC). A further six patients were treated with dacarbazine reintroduced into the 3-weekly regimen (DOPEC). The remaining patient received cisplatin and etoposide. There were two complete responses (both with OPEC) and eight partial responses (two with DOC, three with OPEC and three with DOPEC). Five patients had stable disease and four progressed. Four received further chemotherapy on relapse, producing one complete and one partial response. The median response duration to initial chemotherapy was 10 months (range 3-34). The median survival was 12 months (range 1-42). The main toxicity was haematological, with grade 3-4 neutropenia in 12 patients; eight suffered episodes of sepsis. One death was treatment related. Other toxicity was mild although three patients discontinued vincristine with grade 2 neurotoxicity. The response rate and side effects of these three regimens appear comparable. We conclude that, although these patient numbers are small, combination chemotherapy produces an encouraging response rate (53%; 95% CI 30-75) in malignant neuroendocrine tumours, with acceptable toxicity. PMID:9448967

  7. Clinical oncology in Malaysia: 1914 to present.

    PubMed

    Lim, Gcc

    2006-01-01

    A narration of the development of staff, infrastructure and buildings in the various parts of the country is given in this paper. The role of universities and other institutions of learning, public health, palliative care, nuclear medicine and cancer registries is described together with the networking that has been developed between the government, non-governmental organisations and private hospitals. The training of skilled manpower and the commencement of the Master of Clinical Oncology in the University of Malaya is highlighted. Efforts taken to improve the various aspects of cancer control which includes prevention of cancer, early detection, treatment and palliative care are covered. It is vital to ensure that cancer care services must be accessible and affordable throughout the entire health system, from the primary care level up to the centres for tertiary care, throughout the whole country. PMID:21614216

  8. Clinical oncology in Malaysia: 1914 to present

    PubMed Central

    2006-01-01

    A narration of the development of staff, infrastructure and buildings in the various parts of the country is given in this paper. The role of universities and other institutions of learning, public health, palliative care, nuclear medicine and cancer registries is described together with the networking that has been developed between the government, non-governmental organisations and private hospitals. The training of skilled manpower and the commencement of the Master of Clinical Oncology in the University of Malaya is highlighted. Efforts taken to improve the various aspects of cancer control which includes prevention of cancer, early detection, treatment and palliative care are covered. It is vital to ensure that cancer care services must be accessible and affordable throughout the entire health system, from the primary care level up to the centres for tertiary care, throughout the whole country. PMID:21614216

  9. Selenium in oncology: from chemistry to clinics.

    PubMed

    Micke, Oliver; Schomburg, Lutz; Buentzel, Jens; Kisters, Klaus; Muecke, Ralph

    2009-01-01

    The essential trace element selenium, which is a crucial cofactor in the most important endogenous antioxidative systems of the human body, is attracting more and more the attention of both laypersons and expert groups. The interest of oncologists mainly focuses in the following clinical aspects: radioprotection of normal tissues, radiosensitizing in malignant tumors, antiedematous effect, prognostic impact of selenium, and effects in primary and secondary cancer prevention. Selenium is a constituent of the small group of selenocysteine-containing selenoproteins and elicits important structural and enzymatic functions. Selenium deficiency has been linked to increased infection risk and adverse mood states. It has been shown to possess cancer-preventive and cytoprotective activities in both animal models and humans. It is well established that Se has a key role in redox regulation and antioxidant function, and hence in membrane integrity, energy metabolism and protection against DNA damage. Recent clinical trials have shown the importance of selenium in clinical oncology. Our own clinical study involving 48 patients suggest that selenium has a positive effect on radiation-associated secondary lymphedema in patients with limb edemas, as well as in the head and neck region, including endolaryngeal edema. Another randomized phase III study of our group was performed to examine the cytoprotective properties of selenium in radiation oncology. The aim was to evaluate whether sodium selenite is able to compensate a preexisting selenium deficiency and to prevent radiation induced diarrhea in adjuvant radiotherapy for pelvic gynecologic malignancies. Through this study, the significant benefits of sodium selenite supplementation with regards to selenium deficiency and radiotherapy induced diarrhea in patients with cervical and uterine cancer has been shown for the first time in a prospective randomized trial. Survival data imply that supplementation with selenium does not

  10. Clinical benefits of metformin in gynecologic oncology

    PubMed Central

    IMAI, ATSUSHI; ICHIGO, SATOSHI; MATSUNAMI, KAZUTOSHI; TAKAGI, HIROSHI; YASUDA, KEIGO

    2015-01-01

    Evidence has suggested that diabetes may contribute to the initiation and progression of specific types of cancer. Metformin, a biguanide, has become the preferred first-line therapy for the treatment of type 2 diabetes. Metformin is inexpensive, has a proven safety profile and is able to be safely combined with additional antidiabetic agents. In addition to the well-established antidiabetic effects of metformin, there has also been notable interest in its antitumor properties. The present review discusses the emerging role of metformin as an example of an existing drug, used worldwide in the treatment of diabetes, which has been demonstrated to exert significant in vitro and in vivo anticancer activities and has thus been investigated in clinical trials. In gynecologic oncology, metformin has been suggested to exhibit significant treatment efficacy against endometrial cancer. Three studies have demonstrated the potential therapeutic effects of metformin on the survival outcome of patients with ovarian cancer and in ovarian cancer prevention. However, this evidence was based on observational studies. Metformin has been shown to exert no statistically significant beneficial effect on cervical cancer incidence or mortality. By cancer site, the current limited insights highlight the need for clinical investigations and better-designed studies, along with evaluation of the effects of metformin on cancer at other sites. PMID:26622536

  11. Oral Health Status of Chinese Paediatric and Adolescent Oncology Patients with Chemotherapy in Hong Kong: a Pilot Study

    PubMed Central

    Kung, A.Y.H; Zhang, S; Zheng, L.W; Wong, G.H.M; Chu, C.H

    2015-01-01

    Aim: To study the oral health status of Chinese children and adolescents undergoing chemotherapy in Hong Kong. Method: All Chinese children and adolescent oncology patients aged 18 or below attending the Children's Centre for Cancer and Blood Disease at a hospital for chemotherapy were invited and parental consent was sought before they were accepted into the study. The study comprised of 1) a parental questionnaire, 2) the collection of medical history and 3) a clinical examination for tooth decay (caries) and mucosal status. Results: A total of 69 patients were invited, and they all participated in this study. Their mean age was 9.2±5.0 and 44 (64%) were males. Twenty-six patients (38%) had no caries experience (DMFT and/or dmft = 0). Higher caries experience was detected in participants that were not born in Hong Kong, had completed active chemotherapy, participated in school dental care service and whose parents had low educational levels. There were 41 patients with active chemotherapy, 24 of whom were diagnosed with acute leukaemia, 5 with haematological malignancies other than leukaemia and 11 with solid tumours. Antimetabolites, cytotoxic antibiotics, alkylating agents and plant alkaloids were administered in 49%, 32%, 24% and 22% of them, respectively. Twenty-six (63%) patients showed no mucosal complications. The most common oral complication was oral mucositis (24%) followed by petechiae (10%). Conclusion: About two-thirds of paediatric and adolescent cancer patients had caries experience, which was more common among those who had completed chemotherapy. Oral mucositis followed by petechiae were the two most common complications of receiving chemotherapy. PMID:25674168

  12. Effects of Video Games on the Adverse Corollaries of Chemotherapy in Pediatric Oncology Patients: A Single-Case Analysis.

    ERIC Educational Resources Information Center

    Kolko, David J.; Rickard-Figueroa, Jorge L.

    1985-01-01

    Assessed effects of video games on adverse corollaries of chemotherapy in three pediatric oncology patients. Results indicated that access to video games resulted in reduction in the number of anticipatory symptoms experienced and observed, as well as a diminution in the aversiveness of chemotherapy side effects. (Author/NRB)

  13. Effect of Remote Ischaemic Conditioning in Oncology Patients Undergoing Chemotherapy: Rationale and Design of the ERIC-ONC Study--A Single-Center, Blinded, Randomized Controlled Trial.

    PubMed

    Chung, Robin; Maulik, Angshuman; Hamarneh, Ashraf; Hochhauser, Daniel; Hausenloy, Derek J; Walker, J Malcolm; Yellon, Derek M

    2016-02-01

    Cancer survival continues to improve, and thus cardiovascular consequences of chemotherapy are increasingly important determinants of long-term morbidity and mortality. Conventional strategies to protect the heart from chemotherapy have important hemodynamic or myelosuppressive side effects. Remote ischemic conditioning (RIC) using intermittent limb ischemia-reperfusion reduces myocardial injury in the setting of percutaneous coronary intervention. Anthracycline cardiotoxicity and ischemia-reperfusion injury share common biochemical pathways in cardiomyocytes. The potential for RIC as a novel treatment to reduce subclinical myocyte injury in chemotherapy has never been explored and will be investigated in the Effect of Remote Ischaemic Conditioning in Oncology (ERIC-ONC) trial (clinicaltrials.gov NCT 02471885). The ERIC-ONC trial is a single-center, blinded, randomized, sham-controlled study. We aim to recruit 128 adult oncology patients undergoing anthracycline-based chemotherapy treatment, randomized in a 1:1 ratio into 2 groups: (1) sham procedure or (2) RIC, comprising 4, 5-minute cycles of upper arm blood pressure cuff inflations and deflations, immediately before each cycle of chemotherapy. The primary outcome measure, defining cardiac injury, will be high-sensitivity troponin-T over 6 cycles of chemotherapy and 12 months follow-up. Secondary outcome measures will include clinical, electrical, structural, and biochemical endpoints comprising major adverse cardiovascular clinical events, incidence of cardiac arrhythmia over 14 days at cycle 5/6, echocardiographic ventricular function, N-terminal pro-brain natriuretic peptide levels at 3 months follow-up, and changes in mitochondrial DNA, micro-RNA, and proteomics after chemotherapy. The ERIC-ONC trial will determine the efficacy of RIC as a novel, noninvasive, nonpharmacological, low-cost cardioprotectant in cancer patients undergoing anthracycline-based chemotherapy. PMID:26807534

  14. Effect of Remote Ischaemic Conditioning in Oncology Patients Undergoing Chemotherapy: Rationale and Design of the ERIC‐ONC Study—A Single‐Center, Blinded, Randomized Controlled Trial

    PubMed Central

    Chung, Robin; Maulik, Angshuman; Hamarneh, Ashraf; Hochhauser, Daniel; Hausenloy, Derek J.; Walker, J. Malcolm

    2016-01-01

    ABSTRACT Cancer survival continues to improve, and thus cardiovascular consequences of chemotherapy are increasingly important determinants of long‐term morbidity and mortality. Conventional strategies to protect the heart from chemotherapy have important hemodynamic or myelosuppressive side effects. Remote ischemic conditioning (RIC) using intermittent limb ischemia‐reperfusion reduces myocardial injury in the setting of percutaneous coronary intervention. Anthracycline cardiotoxicity and ischemia‐reperfusion injury share common biochemical pathways in cardiomyocytes. The potential for RIC as a novel treatment to reduce subclinical myocyte injury in chemotherapy has never been explored and will be investigated in the Effect of Remote Ischaemic Conditioning in Oncology (ERIC‐ONC) trial (clinicaltrials.gov NCT 02471885). The ERIC‐ONC trial is a single‐center, blinded, randomized, sham‐controlled study. We aim to recruit 128 adult oncology patients undergoing anthracycline‐based chemotherapy treatment, randomized in a 1:1 ratio into 2 groups: (1) sham procedure or (2) RIC, comprising 4, 5‐minute cycles of upper arm blood pressure cuff inflations and deflations, immediately before each cycle of chemotherapy. The primary outcome measure, defining cardiac injury, will be high‐sensitivity troponin‐T over 6 cycles of chemotherapy and 12 months follow‐up. Secondary outcome measures will include clinical, electrical, structural, and biochemical endpoints comprising major adverse cardiovascular clinical events, incidence of cardiac arrhythmia over 14 days at cycle 5/6, echocardiographic ventricular function, N‐terminal pro‐brain natriuretic peptide levels at 3 months follow‐up, and changes in mitochondrial DNA, micro‐RNA, and proteomics after chemotherapy. The ERIC‐ONC trial will determine the efficacy of RIC as a novel, noninvasive, nonpharmacological, low‐cost cardioprotectant in cancer patients undergoing anthracycline

  15. Advances in nanomedicine towards clinical application in oncology and immunology.

    PubMed

    Herreros, Eduardo; Morales, Sebastián; Cortés, Cristian; Cabaña, Mauricio; Peñaloza, Juan P; Jara, Lilian; Geraldo, Daniela; Otero, Carolina; Fernández-Ramires, Ricardo

    2014-01-01

    Recent advances in nanotechnology and nanobiotechnology have contributed to the development of nanomaterials, able to be used as drug carriers, probes, targets or cytostatic drugs by itself. Nanomedicine is now the leading area in nanotechnology where a large number and types of nanoparticles (NPs) has been developed and several are already in the clinical practice. Chemotherapy is one of the most widely used strategies to treat cancer. Most chemotherapeutic agents have poor solubility, low bioavailability, and are formulated with toxic solvents. NPs have been designed to overcome the lack of specificity of chemotherapeutic agents as well to improve circulation time in blood, taking advantages on tumor cells characteristics. In immunology, recent advances regarding the activation of the innate immune system artificially enhanced by NPs functionalized with immune-stimulators open a new window as novel methods in vaccines. Also, viruses and virus-like particles (VLPs) engineered to stimulate immune response against their similar virus or as molecular platforms for the presentation of foreign epitopes have been described. In this review we focused in the use of different types of NPs in oncology and immunology, pinpointing the main novelties regarding their development and use of nanotechnology in a broad array of applications, ranging from tumor diagnostics, immune-modulation up to cancer therapeutics. PMID:25213311

  16. Chemotherapy for Metastatic Breast Cancer – An Anachronism in the Era of Personalised and Targeted Oncological Therapy?

    PubMed Central

    Schneeweiss, A.; Ruckhäberle, E.; Huober, J.

    2015-01-01

    Based on the findings of modern molecular biology, breast cancer is nowadays considered to be a heterogeneous disease. This leads to the objective of an individualised, more patient-oriented therapy. A series of target molecules for this purpose has already been identified. The principle of targeted oncological therapy was realised decades ago with the introduction of endocrine therapy for patients with hormone receptor-positive tumours. The modern therapy for HER2-positive tumours is a further example for the translation of targeted therapy into clinical routine. For patients with HER2-negative metastatic breast cancer, to date two targeted drugs, bevacizumab and everolimus, are available for routine clinical use. Many other substances are still undergoing clinical development. However, validated predictive markers to aid in therapeutic decision-making and therapy control are still lacking. Chemotherapy constitutes an effective palliative therapy with proven efficacy for the patients. In this process strategies have also been realised for a targeted therapy against tumour cells with the help of chemotherapeutic agents such as, for example, the intracellular activation of the prodrug capecitabine or the active albumin-mediated transport of nab-paclitaxel which leads to higher peri- and intratumoural enrichments. The continuing unchanged relevance of chemotherapy is often underestimated in the current discussions and will be comprehensively evaluated in this review. PMID:26166838

  17. Clinical Trials in the Era of Personalized Oncology

    PubMed Central

    Maitland, Michael L.; Schilsky, Richard L.

    2011-01-01

    The rapid pace of discoveries in tumor biology, imaging technology, and human genetics hold promise for an era of personalized oncology care. The successful development of a handful of new targeted agents has generated much hope and hype about the delivery of safer and more effective new treatments for cancer. The design and conduct of clinical trials has not yet adjusted to a new era of personalized oncology and so we are more in transition to that era than in it. With the development of treatments for breast cancer as a model, we review the approaches to clinical trials and development of novel therapeutics in the prior era of population oncology, the current transitional era, and the future era of personalized oncology. PMID:22034206

  18. [Personal experience with VP-16 in the treatment of malignant lymphomas at the Chemotherapy Clinic of the Oncology Center--M. Skłodowskiej-Curie Institute in Warsaw].

    PubMed

    Pałucka, A; Walewski, J; Siedlecki, P; Zborzil, J

    1990-01-01

    Eighteen patients with advanced malignant lymphomas who had progressed with previous chemotherapy were treated with LEPP (chlorambucil, VP-16, procarbazine, prednisone). One complete response and 5 partial remissions were observed, yielding an overall response rate of 33%, with median response duration of about 2 months. Twenty three patients with advanced Hodgkin's disease all who had progressed with previous chemotherapy (MOPP and ABVD) and 19 of them also after radiation therapy were treated with third line salvage chemotherapy consisting of OPEC (VP- 16, chlorambucil, vincristine and prednisone). Two complete response and 3 partial remissions were obtained for overall response rate of 21% with median duration of about 9 months. PMID:2356146

  19. Multimodal Oncological Therapy Comprising Stents, Brachytherapy, and Regional Chemotherapy for Cholangiocarcinoma

    PubMed Central

    Andrašina, Tomáš; Pánek, Jiří; Kala, Zdeněk; Kiss, Igor; Tuček, Štěpán; Šlampa, Pavel

    2010-01-01

    Background/Aims To prospectively evaluate our palliative management of unresectable cholangiocarcinoma (CC) treated with tailored multimodal oncological therapy. Methods Between January 2005 and January 2010, 50 consecutive patients with unresectable CC and jaundice were palliated with percutaneous drainage. Forty-three patients underwent metallic-stent implantation followed by brachytherapy. Patients were divided into two arms: the intra-arterial chemotherapy arm (IA arm, n=17) consisted of patients treated with locoregional treatment (IA admission of Cisplatin and 5-fluorouracil, or chemoembolization with Lipiodol) and/or systemic chemotherapy, while the systemic chemotherapy arm (IV arm, n=23) included all the other patients, who were treated only with systemic chemotherapy. Results In total, 78 metal self-expandable stents were placed. Hilar involvement with mass-forming and periductal infiltrating types of CC (84%) was predominant. The average number of percutaneous interventional procedures was 11.61 per patient (range, 4-35). The median overall survival from diagnosis of disease for all patients was 13.5 months (range, 11.0-18.8 months). The median overall survival times were 25.2 months (range, 15.2-31.3 months) and 11.5 months (range, 8.5-12.6 months) in the IA and IV arms, respectively (p<0.05). The 1-, 2-, and 3-year survival rates in the IA and IV arms were 88.2%, 52.9%, and 10.1% and 43.5%, 25.4, and 0%, respectively. There were no major complications (WHO III/IV) due to interventional procedures. Conclusions We could reach acceptable prognosis in patients with unresectable CC using complex tailored oncological therapy. However, the main limitations of prolonging survival are performance status, patient compliance and the maintaining of biliary tract patency. PMID:21103300

  20. Documentation of chemotherapy infusion preparation costs in academic- and community-based oncology practices.

    PubMed

    Brixner, Diana I; Oderda, Gary M; Nickman, Nancy A; Beveridge, Roy; Jorgenson, James A

    2006-03-01

    Significant changes in Medicare reimbursement for outpatient oncology services were proposed as part of the Medicare Modernization Act of 2003. The purpose of this study was to identify the "true cost" associated with drug-related handling for the preparation and delivery of chemotherapy doses to estimate the impact of changing reimbursement schema by Medicare. Two academic medical outpatient infusion centers and 2 community cancer centers provided data used to estimate all costs (excluding drug cost) associated with the preparation of chemotherapy doses. The data included both fixed costs (drug storage, space, equipment, and information resources) and variable costs (insurance management, inventory, waste management, pharmacy staff payroll, supplies, and shipping). The average cost for the preparation of chemotherapy doses across all sites was dollar 34.27 (range, dollar 32.08-dollar 41.23). A time-and-motion study was also performed to determine what tasks were conducted by pharmacy staff and how much time was spent in the preparation of the top 15 chemotherapeutic drugs and regimens used in the 4 sites. Data from the 4 centers was projected to show that if 3,990,495 million chemotherapy infusions were administered to a national Medicare population in 2003, when multiplied by the average cost of preparation for infusions determined by the current study (dollar 34.27), the estimated total annual cost to Medicare for chemotherapy preparation by pharmacists is dollar 136,754,263.65. The pharmacists spent most of their days (90% or more) performing tasks directly related to the preparation of these agents. These data provide scientific support for the consideration of appropriate reimbursement for chemotherapy services provided by pharmacists to Medicare beneficiaries. PMID:16507268

  1. Regulatory and clinical considerations for biosimilar oncology drugs.

    PubMed

    Bennett, Charles L; Chen, Brian; Hermanson, Terhi; Wyatt, Michael D; Schulz, Richard M; Georgantopoulos, Peter; Kessler, Samuel; Raisch, Dennis W; Qureshi, Zaina P; Lu, Z Kevin; Love, Bryan L; Noxon, Virginia; Bobolts, Laura; Armitage, Melissa; Bian, John; Ray, Paul; Ablin, Richard J; Hrushesky, William J; Macdougall, Iain C; Sartor, Oliver; Armitage, James O

    2014-12-01

    Biological oncology products are integral to cancer treatment, but their high costs pose challenges to patients, families, providers, and insurers. The introduction of biosimilar agents-molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biological drugs-provide opportunities both to improve health-care access and outcomes, and to reduce costs. Several international regulatory pathways have been developed to expedite entry of biosimilars into global marketplaces. The first wave of oncology biosimilar use was in Europe and India in 2007. Oncology biosimilars are now widely marketed in several countries in Europe, and in Australia, Japan, China, Russia, India, and South Korea. Their use is emerging worldwide, with the notable exception of the USA, where several regulatory and cost barriers to biosimilar approval exist. In this Review, we discuss oncology biosimilars and summarise their regulatory frameworks, clinical experiences, and safety concerns. PMID:25456378

  2. Regulatory and clinical considerations for biosimilar oncology drugs

    PubMed Central

    Bennett, Charles L; Chen, Brian; Hermanson, Terhi; Wyatt, Michael D; Schulz, Richard M; Georgantopoulos, Peter; Kessler, Samuel; Raisch, Dennis W; Qureshi, Zaina P; Lu, Z Kevin; Love, Bryan L; Noxon, Virginia; Bobolts, Laura; Armitage, Melissa; Bian, John; Ray, Paul; Ablin, Richard J; Hrushesky, William J; Macdougall, Iain C; Sartor, Oliver; Armitage, James O

    2015-01-01

    Biological oncology products are integral to cancer treatment, but their high costs pose challenges to patients, families, providers, and insurers. The introduction of biosimilar agents—molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biological drugs—provide opportunities both to improve healthcare access and outcomes, and to reduce costs. Several international regulatory pathways have been developed to expedite entry of biosimilars into global marketplaces. The first wave of oncology biosimilar use was in Europe and India in 2007. Oncology biosimilars are now widely marketed in several countries in Europe, and in Australia, Japan, China, Russia, India, and South Korea. Their use is emerging worldwide, with the notable exception of the USA, where several regulatory and cost barriers to biosimilar approval exist. In this Review, we discuss oncology biosimilars and summarise their regulatory frameworks, clinical experiences, and safety concerns. PMID:25456378

  3. Evidence-based integrative medicine in clinical veterinary oncology.

    PubMed

    Raditic, Donna M; Bartges, Joseph W

    2014-09-01

    Integrative medicine is the combined use of complementary and alternative medicine with conventional or traditional Western medicine systems. The demand for integrative veterinary medicine is growing, but evidence-based research on its efficacy is limited. In veterinary clinical oncology, such research could be translated to human medicine, because veterinary patients with spontaneous tumors are valuable translational models for human cancers. An overview of specific herbs, botanics, dietary supplements, and acupuncture evaluated in dogs, in vitro canine cells, and other relevant species both in vivo and in vitro is presented for their potential use as integrative therapies in veterinary clinical oncology. PMID:25174902

  4. Methods of IR spectroscopy in monitoring of chemotherapy of oncological pathologies using palladium complexes

    NASA Astrophysics Data System (ADS)

    Tolstorozhev, G. B.; Bel'kov, M. V.; Skornyakov, I. V.; Pekhn'o, V. I.; Kozachkova, A. N.; Tsarik, N. V.; Kutsenko, I. P.; Sharykina, N. I.

    2014-11-01

    FTIR spectroscopy is used to study mammary-gland tissues of mice with a sarcoma tumor (strain 180). Spectral features that are typical of malignant tumors are revealed in the FTIR spectra in the sarcoma-tumor tissues. Tumor tissues are studied after treatment using coordination compounds based on palladium complexes with 3-amino-1-hydroxypropylidene-1,1-diphosphonic acid and zoledronic acid. A therapeutic effect is not revealed after treatment using palladium complex with 3-amino-1-hydroxypropylidene-1,1-diphosphonic acid. The suppression of tumor growth amounts to 59% when palladium complexes with zoledronic acid are used. Suppression of tumor growth is accompanied by variations in spectral characteristics. With respect to diagnostic features, the FTIR spectra of tumor tissues after treatment with the palladium complexes with zoledronic acid are similar to the FTIR spectra of tissues that are free of malignant tumors. Specific spectroscopic characteristics that make it possible to control the chemotherapy of oncological pathologies are determined.

  5. Best Practices for Chemotherapy Administration in Pediatric Oncology: Quality and Safety Process Improvements (2015).

    PubMed

    Looper, Karen; Winchester, Kari; Robinson, Deborah; Price, Andrea; Langley, Rachel; Martin, Gina; Jones, Sally; Holloway, Jodi; Rosenberg, Susanne; Flake, Susan

    2016-05-01

    The administration of chemotherapy to children with cancer is a high-risk process that must be performed in a safe and consistent manner with high reliability. Clinical trials play a major role in the treatment of children with cancer; conformance to chemotherapy protocol requirements and accurate documentation in the medical record are critical. Inconsistencies in the administration and documentation of chemotherapy were identified as opportunities for errors to occur. A major process improvement was initiated to establish best practices for nurses who administer chemotherapy to children. An interdisciplinary team was formed to evaluate the current process and to develop best practices based on current evidence, protocol requirements, available resources, and safety requirements. The process improvement focused on the establishment of standardized and safe administration techniques, exact administration times, and consistent electronic documentation that could easily be retrieved in medical record audits. Quality improvement tools including SBAR (Situation, Background, Assessment, Recommendation), process mapping, PDSA (Plan, Do. Study, Act) cycles, and quality metrics were used with this process improvement. The team established best practices in chemotherapy administration to children that have proven to be safe and reliable. Follow-up data have demonstrated that the project was highly successful and improved accuracy, patient and nurse safety, and effectiveness of chemotherapy administration. PMID:26668214

  6. Financial Quality Control of In-Patient Chemotherapy in Germany: Are Additional Payments Cost-Covering for Pharmaco-Oncological Expenses?

    PubMed Central

    Jacobs, Volker R.; Mallmann, Peter

    2011-01-01

    Summary Background Cost-covering in-patient care is increasingly important for hospital providers in Germany, especially with regard to expensive oncological pharmaceuticals. Additional payments (Zusatzentgelte; ZE) on top of flat rate diagnose-related group (DRG) reimbursement can be claimed by hospitals for in-patient use of selected medications. To verify cost coverage of in-patient chemotherapies, the costs of medication were compared to their revenues. Method From January to June 2010, a retrospective cost-revenue study was performed at a German obstetrics/gynecology university clinic. The hospital's pharmacy list of inpatient oncological therapies for breast and gynecological cancer was checked for accuracy and compared with the documented ZEs and the costs and revenues for each oncological application. Results N = 45 in-patient oncological therapies were identified in n = 18 patients, as well as n = 7 bisphosphonate applications; n = 11 ZEs were documented. Costs for oncological medication were € 33,752. The corresponding ZE revenues amounted to only € 13,980, resulting in a loss of € 19,772. All in-patient oncological therapies performed were not cost-covering. Data discrepancy, incorrect documentation and cost attribution, and process aborts were identified. Conclusions Routine financial quality control at the medicine-pharmacy administration interface is implemented, with monthly comparison of costs and revenues, as well as admission status. Non-cost-covering therapies for in-patients should be converted to out-patient therapies. Necessary adjustments of clinic processes are made according to these results, to avoid future losses. PMID:21673822

  7. [Chromolymphography in the oncological surgical clinic].

    PubMed

    Remizov, A L; Bokham, Ia V; Vasil'ev, B V; Stukov, A N; Tobilevich, V P

    1978-05-01

    A new Soviet preparation for colour lymphography--chromolymphotrast--is presented in this paper. Radiopaque lymphography with the use of chromolymphotrast was carried out upon more than 50 patients with carcinoma of the uterine cervix and of the body of the womb. Besides, there is information concerning a successful use of the chromolymphotrast in cases of cancer of the vulva, mammary gland and rectum. Colour lymphography with the use of chromolymphotrast contributes to a more complete removal of lymphatic collectors. After a preliminary lymphography surgical interventions have acquired a radical character in 93.6% of operations on lymphatic nodes, thus adding to a decrease of the incidence rate of regional recurrences. The national medical industry has proceeded to the production of the preparation, which builds up the conditions for a broad use of colour radiopaque lymphography in oncology. PMID:664167

  8. [Introduction of Chemotherapy for Advanced Gastric Cancer Showing Oncologic Emergency Caused by Peritoneal Dissemination--Report of Tow Cases].

    PubMed

    Fujiwara, Yoshiyuki; Omori, Takeshi; Sugimura, Keijiro; Miyata, Hiroshi; Miyoshi, Norikatsu; Akita, Hirofumi; Gotoh, Kunihito; Takahashi, Hidenori; Kobayashi, Shogo; Noura, Shingo; Ohue, Masayuki; Sakon, Masato; Yano, Masahiko

    2015-11-01

    Here, we report 2 patients with gastric cancer and peritoneal dissemination who were successfully treated with chemotherapy after undergoing treatment for an oncologic emergency caused by peritoneal dissemination. Case 1 involved obstruction of the sigmoid colon caused by peritoneal dissemination. After urgent colostomy, S-1/IP IV paclitaxel chemotherapy was introduced. The patient continued the therapy for 2 years and 2 months. Case 2 involved acute renal failure due to bilateral ureter obstruction and obstructive jaundice caused by peritoneal dissemination. This patient underwent emergency treatment consisting of Double-J ureteral stent insertion and endoscopic nasobiliary drainage. He was successfully started on chemotherapy with S-1/oxaliplatin/IP paclitaxel. He continued the therapy for 8 months without symptoms. Aggressive treatment might be effective for advanced gastric cancer showing oncologic emergency. PMID:26805263

  9. Clinical application of PET/MRI in oncology.

    PubMed

    Sotoudeh, Houman; Sharma, Akash; Fowler, Kathryn J; McConathy, Jonathan; Dehdashti, Farrokh

    2016-08-01

    Hybrid imaging with integrated positron emission tomography (PET) and magnetic resonance imaging (MRI) combines the advantages of the high-resolution anatomic data from MRI and functional imaging data from PET, and has the potential to improve the diagnostic evaluation of various types of cancers. The clinical oncologic applications of this newest hybrid imaging technology are evolving and substantial efforts are underway to define the role of PET/MRI in routine clinical use. The current published literature suggests that PET/MRI may play an important role in the evaluation of patients with certain types of malignancies, involving anatomic locations such as the pelvis and the liver. The purpose of this article is to review the current published PET/MRI literature in specific body oncologic applications. In addition, PET/MRI protocols and some of the technical issues of this hybrid imaging will be briefly discussed. J. Magn. Reson. Imaging 2016;44:265-276. PMID:27007987

  10. Future vision for the quality assurance of oncology clinical trials.

    PubMed

    Fitzgerald, Thomas J; Bishop-Jodoin, Maryann; Bosch, Walter R; Curran, Walter J; Followill, David S; Galvin, James M; Hanusik, Richard; King, Steven R; Knopp, Michael V; Laurie, Fran; O'Meara, Elizabeth; Michalski, Jeff M; Saltz, Joel H; Schnall, Mitchell D; Schwartz, Lawrence; Ulin, Kenneth; Xiao, Ying; Urie, Marcia

    2013-01-01

    The National Cancer Institute clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based process improvements for clinical oncology patient care. The cooperative groups are undergoing a transformation process as we further integrate molecular biology into personalized patient care and move to incorporate international partners in clinical trials. To support this vision, data acquisition and data management informatics tools must become both nimble and robust to support transformational research at an enterprise level. Information, including imaging, pathology, molecular biology, radiation oncology, surgery, systemic therapy, and patient outcome data needs to be integrated into the clinical trial charter using adaptive clinical trial mechanisms for design of the trial. This information needs to be made available to investigators using digital processes for real-time data analysis. Future clinical trials will need to be designed and completed in a timely manner facilitated by nimble informatics processes for data management. This paper discusses both past experience and future vision for clinical trials as we move to develop data management and quality assurance processes to meet the needs of the modern trial. PMID:23508883

  11. Acuity-based nurse assignment and patient scheduling in oncology clinics.

    PubMed

    Liang, Bohui; Turkcan, Ayten

    2016-09-01

    The oncology clinics use different nursing care delivery models to provide chemotherapy treatment to cancer patients. Functional and primary care delivery models are the most commonly used methods in the clinics. In functional care delivery model, patients are scheduled for a chemotherapy appointment without considering availabilities of individual nurses, and nurses are assigned to patients according to patient acuities, nursing skill, and patient mix on a given day after the appointment schedule is determined. Patients might be treated by different nurses on different days of their treatment. In primary care delivery model, each patient is assigned to a primary nurse, and the patients are scheduled to be seen by the same nurse every time they come to the clinic for treatment. However, these clinics might experience high variability in daily nurse workload due to treatment protocols that should be followed strictly. In that case, part-time nurses can be utilized to share the excess workload of the primary nurses. The aim of this study is to develop optimization methods to reduce the time spent for nurse assignment and patient scheduling in oncology clinics that use different nursing care delivery models. For the functional delivery model, a multiobjective optimization model with the objectives of minimizing patient waiting times and nurse overtime is proposed to solve the nurse assignment problem. For the primary care delivery model, another multiobjective optimization model with the objectives of minimizing total overtime and total excess workload is proposed to solve the patient scheduling problem. Spreadsheet-based optimization tools are developed for easy implementation. Computational results show that the proposed models provide multiple nondominated solutions, which can be used to determine the optimal staffing levels. PMID:25595434

  12. Prevalence of emotional symptoms in Chilean oncology patients before the start of chemotherapy: potential of the distress thermometer as an ultra-brief screening instrument

    PubMed Central

    Calderón, Jorge; Campla, Cristóbal; D’Aguzan, Nicole; Barraza, Soledad; Padilla, Oslando; Sánchez, Cesar; Palma, Silvia; González, Matías

    2014-01-01

    Emotional distress (ED) is greater for oncology patients in comparison with the general population, and this has implications for the quality of life of the patient and his/her family, adherence to the treatment, and eventually, survivorship. In general, the detection of these symptoms is low, which explains the need for detection systems appropriate to the clinical reality of the oncology team. The objective of this study is to evaluate for the first time the usefulness of an ultra-brief screening instrument [distress thermometer (DT)], in a group of Chilean oncology patients. A total of 166 outpatients were evaluated at the Cancer Center of the Pontificia Universidad Católica de Chile, before starting chemotherapy. Two screening instruments were applied: Hospital Anxiety and Depression Scale (HADS) and DT. The application of HADS resulted in a prevalence of 32.7% of anxiety symptoms (HADS-A ≥ 8), 15.7% of depression symptoms (HADS-D ≥ 8), and 39.8% had a total score of HADS-T ≥ 11. The DT resulted in the prevalence of 32.5% of distress or ED (DT ≥ 5). The validity of the DT was evaluated as a screening tool in comparison with HADS, observing, in relation to the anxiety scale (HADS-A), a sensitivity of 88.9% and specificity of 78.4% (DT ≥ 4); depression (HADS-D), a sensitivity of 69.2% and specificity of 74.3% (DT ≥ 5); and in relation to the total scale (HADS-T), a sensitivity of 68.2% and specificity of 73.0% (DT ≥ 4). This study demonstrates the elevated prevalence of emotional symptoms in Chilean oncology patients, before the start of chemotherapy, and confirms the potential of the DT as a brief screening instrument with easy application. The DT will allow the clinician to increase the detection threshold in the Chilean oncology population, intervene in a timely manner, and contribute to the comprehensive handling of the oncology patient without affecting the time needed for assistance. PMID:24966889

  13. Integrating pain metrics into oncology clinical trials.

    PubMed

    Cleeland, Charles S; O'Mara, Ann; Zagari, Martin; Baas, Carole

    2011-11-01

    Cancer-related pain is highly prevalent and often severe, and as a result is often one of the defining experiences for patients with malignancy. Patients and patients' families almost always live with the ever-present reality that cancer treatment and progression may be accompanied by pain. For patients nearing the end of life, most fear that their final days will be spent living with the terrible effects of the disease, the most important of which is pain. Despite this, there is far less systematic research on the mechanisms of cancer-related pain or on the development of new agents to reduce or eliminate pain in cancer patients compared with research to combat the disease itself. Further, even when the focus of research is treatment of the tumor, the effects of anticancer treatments on pain are often underreported in publications and other forums. To illustrate the relative drought in the cancer pain control area, there have been no new drugs approved for cancer-related pain in recent years. A number of methodologic and logistical challenges that hinder the ability to assess pain response in clinical trials are discussed in this article. Possible ways to address these challenges are also discussed. PMID:22046026

  14. The circadian timing system in clinical oncology.

    PubMed

    Innominato, Pasquale F; Roche, Véronique P; Palesh, Oxana G; Ulusakarya, Ayhan; Spiegel, David; Lévi, Francis A

    2014-06-01

    The circadian timing system (CTS) controls several critical molecular pathways for cancer processes and treatment effects over the 24 hours, including drug metabolism, cell cycle, apoptosis, and DNA damage repair mechanisms. This results in the circadian time dependency of whole-body and cellular pharmacokinetics and pharmacodynamics of anticancer agents. However, CTS robustness and phase varies among cancer patients, based on circadian monitoring of rest- activity, body temperature, sleep, and/or hormonal secretion rhythms. Circadian disruption has been further found in up to 50% of patients with metastatic cancer. Such disruption was associated with poor outcomes, including fatigue, anorexia, sleep disorders, and short progression-free and overall survival. Novel, minimally invasive devices have enabled continuous CTS assessment in non-hospitalized cancer patients. They revealed up to 12-hour differences in individual circadian phase. Taken together, the data support the personalization of chronotherapy. This treatment method aims at the adjustment of cancer treatment delivery according to circadian rhythms, using programmable-in-time pumps or novel release formulations, in order to increase both efficacy and tolerability. A fixed oxaliplatin, 5-fluorouracil and leucovorin chronotherapy protocol prolonged median overall survival in men with metastatic colorectal cancer by 3.3 months as compared to conventional delivery, according to a meta-analysis (P=0.009). Further analyses revealed the need for the prevention of circadian disruption or the restoration of robust circadian function in patients on chronotherapy, in order to further optimize treatment effects. The strengthening of external synchronizers could meet such a goal, through programmed exercise, meal timing, light exposure, improved social support, sleep scheduling, and the properly timed administration of drugs that target circadian clocks. Chrono-rehabilitation warrants clinical testing for improving

  15. Clinical exercise interventions in pediatric oncology: a systematic review.

    PubMed

    Baumann, Freerk T; Bloch, Wilhelm; Beulertz, Julia

    2013-10-01

    Studies in pediatric oncology have shown a positive effect of physical activity on disease- and treatment-related side effects. Although several reviews have approved the benefits of therapeutic exercise for adult cancer patients, no systematic review exists summarizing the evidence of physical activity in pediatric oncology. We identified a total of 17 studies using the PubMed database and Cochrane library. To evaluate the evidence, we used the evaluation system of the Oxford Center for Evidence-Based Medicine 2001. The findings confirm that clinical exercise interventions are feasible and safe, especially with acute lymphoblastic leukemia (ALL) patients and during medical treatment. No adverse effects have been reported. Positive effects were found on fatigue, strength, and quality of life. Single studies present positive effects on the immune system, body composition, sleep, activity levels, and various aspects of physical functioning. Child-specific aspects such as cognitive abilities, growth, adolescence, and reintegration into peer-groups, school, and sports have barely been taken into consideration. The evidence for exercise interventions in pediatric oncology is rated level "3." Although the results are very promising, future research of high methodological quality and focusing on child-specific aspects is needed to establish evidence-based exercise recommendations, particularly for childhood cancer patients. PMID:23857296

  16. Organization of primary care pathway in head and neck oncology (short version): Organization of chemotherapy in head and neck oncology.

    PubMed

    Pavillet, J; Guigay, J; Lacau Saint-Guily, J; Righini, C-A

    2015-09-01

    Chemotherapy may be indicated in head and neck cancer: as induction, associated with radiation therapy, or as a palliative solution, in case of local or locoregional progression if surgery and radiation therapy are contraindicated, and/or in case of metastatic progression. The most frequently used anticancer agents are platins, antimetabolites (5-fluorouracil, methotrexate) and taxanes. For several years now, in some indications, chemotherapy may be associated with targeted anti-EGFR antibody therapy. Prescription of chemotherapy and follow-up in head and neck cancer requires particular attention due to comorbidities related to alcohol abuse and smoking and frequent denutrition. Management thus requires close cooperation between the ENT physician, medical oncologists and radiation oncologists. PMID:26183547

  17. The grading of lymphedema in oncology clinical trials.

    PubMed

    Cheville, Andrea L; McGarvey, Charles L; Petrek, Jeanne A; Russo, Sandra A; Thiadens, Saskia R J; Taylor, Marie E

    2003-07-01

    Lymphedema is a common late toxicity of cancer therapy. This article describes the rationale and process utilized by the Lymphedema Working Group for the revision and expansion of the Common Toxicity Criteria version 2 (CTC v2.0) lymphedema criteria to produce the CTC v3.0 lymphedema criteria. Established clinician-based rating scales and quantitative instruments are reviewed in this article. None of the extant rating scales have been formally validated, nor has their reliability been assessed. Drawbacks of current scales were considered in formulating CTC v3.0 criteria. Most rely exclusively on volume to diagnose and grade lymphedema. This imposes significant clinical limitations, particularly in the assessment of toxicity in oncology clinical trials. Volume-based rating scales are of little value in rating the severity of bilateral limb and nonlimb edema. Problems with nonvolumetric staging systems (eg, CTC v2.0) include insufficient detail to permit useful discrimination of severity among the majority of lymphedema patients. Technologies for objectively quantifying lymphedema have been developed and validated. Although these are briefly reviewed, it is recognized that cost and access issues limit their widespread clinical utility and, as such, were not considered in developing the CTC v3.0 criteria. The CTC v3.0 lymphedema criteria adopted several innovations. Principle among these was the decision to generate separate criteria for volumetric increase, dermal changes, and subcutaneous fibrosis. We anticipate the use of the new CTC v3.0 lymphedema criteria to begin in mid-2003 for grading the key clinical features of this disorder in oncology clinical trials. The purpose of this article is to familiarize the reader with (1) background on the clinical features of lymphedema, (2) information on established lymphedema rating systems, (3) the consensus process and rationale of the Lymphedema Working Group, (4) the new CTC v3.0, and (5) quantitative techniques for

  18. Highlights from the 1st Latin American meeting on metronomic chemotherapy and drug repositioning in oncology, 27–28 May, 2016, Rosario, Argentina

    PubMed Central

    Rosé, Adriana; André, Nicolas; Rozados, Viviana R.; Mainetti, Leandro E; Márquez, Mauricio Menacho; Rico, María José; Schaiquevich, Paula; Villarroel, Milena; Gregianin, Lauro; Graupera, Jaume Mora; García, Wendy Gómez; Epelman, Sidnei; Alasino, Carlos; Alonso, Daniel; Chantada, Guillermo; Scharovsky, O Graciela

    2016-01-01

    Following previous metronomic meetings in Marseille (2011), Milano (2014), and Mumbai (2016), the first Latin American metronomic meeting was held in the School of Medical Sciences, National University of Rosario, Rosario, Argentina on 27 and 28 of May, 2016. For the first time, clinicians and researchers with experience in the field of metronomics, coming from different countries in Latin America, had the opportunity of presenting and discussing their work. The talks were organised in three main sessions related to experience in the pre-clinical, and clinical (paediatric and adult) areas. The different presentations demonstrated that the fields of metronomic chemotherapy and repurposing drugs in oncology, known as metronomics, constitute a branch of cancer therapy in permanent evolution, which have strong groups working in Latin America, both in the preclinical and the clinical settings including large, adequately designed randomised studies. It was shown that metronomics offers treatments, which, whether they are combined or not with the standard therapeutic approaches, are not only effective but also minimally toxic, with the consequent improvement of the patient’s quality of life, and inexpensive, a feature very important in low resource clinical settings. The potential use of metronomic chemotherapy was proposed as a cost/effective treatment in low-/middle-income countries, for adjuvant therapy in selected tumours. The fundamental role of the governmental agencies and non-governmental alliances, as the Metronomic Global Health Initiative, in supporting this research with public interest was underlined. PMID:27610198

  19. Highlights from the 1st Latin American meeting on metronomic chemotherapy and drug repositioning in oncology, 27-28 May, 2016, Rosario, Argentina.

    PubMed

    Rosé, Adriana; André, Nicolas; Rozados, Viviana R; Mainetti, Leandro E; Márquez, Mauricio Menacho; Rico, María José; Schaiquevich, Paula; Villarroel, Milena; Gregianin, Lauro; Graupera, Jaume Mora; García, Wendy Gómez; Epelman, Sidnei; Alasino, Carlos; Alonso, Daniel; Chantada, Guillermo; Scharovsky, O Graciela

    2016-01-01

    Following previous metronomic meetings in Marseille (2011), Milano (2014), and Mumbai (2016), the first Latin American metronomic meeting was held in the School of Medical Sciences, National University of Rosario, Rosario, Argentina on 27 and 28 of May, 2016. For the first time, clinicians and researchers with experience in the field of metronomics, coming from different countries in Latin America, had the opportunity of presenting and discussing their work. The talks were organised in three main sessions related to experience in the pre-clinical, and clinical (paediatric and adult) areas. The different presentations demonstrated that the fields of metronomic chemotherapy and repurposing drugs in oncology, known as metronomics, constitute a branch of cancer therapy in permanent evolution, which have strong groups working in Latin America, both in the preclinical and the clinical settings including large, adequately designed randomised studies. It was shown that metronomics offers treatments, which, whether they are combined or not with the standard therapeutic approaches, are not only effective but also minimally toxic, with the consequent improvement of the patient's quality of life, and inexpensive, a feature very important in low resource clinical settings. The potential use of metronomic chemotherapy was proposed as a cost/effective treatment in low-/middle-income countries, for adjuvant therapy in selected tumours. The fundamental role of the governmental agencies and non-governmental alliances, as the Metronomic Global Health Initiative, in supporting this research with public interest was underlined. PMID:27610198

  20. Clinical Applications of Metabolomics in Oncology: A Review

    PubMed Central

    Spratlin, Jennifer L.; Serkova, Natalie J.; Gail Eckhardt, S.

    2009-01-01

    Metabolomics, an omic science in systems biology, is the global quantitative assessment of endogenous metabolites within a biological system. Either individually or grouped as a metabolomic profile, detection of metabolites is carried out in cells, tissues, or biofluids by either nuclear magnetic resonance spectroscopy or mass spectrometry. There is potential for the metabolome to have a multitude of uses in oncology, including the early detection and diagnosis of cancer and as both a predictive and pharmacodynamic marker of drug effect. Despite this, there is lack of knowledge in the oncology community regarding metabolomics and confusion about its methodologic processes, technical challenges, and clinical applications. Metabolomics, when used as a translational research tool, can provide a link between the laboratory and clinic, particularly because metabolic and molecular imaging technologies, such as positron emission tomography and magnetic resonance spectroscopic imaging, enable the discrimination of metabolic markers noninvasively in vivo. Here, we review the current and potential applications of metabolomics, focusing on its use as a biomarker for cancer diagnosis, prognosis, and therapeutic evaluation. PMID:19147747

  1. Next-Generation Sequencing in Clinical Oncology: Next Steps Towards Clinical Validation

    PubMed Central

    Bennett, Nigel C.; Farah, Camile S.

    2014-01-01

    Compelling evidence supports the transition of next generation sequencing (NGS) technology from a research environment into clinical practice. Before NGS technologies are fully adopted in the clinic, they should be thoroughly scrutinised for their potential as powerful diagnostic and prognostic tools. The importance placed on generating accurate NGS data, and consequently appropriate clinical interpretation, has stimulated much international discussion regarding the creation and implementation of strict guidelines and regulations for NGS clinical use. In the context of clinical oncology, NGS technologies are currently transitioning from a clinical research background into a setting where they will contribute significantly to individual patient cancer management. This paper explores the steps that have been taken, and those still required, for the transition of NGS into the clinical area, with particular emphasis placed on validation in the setting of clinical oncology. PMID:25412366

  2. Radiation Therapy Oncology Group clinical trials for carcinoma of the cervix.

    PubMed

    Grigsby, P. W.

    1999-11-01

    Grigsby PW. Radiation Therapy Oncology Group clinical trials for carcinoma of the cervix. The purpose of this paper is to review the primary data of the clinical trials performed by the Radiation Therapy Oncology Group (RTOG) for patients with carcinoma of the uterine cervix. The trials, their strengths, limitations, and the implications of the results are discussed. During the past 25 years there have been several clinical trials performed by the RTOG to test various hypotheses for improving local control and survival for patients with carcinoma of the uterine cervix. The major research themes that have been appraised are the use of hyperbaric oxygen, altered fractionation radiotherapy, hypoxic cell sensitization, chemo-sensitization, prophylactic paraaortic irradiation, and neutron radiotherapy. There are two general research themes. The initial RTOG trials for cervical cancer attempted to address the issues of tumor volume and hypoxic cells while the latter studies addressed these issues and the issue of micrometastatic disease. The phase III clinical trials performed by the RTOG have not demonstrated a local control or survival advantage in the experimental arm with the use of hyperbaric oxygen, split-course radiotherapy, hypoxic cell sensitization, or neutron radiotherapy. Acceptable toxicity and efficacy results were shown in phase II studies evaluating twice-daily irradiation and chemo-sensitization. The positive phase III trials were RTOG 79-20 which evaluated prophylactic paraaortic irradiation in patients with bulky stages IB, IIA, and IIB disease, and RTOG 90-01 which evaluated concurrent chemotherapy. Results of more recent clinical trials are pending their completion. PMID:11240808

  3. Radiation Therapy Oncology Group clinical trials with misonidazole

    SciTech Connect

    Wasserman, T.H.; Stetz, J.; Phillips, T.L.

    1981-05-15

    This paper presents a review of the progressive clinical trials of the hypoxic cell radiosensitizer, misonidazole, in the Radiation Therapy Oncology Group (RTOG). Presentation is made of all the schemas of the recently completed and currently active RTOG Phase II and Phase III studies. Detailed information is provided on the clinical toxicity of the Phase II trials, specifically regarding neurotoxicity. With limitations in drug total dose, a variety of dose schedules have proven to be tolerable, with a moderate incidence of nausea and vomiting and mild peripheral neuropathy or central neuropathy. No other organ toxicity has been seen, specifically no liver, renal or bone marrow toxicities. An additional Phase III malignant glioma trial in the Brain Tumor Study Group is described.

  4. Radio-chemotherapy in anal cancer: Institutional experience at a large radiation oncology center in Chile

    PubMed Central

    Russo, Moisés; Ovalle, Valentina

    2014-01-01

    Aim In this article the aim is to provide a concise narrative review and inform the institutional experience at a referral center in Chile with the use of radio-chemotherapy in anal cancer. Background Cancer of the anus and anal canal is mainly a loco-regional disease. For years the standard of care has been concomitant radio-chemotherapy, which permits organ preservation and better local control than alternative surgical procedures. Materials and methods A retrospective analysis of 44 patients treated between 2002 and 2010 was performed. Local recurrence, distant recurrence and overall survival were analyzed with the Kaplan–Meier method. Relevant groups where compared with the log-rank test and univariate analysis were done with the Cox proportional hazards model. Results Median follow-up of the cohort was 56 months, with a minimum follow-up of at least 24 months. There was a significant difference between clinical stages in disease free survival (log-rank trend p < 0.001), and a significant difference in overall survival (OS) when comparing clinical stages that were grouped in stage I–IIIa and IIIB (log-rank p = 0.001). On univariate analysis, age older than 60, having received full treatment and dose above 45 Gy were all significantly related to OS (p < 0.05). An overall survival of 45% and disease free survival of 45% at 5 years were found in our series. Conclusions Our findings show that results at the Instituto de Radiomedicina in Chile are comparable to published literature. Dismal results in stage IIIb cases indicate much work remains in therapies to achieve loco-regional control in locally advanced cases. PMID:25061522

  5. Towards a Science of Tumor Forecast for Clinical Oncology

    DOE PAGESBeta

    Yankeelov, Tom; Quaranta, Vito; Evans, Katherine J; Rericha, Erin

    2015-01-01

    We propose that the quantitative cancer biology community make a concerted effort to apply the methods of weather forecasting to develop an analogous theory for predicting tumor growth and treatment response. Currently, the time course of response is not predicted, but rather assessed post hoc by physical exam or imaging methods. This fundamental limitation of clinical oncology makes it extraordinarily difficult to select an optimal treatment regimen for a particular tumor of an individual patient, as well as to determine in real time whether the choice was in fact appropriate. This is especially frustrating at a time when a panoplymore » of molecularly targeted therapies is available, and precision genetic or proteomic analyses of tumors are an established reality. By learning from the methods of weather and climate modeling, we submit that the forecasting power of biophysical and biomathematical modeling can be harnessed to hasten the arrival of a field of predictive oncology. With a successful theory of tumor forecasting, it should be possible to integrate large tumor specific datasets of varied types, and effectively defeat cancer one patient at a time.« less

  6. Toward a science of tumor forecasting for clinical oncology

    SciTech Connect

    Yankeelov, Thomas E.; Quaranta, Vito; Evans, Katherine J.; Rericha, Erin C.

    2015-03-15

    We propose that the quantitative cancer biology community makes a concerted effort to apply lessons from weather forecasting to develop an analogous methodology for predicting and evaluating tumor growth and treatment response. Currently, the time course of tumor response is not predicted; instead, response is only assessed post hoc by physical examination or imaging methods. This fundamental practice within clinical oncology limits optimization of a treatment regimen for an individual patient, as well as to determine in real time whether the choice was in fact appropriate. This is especially frustrating at a time when a panoply of molecularly targeted therapies is available, and precision genetic or proteomic analyses of tumors are an established reality. By learning from the methods of weather and climate modeling, we submit that the forecasting power of biophysical and biomathematical modeling can be harnessed to hasten the arrival of a field of predictive oncology. Furthermore, with a successful methodology toward tumor forecasting, it should be possible to integrate large tumor-specific datasets of varied types and effectively defeat one cancer patient at a time.

  7. Toward a science of tumor forecasting for clinical oncology

    DOE PAGESBeta

    Yankeelov, Thomas E.; Quaranta, Vito; Evans, Katherine J.; Rericha, Erin C.

    2015-03-15

    We propose that the quantitative cancer biology community makes a concerted effort to apply lessons from weather forecasting to develop an analogous methodology for predicting and evaluating tumor growth and treatment response. Currently, the time course of tumor response is not predicted; instead, response is only assessed post hoc by physical examination or imaging methods. This fundamental practice within clinical oncology limits optimization of a treatment regimen for an individual patient, as well as to determine in real time whether the choice was in fact appropriate. This is especially frustrating at a time when a panoply of molecularly targeted therapiesmore » is available, and precision genetic or proteomic analyses of tumors are an established reality. By learning from the methods of weather and climate modeling, we submit that the forecasting power of biophysical and biomathematical modeling can be harnessed to hasten the arrival of a field of predictive oncology. Furthermore, with a successful methodology toward tumor forecasting, it should be possible to integrate large tumor-specific datasets of varied types and effectively defeat one cancer patient at a time.« less

  8. The roots of modern oncology: from discovery of new antitumor anthracyclines to their clinical use.

    PubMed

    Cassinelli, Giuseppe

    2016-06-01

    In May 1960, the Farmitalia CEO Dr. Bertini and the director of the Istituto Nazionale dei Tumori of Milan Prof. Bucalossi (talent scout and city's Mayor) signed a research agreement for the discovery and development up to clinical trials of new natural antitumor agents. This agreement can be considered as a pioneering and fruitful example of a translational discovery program with relevant transatlantic connections. Owing to an eclectic Streptomyces, found near Castel del Monte (Apulia), and to the skilled and motivated participants of both institutions, a new natural antitumor drug, daunomycin, was ready for clinical trials within 3 years. Patent interference by the Farmitalia French partner was overcome by the good quality of the Italian drug and by the cooperation between Prof. Di Marco, director of the Istituto Ricerche Farmitalia Research Laboratories for Microbiology and Chemotherapy, and Prof. Karnofsky, head of the Sloan-Kettering Cancer Institute of New York, leading to the first transatlantic clinical trials. The search for daunomycin's sister anthracyclines led to the discovery and development of adriamycin, one of the best drugs born in Milan. This was the second act prologue of the history of Italian antitumor discovery and clinical oncology, which started in July 1969 when Prof. Di Marco sent Prof. Bonadonna the first vials of adriamycin (doxorubicin) to be tested in clinical trials. This article reviews the Milan scene in the 1960s, a city admired and noted for the outstanding scientific achievements of its private and public institutions in drugs and industrial product discovery. PMID:27103205

  9. Chemotherapy

    MedlinePlus

    ... saved articles window. My Saved Articles » My ACS » Chemotherapy Chemotherapy (chemo) usually refers to the use of ... better sense of control over your cancer treatment. Chemotherapy Basics How Is Chemotherapy Used to Treat Cancer? ...

  10. Contract research organizations in oncology clinical research: Challenges and opportunities.

    PubMed

    Roberts, Daniel A; Kantarjian, Hagop M; Steensma, David P

    2016-05-15

    Contract research organizations (CROs) represent a multibillion dollar industry that is firmly embedded in the contemporary clinical trial process. Over the past 30 years, and especially within the last decade, the reach of CROs has extended to service all phases of drug trials in an increasingly global research environment. The presence of CROs is particularly noticeable in medical oncology because of the large number of investigational compounds developed to treat cancer that are currently undergoing testing in human subjects. Although limited data are available with which to objectively define the effects that CROs have had on the clinical trial process, with the expansion of these organizations, several reports have called into question whether ethical and professional standards in research conduct are at times secondary to economic considerations. CROs can add considerable value to the clinical trial process, but difficulty communicating with CRO representatives and time spent answering trivial data queries generated by CROs are current obstacles for study site personnel interacting with CROs. Further study of the effect of the CRO industry on the clinical trial process is needed to ensure efficient data collection and patient safety while collaboratively developing novel therapies in an expedited fashion. Cancer 2016;122:1476-82. © 2016 American Cancer Society. PMID:27018651

  11. Addressing Low Literacy and Health Literacy in Clinical Oncology Practice

    PubMed Central

    Garcia, Sofia F.; Hahn, Elizabeth A.; Jacobs, Elizabeth A.

    2011-01-01

    Low functional literacy and low health literacy continue to be under-recognized and are associated with poorer patient health outcomes. Health literacy is a dynamic state influenced by how well a healthcare system delivers information and services that match patients’ abilities, needs and preferences. Oncology care poses considerable health literacy demands on patients who are expected to process high stakes information about complex multidisciplinary treatment over lengths of time. Much of the information provided to patients in clinical care and research is beyond their literacy levels. In this paper, we provide an overview of currently available guidelines and resources to improve how the needs of patients with diverse literacy skills are met by cancer care providers and clinics. We present recommendations for health literacy assessment in clinical practice and ways to enhance the usability of health information and services by improving written materials and verbal communication, incorporating multimedia and culturally appropriate approaches, and promoting health literacy in cancer care settings. The paper also includes a list of additional resources that can be used to develop and implement health literacy initiatives in cancer care clinics. PMID:20464884

  12. Effects of Age Expectations on Oncology Social Workers' Clinical Judgment

    ERIC Educational Resources Information Center

    Conlon, Annemarie; Choi, Namkee G.

    2014-01-01

    Objective: This study examined the influence of oncology social workers' expectations regarding aging (ERA) and ERA with cancer (ERAC) on their clinical judgment. Methods: Oncology social workers (N = 322) were randomly assigned to one of four vignettes describing a patient with lung cancer. The vignettes were identical except for the…

  13. A national radiation oncology medical student clerkship survey: Didactic curricular components increase confidence in clinical competency

    PubMed Central

    Jagadeesan, Vikrant S.; Raleigh, David R.; Koshy, Matthew; Howard, Andrew R.; Chmura, Steven J.; Golden, Daniel W.

    2014-01-01

    Purpose/Objectives Students applying to radiation oncology residency programs complete one or more radiation oncology clerkships. This study assesses student experiences and perspectives during radiation oncology clerkships. The impact of didactic components and number of clerkship experiences in relation to confidence in clinical competency and preparation to function as a first year radiation oncology resident are evaluated. Methods and Materials An anonymous, internet-based survey was sent via direct e-mail to all applicants to a single radiation oncology residency program during the 2012–2013 academic year. The survey was composed of three main sections including questions regarding baseline demographic information and prior radiation oncology experience, rotation experiences, and ideal clerkship curriculum content. Results The survey response rate was 37% (70/188). Respondents reported 191 unique clerkship experiences. 27% of respondents (19/70) completed at least one clerkship with a didactic component geared towards their level of training. Completing a clerkship with a didactic component was significantly associated with a respondent’s confidence to function as a first- year radiation oncology resident (Wilcoxon rank-sum p = 0.03). However, the total number of clerkships completed did not correlate with confidence to pursue radiation oncology as a specialty (Spearman’s rho p = 0.48) or confidence to function as a first year resident (Spearman’s rho p = 0.43). Conclusions Based on responses to this survey, rotating students perceive that the majority of radiation oncology clerkships do not have formal didactic curricula. Survey respondents who completed a clerkship with a didactic curriculum reported feeling more prepared to function as a radiation oncology resident. However, completing an increasing number of clerkships does not appear to improve confidence in the decision to pursue radiation oncology as a career or to function as a radiation

  14. A National Radiation Oncology Medical Student Clerkship Survey: Didactic Curricular Components Increase Confidence in Clinical Competency

    SciTech Connect

    Jagadeesan, Vikrant S.; Raleigh, David R.; Koshy, Matthew; Howard, Andrew R.; Chmura, Steven J.; Golden, Daniel W.

    2014-01-01

    Purpose: Students applying to radiation oncology residency programs complete 1 or more radiation oncology clerkships. This study assesses student experiences and perspectives during radiation oncology clerkships. The impact of didactic components and number of clerkship experiences in relation to confidence in clinical competency and preparation to function as a first-year radiation oncology resident are evaluated. Methods and Materials: An anonymous, Internet-based survey was sent via direct e-mail to all applicants to a single radiation oncology residency program during the 2012-2013 academic year. The survey was composed of 3 main sections including questions regarding baseline demographic information and prior radiation oncology experience, rotation experiences, and ideal clerkship curriculum content. Results: The survey response rate was 37% (70 of 188). Respondents reported 191 unique clerkship experiences. Of the respondents, 27% (19 of 70) completed at least 1 clerkship with a didactic component geared towards their level of training. Completing a clerkship with a didactic component was significantly associated with a respondent's confidence to function as a first-year radiation oncology resident (Wilcoxon rank–sum P=.03). However, the total number of clerkships completed did not correlate with confidence to pursue radiation oncology as a specialty (Spearman ρ P=.48) or confidence to function as a first year resident (Spearman ρ P=.43). Conclusions: Based on responses to this survey, rotating students perceive that the majority of radiation oncology clerkships do not have formal didactic curricula. Survey respondents who completed a clerkship with a didactic curriculum reported feeling more prepared to function as a radiation oncology resident. However, completing an increasing number of clerkships does not appear to improve confidence in the decision to pursue radiation oncology as a career or to function as a radiation oncology resident. These results

  15. Nab-paclitaxel plus gemcitabine as first-line palliative chemotherapy in a patient with metastatic pancreatic cancer with Eastern Cooperative Oncology Group performance status of 2

    PubMed Central

    MARTÍN, ANDRÉS J. MUÑOZ; ALFONSO, PILAR GARCÍA; RUPÉREZ, ANA B.; JIMÉNEZ, MIGUEL MARTÍN

    2016-01-01

    Metastatic pancreatic cancer (PC) has been associated with a considerably poor prognosis. Due to its toxicity, first-line combination chemotherapy is limited to patients with a good performance status (PS). Previously nab-paclitaxel plus gemcitabine has been demonstrated to improve the overall survival rate in patients with advanced pancreatic cancer with a good PS. The present study reports a case of a patient with metastatic PC with a poor PS (Eastern Cooperative Oncology Group 2) and a complex set of comorbidities treated with nab-paclitaxel plus gemcitabine as a first-line palliative therapy. Adjusted doses of nab-paclitaxel plus gemcitabine reached a favourable clinical, radiological and biochemical response in the present patient, which increased the quality of life for the patient. Eventually, the patient succumbed to acute cholangitis. Based on the results of the present study, nab-paclitaxel plus gemcitabine appears to be a favourable treatment as first-line palliative chemotherapy for patients with metastatic PC, comorbidities and poor PS. PMID:27347207

  16. Cancer-related fatigue. Clinical practice guidelines in oncology.

    PubMed

    2003-07-01

    These guidelines propose a treatment algorithm in which patients are evaluated regularly for fatigue using a brief screening instrument, and are treated as indicated by their fatigue level. The algorithm's goal is to identify and treat all patients with fatigue that causes distress or interferes with their daily activities or functioning. Management of fatigue begins with primary oncology team members who perform the initial screening and either provide basic education and counseling or expand the initial screening to a more focused evaluation for moderate or higher levels of fatigue. At this point the patient is assessed for current disease and treatment status, a review of body systems, and an in-depth fatigue evaluation. In addition, the patient is assessed for the presence of seven treatable factors known to contribute to fatigue: pain, emotional distress, sleep disturbance, anemia, alterations in nutrition, deconditioning, and comorbidities. If any of these conditions are present, they should be treated according to practice guidelines, with referral to other care professionals as appropriate, and the patient's fatigue should be reevaluated regularly. If none of the seven factors are present or the fatigue is unresolved, selection of appropriate fatigue management and treatment strategies is considered within the context of the patient's clinical status: receiving active cancer treatment, receiving disease-free long-term follow-up, or receiving care at the end of life. Management of fatigue is cause-specific when conditions known to cause fatigue can be identified and treated. When specific causes, such as infection, fluid and electrolyte imbalances, or cardiac dysfunction, cannot be identified and corrected, nonpharmacologic and pharmacologic treatment of the fatigue should be considered. Nonpharmacologic interventions may include a moderate exercise program to improve functional capacity and activity tolerance, psychosocial programs to manage stress and

  17. Symptom Cluster Analyses Based on Symptom Occurrence and Severity Ratings Among Pediatric Oncology Patients During Myelosuppressive Chemotherapy

    PubMed Central

    Baggott, Christina; Cooper, Bruce A.; Marina, Neyssa; Matthay, Katherine K.; Miaskowski, Christine

    2011-01-01

    Background Symptom cluster research is an emerging field in symptom management. The ability to identify symptom clusters that are specific to pediatric oncology patients may lead to improved understanding of symptoms’ underlying mechanisms among patients of all ages. Objective The purpose of this study, in a sample of children and adolescents with cancer who underwent a cycle of myelosuppressive chemotherapy, was to compare the number and types of symptom clusters identified using patients’ ratings of symptom occurrence and symptom severity. Interventions/Methods Children and adolescents with cancer (10 to 18 years of age; N=131) completed the Memorial Symptom Assessment Scale 10–18 on the day they started a cycle of myelosuppressive chemotherapy, using a one week recall of experiences. Symptom data based on occurrence and severity ratings were examined using Exploratory Factor Analysis (EFA). The defined measurement model suggested by the best EFA model was then examined with a latent variable analysis. Results Three clusters were identified when symptom occurrence ratings were evaluated which were classified as a chemotherapy sequelae cluster, mood disturbance cluster, and a neuropsychological discomforts cluster. Analysis of symptom severity ratings yielded similar cluster configurations. Conclusions Cluster configurations remained relatively stable between symptom occurrence and severity ratings. The evaluation of patients at a common point in the chemotherapy cycle may have contributed to these findings. Implications for Practice Additional uniformity in symptom clusters investigations is needed to allow appropriate comparisons among studies. The dissemination of symptom clusters research methodology through publication and presentation may promote uniformity in this field. PMID:21921793

  18. [Evidence and recommendations for oncologic clinical exercise - a personalized treatment concept for cancer patients].

    PubMed

    Baumann, Freerk Theeagnus; Hallek, Michael; Meyer, Janika; Galvão, Daniel Abido; Bloch, Wilhelm; Elter, Thomas

    2015-09-01

    Oncological treatments can lead to acute and chronic cancer related toxicities. In recent years, a large number of clinical studies have reported positive effects of exercise to the bio-psycho-social regeneration of cancer patients. However, very few evidence-based programs have been implemented into practice with little opportunity for cancer patients to engage in such programs. Reviews and RCT studies on exercise and cancer are showing that specific exercise programs have a positive impact on fatigue syndrome, urinary incontinence, lymphedema, polyneuropathy, arthralgia, and androgen deprivation related toxicities. With the increasing evidence for exercise oncology interventions, recommendations arising from clinical trials should be translated into clinical practice and this should be viewed as an important next step in this fast moving field of exercise oncology. For that the personalized treatment concept "Oncologic clinical exercise" (OTT) was developed. PMID:26402184

  19. Utilisation of a thoracic oncology database to capture radiological and pathological images for evaluation of response to chemotherapy in patients with malignant pleural mesothelioma

    PubMed Central

    Carey, George B; Kazantsev, Stephanie; Surati, Mosmi; Rolle, Cleo E; Kanteti, Archana; Sadiq, Ahad; Bahroos, Neil; Raumann, Brigitte; Madduri, Ravi; Dave, Paul; Starkey, Adam; Hensing, Thomas; Husain, Aliya N; Vokes, Everett E; Vigneswaran, Wickii; Armato, Samuel G; Kindler, Hedy L; Salgia, Ravi

    2012-01-01

    Objective An area of need in cancer informatics is the ability to store images in a comprehensive database as part of translational cancer research. To meet this need, we have implemented a novel tandem database infrastructure that facilitates image storage and utilisation. Background We had previously implemented the Thoracic Oncology Program Database Project (TOPDP) database for our translational cancer research needs. While useful for many research endeavours, it is unable to store images, hence our need to implement an imaging database which could communicate easily with the TOPDP database. Methods The Thoracic Oncology Research Program (TORP) imaging database was designed using the Research Electronic Data Capture (REDCap) platform, which was developed by Vanderbilt University. To demonstrate proof of principle and evaluate utility, we performed a retrospective investigation into tumour response for malignant pleural mesothelioma (MPM) patients treated at the University of Chicago Medical Center with either of two analogous chemotherapy regimens and consented to at least one of two UCMC IRB protocols, 9571 and 13473A. Results A cohort of 22 MPM patients was identified using clinical data in the TOPDP database. After measurements were acquired, two representative CT images and 0–35 histological images per patient were successfully stored in the TORP database, along with clinical and demographic data. Discussion We implemented the TORP imaging database to be used in conjunction with our comprehensive TOPDP database. While it requires an additional effort to use two databases, our database infrastructure facilitates more comprehensive translational research. Conclusions The investigation described herein demonstrates the successful implementation of this novel tandem imaging database infrastructure, as well as the potential utility of investigations enabled by it. The data model presented here can be utilised as the basis for further development of other larger

  20. Tumor hypoxia: a new PET imaging biomarker in clinical oncology.

    PubMed

    Tamaki, Nagara; Hirata, Kenji

    2016-08-01

    Tumor hypoxia is associated with tumor progression and resistance to various treatments. Noninvasive imaging using positron emission tomography (PET) and F-18-labeled fluoromisonidazole (FMISO) was recently introduced in order to define and quantify tumor hypoxia. The FMISO uptake was closely correlated with pimonidazole immunohistochemistry and hypoxia-inducible factor 1 expression in basic studies. Tumor hypoxia in head and neck cancers and other tumors in a clinical setting may also indicate resistance to radiation and/or chemotherapy. Hypoxic imaging may thus play a new and important role for suitable radiation planning, including dose escalation and dose reduction based on the image findings. Such radiation-dose painting based on the findings of hypoxia may require high-performance PET imaging to provide high target-to-background ratio images and an optimal quantitative parameter to define the hypoxic region. A multicenter prospective study using data from a large number of patients is also warranted to test the clinical value of hypoxic imaging. PMID:26577447

  1. Effects on platelet function of combination etoposide and carboplatin chemotherapy in pediatric oncology patients.

    PubMed

    Pignatelli, P; Properzi, E; Pisani, M; Clerico, A; Schiavetti, A; Lenti, L; Pulcinelli, F M; Ferroni, P; Gazzaniga, P P

    1998-01-01

    The effects of a therapeutic course of the combination of carboplatin and etoposide on platelet function have been evaluated in 10 pediatric patients with brain tumors. Platelet count, in vitro aggregation tests, P-selectin expression and agonist-induced ATP release were evaluated before, and 7 and 15 days after one cycle of chemotherapy. The analysis of the results demonstrated the presence of an in vitro platelet aggregation defect in response to collagen and arachidonic acid in all patients 7 days after therapy. A concomitant decrease of collagen- and arachidonic acid-induced ATP release was also observed. Both platelet aggregation and ATP release returned to baseline values 15 days after chemotherapy administration. Conversely, in vitro platelet aggregation and secretion induced by ADP and epinephrine were unaltered by carboplatin and etoposide administration. Furthermore, P-selectin expression was negative at baseline and did not change after chemotherapy. These results support the hypothesis that combination etoposide and carboplatin chemotherapy in pediatric patients is responsible for possible disturbances in biochemical pathways required for platelet secretion and aggregation. PMID:16793755

  2. Measuring Clinical Trial–Associated Workload in a Community Clinical Oncology Program

    PubMed Central

    Good, Marjorie J.; Lubejko, Barbara; Humphries, Keisha; Medders, Andrea

    2013-01-01

    Purpose: The ability to quantify clinical trial–associated workload can have a significant impact on the efficiency and success of a research organization. However, methods to effectively estimate the number of research staff needed for clinical trial recruitment, maintenance, compliance, and follow-up are lacking. To address this need, the Wichita Community Clinical Oncology Program (WCCOP) developed and implemented an acuity-based workload assessment tool to facilitate assessment and balancing of workload among its research nursing staff. Methods: An acuity-based measurement tool was developed, assigning acuity scores for individual clinical trials using six trial-related determinants. Using trial acuity scores and numbers of patients per trial, acuity scores for individual research nursing staff were then calculated and compared on a monthly basis. Results: During the 11 years that data were collected, acuity scores increased from 65% to 181%. However, during this same period, WCCOP was able to decrease individual research nurse staff full-time equivalent (FTE) acuity scores and number of patients per FTE. These trends reflect the use of the acuity-based measurement tool to determine actual workload and use of the acuity data to direct hiring decisions. Conclusion: Clinical trial workload has been successfully measured and used to guide staffing by one community clinical oncology program. Further research is needed regarding its applicability to other research programs. PMID:23942924

  3. Integrative oncology drug discovery accompanied by preclinical translational research as prerequisite for clinical development.

    PubMed

    Hoffmann, Jens

    2014-06-01

    The molecular heterogeneity of cancer calls for individualized therapies to become the standard of care. It is now generally accepted that target-specific compounds require specific new development programs. But, even for new drugs with general mode of action (i.e., chemotherapy), tailored treatment approaches, such as specific schedules or combinations, have been shown to improve the therapeutic outcome. Therefore, the preclinical development of new therapeutic agents needs, next to the "classical pharmacodynamic studies", the implementation of integrative translational research (TR) as early as possible. New TR approaches, starting already at target identification and validation (TIV) will allow to defining the optimal patient population for clinical development, to tailor individual treatment of the tumor disease and to choose a rational basis among the manifold options for treatment combinations. We will discuss several examples from TR studies, which have initially been started to evaluate the molecular mode of action and to recognize mechanisms which can lead to resistance. Research was extended later to identify predictive response biomarkers and establish a rationale for combination with different therapies. A detailed gene expression analysis of lung cancer cells and apoptotic pathway interference studies in colon cancer cells provided insight in the molecular mechanisms of action. These new findings are correlated with results from other studies performed during the preclinical development program. We discuss pros and cons, successes and failures of our integrative preclinical development program and provide recommendations for future oncology projects. PMID:25841411

  4. Implementing effective and sustainable multidisciplinary clinical thoracic oncology programs

    PubMed Central

    Freeman, Richard K.; Krasna, Mark J.

    2015-01-01

    Three models of care are described, including two models of multidisciplinary care for thoracic malignancies. The pros and cons of each model are discussed, the evidence supporting each is reviewed, and the need for more (and better) research into care delivery models is highlighted. Key stakeholders in thoracic oncology care delivery outcomes are identified, and the need to consider stakeholder perspectives in designing, validating and implementing multidisciplinary programs as a vehicle for quality improvement in thoracic oncology is emphasized. The importance of reconciling stakeholder perspectives, and identify meaningful stakeholder-relevant benchmarks is also emphasized. Metrics for measuring program implementation and overall success are proposed. PMID:26380186

  5. Tracking the 2015 Gastrointestinal Cancers Symposium: bridging cancer biology to clinical gastrointestinal oncology

    PubMed Central

    Aprile, Giuseppe; Leone, Francesco; Giampieri, Riccardo; Casagrande, Mariaelena; Marino, Donatella; Faloppi, Luca; Cascinu, Stefano; Fasola, Gianpiero; Scartozzi, Mario

    2015-01-01

    The 2015 Gastrointestinal Cancers Symposium (San Francisco, CA, USA; January 15–17) is the world-class conference co-sponsored by the American Society of Clinical Oncology, the American Society for Radiation Oncology, the American Gastroenterological Association Institute, and the Society of Surgical Oncology, in which the most innovative research results in digestive tract oncology are presented and discussed. In its twelfth edition, the meeting has provided new insights focusing on the underpinning biology and clinical management of gastrointestinal malignancies. More than 3,400 health care professionals gathered from all over the world to share their experiences on how to bridge the recent novelties in cancer biology with everyday medical practice. In this article, the authors report on the most significant advances, didactically moving on three different anatomic tracks: gastroesophageal malignancies, pancreatic and biliary cancers, and colorectal adenocarcinomas. PMID:26045669

  6. Integrating Genomics into Clinical Oncology: Ethical and Social Challenges from Proponents of Personalized Medicine

    PubMed Central

    Settersten, Richard A.; Juengst, Eric T.; Fishman, Jennifer R.

    2013-01-01

    Summary The use of molecular tools to individualize health care, predict appropriate therapies and prevent adverse health outcomes has gained significant traction in the field of oncology, under the banner of “personalized medicine.” Enthusiasm for personalized medicine in oncology has been fueled by success stories of targeted treatments for a variety of cancers based on their molecular profiles. Though these are clear indications of optimism for personalized medicine, little is known about the ethical and social implications of personalized approaches in clinical oncology. The objective of this study is to assess how a range of stakeholders engaged in promoting, monitoring, and providing personalized medicine understand the challenges of integrating genomic testing and targeted therapies into clinical oncology. The study involved the analysis of in-depth interviews with 117 basic scientists, clinician-researchers, clinicians in private practice, health professional educators, representatives of funding agencies, medical journal editors, entrepreneurs, and insurers whose experiences and perspectives on personalized medicine span a wide variety of institutional and professional settings. Despite considerable enthusiasm for this shift, promoters, monitors and providers of personalized medicine identified four domains which will still provoke heightened ethical and social concerns: (1) informed consent for cancer genomic testing, (2) privacy, confidentiality, and disclosure of genomic test results, (3) access to genomic testing and targeted therapies in oncology, and (4) the costs of scaling up pharmacogenomic testing and targeted cancer therapies. These specific concerns are not unique to oncology, or even genomics. However, those most invested in the success of personalized medicine view oncologists’ responses to these challenges as precedent-setting because oncology is farther along the path of clinical integration of genomic technologies than other fields

  7. C-arm cone-beam computed tomography in interventional oncology: technical aspects and clinical applications

    PubMed Central

    Floridi, Chiara; Radaelli, Alessandro; Abi-Jaoudeh, Nadine; Grass, Micheal; Lin, Ming De; Chiaradia, Melanie; Geschwind, Jean-Francois; Kobeiter, Hishman; Squillaci, Ettore; Maleux, Geert; Giovagnoni, Andrea; Brunese, Luca; Wood, Bradford; Carrafiello, Gianpaolo; Rotondo, Antonio

    2014-01-01

    C-arm cone-beam computed tomography (CBCT) is a new imaging technology integrated in modern angiographic systems. Due to its ability to obtain cross-sectional imaging and the possibility to use dedicated planning and navigation software, it provides an informed platform for interventional oncology procedures. In this paper, we highlight the technical aspects and clinical applications of CBCT imaging and navigation in the most common loco-regional oncological treatments. PMID:25012472

  8. Bacterial bloodstream infections and antimicrobial susceptibility pattern in pediatric hematology/oncology patients after anticancer chemotherapy

    PubMed Central

    Al-Mulla, Naima A; Taj-Aldeen, Saad J; El Shafie, Sittana; Janahi, Mohammed; Al-Nasser, Abdullah A; Chandra, Prem

    2014-01-01

    Purpose Bloodstream infections in pediatric hematology and oncology represent a major problem worldwide, but this has not been studied in Qatar. In this study, we investigated the burden of infection and the resistance pattern in the bacterial etiology, in the only tertiary pediatric hematology and oncology center in Qatar. Methods All pediatric cancer patients (n=185) were evaluated retrospectively during the period 2004–2011; a total of 70 (38%) patients were diagnosed with bloodstream infections. Bacterial etiology was determined, along with their susceptibility patterns. Neutropenia, duration of neutropenia, fever, duration of fever, and C-reactive protein (CRP) were evaluated throughout the study. Results A total of 70 patients (38%) were diagnosed with acute leukemias, lymphomas, solid tumors, or brain tumors; those patients experienced 111 episodes of bacteremia. The most common Gram-positive (n=64 [55%]) isolates were Staphylococcus epidermidis (n=26), Staphylococcus hominis (n=9), and Staphylococcus haemolyticus (n=7), and the common Gram-negative (n=52 [45%]) isolates were Klebsiella pneumoniae (n=14), Pseudomonas aeruginosa (n=10), and Escherichia coli (n=7). There was a significant association observed between fever with positive blood culture and different types of cancer (P=0.035). The majority of bacteremia (n=68 [61.3%]) occurred in nonneutropenic episodes. Elevated values of CRP (≥5 mg/L) were detected in 82 (95.3%) episodes and were negatively correlated with absolute neutrophil count (ANC) (r=−0.18; P=0.248) among all cases. However, the infection-related fatality rate was 2.2% (n=4), with three caused by Gram-negative pathogens. Multidrug resistant organisms were implicated in 33 (28.4%) cases and caused three of the mortality cases. Conclusion Multidrug resistant organisms cause mortality in pediatric cancer patients. Investigation of antimicrobial susceptibility of these organisms may guide successful antimicrobial therapy and improve

  9. Pediatric Intensive Care Unit admission criteria for haemato-oncological patients: a basis for clinical guidelines implementation.

    PubMed

    Piastra, Marco; Fognani, Giuliana; Franceschi, Alessia

    2011-06-16

    Recent advances in supportive care and progress in the development and use of chemotherapy have considerably improved the prognosis of many children with malignancy, thus the need for intensive care admission and management is increasing, reaching about 40% of patients throughout the disease course. Cancer remains a major death cause in children, though outcomes have considerably improved over the past decades. Prediction of outcome for children with cancer in Pediatric Intensive Care Unit (PICU) obviously requires clinical guidelines, and these are not well defined, as well as admission criteria. Major determinants of negative outcomes remain severe sepsis/septic shock association and respiratory failure, deserving specific approach in children with cancer, particularly those receiving a bone marrow transplantation. A nationwide consensus should be achieved among pediatric intensivists and oncologists regarding the threshold clinical conditions requiring Intensive Care Unit (ICU) admission as well as specific critical care protocols. As demonstrated for the critically ill non-oncologic child, it appears unreasonable that pediatric patients with malignancy can be admitted to an adult Intensive Care Unit ICU. On a national basis a pool of refecence institutions should be identified and early referral to an oncologic PICU is warranted. PMID:21772950

  10. Pediatric Intensive Care Unit admission criteria for haemato-oncological patients: a basis for clinical guidelines implementation

    PubMed Central

    Piastra, Marco; Fognani, Giuliana; Franceschi, Alessia

    2011-01-01

    Recent advances in supportive care and progress in the development and use of chemotherapy have considerably improved the prognosis of many children with malignancy, thus the need for intensive care admission and management is increasing, reaching about 40% of patients throughout the disease course. Cancer remains a major death cause in children, though outcomes have considerably improved over the past decades. Prediction of outcome for children with cancer in Pediatric Intensive Care Unit (PICU) obviously requires clinical guidelines, and these are not well defined, as well as admission criteria. Major determinants of negative outcomes remain severe sepsis/septic shock association and respiratory failure, deserving specific approach in children with cancer, particularly those receiving a bone marrow transplantation. A nationwide consensus should be achieved among pediatric intensivists and oncologists regarding the threshold clinical conditions requiring Intensive Care Unit (ICU) admission as well as specific critical care protocols. As demonstrated for the critically ill non-oncologic child, it appears unreasonable that pediatric patients with malignancy can be admitted to an adult Intensive Care Unit ICU. On a national basis a pool of refecence institutions should be identified and early referral to an oncologic PICU is warranted. PMID:21772950

  11. Simulations to Predict Clinical Trial Outcome of Bevacizumab Plus Chemotherapy vs. Chemotherapy Alone in Patients With First-Line Gastric Cancer and Elevated Plasma VEGF-A.

    PubMed

    Han, K; Claret, L; Piao, Y; Hegde, P; Joshi, A; Powell, J R; Jin, J; Bruno, R

    2016-07-01

    To simulate clinical trials to assess overall survival (OS) benefit of bevacizumab in combination with chemotherapy in selected patients with gastric cancer (GC), a modeling framework linking OS with tumor growth inhibition (TGI) metrics and baseline patient characteristics was developed. Various TGI metrics were estimated using TGI models and data from two phase III studies comparing bevacizumab plus chemotherapy vs. chemotherapy as first-line therapy in 976 GC patients. Time-to-tumor-growth (TTG) was the best TGI metric to predict OS. TTG, Eastern Cooperative Oncology Group (ECOG) score, albumin level, and Asian ethnicity were significant covariates in the final OS model. The model correctly predicted a decreased hazard ratio favorable to bevacizumab in patients with high baseline plasma VEGF-A above the median of 113.4 ng/L. Based on trial simulations, in trials enrolling patients with elevated baseline plasma VEGF-A (500 patients per arm), the expected hazard ratio was 0.82 (95% prediction interval: 0.70-0.95), independent of ethnicity. PMID:27404946

  12. Simulations to Predict Clinical Trial Outcome of Bevacizumab Plus Chemotherapy vs. Chemotherapy Alone in Patients With First‐Line Gastric Cancer and Elevated Plasma VEGF‐A

    PubMed Central

    Claret, L; Piao, Y; Hegde, P; Joshi, A; Powell, JR; Bruno, R

    2016-01-01

    To simulate clinical trials to assess overall survival (OS) benefit of bevacizumab in combination with chemotherapy in selected patients with gastric cancer (GC), a modeling framework linking OS with tumor growth inhibition (TGI) metrics and baseline patient characteristics was developed. Various TGI metrics were estimated using TGI models and data from two phase III studies comparing bevacizumab plus chemotherapy vs. chemotherapy as first‐line therapy in 976 GC patients. Time‐to‐tumor‐growth (TTG) was the best TGI metric to predict OS. TTG, Eastern Cooperative Oncology Group (ECOG) score, albumin level, and Asian ethnicity were significant covariates in the final OS model. The model correctly predicted a decreased hazard ratio favorable to bevacizumab in patients with high baseline plasma VEGF‐A above the median of 113.4 ng/L. Based on trial simulations, in trials enrolling patients with elevated baseline plasma VEGF‐A (500 patients per arm), the expected hazard ratio was 0.82 (95% prediction interval: 0.70–0.95), independent of ethnicity. PMID:27404946

  13. Report on the use of non-clinical studies in the regulatory evaluation of oncology drugs.

    PubMed

    Hayakawa, Yoshihiro; Kawada, Manabu; Nishikawa, Hiroyoshi; Ochiya, Takahiro; Saya, Hideyuki; Seimiya, Hiroyuki; Yao, Ryoji; Hayashi, Masahiro; Kai, Chieko; Matsuda, Akira; Naoe, Tomoki; Ohtsu, Atsushi; Okazaki, Taku; Saji, Hideo; Sata, Masataka; Sugimura, Haruhiko; Sugiyama, Yuichi; Toi, Masakazu; Irimura, Tatsuro

    2016-02-01

    Non-clinical studies are necessary at each stage of the development of oncology drugs. Many experimental cancer models have been developed to investigate carcinogenesis, cancer progression, metastasis, and other aspects in cancer biology and these models turned out to be useful in the efficacy evaluation and the safety prediction of oncology drugs. While the diversity and the degree of engagement in genetic changes in the initiation of cancer cell growth and progression are widely accepted, it has become increasingly clear that the roles of host cells, tissue microenvironment, and the immune system also play important roles in cancer. Therefore, the methods used to develop oncology drugs should continuously be revised based on the advances in our understanding of cancer. In this review, we extensively summarize the effective use of those models, their advantages and disadvantages, ranges to be evaluated and limitations of the models currently used for the development and for the evaluation of oncology drugs. PMID:26919617

  14. Oncologic Outcomes of Stage IVB or Persistent or Recurrent Cervical Carcinoma Patients Treated With Chemotherapy at Siriraj Hospital

    PubMed Central

    Ruengkhachorn, Irene; Leelaphatanadit, Chairat; Therasakvichya, Suwanit; Hunnangkul, Saowalak

    2016-01-01

    , median PFS, and median OS of cervical cancer patients treated by chemotherapy in our center were rather high when compared with those of previous gynecologic oncology group studies. PMID:27051060

  15. Companion diagnostics and molecular imaging-enhanced approaches for oncology clinical trials

    PubMed Central

    Van Heertum, Ronald L; Scarimbolo, Robert; Ford, Robert; Berdougo, Eli; O’Neal, Michael

    2015-01-01

    In the era of personalized medicine, diagnostic approaches are helping pharmaceutical and biotechnology sponsors streamline the clinical trial process. Molecular assays and diagnostic imaging are routinely being used to stratify patients for treatment, monitor disease, and provide reliable early clinical phase assessments. The importance of diagnostic approaches in drug development is highlighted by the rapidly expanding global cancer diagnostics market and the emergent attention of regulatory agencies worldwide, who are beginning to offer more structured platforms and guidance for this area. In this paper, we highlight the key benefits of using companion diagnostics and diagnostic imaging with a focus on oncology clinical trials. Nuclear imaging using widely available radiopharmaceuticals in conjunction with molecular imaging of oncology targets has opened the door to more accurate disease assessment and the modernization of standard criteria for the evaluation, staging, and treatment responses of cancer patients. Furthermore, the introduction and validation of quantitative molecular imaging continues to drive and optimize the field of oncology diagnostics. Given their pivotal role in disease assessment and treatment, the validation and commercialization of diagnostic tools will continue to advance oncology clinical trials, support new oncology drugs, and promote better patient outcomes. PMID:26392755

  16. Clinical PET/MR Imaging in Dementia and Neuro-Oncology.

    PubMed

    Henriksen, Otto M; Marner, Lisbeth; Law, Ian

    2016-10-01

    The introduction of hybrid PET/MRI systems allows simultaneous multimodality image acquisition of high technical quality. This technique is well suited for the brain, and particularly in dementia and neuro-oncology. In routine use combinations of well-established MRI sequences and PET tracers provide the most optimal and clinically valuable protocols. For dementia the [18F]-fluorodeoxyglucose (FDG) has merit with a simultaneous four sequence MRI protocol of 20 min supported by supplementary statistical reading tools and quantitative measurements of the hippocampal volume. Clinical PET/MRI using [18F]-fluoro-ethyl-tyrosine (FET) also abide to the expectations of the adaptive and versatile diagnostic tool necessary in neuro-oncology covering both simple 20 min protocols for routine treatment surveillance and complicated 90 min brain and spinal cord protocols in pediatric neuro-oncology under general anesthesia. The clinical value of adding advanced MRI sequences in multiparametric imaging setting, however, is still undocumented. PMID:27593248

  17. [Introduction of a clinical protocol for extravasation at the National Institute of Oncology, Budapest, Hungary].

    PubMed

    Bartal, Alexandra; Mátrai, Zoltán; Rosta, András; Szûcs, Attila

    2011-03-01

    Extravasation of cytostatics occurs when an infusion containing a cytotoxic drug leaks into the surrounding perivascular and subcutaneous tissues. Incidence of cytostatic extravasation is found to be 0.1-6% according to the literature. Depending on the severity of complications, pain, loss of function in the extremities, or in extreme cases tissue necrosis necessitating an amputation may develop, drawing consequences like delay or interruption of the chemotherapy. Extent of complications is greatly influenced by the type of medication administered, general condition of the patient, and professional preparedness of staff providing the oncological health service. The protocol recently implemented in the National Institute of Oncology is a short, compact guidance for physicians and nurses providing oncological care, so by quick and adequate management of extravasation cases, severe complications could be prevented. More complex practical guidelines including algorithms could be created as a result of a wider collaboration, with the help of which oncological health professionals could easily cope with this rare problem. The authors describe in their review the implementation of the use of dry warm and cold packs, dymethylsulfoxide and hyaluronidase and their function within the algorithm of extravasation treatment. PMID:21617787

  18. Clinical Practice Guidelines and Consensus Statements in Oncology – An Assessment of Their Methodological Quality

    PubMed Central

    Jacobs, Carmel; Graham, Ian D.; Makarski, Julie; Chassé, Michaël; Fergusson, Dean; Hutton, Brian; Clemons, Mark

    2014-01-01

    Background Consensus statements and clinical practice guidelines are widely available for enhancing the care of cancer patients. Despite subtle differences in their definition and purpose, these terms are often used interchangeably. We systematically assessed the methodological quality of consensus statements and clinical practice guidelines published in three commonly read, geographically diverse, cancer-specific journals. Methods Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine’s standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents. Methods Consensus statements and clinical practice guidelines published between January 2005 and September 2013 in Current Oncology, European Journal of Cancer and Journal of Clinical Oncology were evaluated. Each publication was assessed using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) rigour of development and editorial independence domains. For assessment of transparency of document development, 7 additional items were taken from the Institute of Medicine's standards for practice guidelines and the Journal of Clinical Oncology guidelines for authors of guidance documents. Findings Thirty-four consensus statements and 67 clinical practice guidelines were evaluated. The rigour of development score for consensus statements over the three journals was 32% lower than that of clinical practice guidelines. The editorial independence score was 15% lower for consensus statements than clinical practice guidelines. One journal

  19. Investigation the Quality of Life and its Relation with Clinical and Demographic Characteristics in Women with Breast Cancer Under Chemotherapy

    PubMed Central

    Musarezaie, Amir; Ghasemi, Tahere Momeni Ghale; Esfahani, Homayoon Naji

    2012-01-01

    Background: This study was performed to examine quality of life's dimensions and its relationship with some clinical and demographic characteristics on women with breast cancer under chemotherapy referred to the oncology hospital, Isfahan University of medical sciences, Iran. Methods: This Cross sectional study was conducted among 330 breast cancer patients with simple sampling methodology. Data collection instrument included a questionnaire contains 2 parts (clinical and demographic characteristics information and version 2.0 of the SF-36 questionnaire (the international version). The data were analyzed with 99% confidence by carried out using SPSS18 with using descriptive and analytic statistics. Results: The majority of subjects’ quality of life was moderate (53.93%). there was a statistically significant relationship between quality of life among breast cancer patients with chemotherapy sessions (P < 0.05, df =4, χ2 = 16.37). One way Analysis Of Variance (ANOVA) suggested the absence of any significant relationship between quality of life with marital status (f = 0.21; P = 0.92) and employment status (f = 0.26; P = 0.77). Also, Spearman test showed the absence of any significant relationship between quality of life with age (P = 0.60), and the elapsed duration from diagnosis (P = 0.68), however Spearman test showed significant relationship between quality of life and education status (P = 0.002, r = -0.84). Conclusion: With regard to results of this study, there was a direct correlation between the number of chemotherapy sessions and patients quality of life. The attitude of the population toward chemotherapy is usually inhibiting and negative, so patients, students and nurses should be trained about chemotherapy efficacy to improve their attitude about chemotherapy, which in turn would lead to improvement of the patients’ quality of life. PMID:23272284

  20. Optimizing oncology therapeutics through quantitative translational and clinical pharmacology: challenges and opportunities.

    PubMed

    Venkatakrishnan, K; Friberg, L E; Ouellet, D; Mettetal, J T; Stein, A; Trocóniz, I F; Bruno, R; Mehrotra, N; Gobburu, J; Mould, D R

    2015-01-01

    Despite advances in biomedical research that have deepened our understanding of cancer hallmarks, resulting in the discovery and development of targeted therapies, the success rates of oncology drug development remain low. Opportunities remain for objective dose selection informed by exposure-response understanding to optimize the benefit-risk balance of novel therapies for cancer patients. This review article discusses the principles and applications of modeling and simulation approaches across the lifecycle of development of oncology therapeutics. Illustrative examples are used to convey the value gained from integration of quantitative clinical pharmacology strategies from the preclinical-translational phase through confirmatory clinical evaluation of efficacy and safety. PMID:25670382

  1. Reiki as a clinical intervention in oncology nursing practice.

    PubMed

    Bossi, Larraine M; Ott, Mary Jane; DeCristofaro, Susan

    2008-06-01

    Oncology nurses and their patients are frequently on the cutting edge of new therapies and interventions that support coping, health, and healing. Reiki is a practice that is requested with increasing frequency, is easy to learn, does not require expensive equipment, and in preliminary research, elicits a relaxation response and helps patients to feel more peaceful and experience less pain. Those who practice Reiki report that it supports them in self-care and a healthy lifestyle. This article will describe the process of Reiki, review current literature, present vignettes of patient responses to the intervention, and make recommendations for future study. PMID:18515247

  2. Medication double-checking procedures in clinical practice: a cross-sectional survey of oncology nurses' experiences

    PubMed Central

    Pfeiffer, Yvonne; Taxis, Katja

    2016-01-01

    Background Double-checking is widely recommended as an essential method to prevent medication errors. However, prior research has shown that the concept of double-checking is not clearly defined, and that little is known about actual practice in oncology, for example, what kind of checking procedures are applied. Objective To study the practice of different double-checking procedures in chemotherapy administration and to explore nurses' experiences, for example, how often they actually find errors using a certain procedure. General evaluations regarding double-checking, for example, frequency of interruptions during and caused by a check, or what is regarded as its essential feature was assessed. Methods In a cross-sectional survey, qualified nurses working in oncology departments of 3 hospitals were asked to rate 5 different scenarios of double-checking procedures regarding dimensions such as frequency of use in practice and appropriateness to prevent medication errors; they were also asked general questions about double-checking. Results Overall, 274 nurses (70% response rate) participated in the survey. The procedure of jointly double-checking (read-read back) was most commonly used (69% of respondents) and rated as very appropriate to prevent medication errors. Jointly checking medication was seen as the essential characteristic of double-checking—more frequently than ‘carrying out checks independently’ (54% vs 24%). Most nurses (78%) found the frequency of double-checking in their department appropriate. Being interrupted in one's own current activity for supporting a double-check was reported to occur frequently. Regression analysis revealed a strong preference towards checks that are currently implemented at the responders' workplace. Conclusions Double-checking is well regarded by oncology nurses as a procedure to help prevent errors, with jointly checking being used most frequently. Our results show that the notion of independent checking needs to be

  3. Postgraduate Training in Clinical Oncology. Report on a WHO Working Group (The Hague, The Netherlands, December 6-8, 1978).

    ERIC Educational Resources Information Center

    World Health Organization, Copenhagen (Denmark). Regional Office for Europe.

    The 1978 report of the Working Group of Postgraduate Training in Clinical Oncology, convened by the World Health Organization (WHO) Regional Office for Europe in collaboration with the government of The Netherlands, is presented. The groups analyzed models of postgraduate training in clinical oncology and evaluated their suitability in relation to…

  4. Innovative techniques in radiation oncology. Clinical research programs to improve local and regional control in cancer

    SciTech Connect

    Brady, L.W.; Markoe, A.M.; Micaily, B.; Fisher, S.A.; Lamm, F.R. )

    1990-02-01

    There is a growing importance in failure analysis in cancer management. In these analyses locoregional failure as the cause of death emerges as a significant problem in many tumor sites, e.g., head and neck cancer, gynecologic cancer, genitourinary cancer. Because of these data, the radiation oncology community has attributed high priority to research efforts to improve locoregional control. These efforts include the following: (1) brachytherapy alone or with external beam radiation therapy or surgery; (2) intraoperative radiation therapy; (3) hyperthermia with radiation therapy; (4) particle irradiation (protons, neutrons, stripped nuclei, and pions); and (5) routes of administration of the treatment, including infusional (intravenous) chemotherapy with radiation therapy, intraarterial monoclonal antibodies with radionuclides, and intraarterial chemotherapy with radiation therapy. Each area of investigation is discussed.

  5. Venous Thromboembolism Prophylaxis and Treatment in Patients With Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update 2014

    PubMed Central

    Lyman, Gary H.; Bohlke, Kari; Khorana, Alok A.; Kuderer, Nicole M.; Lee, Agnes Y.; Arcelus, Juan Ignacio; Balaban, Edward P.; Clarke, Jeffrey M.; Flowers, Christopher R.; Francis, Charles W.; Gates, Leigh E.; Kakkar, Ajay K.; Key, Nigel S.; Levine, Mark N.; Liebman, Howard A.; Tempero, Margaret A.; Wong, Sandra L.; Somerfield, Mark R.; Falanga, Anna

    2015-01-01

    Purpose To provide current recommendations about the prophylaxis and treatment of venous thromboembolism (VTE) in patients with cancer. Methods PubMed and the Cochrane Library were searched for randomized controlled trials, systematic reviews, meta-analyses, and clinical practice guidelines from November 2012 through July 2014. An update committee reviewed the identified abstracts. Results Of the 53 publications identified and reviewed, none prompted a change in the 2013 recommendations. Recommendations Most hospitalized patients with active cancer require thromboprophylaxis throughout hospitalization. Routine thromboprophylaxis is not recommended for patients with cancer in the outpatient setting. It may be considered for selected high-risk patients. Patients with multiple myeloma receiving antiangiogenesis agents with chemotherapy and/or dexamethasone should receive prophylaxis with either low–molecular weight heparin (LMWH) or low-dose aspirin. Patients undergoing major surgery should receive prophylaxis starting before surgery and continuing for at least 7 to 10 days. Extending prophylaxis up to 4 weeks should be considered in those undergoing major abdominal or pelvic surgery with high-risk features. LMWH is recommended for the initial 5 to 10 days of treatment for deep vein thrombosis and pulmonary embolism as well as for long-term secondary prophylaxis (at least 6 months). Use of novel oral anticoagulants is not currently recommended for patients with malignancy and VTE because of limited data in patients with cancer. Anticoagulation should not be used to extend survival of patients with cancer in the absence of other indications. Patients with cancer should be periodically assessed for VTE risk. Oncology professionals should educate patients about the signs and symptoms of VTE. PMID:25605844

  6. Cancer-related pain management in clinical oncology.

    PubMed

    Cipta, Andre M; Pietras, Christopher J; Weiss, Timothy E; Strouse, Thomas B

    2015-10-01

    Uncontrolled pain is one of the most feared and debilitating symptoms among cancer patients, and many suffer unnecessarily from suboptimal pain control. Cancer-related pain is often multidimensional and can affect all aspects of a patient's life. Hence, achieving adequate pain relief among cancer patients involves a proper assessment of psychosocial, spiritual, and physical pain issues, matched with an individualized treatment plan involving pharmacologic, nonpharmacologic, and procedural therapies when appropriate. Providing effective pain relief can help ease the overall burden of disease among oncology patients while helping them tolerate cancer-directed therapies and achieve the most optimal quality of life throughout all phases of the disease continuum. In this review, the authors will discuss the syndromes, assessment of, and treatment for cancer-related pain in the outpatient setting. PMID:26862909

  7. Making the right software choice for clinically used equipment in radiation oncology.

    PubMed

    Vorwerk, Hilke; Zink, Klemens; Wagner, Daniela Michaela; Engenhart-Cabillic, Rita

    2014-01-01

    The customer of a new system for clinical use in radiation oncology must consider many options in order to find the optimal combination of software tools. Many commercial systems are available and each system has a large number of technical features. However an appraisal of the technical capabilities, especially the options for clinical implementations, is hardly assessable at first view.The intention of this article was to generate an assessment of the necessary functionalities for high precision radiotherapy and their integration in ROKIS (Radiation oncology clinic information system) for future customers, especially with regard to clinical applicability. Therefore we analysed the clinically required software functionalities and divided them into three categories: minimal, enhanced and optimal requirements for high conformal radiation treatment. PMID:24956936

  8. Making the right software choice for clinically used equipment in radiation oncology

    PubMed Central

    2014-01-01

    The customer of a new system for clinical use in radiation oncology must consider many options in order to find the optimal combination of software tools. Many commercial systems are available and each system has a large number of technical features. However an appraisal of the technical capabilities, especially the options for clinical implementations, is hardly assessable at first view. The intention of this article was to generate an assessment of the necessary functionalities for high precision radiotherapy and their integration in ROKIS (Radiation oncology clinic information system) for future customers, especially with regard to clinical applicability. Therefore we analysed the clinically required software functionalities and divided them into three categories: minimal, enhanced and optimal requirements for high conformal radiation treatment. PMID:24956936

  9. Factors Predicting Oncology Care Providers' Behavioral Intention to Adopt Clinical Decision Support Systems

    ERIC Educational Resources Information Center

    Wolfenden, Andrew

    2012-01-01

    The purpose of this quantitative correlation study was to examine the predictors of user behavioral intention on the decision of oncology care providers to adopt or reject the clinical decision support system. The Unified Theory of Acceptance and Use of Technology (UTAUT) formed the foundation of the research model and survey instrument. The…

  10. A Phase II/III Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Ginger (Zingiber officinale) for Nausea Caused by Chemotherapy for Cancer: A Currently Accruing URCC CCOP Cancer Control Study.

    PubMed

    Hickok, Jane T; Roscoe, Joseph A; Morrow, Gary R; Ryan, Julie L

    2007-09-01

    Despite the widespread use of 5-HT3 receptor antagonist antiemetics such as ondansetron and granistron, up to 70% of patients with cancer receiving highly emetogenic chemotherapy agents experience postchemotherapy nausea and vomiting. Delayed postchemotherapy nausea (nausea that occurs >/= 24 hours after chemotherapy administration) and anticipatory nausea (nausea that develops before chemotherapy administration, in anticipation of it) are poorly controlled by currently available antiemetic agents. Scientific studies suggest that ginger (Zingiber officinale) might have beneficial effects on nausea and vomiting associated with motion sickness, surgery, and pregnancy. In 2 small studies of patients with cancer receiving chemotherapy, addition of ginger to standard antiemetic medication further reduced the severity of postchemotherapy nausea. This article describes a phase II/III randomized, dose-finding, placebo-controlled, double-blind clinical trial to assess the efficacy of ginger for nausea associated with chemotherapy for cancer. The study is currently being conducted by private practice oncology groups that are funded by the National Cancer Institute's Community Clinical Oncology Program and affiliated with the University of Rochester Cancer Center Community Clinical Oncology Program Research Base. PMID:18632524

  11. Music therapy services in pediatric oncology: a national clinical practice review.

    PubMed

    Tucquet, Belinda; Leung, Maggie

    2014-01-01

    This article presents the results of a national clinical practice review conducted in Australia of music therapy services in pediatric oncology hospitals. Literature specifically related to music therapy and symptom management in pediatric oncology is reviewed. The results from a national benchmarking survey distributed to all music therapists working with children with cancer in Australian pediatric hospitals are discussed. Patient and family feedback provided from a quality improvement activity conducted at a major pediatric tertiary hospital is summarized, and considerations for future growth as a profession and further research is proposed. PMID:25027188

  12. American Society of Clinical Oncology Statement: Human Papillomavirus Vaccination for Cancer Prevention.

    PubMed

    Bailey, Howard H; Chuang, Linus T; duPont, Nefertiti C; Eng, Cathy; Foxhall, Lewis E; Merrill, Janette K; Wollins, Dana S; Blanke, Charles D

    2016-05-20

    American Society of Clinical Oncology (ASCO), the leading medical professional oncology society, is committed to lessening the burden of cancer and as such will promote underused interventions that have the potential to save millions of lives through cancer prevention. As the main providers of cancer care worldwide, our patients, their families, and our communities look to us for guidance regarding all things cancer related, including cancer prevention. Through this statement and accompanying recommendations, ASCO hopes to increase awareness of the tremendous global impact of human papillomavirus (HPV) -caused cancers, refocus the discussion of HPV vaccination on its likely ability to prevent millions of cancer deaths, and increase HPV vaccination uptake via greater involvement of oncology professionals in ensuring accurate public discourse about HPV vaccination and calling for the implementation of concrete strategies to address barriers to vaccine access and acceptance. PMID:27069078

  13. Single-Cell Sequencing Technology in Oncology: Applications for Clinical Therapies and Research

    PubMed Central

    Ye, Baixin; Gao, Qingping; Zeng, Zhi; Stary, Creed M.; Jian, Zhihong; Xiong, Xiaoxing; Gu, Lijuan

    2016-01-01

    Cellular heterogeneity is a fundamental characteristic of many cancers. A lack of cellular homogeneity contributes to difficulty in designing targeted oncological therapies. Therefore, the development of novel methods to determine and characterize oncologic cellular heterogeneity is a critical next step in the development of novel cancer therapies. Single-cell sequencing (SCS) technology has been recently employed for analyzing the genetic polymorphisms of individual cells at the genome-wide level. SCS requires (1) precise isolation of the single cell of interest; (2) isolation and amplification of genetic material; and (3) descriptive analysis of genomic, transcriptomic, and epigenomic data. In addition to targeted analysis of single cells isolated from tumor biopsies, SCS technology may be applied to circulating tumor cells, which may aid in predicting tumor progression and metastasis. In this paper, we provide an overview of SCS technology and review the current literature on the potential application of SCS to clinical oncology and research. PMID:27313981

  14. American Society of Clinical Oncology Policy Statement Update: Genetic and Genomic Testing for Cancer Susceptibility.

    PubMed

    Robson, Mark E; Bradbury, Angela R; Arun, Banu; Domchek, Susan M; Ford, James M; Hampel, Heather L; Lipkin, Stephen M; Syngal, Sapna; Wollins, Dana S; Lindor, Noralane M

    2015-11-01

    The American Society of Clinical Oncology (ASCO) has long affirmed that the recognition and management of individuals with an inherited susceptibility to cancer are core elements of oncology care. ASCO released its first statement on genetic testing in 1996 and updated that statement in 2003 and 2010 in response to developments in the field. In 2014, the Cancer Prevention and Ethics Committees of ASCO commissioned another update to reflect the impact of advances in this area on oncology practice. In particular, there was an interest in addressing the opportunities and challenges arising from the application of massively parallel sequencing-also known as next-generation sequencing-to cancer susceptibility testing. This technology introduces a new level of complexity into the practice of cancer risk assessment and management, requiring renewed effort on the part of ASCO to ensure that those providing care to patients with cancer receive the necessary education to use this new technology in the most effective, beneficial manner. The purpose of this statement is to explore the challenges of new and emerging technologies in cancer genetics and provide recommendations to ensure their optimal deployment in oncology practice. Specifically, the statement makes recommendations in the following areas: germline implications of somatic mutation profiling, multigene panel testing for cancer susceptibility, quality assurance in genetic testing, education of oncology professionals, and access to cancer genetic services. PMID:26324357

  15. Quantitative Assessment of Workload and Stressors in Clinical Radiation Oncology

    SciTech Connect

    Mazur, Lukasz M.; Mosaly, Prithima R.; Jackson, Marianne; Chang, Sha X.; Burkhardt, Katharin Deschesne; Adams, Robert D.; Jones, Ellen L.; Hoyle, Lesley; Xu, Jing; Rockwell, John; Marks, Lawrence B.

    2012-08-01

    Purpose: Workload level and sources of stressors have been implicated as sources of error in multiple settings. We assessed workload levels and sources of stressors among radiation oncology professionals. Furthermore, we explored the potential association between workload and the frequency of reported radiotherapy incidents by the World Health Organization (WHO). Methods and Materials: Data collection was aimed at various tasks performed by 21 study participants from different radiation oncology professional subgroups (simulation therapists, radiation therapists, physicists, dosimetrists, and physicians). Workload was assessed using National Aeronautics and Space Administration Task-Load Index (NASA TLX). Sources of stressors were quantified using observational methods and segregated using a standard taxonomy. Comparisons between professional subgroups and tasks were made using analysis of variance ANOVA, multivariate ANOVA, and Duncan test. An association between workload levels (NASA TLX) and the frequency of radiotherapy incidents (WHO incidents) was explored (Pearson correlation test). Results: A total of 173 workload assessments were obtained. Overall, simulation therapists had relatively low workloads (NASA TLX range, 30-36), and physicists had relatively high workloads (NASA TLX range, 51-63). NASA TLX scores for physicians, radiation therapists, and dosimetrists ranged from 40-52. There was marked intertask/professional subgroup variation (P<.0001). Mental demand (P<.001), physical demand (P=.001), and effort (P=.006) significantly differed among professional subgroups. Typically, there were 3-5 stressors per cycle of analyzed tasks with the following distribution: interruptions (41.4%), time factors (17%), technical factors (13.6%), teamwork issues (11.6%), patient factors (9.0%), and environmental factors (7.4%). A positive association between workload and frequency of reported radiotherapy incidents by the WHO was found (r = 0.87, P value=.045

  16. BiOsimilaRs in the management of anaemia secondary to chemotherapy in HaEmatology and Oncology: results of the ORHEO observational study

    PubMed Central

    2014-01-01

    Background The approval of epoetin biosimilars in the European Union requires extensive scientific evaluation and stringent regulatory procedures, including post-marketing studies. The ORHEO (place of biOsimilaRs in the therapeutic management of anaemia secondary to chemotherapy in HaEmatology and Oncology) study was an observational, longitudinal, multicentre study performed in France to evaluate the efficacy and safety of biosimilar epoetins for the treatment of chemotherapy-induced anaemia (CIA) in the clinical setting. Methods Patients >18 years with CIA (haemoglobin [Hb] <11 g/dL) in association with solid tumours, lymphoma or myeloma and eligible for treatment with an epoetin biosimilar were included in this study. Patient characteristics were recorded at baseline along with anaemia-related information, such as observed and target Hb (as chosen by the treating clinician), brand and dose of epoetin biosimilar prescribed, and details of any other treatments. Patients were then followed-up at 3 and 6 months. The primary endpoint was Hb response (defined as Hb reaching ≥10 g/dL, an increase of Hb ≥1 g/dL since inclusion visit or reaching physician-defined target Hb, with no blood transfusions in the 3 weeks prior to measurement). Other endpoints included adverse events, achievement of target Hb and associated treatments. Results Overall, 2333 patients >18 years (mean age 66.5 years) with CIA (haemoglobin [Hb] <11 g/dL) in association with solid tumours, lymphoma or myeloma and eligible for biosimilar epoetin treatment were included. 99.9% of patients received epoetin zeta (median dose 30,000 IU/week). Mean baseline Hb was 9.61 g/dL, with 35.6% of patients having moderate anaemia (Hb 8–9.5 g/dL). Hb response was achieved in 81.6% and 86.5% of patients at 3 and 6 months, respectively. Overall mean change in Hb level was 1.52 ± 1.61 and 1.72 ± 1.61 g/dL at 3 and 6 months, respectively. Transfusion and thromboembolic event rates were 9

  17. Current practices and guidelines for clinical next-generation sequencing oncology testing

    PubMed Central

    Strom, Samuel P.

    2016-01-01

    Next-generation sequencing (NGS) has been rapidly integrated into molecular pathology, dramatically increasing the breadth genomic of information available to oncologists and their patients. This review will explore the ways in which this new technology is currently applied to bolster care for patients with solid tumors and hematological malignancies, focusing on practices and guidelines for assessing the technical validity and clinical utility of DNA variants identified during clinical NGS oncology testing. PMID:27144058

  18. A Clinically Translatable Mouse Model for Chemotherapy-Related Fatigue

    PubMed Central

    Zombeck, Jonathan A; Fey, Edward G; Lyng, Gregory D; Sonis, Stephen T

    2013-01-01

    Fatigue is a debilitating and pervasive complication of cancer and cancer care. Clinical research investigating potential therapies is hindered by variability in patient histories, different metrics for measuring fatigue, and environmental factors that may affect fatigue. The purpose of this study was to establish an animal model of chemotherapy-related fatigue. Female HSD:ICR mice were treated with doxorubicin (2.5 mg/kg) or saline in 2 cycles (days 1 through 3 and 10 through 12). After treatment, mice were individually housed in cages equipped with running wheels. Open-field activity and motor coordination were examined after each cycle of treatment and after each week of wheel running. In a separate cohort, modafinil (50 mg/kg) was assessed as a potential treatment for fatigue. Doxorubicin administration resulted in greater than 30% less wheel running compared with that of saline controls. Activity differences were specific to wheel running: neither distance traveled in the open field nor motor coordination according to the rotarod test differed between groups. Compared with control values, RBC counts in the doxorubicin group were decreased on days 15 and 22 but recovered to control levels by study completion. Modafinil was efficacious in increasing wheel running in the doxorubicin group. The current results establish an animal model of chemotherapy-related fatigue that recapitulates the physical symptoms of cancer-related fatigue as manifested as decreased voluntary activity. This model is sensitive to pharmaceutical intervention and can be used to screen potential treatments for fatigue. PMID:24326224

  19. Multi-scale Modeling in Clinical Oncology: Opportunities and Barriers to Success.

    PubMed

    Yankeelov, Thomas E; An, Gary; Saut, Oliver; Luebeck, E Georg; Popel, Aleksander S; Ribba, Benjamin; Vicini, Paolo; Zhou, Xiaobo; Weis, Jared A; Ye, Kaiming; Genin, Guy M

    2016-09-01

    Hierarchical processes spanning several orders of magnitude of both space and time underlie nearly all cancers. Multi-scale statistical, mathematical, and computational modeling methods are central to designing, implementing and assessing treatment strategies that account for these hierarchies. The basic science underlying these modeling efforts is maturing into a new discipline that is close to influencing and facilitating clinical successes. The purpose of this review is to capture the state-of-the-art as well as the key barriers to success for multi-scale modeling in clinical oncology. We begin with a summary of the long-envisioned promise of multi-scale modeling in clinical oncology, including the synthesis of disparate data types into models that reveal underlying mechanisms and allow for experimental testing of hypotheses. We then evaluate the mathematical techniques employed most widely and present several examples illustrating their application as well as the current gap between pre-clinical and clinical applications. We conclude with a discussion of what we view to be the key challenges and opportunities for multi-scale modeling in clinical oncology. PMID:27384942

  20. American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline.

    PubMed

    Runowicz, Carolyn D; Leach, Corinne R; Henry, N Lynn; Henry, Karen S; Mackey, Heather T; Cowens-Alvarado, Rebecca L; Cannady, Rachel S; Pratt-Chapman, Mandi L; Edge, Stephen B; Jacobs, Linda A; Hurria, Arti; Marks, Lawrence B; LaMonte, Samuel J; Warner, Ellen; Lyman, Gary H; Ganz, Patricia A

    2016-02-20

    The purpose of the American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline is to provide recommendations to assist primary care and other clinicians in the care of female adult survivors of breast cancer. A systematic review of the literature was conducted using PubMed through April 2015. A multidisciplinary expert workgroup with expertise in primary care, gynecology, surgical oncology, medical oncology, radiation oncology, and nursing was formed and tasked with drafting the Breast Cancer Survivorship Care Guideline. A total of 1,073 articles met inclusion criteria; and, after full text review, 237 were included as the evidence base. Patients should undergo regular surveillance for breast cancer recurrence, including evaluation with a cancer-related history and physical examination, and should be screened for new primary breast cancer. Data do not support performing routine laboratory tests or imaging tests in asymptomatic patients to evaluate for breast cancer recurrence. Primary care clinicians should counsel patients about the importance of maintaining a healthy lifestyle, monitor for post-treatment symptoms that can adversely affect quality of life, and monitor for adherence to endocrine therapy. Recommendations provided in this guideline are based on current evidence in the literature and expert consensus opinion. Most of the evidence is not sufficient to warrant a strong evidence-based recommendation. Recommendations on surveillance for breast cancer recurrence, screening for second primary cancers, assessment and management of physical and psychosocial long-term and late effects of breast cancer and its treatment, health promotion, and care coordination/practice implications are made.This guideline was developed through a collaboration between the American Cancer Society and the American Society of Clinical Oncology and has been published jointly by invitation and consent in both CA: A Cancer Journal for

  1. Oncologic Angiogenesis Imaging in the clinic---how and why

    PubMed Central

    Lindenberg, Liza; Choyke, Peter L

    2011-01-01

    Summary The ability to control the growth of new blood vessels would be an extraordinary therapeutic tool for many disease processes. Too often, the promises of discoveries in the basic science arena fail to translate to clinical success. While several anti angiogenic therapeutics are now FDA approved, the envisioned clinical benefits have yet to be seen. The ability to clinically non-invasively image angiogenesis would potentially be used to identify patients who may benefit from anti-angiogenic treatments, prognostication/risk stratification and therapy monitoring. This article reviews the current and future prospects of implementing angiogenesis imaging in the clinic. PMID:22132017

  2. An exploration of the experience of compassion fatigue in clinical oncology nurses.

    PubMed

    Perry, Beth; Toffner, Greg; Merrick, Trish; Dalton, Janice

    2011-01-01

    Compassion fatigue (CF) is "debilitating weariness brought about by repetitive, empathic responses to the pain and suffering of others" (LaRowe, 2005, p. 21). The work performed by oncology nurses, and the experiences of the people they care for, place oncology nurses at high risk for CF (Pierce et al., 2007; Ferrell & Coyle, 2008). Thus oncology nurses were chosen as the study focus. This paper details a descriptive exploratory qualitative research study that investigated the experience of CF in Canadian clinical oncology registered nurses (RNs). A conceptual stress process model by Aneshensel, Pearlin, Mullan, Zarit, and Whitlatch (1995) that considers caregivers' stress in four domains provided the study framework (see Figure 1). Nineteen study participants were recruited through an advertisement in the Canadian Oncology Nursing Journal (CONJ). The advertisement directed potential participants to a university-based online website developed for this study. Participants completed a questionnaire and wrote a narrative describing an experience with CF and submitted these through the secure research website. Data were analyzed thematically. Five themes include: defining CF, causes of CF, factors that worsen CF, factors that lessen CF, and outcomes of CF. Participants had limited knowledge about CF, about lack of external support, and that insufficient time to provide high quality, care may precipitate CF. The gap between quality of care nurses wanted to provide and what they were able to do, compounded by coexisting physical and emotional stress, worsened CF. CF was lessened by colleague support, work-life balance, connecting with others, acknowledgement, and maturity and experience. Outcomes of CF included profound fatigue of mind and body, negative effects on personal relationships, and considering leaving the specialty. Recommendations that may enhance oncology nurse well-being are provided. PMID:21661623

  3. Integrating Personalized Medicine in the Canadian Environment: Efforts Facilitating Oncology Clinical Research.

    PubMed

    Syme, Rachel; Carleton, Bruce; Leyens, Lada; Richer, Etienne

    2015-01-01

    There is currently a rapid evolution of clinical practices based on the introduction of patient stratification and molecular diagnosis that is likely to improve health outcomes. Building on a strong research base, complemented by strong support from clinicians and health authorities, the oncology field is at the forefront of this evolution. Yet, clinical research is still facing many challenges that need to be addressed in order to conduct necessary studies and effectively translate medical breakthroughs based on personalized medicine into standards of care. Leveraging its universal health care system and on resources developed to support oncology clinical research, Canada is well positioned to join the international efforts deployed to address these challenges. Available resources include a broad range of structures and funding mechanisms, ranging from direct clinical trial support to post-marketing surveillance. Here, we propose a clinical model for the introduction of innovation for precision medicine in oncology that starts with patients' and clinicians' unmet needs to initiate a cycle of discovery, validation, translation and sustainability development. PMID:26565702

  4. Photoacoustic Imaging in Oncology: Translational Preclinical and Early Clinical Experience.

    PubMed

    Valluru, Keerthi S; Wilson, Katheryne E; Willmann, Jürgen K

    2016-08-01

    Photoacoustic imaging has evolved into a clinically translatable platform with the potential to complement existing imaging techniques for the management of cancer, including detection, characterization, prognosis, and treatment monitoring. In photoacoustic imaging, tissue is optically excited to produce ultrasonographic images that represent a spatial map of optical absorption of endogenous constituents such as hemoglobin, fat, melanin, and water or exogenous contrast agents such as dyes and nanoparticles. It can therefore provide functional and molecular information that allows noninvasive soft-tissue characterization. Photoacoustic imaging has matured over the years and is currently being translated into the clinic with various clinical studies underway. In this review, the current state of photoacoustic imaging is presented, including techniques and instrumentation, followed by a discussion of potential clinical applications of this technique for the detection and management of cancer. (©) RSNA, 2016. PMID:27429141

  5. Processes for quality improvements in radiation oncology clinical trials.

    PubMed

    FitzGerald, T J; Urie, Marcia; Ulin, Kenneth; Laurie, Fran; Yorty, Jeffrey; Hanusik, Richard; Kessel, Sandy; Jodoin, Maryann Bishop; Osagie, Gani; Cicchetti, M Giulia; Pieters, Richard; McCarten, Kathleen; Rosen, Nancy

    2008-01-01

    Quality assurance in radiotherapy (RT) has been an integral aspect of cooperative group clinical trials since 1970. In early clinical trials, data acquisition was nonuniform and inconsistent and computational models for radiation dose calculation varied significantly. Process improvements developed for data acquisition, credentialing, and data management have provided the necessary infrastructure for uniform data. With continued improvement in the technology and delivery of RT, evaluation processes for target definition, RT planning, and execution undergo constant review. As we move to multimodality image-based definitions of target volumes for protocols, future clinical trials will require near real-time image analysis and feedback to field investigators. The ability of quality assurance centers to meet these real-time challenges with robust electronic interaction platforms for imaging acquisition, review, archiving, and quantitative review of volumetric RT plans will be the primary challenge for future successful clinical trials. PMID:18406943

  6. Differences in demographic, clinical, and symptom characteristics and quality of life outcomes among oncology patients with different types of pain.

    PubMed

    Posternak, Victoria; Dunn, Laura B; Dhruva, Anand; Paul, Steven M; Luce, Judith; Mastick, Judy; Levine, Jon D; Aouizerat, Bradley E; Hammer, Marylin; Wright, Fay; Miaskowski, Christine

    2016-04-01

    The purposes of this study, in oncology outpatients receiving chemotherapy (n = 926), were to: describe the occurrence of different types of pain (ie, no pain, only noncancer pain [NCP], only cancer pain [CP], or both CP and NCP) and evaluate for differences in demographic, clinical, and symptom characteristics, and quality of life (QOL) among the 4 groups. Patients completed self-report questionnaires on demographic and symptom characteristics and QOL. Patients who had pain were asked to indicate if it was or was not related to their cancer or its treatment. Medical records were reviewed for information on cancer and its treatments. In this study, 72.5% of the patients reported pain. Of the 671 who reported pain, 21.5% reported only NCP, 37.0% only CP, and 41.5% both CP and NCP. Across the 3 pain groups, worst pain scores were in the moderate to severe range. Compared with the no pain group, patients with both CP and NCP were significantly younger, more likely to be female, have a higher level of comorbidity, and a poorer functional status. In addition, these patients reported: higher levels of depression, anxiety, fatigue, and sleep disturbance; lower levels of energy and attentional function; and poorer QOL. Patients with only NCP were significantly older than the other 3 groups. The most common comorbidities in the NCP group were back pain, hypertension, osteoarthritis, and depression. Unrelieved CP and NCP continue to be significant problems. Oncology outpatients need to be assessed for both CP and NCP conditions. PMID:26683234

  7. Improving Patient Safety in Clinical Oncology: Applying Lessons From Normal Accident Theory.

    PubMed

    Chera, Bhishamjit S; Mazur, Lukasz; Buchanan, Ian; Kim, Hong Jin; Rockwell, John; Milowsky, Matthew I; Marks, Lawrence B

    2015-10-01

    Concerns for patient safety persist in clinical oncology. Within several nonmedical areas (eg, aviation, nuclear power), concepts from Normal Accident Theory (NAT), a framework for analyzing failure potential within and between systems, have been successfully applied to better understand system performance and improve system safety. Clinical oncology practice is interprofessional and interdisciplinary, and our therapies often have narrow therapeutic windows. Thus, many of our processes are, in NAT terms, interactively complex and tightly coupled within and across systems and are therefore prone to unexpected behaviors that can result in substantial patient harm. To improve safety at the University of North Carolina, we have applied the concepts of NAT to our practice to better understand our systems' behavior and adopted strategies to reduce complexity and coupling. Furthermore, recognizing that we cannot eliminate all risks, we have stressed safety mindfulness among our staff to further promote safety. Many specific examples are provided herein. The lessons from NAT are translatable to clinical oncology and may help to promote safety. PMID:26182183

  8. Recommendations for Obesity Clinical Trials in Cancer Survivors: American Society of Clinical Oncology Statement.

    PubMed

    Ligibel, Jennifer A; Alfano, Catherine M; Hershman, Dawn; Ballard, Rachel M; Bruinooge, Suanna S; Courneya, Kerry S; Daniels, Elvan C; Demark-Wahnefried, Wendy; Frank, Elizabeth S; Goodwin, Pamela J; Irwin, Melinda L; Levit, Laura A; McCaskill-Stevens, Worta; Minasian, Lori M; O'Rourke, Mark A; Pierce, John P; Stein, Kevin D; Thomson, Cynthia A; Hudis, Clifford A

    2015-11-20

    Observational evidence has established a relationship between obesity and cancer risk and outcomes. Interventional studies have demonstrated the feasibility and benefits of lifestyle change after cancer diagnosis, and guidelines recommend weight management and regular physical activity in cancer survivors; however, lifestyle interventions are not a routine part of cancer care. The ASCO Research Summit on Advancing Obesity Clinical Trials in Cancer Survivors sought to identify the knowledge gaps that clinical trials addressing energy balance factors in cancer survivors have not answered and to develop a roadmap for the design and implementation of studies with the potential to generate data that could lead to the evidence-based incorporation of weight management and physical activity programs into standard oncology practice. Recommendations highlight the need for large-scale trials evaluating the impact of energy balance interventions on cancer outcomes, as well as the concurrent conduct of studies focused on dissemination and implementation of interventions in diverse populations of cancer survivors, including answering critical questions about the degree of benefit in key subgroups of survivors. Other considerations include the importance of incorporating economic metrics into energy balance intervention trials, the need to establish intermediate biomarkers, and the importance of integrating traditional and nontraditional funding sources. Establishing lifestyle change after cancer diagnosis as a routine part of cancer care will require a multipronged effort to overcome barriers related to study development, funding, and stakeholder engagement. Given the prevalence of obesity and inactivity in cancer survivors in the United States and elsewhere, energy balance interventions hold the potential to reduce cancer morbidity and mortality in millions of patients, and it is essential that we move forward in determining their role in cancer care with the same care and

  9. Is the clinical use of cannabis by oncology patients advisable?

    PubMed

    Bar-Sela, Gil; Avisar, Adva; Batash, Ron; Schaffer, Moshe

    2014-06-01

    The use of the cannabis plant for various medical indications by cancer patients has been rising significantly in the past few years in several European countries, the US and Israel. The increase in use comes from public demand for the most part, and not due to a scientific basis. Cannabis chemistry is complex, and the isolation and extraction of the active ingredient remain difficult. The active agent in cannabis is unique among psychoactive plant materials, as it contains no nitrogen and, thus, is not an alkaloid. Alongside inconclusive evidence of increased risks of lung and head and neck cancers from prolonged smoking of the plant produce, laboratory evidence of the anti-cancer effects of plant components exists, but with no clinical research in this direction. The beneficial effects of treatment with the plant, or treatment with medicine produced from its components, are related to symptoms of the disease: pain, nausea and vomiting, loss of appetite and weight loss. The clinical evidence of the efficacy of cannabis for these indications is only partial. However, recent scientific data from studies with THC and cannabidiol combinations report the first clinical indication of cancer-related pain relief. The difficulties of performing research into products that are not medicinal, such as cannabis, have not allowed a true study of the cannabis plant extract although, from the public point of view, such studies are greatly desirable. PMID:24606496

  10. Pilot Study of Nelarabine in Combination With Intensive Chemotherapy in High-Risk T-Cell Acute Lymphoblastic Leukemia: A Report From the Children's Oncology Group

    PubMed Central

    Dunsmore, Kimberly P.; Devidas, Meenakshi; Linda, Stephen B.; Borowitz, Michael J.; Winick, Naomi; Hunger, Stephen P.; Carroll, William L.; Camitta, Bruce M.

    2012-01-01

    Purpose Children's Oncology Group study AALL00P2 was designed to assess the feasibility and safety of adding nelarabine to a BFM 86–based chemotherapy regimen in children with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL). Patients and Methods In stage one of the study, eight patients with a slow early response (SER) by prednisone poor response (PPR; ≥ 1,000 peripheral blood blasts on day 8 of prednisone prephase) received chemotherapy plus six courses of nelarabine 400 mg/m2 once per day; four patients with SER by high minimal residual disease (MRD; ≥ 1% at day 36 of induction) received chemotherapy plus five courses of nelarabine; 16 patients with a rapid early response (RER) received chemotherapy without nelarabine. In stage two, all patients received six 5-day courses of nelarabine at 650 mg/m2 once per day (10 SER patients [one by MRD, nine by PPR]) or 400 mg/m2 once per day (38 RER patients; 12 SER patients [three by MRD, nine by PPR]). Results The only significant difference in toxicities was decreased neutropenic infections in patients treated with nelarabine (42% with v 81% without nelarabine). Five-year event-free survival (EFS) rates were 73% for 11 stage one SER patients and 67% for 22 stage two SER patients treated with nelarabine versus 69% for 16 stage one RER patients treated without nelarabine and 74% for 38 stage two RER patients treated with nelarabine. Five-year EFS for all patients receiving nelarabine (n = 70) was 73% versus 69% for those treated without nelarabine (n = 16). Conclusion Addition of nelarabine to a BFM 86–based chemotherapy regimen was well tolerated and produced encouraging results in pediatric patients with T-ALL, particularly those with a SER, who have historically fared poorly. PMID:22734022

  11. Importance of dose intensity in neuro-oncology clinical trials: summary report of the Sixth Annual Meeting of the Blood-Brain Barrier Disruption Consortium.

    PubMed

    Doolittle, N D; Anderson, C P; Bleyer, W A; Cairncross, J G; Cloughesy, T; Eck, S L; Guastadisegni, P; Hall, W A; Muldoon, L L; Patel, S J; Peereboom, D; Siegal, T; Neuwelt, E A

    2001-01-01

    Therapeutic options for the treatment of malignant brain tumors have been limited, in part, because of the presence of the blood-brain barrier. For this reason, the Sixth Annual Meeting of the Blood-Brain Barrier Disruption Consortium, the focus of which was the "Importance of Dose Intensity in Neuro-Oncology Clinical Trials," was convened in April 2000, at Government Camp, Mount Hood, Oregon. This meeting, which was supported by the National Cancer Institute, the National Institute of Neurological Disorders and Stroke, and the National Institute of Deafness and Other Communication Disorders, brought together clinicians and basic scientists from across the U.S. to discuss the role of dose intensity and enhanced chemotherapy delivery in the treatment of malignant brain tumors and to design multicenter clinical trials. Optimizing chemotherapy delivery to the CNS is crucial, particularly in view of recent progress identifying certain brain tumors as chemosensitive. The discovery that specific constellations of genetic alterations can predict which tumors are chemoresponsive, and can therefore more accurately predict prognosis, has important implications for delivery of intensive, effective chemotherapy regimens with acceptable toxicities. This report summarizes the discussions, future directions, and key questions regarding dose-intensive treatment of primary CNS lymphoma, CNS relapse of systemic non-Hodgkin's lymphoma, anaplastic oligodendroglioma, high-grade glioma, and metastatic cancer of the brain. The promising role of cytoenhancers and chemoprotectants as part of dose-intensive regimens for chemosensitive brain tumors and development of improved gene therapies for malignant gliomas are discussed. PMID:11305417

  12. Use of procalcitonin in clinical oncology: a literature review.

    PubMed

    Sbrana, Andrea; Torchio, Martina; Comolli, Giuditta; Antonuzzo, Andrea; Danova, Marco

    2016-09-01

    The use of procalcitonin (PCT) as an early marker of infectious episodes in cancer patients is still controversial. We performed a MEDLINE search of peer-reviewed articles published between January 1990 and December 2015, and finally we analysed 15 articles. PCT seems to have a good diagnostic value of infectious episodes in cancer patients and its accuracy seems greater if we consider major events, such as bloodstream infections and sepsis. Serial evaluations of this protein seem to be more accurate in the diagnostic phase and useful to predict outcome and response to antibacterial treatment. On the other hand, some issues have yet to be solved, such as the use of a validated method of determination, the definition of a standard cut-off, and the heterogeneity among different settings of patients (e.g. early versus advanced-stage cancer, or haematological versus solid tumours). However, it is credible to think that PCT use in everyday clinical practice, preferably in combination with other clinical or laboratory tests, might be of help in finding and detecting early infectious complications in cancer patients. PMID:27602414

  13. Targets in clinical oncology: the metabolic environment of the patient.

    PubMed

    Argilés, Josep M; Busquets, Silvia; Moore-Carrasco, Rodrigo; Figueras, Maite; Almendro, Vanessa; López-Soriano, Francisco J

    2007-01-01

    Cancer cachexia is a syndrome characterized by a marked weight loss, anorexia, asthenia and anemia. The degree of cachexia is inversely correlated with the survival time of the patient and it always implies a poor prognosis. Lean body mass depletion is one of the main features of cachexia and it involves not only skeletal muscle but also affects cardiac protein. The cachectic state is invariably associated with the presence and growth of the tumour and leads to a malnutrition status due to the induction of anorexia or decreased food intake. In addition, the competition for nutrients between the tumour and the host leads to an accelerated starvation state which promotes severe metabolic disturbances in the host, including hypermetabolism which leads to an increased energetic inefficiency. Unfortunately, at the clinical level, cachexia is not treated until the patient suffers from a considerable weight loss and wasting. Therefore, it is of great interest to analyze possible early markers of the syndrome. In the present review both metabolic and hormonal markers are described. Although the search for the cachectic factor(s) started a long time ago, and although many scientific and economic efforts have been devoted to its discovery, we are still a long way from fully understanding the underlying basis for this syndrome. The suggested mediators (associated with both depletion of fat stores and muscular tissue) can be divided into two categories: of tumour origin (produced and released by the neoplasm) and humoural factors (mainly cytokines). One of the aims of the present review is to summarize and evaluate the different catabolic mediators (both humoural and tumoural) involved in cancer cachexia, since they may represent targets for clinical investigations. Additionally, an overview of the main therapeutic approaches for the treatment of the cachectic syndrome is presented. PMID:17485280

  14. A comparison of discharge strategies after chemotherapy completion in pediatric patients with acute myeloid leukemia: a report from the Children's Oncology Group.

    PubMed

    Miller, Tamara P; Getz, Kelly D; Kavcic, Marko; Li, Yimei; Huang, Yuan-Shun V; Sung, Lillian; Alonzo, Todd A; Gerbing, Robert; Daves, Marla; Horton, Terzah M; Pulsipher, Michael A; Pollard, Jessica; Bagatell, Rochelle; Seif, Alix E; Fisher, Brian T; Gamis, Alan S; Aplenc, Richard

    2016-07-01

    While most children receive acute myeloid leukemia (AML) chemotherapy as inpatients, there is variability in timing of discharge after chemotherapy completion. This study compared treatment-related morbidity, mortality and cumulative hospitalization in children with AML who were discharged after chemotherapy completion (early discharge) and those who remained hospitalized. Chart abstraction data for 153 early discharge-eligible patients enrolled on a Children's Oncology Group trial were compared by discharge strategy. Targeted toxicities included viridans group streptococcal (VGS) bacteremia, hypoxia and hypotension. Early discharge occurred in 11% of courses post-Induction I. Re-admission occurred in 80-100%, but median hospital stay was 7 days shorter. Patients discharged early had higher rates of VGS (adjusted risk ratio (aRR) = 1.67, 95% CI = 1.11-2.51), hypoxia (aRR = 1.92, 95% CI = 1.06-3.48) and hypotension (aRR = 4.36, 95% CI = 2.01-9.46), but there was no difference in mortality. As pressure increases to shorten hospitalizations, these results have important implications for determining discharge practices in pediatric AML. PMID:26727639

  15. Role of American Society of Clinical Oncology in low- and middle-income countries.

    PubMed

    Patel, Jyoti D; Galsky, Matthew D; Chagpar, Anees B; Pyle, Doug; Loehrer, Patrick J

    2011-08-01

    The American Society of Clinical Oncology (ASCO) is a global community of health care professionals whose stated purpose is to "make a world of difference" by improving cancer care around the world. Unfortunately, cancer survival rates vary significantly among countries with differing financial and infrastructural resources. Because ASCO is a professional oncology society committed to conquering cancer through research, education, prevention, and delivery of high-quality patient care, it is ideally suited to address this issue. ASCO could bring together oncology professionals and other necessary stakeholders from around the world to improve cancer care and lessen suffering for patients worldwide. As part of the ongoing commitment of ASCO to the future of cancer care, the Leadership Development Program was created to foster the leadership skills of early and midcareer oncologists and provide these participants with a working knowledge of the depth and breadth of the organization. As participants in the inaugural class of the ASCO Leadership Development Program, we were charged with investigating how ASCO might favorably affect cancer prevention and treatment in resource-poor countries in a cost-effective, scalable, and sustainable fashion. ASCO can significantly influence cancer care in low- and middle-income countries through a comprehensive approach that promotes cancer awareness and education, improves clinical practice by identifying and removing barriers to delivery of quality cancer care, and fosters innovation to initiate novel solutions to complex problems. PMID:21709190

  16. Ethical Considerations for the Clinical Oncologist in an Era of Oncology Drug Shortages

    PubMed Central

    Spence, Rebecca; Rathmell, W. Kimryn; Bradbury, Angela; Peppercorn, Jeffrey; Grubbs, Stephen; Moy, Beverly

    2014-01-01

    Shortages of injectable drugs affect many cancer patients and providers in the U.S. today. Scholars and policymakers have recently begun to devote increased attention to these issues, but only a few tangible resources exist to guide clinical oncologists in developing strategies for dealing with drug shortages on a recurring basis. This article discusses existing information from the scholarly literature, policy analyses, and other relevant sources and seeks to provide practical ethical guidance to the broad audience of oncology professionals who are increasingly confronted with such cases in their practice. We begin by providing a brief overview of the history, causes, and regulatory context of oncology drug shortages in the U.S., followed by a discussion of ethical frameworks that have been proposed in this setting. We conclude with practical recommendations for ethical professional behavior in these increasingly common and challenging situations. PMID:24449096

  17. Ethical considerations for the clinical oncologist in an era of oncology drug shortages.

    PubMed

    Jagsi, Reshma; Spence, Rebecca; Rathmell, W Kimryn; Bradbury, Angela; Peppercorn, Jeffrey; Grubbs, Stephen; Moy, Beverly

    2014-02-01

    Shortages of injectable drugs affect many cancer patients and providers in the U.S. today. Scholars and policymakers have recently begun to devote increased attention to these issues, but only a few tangible resources exist to guide clinical oncologists in developing strategies for dealing with drug shortages on a recurring basis. This article discusses existing information from the scholarly literature, policy analyses, and other relevant sources and seeks to provide practical ethical guidance to the broad audience of oncology professionals who are increasingly confronted with such cases in their practice. We begin by providing a brief overview of the history, causes, and regulatory context of oncology drug shortages in the U.S., followed by a discussion of ethical frameworks that have been proposed in this setting. We conclude with practical recommendations for ethical professional behavior in these increasingly common and challenging situations. PMID:24449096

  18. Pharmacogenomics in Pediatric Oncology: Review of Gene-Drug Associations for Clinical Use.

    PubMed

    Mlakar, Vid; Huezo-Diaz Curtis, Patricia; Satyanarayana Uppugunduri, Chakradhara Rao; Krajinovic, Maja; Ansari, Marc

    2016-01-01

    During the 3rd congress of the European Society of Pharmacogenomics and Personalised Therapy (ESPT) in Budapest in 2015, a preliminary meeting was held aimed at establishing a pediatric individualized treatment in oncology and hematology committees. The main purpose was to facilitate the transfer and harmonization of pharmacogenetic testing from research into clinics, to bring together basic and translational research and to educate health professionals throughout Europe. The objective of this review was to provide the attendees of the meeting as well as the larger scientific community an insight into the compiled evidence regarding current pharmacogenomics knowledge in pediatric oncology. This preliminary evaluation will help steer the committee's work and should give the reader an idea at which stage researchers and clinicians are, in terms of personalizing medicine for children with cancer. From the evidence presented here, future recommendations to achieve this goal will also be suggested. PMID:27618021

  19. Mucosal malignant melanoma - a clinical, oncological, pathological and genetic survey.

    PubMed

    Mikkelsen, Lauge H; Larsen, Ann-Cathrine; von Buchwald, Christian; Drzewiecki, Krzysztof T; Prause, Jan U; Heegaard, Steffen

    2016-06-01

    Mucosal melanomas constitute 1.3% of all melanomas and they may develop in any mucosal membrane. Conjunctival melanomas (0.5/million/year) and melanomas in the sinonasal cavity (0.5/million/year) are the most common, followed by anorectal melanomas (0.4/million/year) and melanomas in the oral cavity (0.2/million/year). Anorectal melanoma occurs slightly more often in females, whereas oral melanoma has a male predilection. Mucosal melanoma most commonly develops in a patient's sixth or seventh decade of life, and no differences between races have been found except for sinonasal melanoma and conjunctival melanoma, which are very rare in Black people. The symptoms are not tumour-specific and are related to the organ system affected, and the disease is most often diagnosed at an advanced clinical stage. The diagnosis of a primary tumour is difficult, and metastatic cutaneous melanoma and choroidal melanoma must be excluded. Mutations in KIT are frequently found, while BRAF and NRAS mutations are rarely found - except in conjunctival melanomas that carry BRAF mutations. Mutations in the TERT promotor region are also found in mucosal melanomas. Complete surgical resection with free margins is the treatment of choice. The prognosis is poor, with the 5-year survival rate ranging from 0% (gastric melanoma) to 80% (conjunctival melanoma). PMID:27004972

  20. Granulocyte Colony-Stimulating Factor Use in a Large Iranian Hospital: Comparison with American Society of Clinical Oncology (ASCO) Clinical Practice Guideline

    PubMed Central

    Mousavi, Sarah; Dadpoor, Mina; Ashrafi, Farzaneh

    2016-01-01

    Background: Granulocyte Colony Stimulating Factors (GCSF) is high-cost agents commonly recommended for primary and secondary prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia. GCSFs have been shown to be beneficial in some patient subgroups, although they are probably overused in clinical settings. The American Society of Clinical Oncology (ASCO) guidelines summarize current data on the appropriate use of CSFs. The aim of this study was to assess and audit the use of GCSF in a tertiary care center according to the recommendation of ASCO guideline. Subjects and Methods: A prospective observational study from November 2014 to June 2015 was performed on all patients prescribed with filgrastim in the large teaching hospital (Isfahan, Iran). Data was collected on demographics, indication, dosing regimen and duration of treatment, the Absolute Neutrophil Count (ANC) and patient outcome. Results: 91 patients were recorded over the period of the study. 63.7% of prescription complied with the ASCO guideline. Febrile neutropenia post chemotherapy/radiotherapy was the most common appropriate indication (29.3%) followed by primary prophylaxis (25.8%). Fourteen (32%) patients showed ANC recovery in 1-3 days and 16 (37%) within 4-7 days. Ten patients (23%) showed no recovery. The overall mortality was 8 (8.8%) patients. Conclusion: This study revealed that at least one-third of prescribed GCSF was not in accordance with ASCO guideline. Considering the high cost of GCSF in our country and limitation of our resources, we proposed cost-effectiveness studies on GCSF treatment and also the development of a national guideline for optimizing GCSF use. PMID:27252808

  1. Clinically relevant doses of chemotherapy agents reversibly block formation of glioblastoma neurospheres

    PubMed Central

    Mihaliak, Alicia M.; Gilbert, Candace A.; Li, Li; Daou, Marie-Claire; Moser, Richard P.; Reeves, Andrew; Cochran, Brent H.; Ross, Alonzo H.

    2010-01-01

    Glioblastoma patients have a poor prognosis, even after surgery, radiotherapy, and chemotherapy with temozolomide or 1,3-bis(2-chloroethy)-1-nitrosourea. We developed an in vitro recovery model using neurosphere cultures to analyze the efficacy of chemotherapy treatments, and tested whether glioblastoma neurosphere initiating cells are resistant. Concentrations of chemotherapy drugs that inhibit neurosphere formation are similar to clinically relevant doses. Some lines underwent a transient cell cycle arrest and a robust recovery of neurosphere formation. These results indicate that glioblastoma neurospheres can regrow after treatment with chemotherapy drugs. This neurosphere recovery assay will facilitate studies of chemo-resistant subpopulations and methods to enhance glioblastoma therapy. PMID:20435409

  2. Long-Term Survival Advantage and Prognostic Factors Associated With Intraperitoneal Chemotherapy Treatment in Advanced Ovarian Cancer: A Gynecologic Oncology Group Study

    PubMed Central

    Tewari, Devansu; Java, James J.; Salani, Ritu; Armstrong, Deborah K.; Markman, Maurie; Herzog, Thomas; Monk, Bradley J.; Chan, John K.

    2015-01-01

    Purpose To determine long-term survival and associated prognostic factors after intraperitoneal (IP) chemotherapy in patients with advanced ovarian cancer. Patients and Methods Data from Gynecologic Oncology Group protocols 114 and 172 were retrospectively analyzed. Cox proportional hazards regression models were used for statistical analyses. Results In 876 patients, median follow-up was 10.7 years. Median survival with IP therapy was 61.8 months (95% CI, 55.5 to 69.5), compared with 51.4 months (95% CI, 46.0 to 58.2) for intravenous therapy. IP therapy was associated with a 23% decreased risk of death (adjusted hazard ratio [AHR], 0.77; 95% CI, 0.65 to 0.90; P = .002). IP therapy improved survival of those with gross residual (≤ 1 cm) disease (AHR, 0.75; 95% CI, 0.62 to 0.92; P = .006). Risk of death decreased by 12% for each cycle of IP chemotherapy completed (AHR, 0.88; 95% CI, 0.83 to 0.94; P < .001). Factors associated with poorer survival included: clear/mucinous versus serous histology (AHR, 2.79; 95% CI, 1.83 to 4.24; P < .001), gross residual versus no visible disease (AHR, 1.89; 95% CI, 1.48 to 2.43; P < .001), and fewer versus more cycles of IP chemotherapy (AHR, 0.88; 95% CI, 0.83 to 0.94; P < .001). Younger patients were more likely to complete the IP regimen, with a 5% decrease in probability of completion with each year of age (odds ratio, 0.95; 95% CI, 0.93 to 0.96; P < .001). Conclusion The advantage of IP over intravenous chemotherapy extends beyond 10 years. IP therapy enhanced survival of those with gross residual disease. Survival improved with increasing number of IP cycles. PMID:25800756

  3. PET-Based Personalized Management in Clinical Oncology: An Unavoidable Path for the Foreseeable Future.

    PubMed

    Basu, Sandip; Alavi, Abass

    2016-07-01

    It is imperative that the thrust of clinical practice in the ensuing years would be to develop personalized management model for various disorders. PET-computed tomography (PET-CT) based molecular functional imaging has been increasingly utilized for assessment of tumor and other nonmalignant disorders and has the ability to explore disease phenotype on an individual basis and address critical clinical decision making questions related to practice of personalized medicine. Hence, it is essential to make a concerted systematic effort to explore and define the appropriate place of PET-CT in personalized clinical practice in each of malignancies, which would strengthen the concept further. The potential advantages of PET based disease management can be classified into broad categories: (1) Traditional: which includes assessment of disease extent such as initial disease staging and restaging, treatment response evaluation particularly early in the course and thus PET-CT response adaptive decision for continuing the same regimen or switching to salvage schedules; there has been continuous addition of newer application of PET based disease restaging in oncological parlance (eg, Richter transformation); (2) Recent and emerging developments: this includes exploring tumor biology with FDG and non-FDG PET tracers. The potential of multitracer PET imaging (particularly new and novel tracers, eg, 68Ga-DOTA-TOC/NOC/TATE in NET, 68Ga-PSMA and 18F-fluorocholine in prostate carcinoma, 18F-fluoroestradiol in breast carcinoma) has provided a scientific basis to stratify and select appropriate targeted therapies (both radionuclide and nonradionuclide treatment), a major boost for individualized disease management in clinical oncology. Integrating the molecular level information obtained from PET with structural imaging further individualizing treatment plan in radiation oncology, precision of interventions and biopsies of a particular lesion and forecasting disease prognosis. PMID

  4. The American Society of Clinical Oncology's Efforts to Support Global Cancer Medicine.

    PubMed

    Hortobagyi, Gabriel N; El-Saghir, Nagi S; Cufer, Tanja; Cazap, Eduardo; de Guzman, Roselle; Othieno-Abinya, Nicholas Anthony; Sanchez, Jose Angel; Pyle, Doug

    2016-01-01

    Despite much progress in the management of malignant diseases, the number of new cases and cancer-related deaths continues to rise around the world. More than half of new cases occur in economically developing countries, where more than two thirds of cancer deaths are expected. However, implementation of all necessary steps to accomplish the dissemination of state-of-the-art prevention, diagnosis, and management will require increased allocation of resources, and, more importantly, harmonization of the efforts of hundreds of national and international public health agencies, policy-setting bodies, governments, pharmaceutical companies, and philanthropic organizations. More than 30% of the members of the American Society of Clinical Oncology (ASCO) reside and practice outside US borders, and more than half of attendees at all of the scientific congresses and symposia organized by ASCO are international. As cancer has become an increasingly global disease, ASCO has evolved as a global organization. The ASCO Board of Directors currently includes members from France, Brazil, and Canada. In 2013, the ASCO Board of Directors identified a number of strategic priorities for the future. Recognizing the importance of non-US members to the society, their first strategic priority was improving the society's service to non-US members and defining these members' identity in the international oncology community. This article reviews current ASCO activities in the international arena and its future plans in global oncology. PMID:26578614

  5. Population pharmacokinetic–pharmacodynamic modelling in oncology: a tool for predicting clinical response

    PubMed Central

    Bender, Brendan C; Schindler, Emilie; Friberg, Lena E

    2015-01-01

    In oncology trials, overall survival (OS) is considered the most reliable and preferred endpoint to evaluate the benefit of drug treatment. Other relevant variables are also collected from patients for a given drug and its indication, and it is important to characterize the dynamic effects and links between these variables in order to improve the speed and efficiency of clinical oncology drug development. However, the drug-induced effects and causal relationships are often difficult to interpret because of temporal differences. To address this, population pharmacokinetic–pharmacodynamic (PKPD) modelling and parametric time-to-event (TTE) models are becoming more frequently applied. Population PKPD and TTE models allow for exploration towards describing the data, understanding the disease and drug action over time, investigating relevance of biomarkers, quantifying patient variability and in designing successful trials. In addition, development of models characterizing both desired and adverse effects in a modelling framework support exploration of risk-benefit of different dosing schedules. In this review, we have summarized population PKPD modelling analyses describing tumour, tumour marker and biomarker responses, as well as adverse effects, from anticancer drug treatment data. Various model-based metrics used to drive PD response and predict OS for oncology drugs and their indications are also discussed. PMID:24134068

  6. [Rethinking clinical research in surgical oncology. From comic opera to quality control].

    PubMed

    Evrard, Serge

    2016-01-01

    The evidence base for the effectiveness of surgical interventions is relatively poor and data from large, randomized prospective studies are rare with often a poor quality. Many efforts have been made to increase the number of high quality randomized trials in surgery and theoretical proposals have been put forward to improve the situation, but practical implementation of these proposals is seriously lacking. The consequences of this policy are not trivial; with very few patients included in surgical oncology trials, this represents wasted opportunity for advances in cancer treatment. In this review, we cover the difficulties inherent to clinical research in surgical oncology, such as quality control, equipoise, accrual, and funding and promote alternative designs to the randomized controlled trial. Although the classic randomized controlled trial has a valid but limited place in surgical oncology, other prospective designs need to be promoted as a new deal. This new deal not only implicates surgeons but also journal editors, tender jury, as well as regulatory bodies to cover legal gaps currently surrounding surgical innovation. PMID:26610367

  7. American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline.

    PubMed

    Runowicz, Carolyn D; Leach, Corinne R; Henry, N Lynn; Henry, Karen S; Mackey, Heather T; Cowens-Alvarado, Rebecca L; Cannady, Rachel S; Pratt-Chapman, Mandi L; Edge, Stephen B; Jacobs, Linda A; Hurria, Arti; Marks, Lawrence B; LaMonte, Samuel J; Warner, Ellen; Lyman, Gary H; Ganz, Patricia A

    2016-01-01

    Answer questions and earn CME/CNE The purpose of the American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline is to provide recommendations to assist primary care and other clinicians in the care of female adult survivors of breast cancer. A systematic review of the literature was conducted using PubMed through April 2015. A multidisciplinary expert workgroup with expertise in primary care, gynecology, surgical oncology, medical oncology, radiation oncology, and nursing was formed and tasked with drafting the Breast Cancer Survivorship Care Guideline. A total of 1073 articles met inclusion criteria; and, after full text review, 237 were included as the evidence base. Patients should undergo regular surveillance for breast cancer recurrence, including evaluation with a cancer-related history and physical examination, and should be screened for new primary breast cancer. Data do not support performing routine laboratory tests or imaging tests in asymptomatic patients to evaluate for breast cancer recurrence. Primary care clinicians should counsel patients about the importance of maintaining a healthy lifestyle, monitor for post-treatment symptoms that can adversely affect quality of life, and monitor for adherence to endocrine therapy. Recommendations provided in this guideline are based on current evidence in the literature and expert consensus opinion. Most of the evidence is not sufficient to warrant a strong evidence-based recommendation. Recommendations on surveillance for breast cancer recurrence, screening for second primary cancers, assessment and management of physical and psychosocial long-term and late effects of breast cancer and its treatment, health promotion, and care coordination/practice implications are made. PMID:26641959

  8. Clinical and Economic Burden of Emergency Department Presentations for Neutropenia Following Outpatient Chemotherapy for Cancer in Victoria, Australia

    PubMed Central

    Craike, Melinda; Slavin, Monica

    2012-01-01

    Objective. To examine the clinical characteristics and financial charges associated with treating adult cancer patients receiving chemotherapy in outpatient clinics who presented to the emergency department (ED) with neutropenia. Design and Setting. A retrospective audit was conducted across two health services involving ED episodes and subsequent hospital admissions of patients who received chemotherapy through day oncology from January 1 to December 31, 2007 and presented to the ED with neutropenia. ED data were collected from the Victorian Emergency Minimum Dataset and charges were collected from Health Information Services. Descriptive and bivariate statistics were used to describe the patient and clinical characteristics and financial outcomes, and to explore associations between these factors. Results. In total, 200 neutropenic episodes in 159 outpatients were seen in the ED over the survey period. The mean patient age was 56.6 years (standard deviation, 13.2 years) and 47.2% were male. Overall, 70.0% of ED episodes were triaged as Australasian Triage Scale 2 (emergency). The median ED wait time was 10 minutes and the median ED length of stay was 6.8 hours. The median charge for each ED episode was $764.08 Australian dollars. The total combined ED and inpatient charge per episode was in the range of $144.27–$174,732.68, with a median charge of $5,640.87. Conclusions. This study provides important insights into the clinical and economic burden of neutropenia from both the ED and inpatient perspectives. Alternative treatment models, such as outpatient treatment, early discharge programs or prophylactic interventions to reduce the clinical and economic burden of neutropenia on our health system, must be explored. PMID:22707511

  9. Advances in clinical research in gynecologic radiation oncology: an RTOG symposium.

    PubMed

    Gaffney, David; Mundt, Arno; Schwarz, Julie; Eifel, Patricia

    2012-05-01

    There have been inexorable improvements in gynecologic radiation oncology through technologically advances, 3-dimensional imaging, and clinical research. Investment in these 3 critical areas has improved, and will continue to improve, the lives of patients with gynecologic cancer. Advanced technology delivery in gynecologic radiation oncology is challenging owing to the following: (1) setup difficulties, (2) managing considerable internal organ motion, and (3) responding to tumor volume reduction during treatment. Image guidance is a potential route to solve these problems and improve delivery to tumor and sparing organs at risk. Imaging with positron emission tomography-computed tomography and magnetic resonance imaging are contributing significantly to improved accuracy in diagnosis, treatment, and follow-up in cancer of the cervix. Functional imaging by exploiting tumor biology may improve prognosis and treatment. Clinical trials have been the greatest mechanism to improve and establish standards of care in women with vulvar, endometrial, and cervical cancer. There have been multiple technological advances and practice changing trials within the past several decades. Many important questions remain in optimizing care for women with gynecologic malignancies. The performance of clinical trials will be advanced with the use of consistent language (ie, similar staging system and criteria), eligibility criteria that fit the research question, end points that matter, adequate statistical power, complete follow-up, and prompt publication of mature results. PMID:22398709

  10. Effect of Agaricus sylvaticus supplementation on nutritional status and adverse events of chemotherapy of breast cancer: A randomized, placebo-controlled, double-blind clinical trial

    PubMed Central

    Valadares, Fabiana; Garbi Novaes, Maria Rita Carvalho; Cañete, Roberto

    2013-01-01

    Background: Breast cancer (BC) represents the highest incidence of malignancy in women throughout the world. Medicinal fungi can stimulate the body, reduce side-effects associated with chemotherapy and improve the quality of life in patients with cancer. Aim: To evaluate the effects of dietary supplementation of Agaricus sylvaticus on clinical and nutritional parameters in BC patients undergoing chemotherapy. Materials and Methods: A randomized, placebo-controlled, double-blind, clinical trial was carried out at the Oncology Clinic, Hospital of the Federal District-Brazil from September 2007 to July 2009. Forty six patients with BC, Stage II and III, were randomly assigned to receive either nutritional supplement with A. sylvaticus (2.1 g/day) or placebo. Patients were evaluated during treatment period. Results: Patient supplemented with A. sylvaticus improved in clinical parameters and gastrointestinal functions. Poor appetite decreased by 20% with no changes in bowel functions (92.8%), nausea and vomiting (80%). Conclusion: Dietary supplementation with A. sylvaticus improved nutritional status and reduced abnormal bowel functions, nausea, vomiting, and anorexia in patients with BC receiving chemotherapy. PMID:23833361

  11. Vision 20/20: Automation and advanced computing in clinical radiation oncology

    SciTech Connect

    Moore, Kevin L. Moiseenko, Vitali; Kagadis, George C.; McNutt, Todd R.; Mutic, Sasa

    2014-01-15

    This Vision 20/20 paper considers what computational advances are likely to be implemented in clinical radiation oncology in the coming years and how the adoption of these changes might alter the practice of radiotherapy. Four main areas of likely advancement are explored: cloud computing, aggregate data analyses, parallel computation, and automation. As these developments promise both new opportunities and new risks to clinicians and patients alike, the potential benefits are weighed against the hazards associated with each advance, with special considerations regarding patient safety under new computational platforms and methodologies. While the concerns of patient safety are legitimate, the authors contend that progress toward next-generation clinical informatics systems will bring about extremely valuable developments in quality improvement initiatives, clinical efficiency, outcomes analyses, data sharing, and adaptive radiotherapy.

  12. Modeling Chemotherapy-Induced Hair Loss: From Experimental Propositions toward Clinical Reality.

    PubMed

    Botchkarev, Vladimir A; Sharov, Andrey A

    2016-03-01

    Chemotherapy-induced hair loss is one of the most devastating side effects of cancer treatment. To study the effects of chemotherapeutic agents on the hair follicle, a number of experimental models have been proposed. Yoon et al. report that transplantation of human scalp hair follicles onto chemotherapy-treated immunodeficient mice serves as an excellent in vivo model for chemotherapy-induced hair loss. Yoon et al. demonstrate that (i) the response of human hair follicles grafted onto immunodeficient mice to cyclophosphamide resembles the key features of the chemotherapy-induced hair loss seen in patients with cancer and (ii) this human in vivo model for chemotherapy-induced hair loss is closer to clinical reality than to any earlier models. Undoubtedly, this model will serve as a valuable tool for analyses of the mechanisms that underlie this devastating side effect of anti-cancer therapy. PMID:26902124

  13. Nonclinical Evaluations of Small-Molecule Oncology Drugs: Integration into Clinical Dose Optimization and Toxicity Management.

    PubMed

    Dambach, Donna M; Simpson, Natalie E; Jones, Thomas W; Brennan, Richard J; Pazdur, Richard; Palmby, Todd R

    2016-06-01

    Multidisciplinary approaches that incorporate nonclinical pharmacologic and toxicologic characterization of small-molecule oncology drugs into clinical development programs may facilitate improved benefit-risk profiles and clinical toxicity management in patients. The performance of the current nonclinical safety-testing scheme was discussed, highlighting current strengths and areas for improvement. While current nonclinical testing appears to predict the clinical outcome where the prevalence of specific adverse effects are high, nonclinical testing becomes less reliable for predicting clinical adverse effects that occur infrequently, as with some kinase inhibitors. Although adverse effects associated with kinase inhibitors can often be predicted on the basis of target biology, drugs can be promiscuous and inhibit targets with poorly defined function and associated risks. Improvements in adverse effect databases and better characterization of the biologic activities of drug targets may enable better use of computational modeling approaches in predicting adverse effects with kinase inhibitors. Assessing safety of a lead candidate in parallel with other drug properties enables incorporation of a molecule's best features during chemical design, eliminates the worst molecules early, and permits timely investigation/characterization of toxicity mechanisms for identified liabilities. A safety lead optimization and candidate identification strategy that reduces intrinsic toxicity and metabolic risk and enhances selectivity can deliver selective kinase inhibitors that demonstrate on-target adverse effects identified nonclinically. Integrating clinical and nonclinical data during drug development can facilitate better identification and management of oncology drugs. Follow-up nonclinical studies may be used to better understand the risks in a given patient population and minimize or manage these risks more appropriately. Clin Cancer Res; 22(11); 2618-22. ©2016 AACR SEE ALL

  14. Who Enrolls Onto Clinical Oncology Trials? A Radiation Patterns of Care Study Analysis

    SciTech Connect

    Movsas, Benjamin . E-mail: bmovsas1@hfhs.org; Moughan, Jennifer; Owen, Jean; Coia, Lawrence R.; Zelefsky, Michael J.; Hanks, Gerald; Wilson, J. Frank

    2007-07-15

    Purpose: To identify factors significantly influencing accrual to clinical protocols by analyzing radiation Patterns of Care Study (PCS) surveys of 3,047 randomly selected radiotherapy (RT) patients. Methods and Materials: Patterns of Care Study surveys from disease sites studied for the periods 1992-1994 and 1996-1999 (breast cancer, n = 1,080; prostate cancer, n = 1,149; esophageal cancer, n = 818) were analyzed. The PCS is a National Cancer Institute-funded national survey of randomly selected RT institutions in the United States. Patients with nonmetastatic disease who received RT as definitive or adjuvant therapy were randomly selected from eligible patients at each institution. To determine national estimates, individual patient records were weighted by the relative contribution of each institution and patients within each institution. Data regarding participation in clinical trials were recorded. The factors age, gender, race, type of insurance, and practice type of treating institution (academic or not) were studied by univariate and multivariate analyses. Results: Overall, only 2.7% of all patients were accrued to clinical protocols. Of these, 57% were enrolled on institutional review board-approved institutional trials, and 43% on National Cancer Institute collaborative group studies. On multivariate analysis, patients treated at academic facilities (p = 0.0001) and white patients (vs. African Americans, p = 0.0002) were significantly more likely to participate in clinical oncology trials. Age, gender, type of cancer, and type of insurance were not predictive. Conclusions: Practice type and race significantly influence enrollment onto clinical oncology trials. This suggests that increased communication and education regarding protocols, particularly focusing on physicians in nonacademic settings and minority patients, will be essential to enhance accrual.

  15. American Society of Clinical Oncology Position Statement on Obesity and Cancer

    PubMed Central

    Ligibel, Jennifer A.; Alfano, Catherine M.; Courneya, Kerry S.; Demark-Wahnefried, Wendy; Burger, Robert A.; Chlebowski, Rowan T.; Fabian, Carol J.; Gucalp, Ayca; Hershman, Dawn L.; Hudson, Melissa M.; Jones, Lee W.; Kakarala, Madhuri; Ness, Kirsten K.; Merrill, Janette K.; Wollins, Dana S.; Hudis, Clifford A.

    2014-01-01

    Rates of obesity have increased significantly over the last three decades in the United States and globally. In addition to contributing to heart disease and diabetes, obesity is a major unrecognized risk factor for cancer. Obesity is associated with worsened prognosis after cancer diagnosis and also negatively affects the delivery of systemic therapy, contributes to morbidity of cancer treatment, and may raise the risk of second malignancies and comorbidities. Research shows that the time after a cancer diagnosis can serve as a teachable moment to motivate individuals to adopt risk-reducing behaviors. For this reason, the oncology care team—the providers with whom a patient has the closest relationships in the critical period after a cancer diagnosis—is in a unique position to help patients lose weight and make other healthy lifestyle changes. The American Society of Clinical Oncology is committed to reducing the impact of obesity on cancer and has established a multipronged initiative to accomplish this goal by 1) increasing education and awareness of the evidence linking obesity and cancer; 2) providing tools and resources to help oncology providers address obesity with their patients; 3) building and fostering a robust research agenda to better understand the pathophysiology of energy balance alterations, evaluate the impact of behavior change on cancer outcomes, and determine the best methods to help cancer survivors make effective and useful changes in lifestyle behaviors; and 4) advocating for policy and systems change to address societal factors contributing to obesity and improve access to weight management services for patients with cancer. PMID:25273035

  16. Liver resection for colorectal liver metastases with peri-operative chemotherapy: oncological results of R1 resections

    PubMed Central

    Eveno, Clarisse; Karoui, Mehdi; Gayat, Etienne; Luciani, Alain; Auriault, Marie-Luce; Kluger, Michael D; Baumgaertner, Isabelle; Baranes, Laurence; Laurent, Alexis; Tayar, Claude; Azoulay, Daniel; Cherqui, Daniel

    2013-01-01

    Background Retrospective analysis of outcomes of R0 (negative margin) versus R1 (positive margin) liver resections for colorectal metastases (CLM) in the context of peri-operative chemotherapy. Methods All CLM resections between 2000 and 2006 were reviewed. Exclusion criteria included: macroscopically incomplete (R2) resections, the use of local treatment modalities, the presence of extra-hepatic disease and no peri-operative chemotherapy. R0/R1 status was based on pathological examination. Results Of 86 eligible patients, 63 (73%) had R0 and 23 (27%) had R1 resections. The two groups were comparable for the number, size of metastases and type of hepatectomy. The R1 group had more bilobar CLM (52% versus 24%, P = 0.018). The median follow-up was 3.1 years. Five-year overall and disease-free survival were 54% and 21% for the R0 group and 49% and 22% for the R1 group (P = 0.55 and P = 0.39, respectively). An intra-hepatic recurrence was more frequent in the R1 group (52% versus 27%, P = 0.02) and occurred more frequently at the surgical margin (22% versus 3%, P = 0.01). Discussion R1 resections were associated with a higher risk of intra-hepatic and surgical margin recurrence but did not negatively impact survival suggesting that in the era of efficient chemotherapy, the risk of an R1 resection should not be considered as a contraindication to surgery. PMID:23458567

  17. QIN. Promise and pitfalls of quantitative imaging in oncology clinical trials

    PubMed Central

    Kurland, Brenda F.; Gerstner, Elizabeth R.; Mountz, James M.; Schwartz, Lawrence H.; Ryan, Christopher W.; Graham, Michael M.; Buatti, John M.; Fennessy, Fiona M.; Eikman, Edward A.; Kumar, Virendra; Forster, Kenneth M.; Wahl, Richard L.; Lieberman, Frank S.

    2012-01-01

    Quantitative imaging using CT, MRI, and PET modalities will play an increasingly important role in the design of oncology trials addressing molecularly targeted, personalized therapies. The advent of molecularly targeted therapies, exemplified by antiangiogenic drugs, creates new complexities in the assessment of response. The Quantitative Imaging Network (QIN) addresses the need for imaging modalities which can accurately and reproducibly measure not just change in tumor size, but changes in relevant metabolic parameters, modulation of relevant signaling pathways, drug delivery to tumor, and differentiation of apoptotic cell death from other changes in tumor volume. This article provides an overview of the applications of quantitative imaging to phase 0 through phase 3 oncology trials. We describe the use of a range of quantitative imaging modalities in specific tumor types including malignant gliomas, lung cancer, head and neck cancer, lymphoma, breast cancer, prostate cancer, and sarcoma. In the concluding section, we discuss potential constraints on clinical trials using quantitative imaging, including complexity of trial conduct, impact on subject recruitment, incremental costs, and institutional barriers. Strategies for overcoming these constraints are presented. PMID:22898682

  18. Ethical issues of clinical trials in paediatric oncology from 2003 to 2013: a systematic review.

    PubMed

    Dupont, Jean-Claude K; Pritchard-Jones, Kathy; Doz, François

    2016-05-01

    A state-of-the art approach to the debates on ethical issues is key in order to gain guidance on research practices involving sick children and adolescents, as well as to identify research avenues in which it might be worth cooperating, to generate better or supplementary evidence. Based on a systematic literature search using MEDLINE, we report the main ethical developments in paediatric oncology clinical trials from 2003-13. The present knowledge about normative and empirical ethical demands in this setting is quantified and summarised in a list of 46 issues. This list primarily aims to provide readers with a comprehensive account of the main decision nodes and professional attitudes that enable families to make a safe, competent, and satisfactory decision about their child's enrolment, or non-participation, in cancer clinical trials. Our systematic Review shows how important it is for professionals to engage in a constant reflection on optimum trial designs, on the effect of offering trial participation on key family dynamics, and on the ways to understand families' needs and values accurately. In view of present scientific developments, we further emphasise the need to enhance societal awareness about research in children and adolescents, to prevent so-called research fatigue in small populations due to multiple solicitations or inadequate legal demands, and to reassess longstanding ethical certainties in the strictest view of promoting sick children's interests. This systematic Review allows a series of questions to be drawn to guide and encourage collective and individual endeavours that should lead to constant improvements in our research practices in paediatric clinical oncology research. PMID:27301046

  19. Medical Student Knowledge of Oncology and Related Disciplines: a Targeted Needs Assessment.

    PubMed

    Oskvarek, Jonathan; Braunstein, Steve; Farnan, Jeanne; Ferguson, Mark K; Hahn, Olwen; Henderson, Tara; Hong, Susan; Levine, Stacie; Rosenberg, Carol A; Golden, Daniel W

    2016-09-01

    Despite increasing numbers of cancer survivors, non-oncology physicians report discomfort and little training regarding oncologic and survivorship care. This pilot study assesses medical student comfort with medical oncology, surgical oncology, radiation oncology, hospice/palliative medicine, and survivorship care. A survey was developed with input from specialists in various fields of oncologic care at a National Cancer Institute-designated comprehensive cancer center. The survey included respondent demographics, reports of experience with oncology, comfort ratings with oncologic care, and five clinical vignettes. Responses were yes/no, multiple choice, Likert scale, or free response. The survey was distributed via email to medical students (MS1-4) at two US medical schools. The 105 respondents were 34 MS1s (32 %), 15 MS2s and MD/PhDs (14 %), 26 MS3s (25 %), and 30 MS4s (29 %). Medical oncology, surgical oncology, and hospice/palliative medicine demonstrated a significant trend for increased comfort from MS1 to MS4, but radiation oncology and survivorship care did not. MS3s and MS4s reported the least experience with survivorship care and radiation oncology. In the clinical vignettes, students performed the worst on the long-term chemotherapy toxicity and hospice/palliative medicine questions. Medical students report learning about components of oncologic care, but lack overall comfort with oncologic care. Medical students also fail to develop an increased self-assessed level of comfort with radiation oncology and survivorship care. These pilot results support development of a formalized multidisciplinary medical school oncology curriculum at these two institutions. An expanded national survey is being developed to confirm these preliminary findings. PMID:26153490

  20. Clinical roundtable monograph. Treatment of chemotherapy-induced nausea and vomiting: a post-MASCC 2010 discussion.

    PubMed

    Kris, Mark G; Urba, Susan G; Schwartzberg, Lee S

    2011-01-01

    Chemotherapy-induced nausea and vomiting (CINV) is one of the most common and troubling side effects of treatment, and the side effect cancer patients tend to fear most. An improved understanding of the pathophysiology underlying CINV, together with a clear definition of the risk for nausea and vomiting associated with specific chemotherapeutic agents, has for allowed the development of specific and effective antiemetic regimens. Anti­emesis is most effective when used prophylactically, a principle shared among CINV management guidelines. Several antiemetic drug classes are available; among the most effective of these are serotonin (5HT₃) receptor antagonists, neurokinin 1 (NK₁) receptor antagonists, and steroids (primarily dexamethasone), although others are commonly used as well. When choosing an appropriate antiemetic regimen, clinicians should consider patient-specific factors such as sex and prior history of CINV, as well as treatment-specific factors such as the emetogenic potential of each chemotherapeutic agent. Using these factors, clinicians can follow the available algorithms included in guidelines from groups such as the National Comprehensive Cancer Network, the American Society of Clinical Oncology, and the Multinational Association for Supportive Care in Cancer. Ongoing and future clinical trials will be pivotal in helping to further delineate the optimal strategies to prevent and manage CINV in cancer patients. PMID:21370520

  1. Increasing Minority Enrollment Onto Clinical Trials: Practical Strategies and Challenges Emerge From the NRG Oncology Accrual Workshop.

    PubMed

    Brooks, Sandra E; Muller, Carolyn Y; Robinson, William; Walker, Eleanor M; Yeager, Kate; Cook, Elise D; Friedman, Sue; Somkin, Carol P; Brown, Carol Leslie; McCaskill-Stevens, Worta

    2015-11-01

    Racial and ethnic diversity has historically been difficult to achieve in National Cancer Institute-sponsored clinical trials, even while as many as 80% of those trials have faced difficulty in meeting overall recruitment targets. In an attempt to address these issues, NRG Oncology recently convened a comprehensive workshop titled "Clinical Trials Enrollment: Challenges and Opportunities." Discussants at the workshop included representatives of the three legacy groups of the NRG (ie, Gynecologic Oncology Group, National Surgical Adjuvant Breast and Bowel Program, and Radiation Therapy Oncology Group), a minority-based community clinical oncology program, a large integrated health care system, the leadership of the National Cancer Institute, and a large patient advocacy group. This article summarizes the concepts discussed at the workshop, which included: needs assessments, infrastructural support, training of investigators and research staff, specific clinical trial recruitment strategies (both system and community based), and development and mentoring of young investigators. Many new, more specific tactics, including use of diverse cancer care settings, direct-to-consumer communication, and the need for centralized information technology such as the use of software to match trials to special populations, are presented. It was concluded that new, innovative trial designs and the realities of limited funding would require the adoption of effective and efficient recruiting strategies, specialized training, and stakeholder engagement. US clinical research programs must generate and embrace new ideas and pilot test novel recruitment strategies if they are to maintain their historic role as world leaders in cancer care innovation and delivery. PMID:26464496

  2. Overview, prevention and management of chemotherapy extravasation

    PubMed Central

    Kreidieh, Firas Y; Moukadem, Hiba A; El Saghir, Nagi S

    2016-01-01

    Chemotherapy extravasation remains an accidental complication of chemotherapy administration and may result in serious damage to patients. We review in this article the clinical aspects of chemotherapy extravasation and latest advances in definitions, classification, prevention, management and guidelines. We review the grading of extravasation and tissue damage according to various chemotherapeutic drugs and present an update on treatment and new antidotes including dexrazoxane for anthracyclines extravasation. We highlight the importance of education and training of the oncology team for prevention and prompt pharmacological and non-pharmacological management and stress the availability of new antidotes like dexrazoxane wherever anthracyclines are being infused. PMID:26862492

  3. Impact of an oncology palliative care clinic on access to home care services.

    PubMed

    Jang, Raymond W; Burman, Debika; Swami, Nadia; Kotler, Jennifer; Banerjee, Subrata; Ridley, Julia; Mak, Ernie; Bryson, John; Rodin, Gary; Le, Lisa W; Zimmermann, Camilla

    2013-08-01

    Home care (HC) is important for patients with cancer as performance status declines. Our study of 1224 patients at a Canadian cancer center examined the impact of an oncology palliative care clinic (OPCC) on HC referral. The HC referral frequency was calculated before and after the first OPCC consultation, in total and according to performance status (Palliative Performance Scale, PPS). Characteristics associated with HC referral were investigated. After the first OPCC consultation, there was an increase in HC referral from 39% (477 of 1224; 49% of those with PPS ≤60) to 69% (841 of 1224; 88% of those with PPS ≤60). Factors independently associated with HC referral were poor PPS (P < .001) and older age (P = .003). Thus OPCC involvement resulted in markedly increased HC referrals, particularly for older patients with poor performance status. PMID:22777408

  4. Digital Audio Recording of Initial Patient Visits to an Ocular Oncology Clinic: A Pilot Study.

    PubMed

    Seider, Michael I; Damato, Bertil E

    2015-05-01

    It is challenging for patients to receive a new diagnosis of a life-threatening ocular tumor when visiting an ocular oncology clinic for the first time. Audio recording of patient-physician interactions has been shown to be an effective memory aid and stress-reducing technique for patients with various types of nonophthalmic cancer. This study evaluated a protocol for digitally recording the initial conversation between the ocular oncologist and the patient. Twenty patients were enrolled in the study, and 13 patients (65%) returned the survey. All of the patients who returned the survey reported being "very satisfied" with the audio recording, indicating that patients with a newly diagnosed ocular tumor were highly satisfied with the audio recording of their conversations with the ocular oncologist. Although larger studies are needed to confirm this conclusion, the initial results are encouraging. PMID:26057768

  5. Clinical guidance on the perioperative use of targeted agents in solid tumor oncology.

    PubMed

    Mellor, James D; Cassumbhoy, Michelle; Jefford, Michael

    2011-06-01

    The use of targeted anti-cancer agents is increasing. It is common to utilize a multi-modal treatment approach towards solid tumors, often including surgical resection, and it has become apparent that some targeted agents can impair wound healing or cause an increased risk of perioperative complications. This article reviews targeted agents used in solid tumor oncology with an emphasis on clinically relevant details. Overall, the evidence of targeted agents causing surgical complications is limited. The greatest amount of evidence exists for bevacizumab causing perioperative complications, possibly due to its extended half-life. There are limited data for cetuximab, sorafenib and sunitinib and very little for other solid tumor targeted agents. Our findings suggest that there should be heightened pharmacovigilence around targeted agents with respect to perioperative complications and increased post-surgical support for patients to aid early detection of postoperative complications until definitive data become available. PMID:21585689

  6. Cancer stem-like cells: the dark knights of clinical hematology and oncology.

    PubMed

    Frinc, Ioana; Muresan, Mihai-Stefan; Zaharie, Florin; Petrov, Ljubomir; Irimie, Alexandra; Berce, Cristian; Berindan-Neagoe, Ioana; Tomuleasa, Ciprian

    2014-01-01

    According to recent epidemiological studies, malignant diseases represent the second cause of mortality worldwide and metastasis is the main cause of morbidity and mortality in most cancers. Even if the concept of "cancer stem cells" (CSCs) was anticipated by the genius of Rudolph Virchow, the father of modern pathology, more than 150 years ago, it is only in last few years that that scientists have begun to develop strategies aimed at inhibiting CSCs at a molecular level, the only way cancer can truly be attacked, by crossing the border between histology and molecular biology. The current concise review aims at emphasizing the main characteristics of tumor initiating cells, bridging the basic science to clinical hematology and oncology. PMID:24965388

  7. Uncaria tomentosa for Reducing Side Effects Caused by Chemotherapy in CRC Patients: Clinical Trial.

    PubMed

    Farias, I L G; Araújo, M C S; Farias, J G; Rossato, L V; Elsenbach, L I; Dalmora, S L; Flores, N M P; Durigon, M; Cruz, I B M; Morsch, V M; Schetinger, M R C

    2012-01-01

    To evaluate the effectiveness of Uncaria tomentosa in minimizing the side effects of chemotherapy and improving the antioxidant status of colorectal cancer (CRC) patients, a randomized clinical trial was conducted. Patients (43) undergoing adjuvant/palliative chemotherapy with 5-Fluorouracil/leucovorin + oxaliplatin (FOLFOX4) were split into two groups: the UT group received chemotherapy plus 300 mg of Uncaria tomentosa daily and the C group received only FOLFOX4 and served as a control. Blood samples were collected before each of the 6 cycles of chemotherapy, and hemograms, oxidative stress, enzymes antioxidants, immunologic parameters, and adverse events were analyzed. The use of 300 mg of Uncaria tomentosa daily during 6 cycles of FOLFOX4 did not change the analyzed parameters, and no toxic effects were observed. PMID:21869902

  8. Uncaria tomentosa for Reducing Side Effects Caused by Chemotherapy in CRC Patients: Clinical Trial

    PubMed Central

    Farias, I. L. G.; Araújo, M. C. S.; Farias, J. G.; Rossato, L. V.; Elsenbach, L. I.; Dalmora, S. L.; Flores, N. M. P.; Durigon, M.; Cruz, I. B. M.; Morsch, V. M.; Schetinger, M. R. C.

    2012-01-01

    To evaluate the effectiveness of Uncaria tomentosa in minimizing the side effects of chemotherapy and improving the antioxidant status of colorectal cancer (CRC) patients, a randomized clinical trial was conducted. Patients (43) undergoing adjuvant/palliative chemotherapy with 5-Fluorouracil/leucovorin + oxaliplatin (FOLFOX4) were split into two groups: the UT group received chemotherapy plus 300 mg of Uncaria tomentosa daily and the C group received only FOLFOX4 and served as a control. Blood samples were collected before each of the 6 cycles of chemotherapy, and hemograms, oxidative stress, enzymes antioxidants, immunologic parameters, and adverse events were analyzed. The use of 300 mg of Uncaria tomentosa daily during 6 cycles of FOLFOX4 did not change the analyzed parameters, and no toxic effects were observed. PMID:21869902

  9. Improving the Evidence Base for Treating Older Adults With Cancer: American Society of Clinical Oncology Statement.

    PubMed

    Hurria, Arti; Levit, Laura A; Dale, William; Mohile, Supriya G; Muss, Hyman B; Fehrenbacher, Louis; Magnuson, Allison; Lichtman, Stuart M; Bruinooge, Suanna S; Soto-Perez-de-Celis, Enrique; Tew, William P; Postow, Michael A; Cohen, Harvey J

    2015-11-10

    The American Society of Clinical Oncology (ASCO) convened a subcommittee to develop recommendations on improving the evidence base for treating older adults with cancer in response to a critical need identified by the Institute of Medicine. Older adults experience the majority of cancer diagnoses and deaths and make up the majority of cancer survivors. Older adults are also the fastest growing segment of the US population. However, the evidence base for treating this population is sparse, because older adults are underrepresented in clinical trials, and trials designed specifically for older adults are rare. The result is that clinicians have less evidence on how to treat older adults, who represent the majority of patients with cancer. Clinicians and patients are forced to extrapolate from trials conducted in younger, healthier populations when developing treatment plans. This has created a dearth of knowledge regarding the risk of toxicity in the average older patient and about key end points of importance to older adults. ASCO makes five recommendations to improve evidence generation in this population: (1) Use clinical trials to improve the evidence base for treating older adults with cancer, (2) leverage research designs and infrastructure for generating evidence on older adults with cancer, (3) increase US Food and Drug Administration authority to incentivize and require research involving older adults with cancer, (4) increase clinicians' recruitment of older adults with cancer to clinical trials, and (5) use journal policies to improve researchers' reporting on the age distribution and health risk profiles of research participants. PMID:26195697

  10. Efficacy and learning curve of a hand-held echocardiography device in an oncology outpatient clinic: Expanding the use of echoscopic heart examination beyond cardiology

    PubMed Central

    PéREZ DE ISLA, LEOPOLDO PÉREZ; MORENO, FERNANDO; GARCIA SAEZ, JOSE ANGEL GARCIA; CLAVERO, MATIAS; MORENO, NUNO; AGUADO DE LA ROSA, CARLOS AGUADO; DE AGUSTIN, JOSE ALBERTO; GOMEZ DE DIEGO, JOSE JUAN GOMEZ; COBOS, MIGUEL ANGEL; SALTIJERAL, ADRIANA; MACAYA, CARLOS; GARCIA-FERNANDEZ, MIGUEL ANGEL

    2015-01-01

    Certain chemotherapy drugs for breast cancer may induce cardiotoxicity and these patients should be echocardiographically monitored. The performance of a focused echocardiographic evaluation (echoscopy) at the patient's location by a non-cardiologist appears to be feasible. The aim of the present study was to assess the accuracy of echoscopy performed by medical oncologists in an outpatient clinic using hand-held echocardiography devices. The study cohort comprised consecutive unselected patients who attended an oncology outpatient clinic. Two medical oncologists attended a one-week training period, which included theoretical and practical teaching by an expert cardiologist. Every subject underwent two echo examinations. The first examination was performed by an oncologist using a hand-held echo device and the second was performed by a cardiologist using a ‘premium’ device. Out of the 101 enrolled patients, 32 were men (31.7%) and the mean age was 56.03±16.88 years. There was a good global agreement [intra-class correlation coefficient (ICC): 0.65 for left ventricular ejection fraction (LVEF)]. When the results were analyzed depending on the period of time when the echo studies were performed, a clear and short learning curve was observed: LVEF started at ICC=0.58 and increased to 0.66 and 0.77 in the second and third period, respectively. There were extremely few clinically significant differences and a learning curve was also evident. In conclusion, cardiac echoscopy performed by an oncologist with a hand-held device may lead to a similar clinical management as a study performed by an expert cardiologist with a ‘premium’ system in patients under chemotherapy following a short training period. PMID:26171188

  11. Cognitive function during and six months following chemotherapy for front-line treatment of ovarian, primary peritoneal or fallopian tube cancer: An NRG oncology/gynecologic oncology group study☆

    PubMed Central

    Hess, Lisa M.; Huang, Helen Q.; Hanlon, Alexandra L.; Robinson, William R.; Johnson, Rhonda; Chambers, Setsuko K.; Mannel, Robert S.; Puls, Larry; Davidson, Susan A.; Method, Michael; Lele, Shashikant; Havrilesky, Laura; Nelson, Tina; Alberts, David S.

    2015-01-01

    Objectives Changes in cognitive function have been identified in and reported by many cancer survivors. These changes have the potential to impact patient quality of life and functional ability. This prospective longitudinal study was designed to quantify the incidence of change in cognitive function in newly diagnosed ovarian cancer patients throughout and following primary chemotherapy. Methods Eligible patients had newly diagnosed, untreated ovarian cancer and had planned to receive chemotherapy. Web-based and patient reported cognitive assessments and quality of life questionnaires were conducted prior to chemotherapy, prior to cycle four, after cycle six, and six months after completion of primary therapy. Results Two-hundred-thirty-one evaluable patients entered this study between May 2010 and October 2011. At the cycle 4 time point, 25.2% (55/218) of patients exhibited cognitive impairment in at least one domain. At the post-cycle 6 and 6-month follow up time points, 21.1% (44/208) and 17.8% (30/169) of patients, respectively, demonstrated impairment in at least one domain of cognitive function. There were statistically significant, but clinically small, improvements in processing speed (p < 0.001) and attention (p < 0.001) but not in motor response time (p = 0.066), from baseline through the six-month follow up time period. Conclusions This was a large, prospective study designed to measure cognitive function in ovarian cancer. A subset of patients had evidence of cognitive decline from baseline during chemotherapy treatment in this study as measured by the web-based assessment; however, changes were generally limited to no more than one domain. PMID:26456812

  12. Benefit from prolonged dose-intensive chemotherapy for infants with malignant brain tumors is restricted to patients with ependymoma: a report of the Pediatric Oncology Group randomized controlled trial 9233/34

    PubMed Central

    Strother, Douglas R.; Lafay-Cousin, Lucie; Boyett, James M.; Burger, Peter; Aronin, Patricia; Constine, Louis; Duffner, Patricia; Kocak, Mehmet; Kun, Larry E.; Horowitz, Marc E.; Gajjar, Amar

    2014-01-01

    Background The randomized controlled Pediatric Oncology Group study 9233 tested the hypothesis that dose-intensive (DI) chemotherapy would improve event-free survival (EFS) for children <3 years of age with newly diagnosed malignant brain tumors. Methods Of 328 enrolled eligible patients, diagnoses were medulloblastoma (n = 112), ependymoma (n = 82), supratentorial primitive neuroectodermal tumor (sPNET, n = 38) and other malignant brain tumors (n = 96), and were randomized to 72 weeks of standard dose chemotherapy (Regimen A, n = 162) or DI chemotherapy (Regimen B, n = 166). Radiation therapy (RT) was recommended for patients with evidence of disease at completion of chemotherapy or who relapsed within 6 months of chemotherapy completion. Results Distributions of EFS for Regimens A and B were not significantly different (P = 0.32) with 2- and 10-year rates of 22.8% ± 3.3% and 15.4% ± 3.7%, and 27.1% ± 3.4% and 20.8% ± 3.8%, respectively. Thus, the study hypothesis was rejected. While distributions of EFS and OS were not significantly different between Regimens A and B for patients with medulloblastoma and sPNET, DI chemotherapy resulted in significantly improved EFS distribution (P = .0011) (2-year EFS rates of 42.1% vs. 19.6% with SD chemotherapy), but not OS distribution, for patients with centrally confirmed ependymoma. The degree of surgical resection affected EFS, OS or both for most tumor groups. Approximately 20%, 40% and 20% of patients with medulloblastoma, ependymoma treated with DI chemotherapy, and sPNET, respectively appear to have been cured without RT. Of 11 toxic deaths on study, 10 occurred on the DI chemotherapy arm. Conclusions Prolonged dose-intensive chemotherapy given to infants with malignant brain tumors resulted in increased EFS only for patients with ependymoma. PMID:24335695

  13. Ovarian cancer clinical trial endpoints: Society of Gynecologic Oncology white paper

    PubMed Central

    Herzog, Thomas J.; Armstrong, Deborah K.; Brady, Mark F.; Coleman, Robert L.; Einstein, Mark H.; Monk, Bradley J.; Mannel, Robert S.; Thigpen, J. Tate; Umpierre, Sharee A.; Villella, Jeannine A.; Alvarez, Ronald D.

    2015-01-01

    Objective To explore the value of multiple clinical endpoints in the unique setting of ovarian cancer. Methods A clinical trial workgroup was established by the Society of Gynecologic Oncology to develop a consensus statement via multiple conference calls, meetings and white paper drafts. Results Clinical trial endpoints have profound effects on late phase clinical trial design, result interpretation, drug development, and regulatory approval of therapeutics. Selection of the optimal clinical trial endpoint is particularly provocative in ovarian cancer where long overall survival (OS) is observed. The lack of new regulatory approvals and the lack of harmony between regulatory bodies globally for ovarian cancer therapeutics are of concern. The advantages and disadvantages of the numerous endpoints available are herein discussed within the unique context of ovarian cancer where both crossover and post-progression therapies potentially uncouple surrogacy between progression-free survival (PFS) and OS, the two most widely supported and utilized endpoints. The roles of patient reported outcomes (PRO) and health related quality of life (HRQoL) are discussed, but even these widely supported parameters are affected by the unique characteristics of ovarian cancer where a significant percentage of patients may be asymptomatic. Original data regarding the endpoint preferences of ovarian cancer advocates is presented. Conclusions Endpoint selection in ovarian cancer clinical trials should reflect the impact on disease burden and unique characteristics of the treatment cohort while reflecting true patient benefit. Both OS and PFS have led to regulatory approvals and are clinically important. OS remains the most objective and accepted endpoint because it is least vulnerable to bias; however, the feasibility of OS in ovarian cancer is compromised by the requirement for large trial size, prolonged time-line for final analysis, and potential for unintended loss of treatment effect

  14. Ecological analysis of the first generation of community clinical oncology programs.

    PubMed Central

    Schopler, J H

    1993-01-01

    OBJECTIVE. An ecological framework is proposed for assessing factors important to consider in allocating funds to promote sound performance of interorganizational programs. DATA SOURCE/STUDY SETTING. This framework is used to examine the first generation of Community Clinical Oncology Programs (CCOPs) funded by the National Cancer Institute (NCI) from 1983-1986 to coordinate clinical research activity at the local level. The research reported is based on secondary data collected for the Community Cancer Care Evaluation at the Fred Hutchinson Cancer Center. STUDY DESIGN. A repeated measures design was used to analyze differences in the level and patterns of CCOP productivity, a measure of the number of patients enrolled on NCI-approved Phase III trials. The predictive dimensions include (1) measures of environmental inputs (population density, organizational dominance, professional support, NCI funding); (2) measures of organizational inputs (number of hospitals, number of staff, number of physicians, NCI experience, clinical research experience); and (3) structural measures (functional specialization, administrative concentration). Predicted relationships were assessed using general linear models procedures. DATA COLLECTION/EXTRACTION METHODS. Data obtained from NCI files were supplemented by interviews with NCI personnel and published statistics. PRINCIPAL FINDINGS. Funding level, clinical research experience, and number of staff are the most important predictors of patient enrollment. Clinical research experience has a positive relationship with patient enrollment and a negative association with changes in enrollment. The reversal is explained by the influence of the CCOPs that had the greatest amount of clinical research experience at the beginning of the program. CONCLUSIONS. The ecological approach provides a useful framework for understanding factors that should be considered in funding interorganizational programs and promoting their development. Most

  15. Clinical analysis of chronic lung injury in patients with non-Hodgkin lymphoma after CHOP chemotherapy.

    PubMed

    Sun, Zhenchang; Li, Xin; Wu, Xiaolong; Fu, Xiaorui; Li, Ling; Zhang, Lei; Chang, Yu; Zhang, Mingzhi

    2014-12-01

    We conducted a preliminarily study on the clinical characteristics of chronic lung injury (CLI) in patients with non-Hodgkin lymphoma (NHL) after CHOP chemotherapy and observed the effects of this injury on CHOP treatment efficacy. Sixty patients who were diagnosed as NHL and received CHOP chemotherapy in hospital were enrolled for this clinical trial. CLI was assessed by clinical symptoms and computed tomography (CT) scan conducted before and after chemotherapy. The effect of CLI on the efficacy of CHOP chemotherapy in patients with NHL was evaluated by comparing treatment response and recurrence rate to patients with no signs of lung injury. Our CT scans revealed multiple signs of CLI in 35 patients (56.67 %), such as pulmonary diffuse, limited infiltration shadow or ground glass-like changes. Among them, 23 patients (38.33 %) showed bilateral diffuse lung injury and 12 (20.00 %) showed topical lung injury. Most patients suffering from 6 to 12 months delayed recurrence exhibited signs of CLI. The inflammatory response of CLI may increase the risk of disease progression and recurrence. Therefore, early diagnosis and intervention, which play a positive role in the clinical treatment and the long-term efficacy, are critical for patients with NHL. PMID:25201066

  16. Immunodynamics: a cancer immunotherapy trials network review of immune monitoring in immuno-oncology clinical trials.

    PubMed

    Kohrt, Holbrook E; Tumeh, Paul C; Benson, Don; Bhardwaj, Nina; Brody, Joshua; Formenti, Silvia; Fox, Bernard A; Galon, Jerome; June, Carl H; Kalos, Michael; Kirsch, Ilan; Kleen, Thomas; Kroemer, Guido; Lanier, Lewis; Levy, Ron; Lyerly, H Kim; Maecker, Holden; Marabelle, Aurelien; Melenhorst, Jos; Miller, Jeffrey; Melero, Ignacio; Odunsi, Kunle; Palucka, Karolina; Peoples, George; Ribas, Antoni; Robins, Harlan; Robinson, William; Serafini, Tito; Sondel, Paul; Vivier, Eric; Weber, Jeff; Wolchok, Jedd; Zitvogel, Laurence; Disis, Mary L; Cheever, Martin A

    2016-01-01

    The efficacy of PD-1/PD-L1 targeted therapies in addition to anti-CTLA-4 solidifies immunotherapy as a modality to add to the anticancer arsenal. Despite raising the bar of clinical efficacy, immunologically targeted agents raise new challenges to conventional drug development paradigms by highlighting the limited relevance of assessing standard pharmacokinetics (PK) and pharmacodynamics (PD). Specifically, systemic and intratumoral immune effects have not consistently correlated with standard relationships between systemic dose, toxicity, and efficacy for cytotoxic therapies. Hence, PK and PD paradigms remain inadequate to guide the selection of doses and schedules, both starting and recommended Phase 2 for immunotherapies. The promise of harnessing the immune response against cancer must also be considered in light of unique and potentially serious toxicities. Refining immune endpoints to better inform clinical trial design represents a high priority challenge. The Cancer Immunotherapy Trials Network investigators review the immunodynamic effects of specific classes of immunotherapeutic agents to focus immune assessment modalities and sites, both systemic and importantly intratumoral, which are critical to the success of the rapidly growing field of immuno-oncology. PMID:26981245

  17. Physician Recruitment of Patients to Non-Therapeutic Oncology Clinical Trials: Ethics Revisited

    PubMed Central

    Black, Lee; Batist, Gerald; Avard, Denise; Rousseau, Caroline; Diaz, Zuanel; Knoppers, Bartha Maria

    2013-01-01

    Tailoring medical treatment to individual patients requires a strong foundation in research to provide the data necessary to understand the relationship between the disease, the patient, and the type of treatment advocated for. Non-therapeutic oncology clinical trials studying therapeutic resistance require the participation of patients, yet only a small percentage enroll. Treating physicians are often relied on to recruit patients, but they have a number of ethical obligations that might be perceived as barriers to recruiting. Concepts such as voluntariness of consent and conflicts of interest can have an impact on whether physicians will discuss clinical trials with their patients and how patients perceive the information. However, these ethical obligations should not be prohibitive to physician recruitment of patients – precautions can be taken to ensure that patients’ consent to research participation is fully voluntary and devoid of conflict, such as the use of other members of the research team than the treating physician to discuss the trial and obtain consent, and better communication between researchers, clinicians, and patients. These can ensure that research benefits are maximized for the good of patients and society. PMID:23483771

  18. [Potential clinical benefit of therapeutic drug monitoring of imatinib in oncology].

    PubMed

    Turjap, M; Juřica, J; Demlová, R

    2015-01-01

    Imatinib mesylate is a competitive inhibitor of BCR/ ABL tyrosine kinase and inhibits also several receptor tyrosin kinases. Since its launch to the market, imatinib has proven to be very valuable in the treatment of Philadelphia chromosome (BCR/ ABL) -  positive (Ph+) chronic myeloid leukemia and Kit (CD117) positive gastrointestinal stromal tumors. The drug is metabolized by cytochrome P450, and there are many clinically important pharmacokinetic drug-drug interactions described in the literature. Frequent polypharmacy in oncological patients increases probability of such interactions, and also adherence may play its role during longterm treatment. Fixed dosing therapeutic regimens fail to respect known interindividual variability in pharmacokinetics of the drug and thus, some patients may not achieve sufficient plasma concentrations. Based on current evidence, there seems to be a relationship between plasma concentration and clinical response to imatinib. Therefore, imatinib appears to be suitable candidate for therapeutic drug monitoring. Here, we present an overview of pharmacokinetics, drug-drug interactions and current knowledge and suggestions on therapeutic drug monitor-ing of imatinib, its potential benefits and limitations. PMID:25882020

  19. Inside the 2016 American Society of Clinical Oncology Genitourinary Cancers Symposium: part 2 - prostate and bladder cancer.

    PubMed

    Buti, Sebastiano; Ciccarese, Chiara; Iacovelli, Roberto; Bersanelli, Melissa; Scarpelli, Marina; Lopez-Beltran, Antonio; Cheng, Liang; Montironi, Rodolfo; Tortora, Giampaolo; Massari, Francesco

    2016-09-01

    The American Society of Clinical Oncology Genitourinary Cancers Symposium, Moscone West Building, San Francisco, CA, USA, 7-9 January 2016 The American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, held in San Francisco (CA, USA), from 7 to 9 January 2016, focused on 'patient-centric care: translating research to results'. Every year, this meeting is a must for anyone studying genitourinary tumors to keep abreast of the most recent innovations in this field, exchange views on behaviors customarily adopted in daily clinical practice and discuss future topics of scientific research. This two-part report highlights the key themes presented at the 2016 ASCO Genitourinary Cancers Symposium, with part 1 reporting the main novelties of kidney cancer and part 2 discussing the most relevant issues which have emerged for bladder and prostate tumors. PMID:27312584

  20. Invited review: study design considerations for clinical research in veterinary radiology and radiation oncology.

    PubMed

    Scrivani, Peter V; Erb, Hollis N

    2013-01-01

    High quality clinical research is essential for advancing knowledge in the areas of veterinary radiology and radiation oncology. Types of clinical research studies may include experimental studies, method-comparison studies, and patient-based studies. Experimental studies explore issues relative to pathophysiology, patient safety, and treatment efficacy. Method-comparison studies evaluate agreement between techniques or between observers. Patient-based studies investigate naturally acquired disease and focus on questions asked in clinical practice that relate to individuals or populations (e.g., risk, accuracy, or prognosis). Careful preplanning and study design are essential in order to achieve valid results. A key point to planning studies is ensuring that the design is tailored to the study objectives. Good design includes a comprehensive literature review, asking suitable questions, selecting the proper sample population, collecting the appropriate data, performing the correct statistical analyses, and drawing conclusions supported by the available evidence. Most study designs are classified by whether they are experimental or observational, longitudinal or cross-sectional, and prospective or retrospective. Additional features (e.g., controlled, randomized, or blinded) may be described that address bias. Two related challenging aspects of study design are defining an important research question and selecting an appropriate sample population. The sample population should represent the target population as much as possible. Furthermore, when comparing groups, it is important that the groups are as alike to each other as possible except for the variables of interest. Medical images are well suited for clinical research because imaging signs are categorical or numerical variables that might be predictors or outcomes of diseases or treatments. PMID:23578318

  1. [Understanding positon emission tomography (PET) with [18F]-FDG in clinical oncology. Informations dedicated to patients and relatives].

    PubMed

    Bourguet, Patrick; Brusco, Sylvie; Corone, Corinne; Devillers, Anne; Foehrenbach, Hervé; Lumbroso, Jean-Daniel; Maszelin, Philippe; Montravers, Françoise; Moretti, Jean-Luc; Rain, Jean-Didier; Talbot, Jean-Noël; Carretier, Julien; Leichtnam-Dugarin, Line; Delavigne, Valérie; Philip, Thierry; Fervers, Béatrice

    2005-07-01

    In response to the evolution of the information-seeking behaviour of patients and concerns from health professionals regarding cancer patient information, the French National Federation of Comprehensive Cancer Centres (FNCLCC) introduced, in 1998, an information and education program dedicated to patients and relatives, the SOR SAVOIR PATIENT program (SSP). The methodology of this program adheres to established quality criteria regarding the elaboration of patient information. Cancer patient information, developed in this program, is based on clinical practice guidelines produced by the FNCLCC and the twenty French regional cancer centres, the National League against Cancer, the French Hospital Federation, the National Oncology Federation of Regional and University Hospitals, the French Oncology Federation of General Hospitals, many learned societies, as well as an active participation of patients, former patients and caregivers. The guidelines, "Standards, Options: Recommendations" (SOR) are used as primary information sources. The handbook SOR SAVOIR PATIENT Understanding positron emission tomography (PET) with [18F]-FDG in clinical oncology, integrally published in this issue of the Bulletin du Cancer, is an adapted version of the clinical practice guidelines (CPG) Standards, Options and Recommendations for positron emission tomography (PET) with [18F]-FDG in clinical oncology. The main objectives of this article are to allow persons affected by cancer and their close relatives to better understand this medical imaging technique and its implementation. This document also offers health professionals a synthetic evidence-based patient information source that should help them communicate that information during the physician-patient encounter. Positron emission tomography (PET) is a scintigraphy technique using a radiotracer, [18F]-fluorodeoxyglucose (abbreviated [18F]-FDG), administered intravenously into the patient's arm. This tracer, similar to glucose (sugar

  2. Monitoring of the Environment at the Transplant Unit—Hemato-Oncology Clinic

    PubMed Central

    Matoušková, Ivanka; Holy, Ondřej

    2014-01-01

    Aims: Aim of this study was to monitor the environment at the Transplant Unit—Hemato-Oncology Clinic, University Hospital Olomouc (Olomouc, Czech Republic) and identify risks for the patients. Methods and Results: Microorganisms were cultivated under standard aerobic conditions. Strains were biochemically identified using the BD Phoenix™ PID Panel (USA). Legionella pneumophila was identified by DNA sequencing. From the air, the most frequently isolated strains were coagulase-negative staphylococci (94.3%), Micrococcus spp. and Bacillus spp. No Gram-negative strains were isolated from the air. From the surfaces, the most frequently isolated Gram-positive strains were coagulase-negative staphylococci (67.4%), Bacillus spp., enterococci (5.5%), Staphylococcus aureus (2.3%) and Micrococcus spp. (1.7%). From the surfaces, the most frequently isolated Gram-negative strains were from genera Pseudomonas (28%), Enterobacter (28%), E. coli (6%), and Klebsiella spp. (5%). From the personnel, the most frequently isolated Gram-positive strains were coagulase-negative staphylococci (59.6%), Bacillus spp. (24.1%) and Staphylococcus aureus (9.8%). From the personnel, the most frequently isolated Gram-negative strains were Enterobacter spp. (61%), Klebsiella oxytoca (18%), and E. coli (11%). Microscopic filamentous fungi were isolated in 13 cases (2.71%). Isolated strains were Aspergillus spp. (4), Trichoderma spp. (2), Penicillium spp. (2), one case of the strains Paecilomyces spp., Eurotium spp., Monilia spp. Conclusions: The study found no significant deviations in the microbial contamination of the cleanroom air. The personnel entrance of the Transplant Unit represent a high risk area, an extreme value (7270 CFU/m3) was recorded. Regime measures are fully effective, no other deficiencies were found. Significance and Impact of the Study: This epidemiological study, which was held for the duration of one year at the Transplant Unit—Hemato-Oncology Clinic, University

  3. Antimalarial Chemotherapy: Natural Product Inspired Development of Preclinical and Clinical Candidates with Diverse Mechanisms of Action.

    PubMed

    Fernández-Álvaro, Elena; Hong, W David; Nixon, Gemma L; O'Neill, Paul M; Calderón, Félix

    2016-06-23

    Natural products have played a pivotal role in malaria chemotherapy progressing from quinine and artemisinin to ozonide-based compounds. Many of these natural products have served as template for the design and development of antimalarial drugs currently in the clinic or in the development phase. In this review, we will detail those privileged scaffolds that have guided medicinal chemistry efforts yielding molecules that have reached the clinic. PMID:26791529

  4. Soft Tissue Sarcoma, Version 2.2016, NCCN Clinical Practice Guidelines in Oncology.

    PubMed

    von Mehren, Margaret; Randall, R Lor; Benjamin, Robert S; Boles, Sarah; Bui, Marilyn M; Conrad, Ernest U; Ganjoo, Kristen N; George, Suzanne; Gonzalez, Ricardo J; Heslin, Martin J; Kane, John M; Koon, Henry; Mayerson, Joel; McCarter, Martin; McGarry, Sean V; Meyer, Christian; O'Donnell, Richard J; Pappo, Alberto S; Paz, I Benjamin; Petersen, Ivy A; Pfeifer, John D; Riedel, Richard F; Schuetze, Scott; Schupak, Karen D; Schwartz, Herbert S; Tap, William D; Wayne, Jeffrey D; Bergman, Mary Anne; Scavone, Jillian

    2016-06-01

    Soft tissue sarcomas (STS) are rare solid tumors of mesenchymal cell origin that display a heterogenous mix of clinical and pathologic characteristics. STS can develop from fat, muscle, nerves, blood vessels, and other connective tissues. The evaluation and treatment of patients with STS requires a multidisciplinary team with demonstrated expertise in the management of these tumors. The complete NCCN Guidelines for Soft Tissue Sarcoma (available at NCCN.org) provide recommendations for the diagnosis, evaluation, and treatment of extremity/superficial trunk/head and neck STS, as well as intra-abdominal/retroperitoneal STS, gastrointestinal stromal tumor, desmoid tumors, and rhabdomyosarcoma. This manuscript discusses guiding principles for the diagnosis and staging of STS and evidence for treatment modalities that include surgery, radiation, chemoradiation, chemotherapy, and targeted therapy. PMID:27283169

  5. Cognition and Quality of Life After Chemotherapy Plus Radiotherapy (RT) vs. RT for Pure and Mixed Anaplastic Oligodendrogliomas: Radiation Therapy Oncology Group Trial 9402

    SciTech Connect

    Wang Meihua; Cairncross, Gregory; Shaw, Edward

    2010-07-01

    Purpose: Radiation Therapy Oncology Group 9402 compared procarbazine, lomustine, and vincristine (PCV) chemotherapy plus radiation therapy (PCV + RT) vs. RT alone for anaplastic oligodendroglioma. Here we report longitudinal changes in cognition and quality of life, effects of patient factors and treatments on cognition, quality of life and survival, and prognostic implications of cognition and quality of life. Methods and Materials: Cognition was assessed by Mini Mental Status Examination (MMSE) and quality of life by Brain-Quality of Life (B-QOL). Scores were analyzed for survivors and within 5 years of death. Shared parameter models evaluated MMSE/B-QOL with survival. Results: For survivors, MMSE and B-QOL scores were similar longitudinally and between treatments. For those who died, MMSE scores remained stable initially, whereas B-QOL slowly declined; both declined rapidly in the last year of life and similarly between arms. In the aggregate, scores decreased over time (p = 0.0413 for MMSE; p = 0.0016 for B-QOL) and were superior with age <50 years (p < 0.001 for MMSE; p = 0.0554 for B-QOL) and Karnofsky Performance Score (KPS) 80-100 (p < 0.001). Younger age and higher KPS were associated with longer survival. After adjusting for patient factors and drop-out, survival was longer after PCV + RT (HR = 0.66, 95% CI = 0.49-0.9, p = 0.0084; HR = 0.74, 95% CI = 0.54-1.01, p = 0.0592) in models with MMSE and B-QOL. In addition, there were no differences in MMSE and B-QOL scores between arms (p = 0.4752 and p = 0.2767, respectively); higher scores predicted longer survival. Conclusion: MMSE and B-QOL scores held steady in the upper range in both arms for survivors. Younger, fitter patients had better MMSE and B-QOL and longer survival.

  6. Clinical cancer advances 2011: Annual Report on Progress Against Cancer from the American Society of Clinical Oncology.

    PubMed

    Vogelzang, Nicholas J; Benowitz, Steven I; Adams, Sylvia; Aghajanian, Carol; Chang, Susan Marina; Dreyer, Zoann Eckert; Janne, Pasi A; Ko, Andrew H; Masters, Greg A; Odenike, Olatoyosi; Patel, Jyoti D; Roth, Bruce J; Samlowski, Wolfram E; Seidman, Andrew D; Tap, William D; Temel, Jennifer S; Von Roenn, Jamie H; Kris, Mark G

    2012-01-01

    A message from ASCO'S President. It has been forty years since President Richard Nixon signed the National Cancer Act of 1971, which many view as the nation's declaration of the "War on Cancer." The bill has led to major investments in cancer research and significant increases in cancer survival. Today, two-thirds of patients survive at least five years after being diagnosed with cancer compared with just half of all diagnosed patients surviving five years after diagnosis in 1975. The research advances detailed in this year's Clinical Cancer Advances demonstrate that improvements in cancer screening, treatment, and prevention save and improve lives. But although much progress has been made, cancer remains one of the world's most serious health problems. In the United States, the disease is expected to become the nation's leading cause of death in the years ahead as our population ages. I believe we can accelerate the pace of progress, provided that everyone involved in cancer care works together to achieve this goal. It is this viewpoint that has shaped the theme for my presidential term: Collaborating to Conquer Cancer. In practice, this means that physicians and researchers must learn from every patient's experience, ensure greater collaboration between members of a patient's medical team, and involve more patients in the search for cures through clinical trials. Cancer advocates, insurers, and government agencies also have important roles to play. Today, we have an incredible opportunity to improve the quality of cancer care by drawing lessons from the real-world experiences of patients. The American Society of Clinical Oncology (ASCO) is taking the lead in this area, in part through innovative use of health information technology. In addition to our existing quality initiatives, ASCO is working with partners to develop a comprehensive rapid-learning system for cancer care. When complete, this system will provide physicians with personalized, real

  7. [Surgical procedure after primary chemotherapy of breast carcinoma--an unresolved clinical problem].

    PubMed

    Nitz, U; Rezai, M; Daubel, A; Mohrmann, S; Bender, H G

    2000-01-01

    Neoadjuvant chemotherapy has more and more become clinical routine during the past years. Results from large randomized trials like NSABP-B18 show that survival parameters are not affected if sequence of therapy is changed. Survival parameters have been intensively studied, but surgical standards after primary chemotherapy are much less well defined. Results from the early trials comparing lumpectomy or quadrantectomy with mastectomy are generally transposed to the neoadjuvant situation. In this context the "result of downstaging" is surgically treated like otherwise the primary tumor would have been treated. Though local recurrence rates reported after primary chemotherapy are not increased within the whole population this may not be correct for subgroups. E.g. within the NSABP-B18 trial significantly higher local recurrence rates are reported for those patients who initially were proposed to have mastectomy and who actually received lumpectomy after effective primary chemotherapy. Another unresolved problem is surgery after complete remission, which as histopathology demonstrates corresponds often not to pathological complete remission. Therefore in most cases the initially involved area is resected, which may result in a more radical surgical approach to complete remission than to partial remission. Further standardisation of surgical approach to patients after neoadjuvant chemotherapy should be evaluated within phase III trials. PMID:10857211

  8. A Phase 3 Trial of 2 Years of Androgen Suppression and Radiation Therapy With or Without Adjuvant Chemotherapy for High-Risk Prostate Cancer: Final Results of Radiation Therapy Oncology Group Phase 3 Randomized Trial NRG Oncology RTOG 9902

    SciTech Connect

    Rosenthal, Seth A.; Hunt, Daniel; Sartor, A. Oliver; Pienta, Kenneth J.; Gomella, Leonard; Grignon, David; Rajan, Raghu; Kerlin, Kevin J.; Jones, Christopher U.; Dobelbower, Michael; Shipley, William U.; Zeitzer, Kenneth; Hamstra, Daniel A.; Donavanik, Viroon; Rotman, Marvin; Hartford, Alan C.; Michalski, Jeffrey; Seider, Michael; Kim, Harold; and others

    2015-10-01

    Purpose: Long-term (LT) androgen suppression (AS) with radiation therapy (RT) is a standard treatment of high-risk, localized prostate cancer (PCa). Radiation Therapy Oncology Group 9902 was a randomized trial testing the hypothesis that adjuvant combination chemotherapy (CT) with paclitaxel, estramustine, and oral etoposide plus LT AS plus RT would improve overall survival (OS). Methods and Materials: Patients with high-risk PCa (prostate-specific antigen 20-100 ng/mL and Gleason score [GS] ≥7 or clinical stage ≥T2 and GS ≥8) were randomized to RT and AS (AS + RT) alone or with adjuvant CT (AS + RT + CT). CT was given as four 21-day cycles, delivered beginning 28 days after 70.2 Gy of RT. AS was given as luteinizing hormone-releasing hormone for 24 months, beginning 2 months before RT plus an oral antiandrogen for 4 months before and during RT. The study was designed based on a 6% improvement in OS from 79% to 85% at 5 years, with 90% power and a 2-sided alpha of 0.05. Results: A total of 397 patients (380 eligible) were randomized. The patients had high-risk PCa, 68% with GS 8 to 10 and 34% T3 to T4 tumors, and median prostate-specific antigen of 22.6 ng/mL. The median follow-up period was 9.2 years. The trial closed early because of excess thromboembolic toxicity in the CT arm. The 10-year results for all randomized patients revealed no significant difference between the AS + RT and AS + RT + CT arms in OS (65% vs 63%; P=.81), biochemical failure (58% vs 54%; P=.82), local progression (11% vs 7%; P=.09), distant metastases (16% vs 14%; P=.42), or disease-free survival (22% vs 26%; P=.61). Conclusions: NRG Oncology RTOG 9902 showed no significant differences in OS, biochemical failure, local progression, distant metastases, or disease-free survival with the addition of adjuvant CT to LT AS + RT. The trial results provide valuable data regarding the natural history of high-risk PCa treated with LT AS + RT and have implications for

  9. Patients' experiences of receiving chemotherapy in outpatient clinic and/or onboard a unique nurse-led mobile chemotherapy unit: a qualitative study.

    PubMed

    Mitchell, T

    2013-07-01

    There is a drive in the UK to revise chemotherapy provision for people living in rural communities. Using a different model of treatment delivery might impact positively upon the experience of receiving chemotherapy. In 2007 the first nurse-led mobile chemotherapy unit (MCU) in the UK was launched in the South West of England with the intention of providing treatment closer to home. The aim of the research was to explore experiences of people with cancer who received chemotherapy treatment in outpatient clinic and/or onboard the MCU using an interpretive phenomenological approach. Interviews were conducted with 20 people and data were interpreted using thematic analysis. The cancer and chemotherapy journey was described as being undertaken by the participant and their significant other. Available car parking and travelling impacted upon quality of life, as did the environment and accessibility of nurses to discuss issues with participants. The most important, distinguishing feature between receiving chemotherapy in outpatient clinic and the MCU was the amount of time spent waiting. Having treatment on the MCU was perceived to be less formal and therefore less stressful. Participants reported significant savings in time spent travelling, waiting and having treatment, expenditure on fuel and companion costs. PMID:23611562

  10. American Society of Clinical Oncology policy statement update: genetic testing for cancer susceptibility.

    PubMed

    2003-06-15

    As the leading organization representing cancer specialists involved in patient care and clinical research, the American Society of Clinical Oncology (ASCO) reaffirms its commitment to integrating cancer risk assessment and management, including molecular analysis of cancer predisposition genes, into the practice of oncology and preventive medicine. The primary goal of this effort is to foster expanded access to, and continued advances in, medical care provided to patients and families affected by hereditary cancer syndromes. The 1996 ASCO Statement on Genetic Testing for Cancer Susceptibility set forth specific recommendations relating to clinical practice, research needs, educational opportunities, requirement for informed consent, indications for genetic testing, regulation of laboratories, and protection from discrimination, as well as access to and reimbursement for cancer genetics services. In updating this Statement, ASCO endorses the following principles: Indications for Genetic Testing: ASCO recommends that genetic testing be offered when 1) the individual has personal or family history features suggestive of a genetic cancer susceptibility condition, 2) the test can be adequately interpreted, and 3) the results will aid in diagnosis or influence the medical or surgical management of the patient or family members at hereditary risk of cancer. ASCO recommends that genetic testing only be done in the setting of pre- and post-test counseling, which should include discussion of possible risks and benefits of cancer early detection and prevention modalities. Special Issues in Testing Children for Cancer Susceptibility: ASCO recommends that the decision to offer testing to potentially affected children should take into account the availability of evidence-based risk-reduction strategies and the probability of developing a malignancy during childhood. Where risk-reduction strategies are available or cancer predominantly develops in childhood, ASCO believes that

  11. [IAEA Training Course Series TCS-37 Clinical Training of Medical Physicists Specializing in Radiation Oncology].

    PubMed

    Imamura, Kiyonari

    2015-01-01

    Training program IAEA TCS-37 (Training course series No.37) "Clinical Training of Medical Physicists Specializing in Radiation Oncology (2009)" was fixed to practical training syllabus at faculty and graduate course of medical physics of a university. TCS-47 for diagnostic radiology (2010) and TCS-50 for nuclear medicine (2011) were also involved in the syllabus. These training courses had been developed by IAEA RCA RAS6038 project since 2002. In this paper, first, comparison with other training programs in the world was made in terms of (1) Degree of extent of subject or field, (2) Concreteness or specificity, (3) Degree of completion, (4) Method of certification and (5) Practicability. IAEA TCS series got the most points among ten programs such as EMERALD/EMIT, AAPM rpt.No.90 and CAMPEP accredited programs. Second, TCS-37, TCS47 and TCS50 were broken down to 6, 5 and 6 subjects of training course respectively. Third, each subject was further broken down to 15 times of training schedule where every time was composed by 3 hours of training. Totally 45 hours of a subject were assigned to one semester for getting one unit of credit. Seventeen units should be credited up to three years in graduate course to finish the whole program. PMID:26882699

  12. Mass Spectrometry Strategies for Clinical Metabolomics and Lipidomics in Psychiatry, Neurology, and Neuro-Oncology

    PubMed Central

    Wood, Paul L

    2014-01-01

    Metabolomics research has the potential to provide biomarkers for the detection of disease, for subtyping complex disease populations, for monitoring disease progression and therapy, and for defining new molecular targets for therapeutic intervention. These potentials are far from being realized because of a number of technical, conceptual, financial, and bioinformatics issues. Mass spectrometry provides analytical platforms that address the technical barriers to success in metabolomics research; however, the limited commercial availability of analytical and stable isotope standards has created a bottleneck for the absolute quantitation of a number of metabolites. Conceptual and financial factors contribute to the generation of statistically under-powered clinical studies, whereas bioinformatics issues result in the publication of a large number of unidentified metabolites. The path forward in this field involves targeted metabolomics analyses of large control and patient populations to define both the normal range of a defined metabolite and the potential heterogeneity (eg, bimodal) in complex patient populations. This approach requires that metabolomics research groups, in addition to developing a number of analytical platforms, build sufficient chemistry resources to supply the analytical standards required for absolute metabolite quantitation. Examples of metabolomics evaluations of sulfur amino-acid metabolism in psychiatry, neurology, and neuro-oncology and of lipidomics in neurology will be reviewed. PMID:23842599

  13. A Clinical Librarian-Nursing Partnership to Bridge Clinical Practice and Research in an Oncology Setting.

    PubMed

    Ginex, Pamela K; Hernandez, Marisol; Vrabel, Mark

    2016-09-01

    Nurses today work in practice settings where the expectation is to "draw upon the best evidence to provide the care most appropriate to each patient" (Olsen, Goolsby, & McGinnis, 2009, p. 10) while caring for patients with high acuity in highly specialized settings. Within the nursing profession, the Magnet Recognition Program® advocates for exemplary professional practice and the generation of new knowledge through research and clinical innovation. Nurses working in a clinical setting are often the best resource to identify important clinical questions and gaps in practice, but a lack of resources presents challenges to nurses in fully developing their questions and identifying the most appropriate methods to answer them. These challenges often fall into three broad categories: individual nurse characteristics, organizational characteristics, and environmental characteristics (Dobbins, Ciliska, Cockerill, Barnsley, & DiCenso, 2002). Creating a dedicated partnership between nurses and library staff is one method that can overcome these challenges to use existing resources and support nurses who are asking and answering important clinical questions (DePalma, 2005; Vrabel, 2005). 
. PMID:27541547

  14. GNOSIS: Guidelines for neuro-oncology: Standards for investigational studies—reporting of phase 1 and phase 2 clinical trials

    PubMed Central

    Chang, Susan M.; Reynolds, Sharon L.; Butowski, Nicholas; Lamborn, Kathleen R.; Buckner, Jan C.; Kaplan, Richard S.; Bigner, Darell D.

    2005-01-01

    We present guidelines to standardize the reporting of phase 1 and phase 2 neuro-oncology trials. The guidelines are also intended to assist with accurate interpretation of results from these trials, to facilitate the peer-review process, and to expedite the publication of important and accurate manuscripts. Our guidelines are summarized in a checklist format that can be used as a framework from which to construct a phase 1 or 2 clinical trial. PMID:16212807

  15. Multidrug chemotherapy (vincristine-bleomycin-methotrexate) followed by radiotherapy in inoperable carcinomas of the head and neck: preliminary report of a pilot study of the Radiation Therapy Oncology Group

    SciTech Connect

    Marcial, V.A.; Velez-Garcia, E.; Figueroa-Valles, N.R.; Cintron, J.; Vallecillo, L.A.

    1980-06-01

    This is a preliminary report on the Radiation Therapy Oncology Group (RTOG) pilot study 77-08, of a combination of chemotherapy with vincristine-bleomycin-methotrexate, followed by radiotherapy, for inoperable carcinomas of the head and neck. The main objectives of the study were to determine toxicity and tumor control. Patients who were included had untreated carcinomas, with no distant metastases, and with adequate pulmonary, renal, and liver function. Forty patients were registered for the study. Chemotherapy started with vincristine--1.5 mgs/m/sup 2/ (maximum of 2 mgs) by I.V. injection, followed by bleomycin drip for 48 hours (15 units/day), and then methotrexate (200 mgs/m/sup 2/ divided in equal doses 6 hours apart) with folinic acid rescue. Eleven patients received one course of the stated chemotherapy; 28 were given two courses with one week rest period between them. Radical curative radiotherapy was started usually two weeks after chemotherapy. A surgical procedure was considered if the patient was found operable after receiving a dose of 5000 rad with continuous therapy or at 3000 rad with split-course therapy. The level of toxicity that resulted from this combined therapy was considered acceptable. The percentage of complete response of the primary tumor was 6% with chemotherapy; this increased to 46% after irradiation, and to 65% when surgery was added.

  16. Why Providers Participate in Clinical Trials: Considering the National Cancer Institute’s Community Clinical Oncology Program

    PubMed Central

    McAlearney, Ann Scheck; Song, Paula H.; Reiter, Kristin L.

    2012-01-01

    Background The translation of research evidence into practice is facilitated by clinical trials such as those sponsored by the National Cancer Institute’s Community Clinical Oncology Program (CCOP) that help disseminate cancer care innovations to community-based physicians and provider organizations. However, CCOP participation involves unsubsidized costs and organizational challenges that raise concerns about sustained provider participation in clinical trials. Objectives This study was designed to improve our understanding of why providers participate in the CCOP in order to inform the decision-making process of administrators, clinicians, organizations, and policy-makers considering CCOP participation. Research Methods We conducted a multi-site qualitative study of five provider organizations engaged with the CCOP. We interviewed 41 administrative and clinician key informants, asking about what motivated CCOP participation, and what benefits they associated with involvement. We deductively and inductively analyzed verbatim interview transcripts, and explored themes that emerged. Results Interviewees expressed both “altruistic” and “self-interested” motives for CCOP participation. Altruistic reasons included a desire to increase access to clinical trials and feeling an obligation to patients. Self-interested reasons included the desire to enhance reputation, and a need to integrate disparate cancer care activities. Perceived benefits largely matched expressed motives for CCOP participation, and included internal and external benefits to the organization, and quality of care benefits for both patients and participating physicians. Conclusion The motives and benefits providers attributed to CCOP participation are consistent with translational research goals, offering evidence that participation can contribute value to providers by expanding access to innovative medical care for patients in need. PMID:22925970

  17. Clinical efficacy of chemotherapy combined with verapamil in metastatic colorectal patients.

    PubMed

    Liu, Y; Lu, Z; Fan, P; Duan, Q; Li, Y; Tong, S; Hu, B; Lv, R; Hu, L; Zhuang, J

    2011-11-01

    In order to determine the clinical efficacy and adverse reactions of chemotherapy and verapamil infusion through a target artery to treat colorectal cancer patients with metastasis after failure with previous conventional treatments. Patients with metastatic colon cancer (n = 36) received an infusion of verapamil, interleukin-2, oxaliplatin (or hydroxy camptothecin or irinotecan hydrochloride), fluorouracil and calcium folinate through target artery using the Seldinger puncture technique. From the second day of infusion, the patients were treated with fluorouracil and calcium folinate via systematic intravenous injection for 2-3 days. Efficacy was evaluated after at least two treatment courses. The objective response including complete or partial response was 58.3% in the 36 patients; clinical benefit rate, evaluated by Karnofsky Performance Status score was 91.7%; by weight was 83.3%; by the amount of painkiller consumed was 80.6%. No patient experienced side effects associated with heart function. Post-treatment, the P-R period, Q-T period, QRS, and heart rate were not significantly different than before treatment. Liver function was significantly improved. Side effects of chemotherapy were minor in comparison to those observed with intravenous chemotherapy. Infusion of verapamil and chemotherapy directly into pelvic tumor tissue can increase treatment efficacy and has been shown to be a relatively safe technique. PMID:21562945

  18. Preclinical development of camptothecin derivatives and clinical trials in pediatric oncology.

    PubMed

    Vassal, G; Pondarré, C; Boland, I; Cappelli, C; Santos, A; Thomas, C; Lucchi, E; Imadalou, K; Pein, F; Morizet, J; Gouyette, A

    1998-03-01

    Although the prognosis of childhood cancers has dramatically improved over the last three decades, new active drugs are needed. Camptothecins represent a very attractive new class of anticancer drugs to develop in paediatric oncology. The preclinical and clinical development of two of these DNA-topoisomerase I inhibitors, i.e. topotecan and irinotecan, is ongoing in paediatric malignancies. Here we review the currently available results of this evaluation. Topotecan proved to be active against several paediatric tumour xenografts. In paediatric phase I studies exploring several administration schedules, myelosuppression was dose-limiting. The preliminary results of topotecan evaluation in phase II study showed antitumour activity in neuroblastoma (response rate: 15% at relapse and 37% in newly diagnosed patients with disseminated disease) and in metastatic rhabdomyosarcoma (40% in untreated patients). Topotecan-containing drug combinations are currently investigated. Irinotecan displayed a broad spectrum of activity in paediatric solid tumour xenografts, including rhabdo-myosarcoma, neuroblastoma, peripheral primitive neuroectodermal tumour, medulloblastoma, ependymoma, malignant glioma and juvenile colon cancer. For several of these histology types, tumour-free survivors have been observed among animals bearing an advanced-stage tumour at time of treatment. The clinical evaluation of irinotecan in children is ongoing. Irinotecan undergoes a complex in vivo biotransformation involving several enzyme systems, such as carboxylesterase, UDPGT and cytochrome P450, in children as well as in adults. Preclinical studies of both drugs have shown that their activity was schedule-dependent. The optimal schedule of administration is an issue that needs to be addressed in children. In conclusion, the preliminary results of the paediatric evaluation of camptothecin derivatives show very encouraging results in childhood malignancies. The potential place of camptothecins in the

  19. Challenges and Facilitators of Community Clinical Oncology Program Participation: A Qualitative Study

    PubMed Central

    McAlearney, Ann Scheck; Reiter, Kristin L.; Weiner, Bryan J.; Minasian, Lori; Song, Paula H.

    2013-01-01

    EXECUTIVE SUMMARY Successful participation in the National Cancer Institute’s (NCI) Community Clinical Oncology Program (CCOP) can expand access to clinical trials and promote cancer treatment innovations for patients and communities otherwise removed from major cancer centers. Yet CCOP participation involves administrative, financial, and organizational challenges that can impact hospital and provider participants. This study was designed to improve our understanding of challenges associated with CCOP participation from the perspectives of involved providers, and to learn about opportunities to overcome these challenges. We conducted five case studies of hospitals and providers engaged with the CCOP. Across organizations we interviewed forty-one administrative, physician, and nurse key informants. We asked about CCOP participation, focusing on issues related to implementation, operations, and organizational support. We analyzed interview transcripts both deductively and inductively, exploring themes that emerged. Interviewees noted seven challenges associated with CCOP participation: 1) lack of appreciation for the value of participation; 2) poor understanding about CCOP operations; 3) cost; 4) need to meet CCOP requirements; 5) required workflow changes; 6) managing patient recruitment and physician involvement; and 7) sustaining hospital leadership support. Informants also suggested three major opportunities to facilitate participation: 1) increase awareness of the CCOP; 2) enhance commitment to the CCOP; and 3) promote and support champions of the CCOP. Improving our understanding of the challenges and facilitators of CCOP participation may help hospitals and providers in efforts to increase and sustain participation in the CCOP, thus helping to helping to preserve access to innovative medical treatment options for patients in need. PMID:23424817

  20. Bioinformatics for precision medicine in oncology: principles and application to the SHIVA clinical trial

    PubMed Central

    Servant, Nicolas; Roméjon, Julien; Gestraud, Pierre; La Rosa, Philippe; Lucotte, Georges; Lair, Séverine; Bernard, Virginie; Zeitouni, Bruno; Coffin, Fanny; Jules-Clément, Gérôme; Yvon, Florent; Lermine, Alban; Poullet, Patrick; Liva, Stéphane; Pook, Stuart; Popova, Tatiana; Barette, Camille; Prud’homme, François; Dick, Jean-Gabriel; Kamal, Maud; Le Tourneau, Christophe; Barillot, Emmanuel; Hupé, Philippe

    2014-01-01

    Precision medicine (PM) requires the delivery of individually adapted medical care based on the genetic characteristics of each patient and his/her tumor. The last decade witnessed the development of high-throughput technologies such as microarrays and next-generation sequencing which paved the way to PM in the field of oncology. While the cost of these technologies decreases, we are facing an exponential increase in the amount of data produced. Our ability to use this information in daily practice relies strongly on the availability of an efficient bioinformatics system that assists in the translation of knowledge from the bench towards molecular targeting and diagnosis. Clinical trials and routine diagnoses constitute different approaches, both requiring a strong bioinformatics environment capable of (i) warranting the integration and the traceability of data, (ii) ensuring the correct processing and analyses of genomic data, and (iii) applying well-defined and reproducible procedures for workflow management and decision-making. To address the issues, a seamless information system was developed at Institut Curie which facilitates the data integration and tracks in real-time the processing of individual samples. Moreover, computational pipelines were developed to identify reliably genomic alterations and mutations from the molecular profiles of each patient. After a rigorous quality control, a meaningful report is delivered to the clinicians and biologists for the therapeutic decision. The complete bioinformatics environment and the key points of its implementation are presented in the context of the SHIVA clinical trial, a multicentric randomized phase II trial comparing targeted therapy based on tumor molecular profiling versus conventional therapy in patients with refractory cancer. The numerous challenges faced in practice during the setting up and the conduct of this trial are discussed as an illustration of PM application. PMID:24910641

  1. Do Case Rates Affect Physicians' Clinical Practice in Radiation Oncology?: An Observational Study

    PubMed Central

    Loy, Bryan A.; Shkedy, Clive I.; Powell, Adam C.; Happe, Laura E.; Royalty, Julie A.; Miao, Michael T.; Smith, Gary L.; Long, James W.; Gupta, Amit K.

    2016-01-01

    Case rate payments combined with utilization monitoring may have the potential to improve the quality of care by reducing over and under-treatment. Thus, a national managed care organization introduced case rate payments at one multi-site radiation oncology provider while maintaining only fee-for-service payments at others. This study examined whether the introduction of the payment method had an effect on radiation fractions administered when compared to clinical guidelines. The number of fractions of radiation therapy delivered to patients with bone metastases, breast, lung, prostate, and skin cancer was assessed for concordance with clinical guidelines. The proportion of guideline-based care ascertained from the payer's claims database was compared before (2011) and after (2013) the payment method introduction using relative risks (RR). After the introduction of case rates, there were no significant changes in guideline-based care in breast, lung, and skin cancer; however, patients with bone metastases and prostate cancer were significantly more likely to have received guideline-based care (RR = 2.0 and 1.1, respectively, p<0.05). For the aggregate of all cancers, the under-treatment rate significantly declined (p = 0.008) from 4% to 0% after the introduction of case rate payments, while the over-treatment rate remained steady at 9%, with no significant change (p = 0.20). These findings suggest that the introduction of case rate payments did not adversely affect the rate of guideline-based care at the provider examined. Additional research is needed to isolate the effect of the payment model and assess implications in other populations. PMID:26870963

  2. Do Case Rates Affect Physicians' Clinical Practice in Radiation Oncology?: An Observational Study.

    PubMed

    Loy, Bryan A; Shkedy, Clive I; Powell, Adam C; Happe, Laura E; Royalty, Julie A; Miao, Michael T; Smith, Gary L; Long, James W; Gupta, Amit K

    2016-01-01

    Case rate payments combined with utilization monitoring may have the potential to improve the quality of care by reducing over and under-treatment. Thus, a national managed care organization introduced case rate payments at one multi-site radiation oncology provider while maintaining only fee-for-service payments at others. This study examined whether the introduction of the payment method had an effect on radiation fractions administered when compared to clinical guidelines. The number of fractions of radiation therapy delivered to patients with bone metastases, breast, lung, prostate, and skin cancer was assessed for concordance with clinical guidelines. The proportion of guideline-based care ascertained from the payer's claims database was compared before (2011) and after (2013) the payment method introduction using relative risks (RR). After the introduction of case rates, there were no significant changes in guideline-based care in breast, lung, and skin cancer; however, patients with bone metastases and prostate cancer were significantly more likely to have received guideline-based care (RR = 2.0 and 1.1, respectively, p<0.05). For the aggregate of all cancers, the under-treatment rate significantly declined (p = 0.008) from 4% to 0% after the introduction of case rate payments, while the over-treatment rate remained steady at 9%, with no significant change (p = 0.20). These findings suggest that the introduction of case rate payments did not adversely affect the rate of guideline-based care at the provider examined. Additional research is needed to isolate the effect of the payment model and assess implications in other populations. PMID:26870963

  3. Clinical phase I/II research on ultrasound thermo-chemotherapy in oral and maxillofacial-head and neck carcinoma

    NASA Astrophysics Data System (ADS)

    Shen, Guofeng; Ren, Guoxin; Guo, Wei; Chen, Yazhu

    2012-11-01

    The principle of a ultrasound thermo-chemotherapy instrument and the clinical phase I/II research on short-term and long-term therapeutic effect and main side-effect of ultrasound hyperthermia combined with chemotherapy in oral and maxillofacial-head & neck carcinoma by the instrument will be presented in this paper.

  4. Development of regional chemotherapies: feasibility, safety and efficacy in clinical use and preclinical studies

    PubMed Central

    Cai, Shuang; Bagby, Taryn R; Forrest, M Laird

    2011-01-01

    Conventional oral and intravenous chemotherapies permeate throughout the body, exposing healthy tissues to similar cytotoxic drug levels as tumors. This leads to significant dose-limiting toxicities that may prevent patients from receiving sufficient treatment to overcome cancers. Therefore, a number of locoregional drug-delivery strategies have been evaluated and implemented in preclinical studies, clinical trials and in practice, in the past decades to minimize systemic toxicities from chemotherapeutic agents and to improve treatment outcomes. Localized treatment is beneficial because many cancers, such as melanoma, peritoneal cancer and breast cancer, advance locally adjacent to the site of the primary tumors prior to their circulatory invasion. In this article, we will review the feasibility, safety and efficacy of multiple localized chemotherapies in clinical use and preclinical development. PMID:22229080

  5. Radiation Therapy Oncology Group Translational Research Program Stem Cell Symposium: Incorporating Stem Cell Hypotheses into Clinical Trials

    SciTech Connect

    Woodward, Wendy A. Bristow, Robert G.; Clarke, Michael F.; Coppes, Robert P.; Cristofanilli, Massimo; Duda, Dan G.; Fike, John R.; Hambardzumyan, Dolores; Hill, Richard P.; Jordan, Craig T.; Milas, Luka; Pajonk, Frank; Curran, Walter J.; Dicker, Adam P.; Chen Yuhchyau

    2009-08-01

    At a meeting of the Translation Research Program of the Radiation Therapy Oncology Group held in early 2008, attendees focused on updating the current state of knowledge in cancer stem cell research and discussing ways in which this knowledge can be translated into clinical use across all disease sites. This report summarizes the major topics discussed and the future directions that research should take. Major conclusions of the symposium were that the flow cytometry of multiple markers in fresh tissue would remain the standard technique of evaluating cancer-initiating cells and that surrogates need to be developed for both experimental and clinical use.

  6. Adjuvant Chemotherapy Following Complete Resection of Soft Tissue Sarcoma in Adults: A Clinical Practice Guideline

    PubMed Central

    Bramwell, Vivien H. C.; Bell, Robert; Davis, Aileen M.; Charette, Manya L.; The members of the cancer care Ontario practice guidelines initiative sarcoma disease site group

    2002-01-01

    Purpose. To review the literature and make recommendations for the use of anthracycline-based adjuvant chemotherapy in adult patients with soft tissue sarcoma (STS). Patients. The recommendations apply to patients >15 years old with completely resected STS. Methods. A systematic overview of the published literature was combined with a consensus process around the interpretation of the evidence in the context of conventional practice to develop an evidence-based practice guideline. Results. Four meta-analyses and 17 randomized clinical trials comparing anthracycline-based adjuvant chemotherapy versus observation were reviewed. The Sarcoma Meta-Analysis Collaboration (SMAC) was the best analysis because it assessed individual patient data and had the longest follow-up. The results of the SMAC meta-analysis together with data from more recently published randomized trials, as well as our analysis of the toxicity and compliance data, are incorporated in this systematic review. Discussion. It is reasonable to consider anthracycline-based adjuvant chemotherapy in patients who have had removal of a sarcoma with features predicting a high likelihood of relapse (deep location, size >5 cm, high histological grade). Although the benefits of adjuvant chemotherapy are most apparent in patients with extremity sarcomas, patients with high-risk tumours at other sites should also be considered for such therapy. PMID:18521341

  7. Clinical Predictors of Survival for Patients with Stage IV Cancer Referred to Radiation Oncology

    PubMed Central

    Kao, Johnny; Gold, Kenneth D.; Zarrili, Gina; Copel, Emily; Silverman, Andrew J.; Ramsaran, Shanata S.; Yens, David; Ryu, Samuel

    2015-01-01

    Background There is an urgent need for a robust, clinically useful predictive model for survival in a heterogeneous group of patients with metastatic cancer referred to radiation oncology. Methods From May 2012 to August 2013, 143 consecutive patients with stage IV cancer were prospectively evaluated by a single radiation oncologist. We retrospectively analyzed the effect of 29 patient, laboratory and tumor-related prognostic factors on overall survival using univariate analysis. Variables that were statistically significant on univariate analysis were entered into a multivariable Cox regression to identify independent predictors of overall survival. Results The median overall survival was 5.5 months. Four prognostic factors significantly predicted survival on multivariable analysis including ECOG performance status (0–1 vs. 2 vs. 3–4), number of active tumors (1 to 5 vs. ≥6), albumin levels (≥3.4 vs. 2.4 to 3.3 vs. <2.4 and primary tumor site (Breast, Kidney or Prostate vs. Other). Risk group stratification was performed by assigning points for adverse prognostic factors resulting in very low, low, intermediate and high risk groups. The median survival was >31.4 months for very low risk patients compared to 14.5 months for low risk, 4.1 months for intermediate risk and 1.2 months for high risk (p<0.001). Conclusions These data suggest that a model that considers performance status, extent of disease, primary tumor site and serum albumin represents a simple model to accurately predict survival for patients with stage IV cancer who are potential candidates for radiation therapy. PMID:25894552

  8. An ICT infrastructure to integrate clinical and molecular data in oncology research

    PubMed Central

    2012-01-01

    Background The ONCO-i2b2 platform is a bioinformatics tool designed to integrate clinical and research data and support translational research in oncology. It is implemented by the University of Pavia and the IRCCS Fondazione Maugeri hospital (FSM), and grounded on the software developed by the Informatics for Integrating Biology and the Bedside (i2b2) research center. I2b2 has delivered an open source suite based on a data warehouse, which is efficiently interrogated to find sets of interesting patients through a query tool interface. Methods Onco-i2b2 integrates data coming from multiple sources and allows the users to jointly query them. I2b2 data are then stored in a data warehouse, where facts are hierarchically structured as ontologies. Onco-i2b2 gathers data from the FSM pathology unit (PU) database and from the hospital biobank and merges them with the clinical information from the hospital information system. Our main effort was to provide a robust integrated research environment, giving a particular emphasis to the integration process and facing different challenges, consecutively listed: biospecimen samples privacy and anonymization; synchronization of the biobank database with the i2b2 data warehouse through a series of Extract, Transform, Load (ETL) operations; development and integration of a Natural Language Processing (NLP) module, to retrieve coded information, such as SNOMED terms and malignant tumors (TNM) classifications, and clinical tests results from unstructured medical records. Furthermore, we have developed an internal SNOMED ontology rested on the NCBO BioPortal web services. Results Onco-i2b2 manages data of more than 6,500 patients with breast cancer diagnosis collected between 2001 and 2011 (over 390 of them have at least one biological sample in the cancer biobank), more than 47,000 visits and 96,000 observations over 960 medical concepts. Conclusions Onco-i2b2 is a concrete example of how integrated Information and Communication

  9. Phase II Study of Accelerated High-Dose Radiotherapy With Concurrent Chemotherapy for Patients With Limited Small-Cell Lung Cancer: Radiation Therapy Oncology Group Protocol 0239

    SciTech Connect

    Komaki, Ritsuko; Paulus, Rebecca; Ettinger, David S.; Videtic, Gregory M.M.; Bradley, Jeffrey D.; Glisson, Bonnie S.; Sause, William T.; Curran, Walter J.; Choy, Hak

    2012-07-15

    Purpose: To investigate whether high-dose thoracic radiation given twice daily during cisplatin-etoposide chemotherapy for limited small-cell lung cancer (LSCLC) improves survival, acute esophagitis, and local control rates relative to findings from Intergroup trial 0096 (47%, 27%, and 64%). Patients and Methods: Patients were accrued over a 3-year period from 22 US and Canadian institutions. Patients with LSCLC and good performance status were given thoracic radiation to 61.2 Gy over 5 weeks (daily 1.8-Gy fractions on days 1-22, then twice-daily 1.8-Gy fractions on days 23-33). Cisplatin (60 mg/m{sup 2} IV) was given on day 1 and etoposide (120 mg/m{sup 2} IV) on days 1-3 and days 22-24, followed by 2 cycles of cisplatin plus etoposide alone. Patients who achieved complete response were offered prophylactic cranial irradiation. Endpoints included overall and progression-free survival; severe esophagitis (Common Toxicity Criteria v 2.0) and treatment-related fatalities; response (Response Evaluation Criteria in Solid Tumors); and local control. Results: Seventy-two patients were accrued from June 2003 through May 2006; 71 were evaluable (median age 63 years; 52% female; 58% Zubrod 0). Median survival time was 19 months; at 2 years, the overall survival rate was 36.6% (95% confidence interval [CI] 25.6%-47.7%), and progression-free survival 19.7% (95% CI 11.4%-29.6%). Thirteen patients (18%) experienced severe acute esophagitis, and 2 (3%) died of treatment-related causes; 41% achieved complete response, 39% partial response, 10% stable disease, and 6% progressive disease. The local control rate was 73%. Forty-three patients (61%) received prophylactic cranial irradiation. Conclusions: The overall survival rate did not reach the projected goal; however, rates of esophagitis were lower, and local control higher, than projected. This treatment strategy is now one of three arms of a prospective trial of chemoradiation for LSCLC (Radiation Therapy Oncology Group 0538

  10. Impact of Ultrahigh Baseline PSA Levels on Biochemical and Clinical Outcomes in Two Radiation Therapy Oncology Group Prostate Clinical Trials

    SciTech Connect

    Rodrigues, George; Bae, Kyounghwa; Roach, Mack; Lawton, Colleen; Donnelly, Bryan; Grignon, David; Hanks, Gerald; Porter, Arthur; Lepor, Herbert; Sandler, Howard

    2011-06-01

    Purpose: To assess ultrahigh (UH; prostate-specific antigen [PSA]levels {>=}50 ng/ml) patient outcomes by comparison to other high-risk patient outcomes and to identify outcome predictors. Methods and Materials: Prostate cancer patients (PCP) from two Phase III Radiation Therapy Oncology Group clinical trials (studies 9202 and 9413) were divided into two groups: high-risk patients with and without UH baseline PSA levels. Predictive variables included age, Gleason score, clinical T stage, Karnofsky performance score, and treatment arm. Outcomes included overall survival (OS), distant metastasis (DM), and biochemical failure (BF). Unadjusted and adjusted hazard ratios (HRs) were calculated using either the Cox or Fine and Gray's regression model with associated 95% confidence intervals (CI) and p values. Results: There were 401 patients in the UH PSA group and 1,792 patients in the non-UH PSA PCP group of a total of 2,193 high-risk PCP. PCP with UH PSA were found to have inferior OS (HR, 1.19; 95% CI, 1.02-1.39, p = 0.02), DM (HR, 1.51; 95% CI, 1.19-1.92; p = 0.0006), and BF (HR, 1.50; 95% CI, 1.29-1.73; p < 0.0001) compared to other high-risk PCP. In the UH cohort, PSA level was found to be a significant factor for the risk of DM (HR, 1.01; 95% CI, 1.001-1.02) but not OS and BF. Gleason grades of 8 to 10 were found to consistently predict for poor OS, DM, and BF outcomes (with HR estimates ranging from 1.41-2.36) in both the high-risk cohort and the UH cohort multivariable analyses. Conclusions: UH PSA levels at diagnosis are related to detrimental changes in OS, DM, and BF. All three outcomes can be modeled by various combinations of all predictive variables tested.

  11. Prevalence and incidence of liver enzyme elevations in a pooled oncology clinical trial cohort.

    PubMed

    Shantakumar, Sumitra; Landis, Sarah; Lawton, Andy; Hunt, Christine M

    2016-06-01

    Few epidemiologic studies describe longitudinal liver chemistry (LC) elevations in cancer patients. A population-based retrospective cohort was identified from 31 Phase 2-3 oncology trials (excluding targeted therapies) conducted from 1985 to 2005 to evaluate background rates of LC elevations in patients (n = 3998) with or without liver metastases. Patients with baseline liver metastases (29% of patients) presented with a 3% prevalence of alanine transaminase (ALT) ≥ 3x upper limits normal (ULN) and 0.2% prevalence of bilirubin ≥ 3xULN. During follow-up, the incidence (per 1000 person-months) of new onset ALT elevations ≥3xULN was 6.1 (95% CI: 4.5, 8.0) and 2.2 (95% CI: 0.9, 4.5) in patients without and with liver metastases, respectively. No new incident cases of ALT and bilirubin elevations suggestive of severe liver injury occurred among those with liver metastases; a single case occurred among those without metastasis. Regardless of the presence of liver metastases, LC elevations were rare in cancer patients during oncology trials, which may be due to enrollment criteria. Our study validates uniform thresholds for detection of LC elevations in oncology studies and serves as an empirical referent point for comparing liver enzyme abnormalities in oncology trials of novel targeted therapies. These data support uniform LC stopping criteria in oncology trials. PMID:27025923

  12. The role of stereotactic ablative radiotherapy in oncological and non-oncological clinical settings: highlights from the 7th Meeting of AIRO--Young Members Working Group (AIRO Giovani).

    PubMed

    Franco, Pierfrancesco; De Bari, Berardino; Ciammella, Patrizia; Fiorentino, Alba; Chiesa, Silvia; Amelio, Dante; Pinzi, Valentina; Bonomo, Pierluigi; Vagge, Stefano; Fiore, Michele; Comito, Tiziana; Cecconi, Agnese; Mortellaro, Gianluca; Bruni, Alessio; Trovò, Marco; Filippi, Andrea Riccardo; Greto, Daniela; Alongi, Filippo

    2014-01-01

    Stereotactic ablative radiotherapy is a modern cancer treatment strategy able to deliver highly focused radiation in one or a few fractions with a radical intent in several clinical settings. Young radiation oncologists need a constant and tailored update in this context to improve patient care in daily clinical practice. A recent meeting of AIRO Giovani (AIRO--Young Members Working Group) was specifically addressed to this topic, presenting state-of-the-art knowledge, based on the latest evidence in this field. Highlights of the congress are summarized and presented in this report, including thorough contributions of the speakers dealing with the role of stereotactic ablative radiotherapy in both oncological and non-oncological diseases, divided according to anatomical and clinical scenarios: intra-cranial settings (brain malignant primary tumors, metastases, benign tumors and functional disorders) and extra-cranial indications (lung primary tumors and metastases, thoracic re-irradiation, liver, lymph node and bone metastases, prostate cancer). With literature data discussed during the congress as a background, stereotactic ablative radiotherapy has proved to be a consolidated treatment approach in specific oncological and non-oncological scenarios, as well as a promising option in other clinical settings, requiring a further prospective validation in the near future. We herein present an updated overview of stereotactic ablative radiotherapy use in the clinic. PMID:25688503

  13. Early Clinical Outcome With Concurrent Chemotherapy and Extended-Field, Intensity-Modulated Radiotherapy for Cervical Cancer

    SciTech Connect

    Beriwal, Sushil . E-mail: beriwals@upmc.edu; Gan, Gregory N.; Heron, Dwight E.; Selvaraj, Raj N.; Kim, Hayeon; Lalonde, Ron; Kelley, Joseph L.; Edwards, Robert P.

    2007-05-01

    Purpose: To assess the early clinical outcomes with concurrent cisplatin and extended-field intensity-modulated radiotherapy (EF-IMRT) for carcinoma of the cervix. Methods and Materials: Thirty-six patients with Stage IB2-IVA cervical cancer treated with EF-IMRT were evaluated. The pelvic lymph nodes were involved in 19 patients, and of these 19 patients, 10 also had para-aortic nodal disease. The treatment volume included the cervix, uterus, parametria, presacral space, upper vagina, and pelvic, common iliac, and para-aortic nodes to the superior border of L1. Patients were assessed for acute toxicities according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 3.0. All late toxicities were scored with the Radiation Therapy Oncology Group late toxicity score. Results: All patients completed the prescribed course of EF-IMRT. All but 2 patients received brachytherapy. Median length of treatment was 53 days. The median follow-up was 18 months. Acute Grade {>=}3 gastrointestinal, genitourinary, and myelotoxicity were seen in 1, 1, and 10 patients, respectively. Thirty-four patients had complete response to treatment. Of these 34 patients, 11 developed recurrences. The first site of recurrence was in-field in 2 patients (pelvis in 1, pelvis and para-aortic in 1) and distant in 9 patients. The 2-year actuarial locoregional control, disease-free survival, overall survival, and Grade {>=}3 toxicity rates for the entire cohort were 80%, 51%, 65%, and 10%, respectively. Conclusion: Extended-field IMRT with concurrent chemotherapy was tolerated well, with acceptable acute and early late toxicities. The locoregional control rate was good, with distant metastases being the predominant mode of failure. We are continuing to accrue a larger number of patients and longer follow-up data to further extend our initial observations with this approach.

  14. Cisplatin based chemotherapy in testicular cancer patients: long term platinum excretion and clinical effects.

    PubMed

    Hohnloser, J H; Schierl, R; Hasford, B; Emmerich, B

    1996-09-20

    Patients with advanced testicular cancer (TC) have a very good long-term prognosis owing to cisplatin-based polychemotherapy. Platinum is believed to be excreted at a rapid rate via urine within weeks after chemotherapy. As a new, highly sensitive method has become available detecting even natural background platinum levels in body fluids, this study was set up to analyze urinary and serum platinum levels in long-term survivors of testicular neoplasm after cisplatin based polychemotherapy and to correlate clinical data with urinary and serum platinum levels. Urinary platinum concentrations were measured in 64 healthy controls (C) and 22 male patients (TC) 150 to 3022 days after the last application of i.v. cisplatin using voltammetry after UV-photolysis. In the latter group (TC), serum platinum levels were measured as well. Clinical data were analysed as to long-term organ toxicity. Mean urinary platinum levels were 2700 times higher in the patient group (TC) than natural background noise (p < 0.0001). There was a decline of urinary and serum platinum levels over time, being significantly above normal even 8 years after cisplatin exposure. The only significant variables related to the urine platinum concentration were a) the interval between the last i.v. cisplatin application and time of study and b) the total dose given. Not significant were the number of chemotherapy cycles, pre-therapy renal disease, patient age, tumour resection before/after chemotherapy, site of pre/post therapy resection, clinical staging, histological subtypes or tumour markers. Post-therapy renal disease or peripheral nerve damage were not significantly associated with urinary platinum levels. Our data indicate that even 8 years after cisplatin based chemotherapy 500 times elevated urinary and serum platinum levels can be measured in testicular cancer patients. No organ toxicity related to long-term platinum excretion could be detected. This may be due to our small sample size. PMID

  15. Quality Research in Radiation Oncology Analysis of Clinical Performance Measures in the Management of Gastric Cancer

    SciTech Connect

    Goodman, Karyn A.; Khalid, Najma; Kachnic, Lisa A.; Minsky, Bruce D.; Crozier, Cheryl; Owen, Jean B.; Devlin, Phillip M.

    2013-02-01

    -based planning with use of DVH to evaluate normal tissue doses. Most patients completed adjuvant RT in the prescribed time frame. IMRT and IGRT were not routinely incorporated into clinical practice during the 2005-2007 period. These data will be a benchmark for future Quality Research in Radiation Oncology GC surveys.

  16. Quality of Cancer Family History and Referral for Genetic Counseling and Testing Among Oncology Practices: A Pilot Test of Quality Measures As Part of the American Society of Clinical Oncology Quality Oncology Practice Initiative

    PubMed Central

    Wood, Marie E.; Kadlubek, Pamela; Pham, Trang H.; Wollins, Dana S.; Lu, Karen H.; Weitzel, Jeffrey N.; Neuss, Michael N.; Hughes, Kevin S.

    2014-01-01

    Purpose Family history of cancer (CFH) is important for identifying individuals to receive genetic counseling/testing (GC/GT). Prior studies have demonstrated low rates of family history documentation and referral for GC/GT. Methods CFH quality and GC/GT practices for patients with breast (BC) or colon cancer (CRC) were assessed in 271 practices participating in the American Society of Clinical Oncology Quality Oncology Practice Initiative in fall 2011. Results A total of 212 practices completed measures regarding CFH and GC/GT practices for 10,466 patients; 77.4% of all medical records reviewed documented presence or absence of CFH in first-degree relatives, and 61.5% of medical records documented presence or absence of CFH in second-degree relatives, with significantly higher documentation for patients with BC compared with CRC. Age at diagnosis was documented for all relatives with cancer in 30.7% of medical records (BC, 45.2%; CRC, 35.4%; P ≤ .001). Referall for GC/GT occurred in 22.1% of all patients with BC or CRC. Of patients with increased risk for hereditary cancer, 52.2% of patients with BC and 26.4% of those with CRC were referred for GC/GT. When genetic testing was performed, consent was documented 77.7% of the time, and discussion of results was documented 78.8% of the time. Conclusion We identified low rates of complete CFH documentation and low rates of referral for those with BC or CRC meeting guidelines for referral among US oncologists. Documentation and referral were greater for patients with BC compared with CRC. Education and support regarding the importance of accurate CFH and the benefits of proactive high-risk patient management are clearly needed. PMID:24493722

  17. In Vitro Adenosine Triphosphate-Based Chemotherapy Response Assay as a Predictor of Clinical Response to Fluorouracil-Based Adjuvant Chemotherapy in Stage II Colorectal Cancer

    PubMed Central

    Kwon, Hye Youn; Kim, Im-kyung; Kang, Jeonghyun; Sohn, Seung-Kook; Lee, Kang Young

    2016-01-01

    Purpose We evaluated the usefulness of the in vitro adenosine triphosphate-based chemotherapy response assay (ATP-CRA) for prediction of clinical response to fluorouracil-based adjuvant chemotherapy in stage II colorectal cancer. Materials and Methods Tumor specimens of 86 patients with pathologically confirmed stage II colorectal adenocarcinoma were tested for chemosensitivity to fluorouracil. Chemosensitivity was determined by cell death rate (CDR) of drug-exposed cells, calculated by comparing the intracellular ATP level with that of untreated controls. Results Among the 86 enrolled patients who underwent radical surgery followed by fluorouracil-based adjuvant chemotherapy, recurrence was found in 11 patients (12.7%). The CDR ≥ 20% group was associated with better disease-free survival than the CDR < 20% group (89.4% vs. 70.1%, p=0.027). Multivariate analysis showed that CDR < 20% and T4 stage were poor prognostic factors for disease-free survival after fluorouracil-based adjuvant chemotherapy. Conclusion In stage II colorectal cancer, the in vitro ATP-CRA may be useful in identifying patients likely to benefit from fluorouracil-based adjuvant chemotherapy. PMID:26511802

  18. Efficacy of dexmethylphenidate for the treatment of fatigue after cancer chemotherapy: a randomized clinical trial.

    PubMed

    Lower, Elyse E; Fleishman, Stewart; Cooper, Alyse; Zeldis, Jerome; Faleck, Herbert; Yu, Zhinuan; Manning, Donald

    2009-11-01

    Cancer and its treatment can induce subjective and objective evidence of diminished functional capacity encompassing physical fatigue and cognitive impairment. Dexmethylphenidate (D-MPH; the D-isomer of methylphenidate) was evaluated for treatment of chemotherapy-related fatigue and cognitive impairment. A randomized, double-blind, placebo-controlled, parallel-group study evaluated the potential therapeutic effect and safety of D-MPH in the treatment of patients with chemotherapy-related fatigue. Change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue Subscale (FACIT-F) total score at Week 8 was the primary outcome measure. One hundred fifty-four patients (predominantly with breast and ovarian cancers) were randomized and treated. Compared with placebo, D-MPH-treated subjects demonstrated a significant improvement in fatigue symptoms at Week 8 in the FACIT-F (P=0.02) and the Clinical Global Impression-Severity scores (P=0.02), without clinically relevant changes in hemoglobin levels. Cognitive function was not significantly improved. There was a higher rate of study drug-related adverse events (AEs) (48 of 76 [63%] vs. 22 of 78 [28%]) and a higher discontinuation rate because of AEs (8 of 76 [11%] vs. 1 of 78 [1.3%]) in D-MPH-treated subjects compared with placebo-treated subjects. The most commonly reported AEs independent of study drug relationship in D-MPH-treated subjects were headache, nausea, and dry mouth, and in placebo-treated subjects were headache, diarrhea, and insomnia. D-MPH produced significant improvement in fatigue in subjects previously treated with cytotoxic chemotherapy. Further studies with D-MPH or other agents to explore treatment response in chemotherapy-associated fatigue should be considered. PMID:19896571

  19. Group Therapy with Patients in the Waiting Room of an Oncology Clinic.

    ERIC Educational Resources Information Center

    Arnowitz, Edward; And Others

    1983-01-01

    Describes a therapy group for cancer patients, conducted by cotherapists in an oncology waiting room. Group members provided mutual support and shared concerns and coping methods. Medical staff members became more involved and were more able to address the affective needs of the patients and their families. (JAC)

  20. Identifying, Understanding, and Overcoming Barriers to the Use of Clinical Practice Guidelines in Pediatric Oncology

    ClinicalTrials.gov

    2016-07-25

    B-Cell Non-Hodgkin Lymphoma; Chemotherapy-Related Nausea and/or Vomiting; Childhood Acute Myeloid Leukemia; Childhood Burkitt Lymphoma; Childhood Neoplasm; Febrile Neutropenia; Hematopoietic Cell Transplantation Recipient; Recurrent Childhood Acute Lymphoblastic Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia

  1. Report on the 10th International Conference of the Asian Clinical Oncology Society (ACOS 2012).

    PubMed

    Kim, Yeul Hong; Yang, Han-Kwang; Kim, Tae Won; Lee, Jung Shin; Seong, Jinsil; Lee, Woo Yong; Ahn, Yong Chan; Lim, Ho Yeong; Won, Jong-Ho; Park, Kyong Hwa; Cho, Kyung Sam

    2013-04-01

    The 10th International Conference of the Asian Clinical Oncology Society (ACOS 2012) in conjunction with the 38th Annual Meeting of the Korean Cancer Association, was held on June 13 to 15 (3 days) 2012 at COEX Convention and Exhibition Center in Seoul, Korea. ACOS has a 20-year history starting from the first conference in Osaka, Japan, which was chaired by Prof. Tetsuo Taguchi and the ACOS conferences have since been conducted in Asian countries every 2 years. Under the theme of "Work Together to Make a Difference for Cancer Therapy in Asia", the 10th ACOS was prepared to discuss various subjects through a high-quality academic program, exhibition, and social events. The ACOS 2012 Committee was composed of the ACOS Organizing Committee, Honorary Advisors, Local Advisors, and ACOS 2012 Organizing Committee. The comprehensive academic program had a total of 92 sessions (3 Plenary Lectures, 1 Award Lectures, 1 Memorial Lectures, 9 Special Lectures, 15 Symposia, 1 Debate & Summary Sessions, 1 Case Conferences, 19 Educational Lectures, 1 Research & Development Session, 18 Satellite Symposia, 9 Meet the Professors, 14 Oral Presentations) and a total 292 presentations were delivered throughout the entire program. Amongst Free Papers, 462 research papers (110 oral presentations and 352 poster presentations) were selected to be presented. This conference was the largest of all ACOS conferences in its scale with around 1,500 participants from 30 countries. Furthermore, despite strict new financial policies and requirements governing fundraising alongside global economic stagnation, a total of 14 companies participated as sponsors and an additional 35 companies purchased 76 exhibition booths. Lastly, the conference social events provided attendees with a variety of opportunities to experience and enjoy Korea's rich culture and traditions during the Opening Ceremony, Welcome Reception, Invitee Dinner, Banquet, and Closing Ceremony. Overall, ACOS 2012 reinforced and promoted

  2. Computerized prescriber order entry in the outpatient oncology setting: from evidence to meaningful use

    PubMed Central

    Kukreti, V.; Cosby, R.; Cheung, A.; Lankshear, S.

    2014-01-01

    Background Chemotherapy is an effective treatment in the fight against many cancers. Medication errors in oncology can be particularly serious given the narrow therapeutic window of antineoplastic drugs and their high toxicities. Computerized prescriber order entry (cpoe) has consistently been shown to reduce medication errors and adverse drug events in various settings, but its use in the oncology setting has not been well established. To gain a better understanding of the meaningful use of cpoe systems in the outpatient chemotherapy setting, we undertook a systematic review of systemic therapy cpoe. Methods A province-wide expert panel consisting of clinical experts, health information professionals, and specialists in human factors design provided guidance in the development of the research questions, search terms, databases, and inclusion criteria. The systematic review was undertaken by a core team consisting of a medical oncologist, nurse, pharmacist, and methodologist. The medline, embase, cinahl, and compendex databases were searched for relevant evidence. Results The database searches resulted in 5642 hits, of which 9 met the inclusion criteria and were retained. In the oncology setting, cpoe systems generally reduce chemotherapy medication errors; however, specific types of errors increase with the use of cpoe. These systems affect practice both positively and negatively with respect to time, workload, and productivity. Conclusions Despite the paucity of oncology-specific research, cpoe should be used in outpatient chemotherapy delivery to reduce chemotherapy-related medication errors. Adoption by clinicians will be enhanced by cpoe processes that complement current practice and workflow processes. PMID:25089110

  3. Clinical roundtable monograph: New data in emerging treatment options for chemotherapy-induced nausea and vomiting.

    PubMed

    Morrow, Gary R; Navari, Rudolph M; Rugo, Hope S

    2014-03-01

    Chemotherapy-induced nausea and vomiting (CINV) has long been one of the most troublesome adverse effects of chemotherapy, leading to significant detriments in quality of life and functioning, increased economic costs, and, in some cases, the discontinuation of effective cancer therapy. The past 2 decades have witnessed a dramatic increase in the number of effective antiemetic agents, with the introduction of the serotonin (5-hydroxytryptamine [5-HT₃]) receptor antagonists (ondansetron, granisetron, and palonosetron), the neurokinin-1 (NK₁) receptor antagonists (aprepitant and fosaprepitant), and the identification of other agents that have demonstrated efficacy against CINV, including corticosteroids. These agents often provide excellent control of emesis. Nausea, however, has proven more intractable, particularly in the days after administration of chemotherapy. Newer antiemetic agents under study may provide additional CINV control, particularly against delayed nausea. New agents undergoing review by the US Food and Drug Administration for the prevention of CINV include the novel NK₁ receptor antagonist rolapitant and a fixed-dose combination consisting of the novel NK₁ receptor antagonist netupitant and palonosetron (NEPA). Adherence to clinical practice guidelines has been shown to significantly improve CINV control. As antiemetic therapy continues to evolve, it will be important for clinicians to stay informed of new developments and changes in guidelines. PMID:24874107

  4. Summary of the UPICT Protocol for 18F-FDG PET/CT Imaging in Oncology Clinical Trials.

    PubMed

    Graham, Michael M; Wahl, Richard L; Hoffman, John M; Yap, Jeffrey T; Sunderland, John J; Boellaard, Ronald; Perlman, Eric S; Kinahan, Paul E; Christian, Paul E; Hoekstra, Otto S; Dorfman, Gary S

    2015-06-01

    The Uniform Protocols for Imaging in Clinical Trials (UPICT) (18)F-FDG PET/CT protocol is intended to guide the performance of whole-body FDG PET/CT studies within the context of single- and multiple-center clinical trials of oncologic therapies by providing acceptable (minimum), target, and ideal standards for all phases of imaging. The aim is to minimize variability in intra- and intersubject, intra- and interplatform, interexamination, and interinstitutional primary or derived data. The goal of this condensed version of the much larger document is to make readers aware of the general content and subject area. The document has several main subjects: context of the imaging protocol within the clinical trial; site selection, qualification, and training; subject scheduling; subject preparation; imaging-related substance preparation and administration; imaging procedure; image postprocessing; image analysis; image interpretation; archiving and distribution of data; quality control; and imaging-associated risks and risk management. PMID:25883122

  5. Summary of the UPICT Protocol for 18F-FDG PET/CT Imaging in Oncology Clinical Trials

    PubMed Central

    Graham, Michael M.; Wahl, Richard L.; Hoffman, John M.; Yap, Jeffrey T.; Sunderland, John J.; Boellaard, Ronald; Perlman, Eric S.; Kinahan, Paul E.; Christian, Paul E.; Hoekstra, Otto S.; Dorfman, Gary S.

    2015-01-01

    The Uniform Protocols for Imaging in Clinical Trials (UPICT) 18F-FDG PET/CT protocol is intended to guide the performance of whole-body FDG PET/CT studies within the context of single- and multiple-center clinical trials of oncologic therapies by providing acceptable (minimum), target, and ideal standards for all phases of imaging. The aim is to minimize variability in intra- and intersubject, intra- and inter-platform, interexamination, and interinstitutional primary or derived data. The goal of this condensed version of the much larger document is to make readers aware of the general content and subject area. The document has several main subjects: context of the imaging protocol within the clinical trial; site selection, qualification, and training; subject scheduling; subject preparation; imaging-related substance preparation and administration; imaging procedure; image postprocessing; image analysis; image interpretation; archiving and distribution of data; quality control; and imaging-associated risks and risk management. PMID:25883122

  6. Feasibility of quality of life assessment in routine clinical oncology practice: a Tunisian study.

    PubMed

    Masmoudi, A; Frikha, M; Daoud, J

    2009-01-01

    Limited research has been devoted to quality of life (QOL) of cancer patients in developing countries. To assess the feasibility of QOL assessment in a cohort of Tunisian cancer patients, the EORTC QLQ-C30 questionnaire was administered to 23 women treated with adjuvant chemotherapy for early breast cancer on an outpatient basis at baseline and during the 3rd cycle of chemotherapy. We observed a significant deterioration in physical functioning, cognitive functioning and social functioning during chemotherapy. However, a wide range of methodological and practical obstacles to routine QOL evaluation were identified through this study. Further improvement of cancer care infrastructure and public education is still needed before reliable QOL studies can be performed. PMID:19554983

  7. Community Clinical Oncology Program (CCOP), Minority-Based Community Clinical Oncology Program (MBCCOP), and Research Base Meeting | Division of Cancer Prevention

    Cancer.gov

    Meeting ObjectivesPresent CCOP Programmatic updatesKeynote speakers will present on "Clinical Trials in the next Decade" and Health Disparities and Clinical ResearchCreate a forum for dialogue among CCOP and MBCCOP investigators with Research Base representatives and DCP/NCI staffProvide information updates on relevant NCI/NIH initiativesExchange information/tools for benchmarking your research programProvide the opportunity to network and share ideasParticipantsPrincipal Investigators, Administrators, and othe |

  8. Toward successful migration to computerized physician order entry for chemotherapy

    PubMed Central

    Jeon, J.; Taneva, S.; Kukreti, V.; Trbovich, P.; Easty, A.C.; Rossos, P.G.; Cafazzo, J.A.

    2014-01-01

    Background Computerized physician order entry (cpoe) systems allow for medical order management in a clinical setting. Use of a cpoe has been shown to significantly improve chemotherapy safety by reducing the number of prescribing errors. Usability of these systems has been identified as a critical factor in their successful adoption. However, there is a paucity of literature investigating the usability of cpoe for chemotherapy and describing the experiences of cancer care providers in implementing and using a cpoe system. Methods A mixed-methods study, including a national survey and a workshop, was conducted to determine the current status of cpoe adoption in Canadian oncology institutions, to identify and prioritize knowledge gaps in cpoe usability and adoption, and to establish a research agenda to bridge those gaps. Survey respondents were representatives of cancer care providers from each Canadian province. The workshop participants were oncology clinicians, human factors engineers, patient safety researchers, policymakers, and hospital administrators from across Canada, with participation from the United States. Results A variety of issues related to implementing and using a cpoe for chemotherapy were identified. The major issues concerned the need for better understanding of current practices of chemotherapy ordering, preparation, and administration; a lack of system selection and procurement guidance; a lack of implementation and maintenance guidance; poor cpoe usability and workflow support; and other cpoe system design issues. An additional three research themes for addressing the existing challenges and advancing successful adoption of cpoe for chemotherapy were identified: The need to investigate variances in workflows and practices in chemotherapy ordering and administrationThe need to develop best-practice cpoe procurement and implementation guidance specifically for chemotherapyThe need to measure the effects of cpoe implementation in medical

  9. Highlights from the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (June 3-7, 2016 - Chicago, Illinois, USA).

    PubMed

    Kibble, A; Al-Shamahi, A; Kuennemann, K; Marqués, F; Tremosa, L; Cole, P

    2016-07-01

    The theme of the 52nd Annual American Society of Clinical Oncology (ASCO) meeting, 'Collective Wisdom', was intended to represent the importance of consolidating clinical advances with expertise in areas such as health informatics, pathology and economics in order to improve the role of practice providers in delivering cancer patients every component of quality care. As expected, immunotherapy and precision medicine featured heavily in the 2016 program. Gathering 30,000 oncology professionals in Chicago, educational and science sessions gave the attendees the opportunity to discuss and view ground-breaking research. PMID:27540600

  10. "Green Oncology": the Italian medical oncologists' challenge to reduce the ecological impact of their clinical activity.

    PubMed

    Bretti, Sergio; Porcile, Gianfranco; Romizi, Roberto; Palazzo, Salvatore; Oliani, Cristina; Crispino, Sergio; Labianca, Roberto

    2014-01-01

    For decades Western medicine has followed a biomedical model based on linear thinking and an individualized, disease-oriented doctor-patient relationship. Today this framework must be replaced by a biopsychosocial model based on complexity theory and a person-oriented medical team-patient relationship, taking into account the psychological and social determinants of health and disease. However, the new model is already proving no longer adequate or appropriate, and current events are urging us to develop an ecological model in which the medical team takes into account both individual illness and population health as a whole, since we are all part of the biosphere. In recent years, the rising costs of cancer treatment have raised a serious issue of economic sustainability. As the population of our planet, we now need to rapidly address this issue, and everyone of us must try to reduce their ecological footprint, measured as CO2 production. Medical oncologists need to reduce the ecological footprint of their professional activity by lowering the consumption of economic resources and avoiding environmental damage as much as possible. This new paradigm is endorsed by the Italian College of Hospital Medical Oncology Directors (CIPOMO). A working group of this organization has drafted the "Green Oncology Position Paper": a proposal of Italian medical oncology (in accordance with international guidelines) that oncologists, while aiming for the same end results, make a commitment toward the more appropriate management of health care and the careful use of resources in order to protect the environment and the ecosphere during the daily exercise of their professional activities. PMID:25076260

  11. Chemotherapy-Induced Monoamine Oxidase Expression in Prostate Carcinoma Functions as a Cytoprotective Resistance Enzyme and Associates with Clinical Outcomes

    PubMed Central

    Huang, Chung-Ying; Harris, William P.; Sim, Hong Gee; Lucas, Jared M.; Coleman, Ilsa; Higano, Celestia S.; Gulati, Roman; True, Lawrence D.; Vessella, Robert; Lange, Paul H.; Garzotto, Mark; Beer, Tomasz M.; Nelson, Peter S.

    2014-01-01

    To identify molecular alterations in prostate cancers associating with relapse following neoadjuvant chemotherapy and radical prostatectomy patients with high-risk localized prostate cancer were enrolled into a phase I-II clinical trial of neoadjuvant chemotherapy with docetaxel and mitoxantrone followed by prostatectomy. Pre-treatment prostate tissue was acquired by needle biopsy and post-treatment tissue was acquired by prostatectomy. Prostate cancer gene expression measurements were determined in 31 patients who completed 4 cycles of neoadjuvant chemotherapy. We identified 141 genes with significant transcript level alterations following chemotherapy that associated with subsequent biochemical relapse. This group included the transcript encoding monoamine oxidase A (MAOA). In vitro, cytotoxic chemotherapy induced the expression of MAOA and elevated MAOA levels enhanced cell survival following docetaxel exposure. MAOA activity increased the levels of reactive oxygen species and increased the expression and nuclear translocation of HIF1α. The suppression of MAOA activity using the irreversible inhibitor clorgyline augmented the apoptotic responses induced by docetaxel. In summary, we determined that the expression of MAOA is induced by exposure to cytotoxic chemotherapy, increases HIF1α, and contributes to docetaxel resistance. As MAOA inhibitors have been approved for human use, regimens combining MAOA inhibitors with docetaxel may improve clinical outcomes. PMID:25198178

  12. Differential Effectiveness of Clinically-Relevant Analgesics in a Rat Model of Chemotherapy-Induced Mucositis

    PubMed Central

    Whittaker, Alexandra L.; Lymn, Kerry A.; Wallace, Georgia L.; Howarth, Gordon S.

    2016-01-01

    Chemotherapy-induced intestinal mucositis is characterized by pain and a pro-inflammatory tissue response. Rat models are frequently used in mucositis disease investigations yet little is known about the presence of pain in these animals, the ability of analgesics to ameliorate the condition, or the effect that analgesic administration may have on study outcomes. This study investigated different classes of analgesics with the aim of determining their analgesic effects and impact on research outcomes of interest in a rat model of mucositis. Female DA rats were allocated to 8 groups to include saline and chemotherapy controls (n = 8). Analgesics included opioid derivatives (buprenorphine; 0.05mg/kg and tramadol 12.5mg/kg) and NSAID (carprofen; 15mg/kg) in combination with either saline or 5-Fluorouracil (5-FU; 150mg/kg). Research outcome measures included daily clinical parameters, pain score and gut histology. Myeloperoxidase assay was performed to determine gut inflammation. At the dosages employed, all agents had an analgesic effect based on behavioural pain scores. Jejunal myeloperoxidase activity was significantly reduced by buprenorphine and tramadol in comparison to 5-FU control animals (53%, p = 0.0004 and 58%, p = 0.0001). Carprofen had no ameliorating effect on myeloperoxidase levels. None of the agents reduced the histological damage caused by 5-FU administration although tramadol tended to increase villus length even when administered to healthy animals. These data provide evidence that carprofen offers potential as an analgesic in this animal model due to its pain-relieving efficacy and minimal effect on measured parameters. This study also supports further investigation into the mechanism and utility of opioid agents in the treatment of chemotherapy-induced mucositis. PMID:27463799

  13. Gene patents and personalized cancer care: impact of the Myriad case on clinical oncology.

    PubMed

    Offit, Kenneth; Bradbury, Angela; Storm, Courtney; Merz, Jon F; Noonan, Kevin E; Spence, Rebecca

    2013-07-20

    Genomic discoveries have transformed the practice of oncology and cancer prevention. Diagnostic and therapeutic advances based on cancer genomics developed during a time when it was possible to patent genes. A case before the Supreme Court, Association for Molecular Pathology v Myriad Genetics, Inc seeks to overturn patents on isolated genes. Although the outcomes are uncertain, it is suggested here that the Supreme Court decision will have few immediate effects on oncology practice or research but may have more significant long-term impact. The Federal Circuit court has already rejected Myriad's broad diagnostic methods claims, and this is not affected by the Supreme Court decision. Isolated DNA patents were already becoming obsolete on scientific grounds, in an era when human DNA sequence is public knowledge and because modern methods of next-generation sequencing need not involve isolated DNA. The Association for Molecular Pathology v Myriad Supreme Court decision will have limited impact on new drug development, as new drug patents usually involve cellular methods. A nuanced Supreme Court decision acknowledging the scientific distinction between synthetic cDNA and genomic DNA will further mitigate any adverse impact. A Supreme Court decision to include or exclude all types of DNA from patent eligibility could impact future incentives for genomic discovery as well as the future delivery of medical care. Whatever the outcome of this important case, it is important that judicial and legislative actions in this area maximize genomic discovery while also ensuring patients' access to personalized cancer care. PMID:23766521

  14. Oncologic imaging

    SciTech Connect

    Bragg, D.G.; Rubin, P.; Youker, J.E.

    1985-01-01

    This book presents papers on nuclear medicine. Topics considered include the classification of cancers, oncologic diagnosis, brain and spinal cord neoplasms, lymph node metastases, the larynx and hypopharynx, thyroid cancer, breast cancer, esophageal cancer, bladder cancer, tumors of the skeletal system, pediatric oncology, computed tomography and radiation therapy treatment planning, and the impact of future technology on oncologic diagnosis.

  15. What Medical Oncologist Residents Think about the Italian Speciality Schools: A Survey of the Italian Association of Medical Oncology (AIOM) on Educational, Clinical and Research Activities

    PubMed Central

    Moretti, Anna; De Angelis, Carmine; Lambertini, Matteo; Cremolini, Chiara; Imbimbo, Martina; Berardi, Rossana; Di Maio, Massimo; Cascinu, Stefano; La Verde, Nicla

    2016-01-01

    Background and objectives Relevant heterogeneity exists among Postgraduate Schools in Medical Oncology, also within the same country. In order to provide a comprehensive overview of the landscape of Italian Postgraduate Schools in Medical Oncology, the Italian Association of Medical Oncology (AIOM) undertook an online survey, inviting all the residents to describe their daily activities and to express their overall satisfaction about their programs. Methods A team composed of five residents and three consultants in medical oncology prepared a 38 items questionnaire that was published online in a reserved section, accessible through a link sent by e-mail. Residents were invited to anonymously fill in the questionnaire that included the following sub-sections: quality of teaching, clinical and research activity, overall satisfaction. Results Three-hundred and eleven (57%) out of 547 invited residents filled in the questionnaire. Two-hundred and twenty-three (72%) participants declared that attending lessons was frequently difficult and 153 (49%) declared they did not gain substantial improvement in their knowledge from them. Fifty-five percent stated that they did not receive lessons on palliative care. Their overall judgment about didactic activity was low in 63% of the interviewed. The satisfaction for clinical activity was in 86% of cases good: 84% recognized that, during the training period, they acquired a progressive independence on patients' management. About research activity, the majority (79%) of participants in the survey was actively engaged in managing patients included in clinical trials but the satisfaction level for the involvement in research activities was quite low (54%). Overall, 246 residents (79%) gave a positive global judgment of their Medical Oncology Schools. Conclusions The landscape of Italian Postgraduate Schools in Medical Oncology is quite heterogeneous across the country. Some improvements in the organization of teaching and in the

  16. Oral single-agent chemotherapy in older patients with solid tumours: A position paper from the International Society of Geriatric Oncology (SIOG).

    PubMed

    Biganzoli, L; Lichtman, S; Michel, J-P; Papamichael, D; Quoix, E; Walko, C; Aapro, M

    2015-11-01

    Compared with intravenous (i.v.) chemotherapy, oral administration is convenient, requires fewer healthcare resources, is generally preferred by patients, and may be appropriate in older people with breast, colorectal and lung cancers. The effects of organ dysfunction on drug metabolism and drug interactions in patients with multiple comorbidities must be considered but are not specific to oral chemotherapy. Single-agent oral chemotherapy with capecitabine or vinorelbine is active in older patients with advanced or metastatic breast cancer. Choice of treatment is based mainly on different safety profiles. In the adjuvant treatment of colorectal cancer (CRC), single-agent oral capecitabine is an effective alternative to i.v. fluorouracil (5-FU) regimens. In metastatic CRC, oral, single-agent capecitabine has recently shown encouraging median overall survival in combination with bevacizumab. In non-small cell lung cancer, fit older patients, like their younger counterparts, benefit from platinum-based doublets, with carboplatin preferred to cisplatin. Single agent vinorelbine is an option for those less suited to combination chemotherapy, and oral may be an alternative to i.v. administration. For elderly cancer patients in general, metronomic chemotherapy combines good tolerability with acceptable activity. PMID:26340809

  17. Pooled Analysis of Clinical Outcomes with Neoadjuvant Cisplatin and Gemcitabine Chemotherapy for Muscle Invasive Bladder Cancer

    PubMed Central

    Yuh, Bertram E.; Ruel, Nora; Wilson, Timothy G.; Vogelzang, Nicholas; Pal§, Sumanta K.

    2014-01-01

    Purpose Neoadjuvant chemotherapy for muscle invasive bladder cancer has been shown to confer a survival advantage in phase III studies. Although cisplatin and gemcitabine are often used in this setting, a comprehensive evaluation of this regimen is lacking. In this review we summarize the efficacy of neoadjuvant cisplatin and gemcitabine chemotherapy for muscle invasive bladder cancer based on currently published studies. Materials and Methods A systematic literature review was conducted in April 2012 searching MEDLINE® databases. Articles were selected if they included patients with muscle invasive bladder cancer, evaluated the combination of cisplatin and gemcitabine as neoadjuvant treatment, and reported pathological data after cystectomy. Cisplatin and gemcitabine dosing regimens and clinical data were further summarized using weighted averages. Results Seven studies encompassing 164 patients were published between 2007 and 2012. The majority of patients (79%) received cisplatin and gemcitabine on a 21-day cycle. A weighted average of 19.2 lymph nodes was obtained at cystectomy, and 29.7% of patients were found to have pN1 disease. Pathological down staging to pT0 and less than pT2 occurred in 42 (25.6%) and 67 (46.5%) patients, respectively. Conclusions Neoadjuvant cisplatin and gemcitabine yield appreciable pathological response rates in patients with muscle invasive bladder cancer. Since pathological response has been implicated as a potential surrogate for survival in muscle invasive bladder cancer, these data suggest that neoadjuvant cisplatin and gemcitabine may warrant further prospective assessment. PMID:23123547

  18. Clinically-relevant chemotherapy interactions with complementary and alternative medicines in patients with cancer.

    PubMed

    Yap, Kevin Yi-Lwern; See, Cheng Shang; Chan, Alexandre

    2010-01-01

    Complementary and alternative medicines (CAMs), in particular herbal medicines, are commonly used by cancer patients in conjunction with chemotherapy treatment for their anticancer properties and supportive care. However, the effects of many of these herbs are not well-documented due to limited studies done on them. Severe herb-drug interactions (HDIs) have been recorded in some cases, and failure to recognize these harmful HDIs can lead to dire consequences in cancer patients. This study discusses clinically-relevant interactions between anticancer drugs (ACDs) and herbs classified into 7 categories: cancer treatment and prevention, immune-system-related, alopecia, nausea and vomiting, peripheral neuropathy and pain, inflammation, and fatigue. Some promising patents which contain these herbs and thus may manifest these interactions are also presented in this article. Pharmacokinetic interactions involved mainly induction or inhibition of the cytochrome P450 isozymes and p-glycoprotein, while pharmacodynamic interactions were related to increased risks of central nervous system-related effects, hepatotoxicity and bleeding, among others. Clinicians should be vigilant when treating cancer patients who take CAMs with concurrent chemotherapy since they face a high risk of HDIs. These HDIs can be minimized or avoided by selecting herb-drug pairs which are less likely to interact. Furthermore, close monitoring of pharmacological effects and plasma drug levels should be carried out to avoid toxicity and ensure adequate chemotherapeutic coverage in patients with cancer. PMID:20653549

  19. Global radiation oncology waybill

    PubMed Central

    Muñoz-Garzón, Victor; Rovirosa, Ángeles; Ramos, Alfredo

    2013-01-01

    Background/aim Radiation oncology covers many different fields of knowledge and skills. Indeed, this medical specialty links physics, biology, research, and formation as well as surgical and clinical procedures and even rehabilitation and aesthetics. The current socio-economic situation and professional competences affect the development and future or this specialty. The aim of this article was to analyze and highlight the underlying pillars and foundations of radiation oncology, indicating the steps implicated in the future developments or competences of each. Methods This study has collected data from the literature and includes highlights from discussions carried out during the XVII Congress of the Spanish Society of Radiation Oncology (SEOR) held in Vigo in June, 2013. Most of the aspects and domains of radiation oncology were analyzed, achieving recommendations for the many skills and knowledge related to physics, biology, research, and formation as well as surgical and clinical procedures and even supportive care and management. Results Considering the data from the literature and the discussions of the XVII SEOR Meeting, the “waybill” for the forthcoming years has been described in this article including all the aspects related to the needs of radiation oncology. Conclusions Professional competences affect the development and future of this specialty. All the types of radio-modulation are competences of radiation oncologists. On the other hand, the pillars of Radiation Oncology are based on experience and research in every area of Radiation Oncology. PMID:24416572

  20. Identifying oncological emergencies.

    PubMed

    Guddati, Achuta K; Kumar, Nilay; Segon, Ankur; Joy, Parijat S; Marak, Creticus P; Kumar, Gagan

    2013-01-01

    Prompt identification and treatment of life-threatening oncological conditions is of utmost importance and should always be included in the differential diagnosis. Oncological emergencies can have a myriad of presentations ranging from mechanical obstruction due to tumor growth to metabolic conditions due to abnormal secretions from the tumor. Notably, hematologic and infectious conditions may complicate the presentation of oncological emergencies. Advanced testing and imaging is generally required to recognize these serious presentations of common malignancies. Early diagnosis and treatment of these conditions can significantly affect the patient's clinical outcome. PMID:23873016

  1. A web-based system for clinical decision support and knowledge maintenance for deterioration monitoring of hemato-oncological patients.

    PubMed

    Wicht, Andreas; Wetter, Thomas; Klein, Ulrike

    2013-07-01

    We introduce a web-based clinical decision support system (CDSS) and knowledge maintenance based on rules and a set covering method focusing on the problem of detecting serious comorbidities in hemato-oncological patients who are at high risk of developing serious infections and life threatening complications. We experienced that diagnostic problems which are characterized by fuzzy, uncertain knowledge and overlapping signs, still reveal some kind of patterns that can be transferred into a computer-based decision model. We applied a multi-stage evaluation process to assess the system's diagnostic performance. Depending on how system behavior was compared to presumably correct judgment of a case the correctness rate for closed cases with all data available varied between 58% and 71%, the overall rate after critical review was 84%. However, the real time behavior of our approach which data becoming available as time passes still has to be evaluated and observational studies need to be conducted. PMID:23522434

  2. [Oncological intensive care: 2011 year's review].

    PubMed

    Sculier, J P; Berghmans, T; Meert, A P

    2012-01-01

    The objective of this paper is to review the literature published in 2011 in the field of intensive care and emergency related to oncology. Are discussed because of new original publications: prognosis, resuscitation techniques, oncologic emergencies, serious toxicities of cytotoxic chemotherapy and targeted therapies, complicated aplastic anemia, toxicity of bisphosphonates, respiratory complications, pulmonary embolism and neurological complications. PMID:23373125

  3. Saudi Oncology Society and Saudi Urology Association combined clinical management guidelines for testicular germ cell tumors

    PubMed Central

    Alotaibi, Mohammed; Saadeddin, Ahmad; Bazarbashi, Shouki; Alkhateeb, Sultan; Alghamdi, Abdullah; Alghamdi, Khalid; Murshid, Esam; Abusamra, Ashraf; Rabah, Danny; Ahmad, Imran; Al-Mansour, Mubarak; Alsharm, Abdullah

    2016-01-01

    This is an update to the previously published Saudi guidelines for the evaluation, medical, and surgical management of patients diagnosed with testicular germ cell tumors. It is categorized according to the stage of the disease using the tumor-node-metastasis staging system 7th edition. The guidelines are presented with supporting evidence level, they are based on comprehensive literature review, several internationally recognized guidelines, and the collective expertise of the guidelines committee members (authors) who were selected by the Saudi Oncology Society and Saudi Urological Association. Considerations to the local availability of drugs, technology and expertise have been regarded. These guidelines should serve as a roadmap for the urologists, oncologists, general physicians, support groups, and health care policy makers in the management of patients diagnosed with testicular germ cell tumors. PMID:27141181

  4. Saudi Oncology Society and Saudi Urology Association combined clinical management guidelines for renal cell carcinoma

    PubMed Central

    Alghamdi, Abdullah; Alkhateeb, Sultan; Alghamdi, Khalid; Bazarbashi, Shouki; Murshid, Esam; Alotaibi, Mohammed; Abusamra, Ashraf; Rabah, Danny; Ahmad, Imran; Al-Mansour, Mubarak; Saadeddin, Ahmad; Alsharm, Abdullah

    2016-01-01

    This is an update to the previously published Saudi guidelines for the evaluation, medical, and surgical management of patients diagnosed with renal cell carcinoma (RCC). It is categorized according to the stage of the disease using the tumor node metastasis staging system 7th edition. The guidelines are presented with supporting evidence level, they are based on comprehensive literature review, several internationally recognized guidelines, and the collective expertise of the guidelines committee members (authors) who were selected by the Saudi Oncology Society and Saudi Urological Association. Considerations to the local availability of drugs, technology, and expertise have been regarded. These guidelines should serve as a roadmap for the urologists, oncologists, general physicians, support groups, and healthcare policy makers in the management of patients diagnosed with RCC. PMID:27141180

  5. Saudi oncology society and Saudi urology association combined clinical management guidelines for prostate cancer

    PubMed Central

    Abusamra, Ashraf; Murshid, Esam; Kushi, Hussain; Alkhateeb, Sultan; Al-Mansour, Mubarak; Saadeddin, Ahmad; Rabah, Danny; Bazarbashi, Shouki; Alotaibi, Mohammed; Alghamdi, Abdullah; Alghamdi, Khalid; Alsharm, Abdullah; Ahmad, Imran

    2016-01-01

    This is an update to the previously published Saudi guidelines for the evaluation, medical, and surgical management of patients diagnosed with prostate cancer. It is categorized according to the stage of the disease using the tumor node metastasis staging system 7th edition. The guidelines are presented with supporting evidence level, they are based on comprehensive literature review, several internationally recognized guidelines, and the collective expertise of the guidelines committee members (authors) who were selected by the Saudi oncology society and Saudi urological association. Considerations to the local availability of drugs, technology, and expertise have been regarded. These guidelines should serve as a roadmap for the urologists, oncologists, general physicians, support groups, and health care policy makers in the management of patients diagnosed with adenocarcinoma of the prostate to. PMID:27141178

  6. Non-surgical management of early breast cancer in the United Kingdom: follow-up. Clinical Audit Sub-committee of the Faculty of Clinical Oncology, Royal College of Radiologists, and the Joint Council for Clinical Oncology.

    PubMed

    Maher, E J

    1995-01-01

    Follow-up of operable breast cancer patients takes up a significant proportion of British oncologists' time, with 90% seeing 5-50 patients each week. Procedures vary greatly, but, in patients treated by surgery and radiotherapy, care is usually shared, with alternating visits to see each team. Currently, the general practitioner has sole responsibility for follow-up in less than 3% of patients. They tend to be followed up in general, rather than specialist, clinics. There is almost universal agreement that routine blood tests, radiographs and scans are not indicated as part of routine follow-up, but the role of mammography in evaluating an irradiated breast remains a source of debate. Just over a half of the oncologists surveyed order baseline mammography of both treated and contralateral breasts, usually between 6 and 12 months after local excision and radiotherapy, with further follow-up 1-3-yearly thereafter. Ten per cent of the participating oncologists never suggest follow-up mammography. Patients tend to be followed in oncology clinics at 3-4-monthly intervals for the first 2 years, 6-monthly in the third and fourth years and, thereafter, yearly. Fifteen per cent of oncologists discharge patients at 5 years, with the discharge rate rising to 43% at 10 years; around one-third modify follow-up according to the age of the patient. The aims of follow-up were seen to include detection of curable disease, but other goals were perceived as equally important (e.g. detection of iatrogenic problems, audit, counselling, education and the provision of early palliation of incurable and metastatic disease. Breast cancer is no longer seen as an absolute contraindication to either pregnancy or the use of hormone replacement therapy (HRT); however, oncologists are uncertain about the appropriate use of HRT, either alone or with tamoxifen. This audit highlights a number of research areas: the identification of the appropriate site and skill-mix for follow-up of patients

  7. Evaluating an oncology systemic therapy computerized physician order entry system using international guidelines.

    PubMed

    Gandhi, Sonal; Tyono, Ivan; Pasetka, Mark; Trudeau, Maureen

    2014-03-01

    Chemotherapy is prone to medication error resulting from complexities in ordering and administration. Computerized physician order entry (CPOE) has been established as an important tool to minimize such errors and hence improve patient safety. As a leading Canadian advisory body in oncology, Cancer Care Ontario (CCO) has been a champion in developing and implementing its own cancer systemic therapy CPOE, the Oncology Patient Information System (OPIS). This article reviews and consolidates principles for oncology CPOE systems as found in the literature and in guidelines created by three international oncology organizations (American Society of Clinical Oncology, Clinical Oncological Society of Australia, and CCO). It then evaluates OPIS by these standards and provides a working example of what a cancer CPOE system should look like. This document can therefore be used as a framework to help develop and evaluate cancer CPOE platforms in different national settings. As end users, oncologists are considered key stakeholders in developing such systems and thus should be well informed about CPOE principles to help make decisions on the appropriate implementation of these platforms in their local practice settings. In addition, oncologists are also important champions for the successful uptake of oncology CPOE platforms and would benefit from a better understanding of whether proposed or existing local CPOE systems meet established standards. PMID:24254406

  8. First-in-class, first-in-human phase I results of targeted agents: highlights of the 2008 American society of clinical oncology meeting.

    PubMed

    Molckovsky, Andrea; Siu, Lillian L

    2008-01-01

    This review summarizes phase I trial results of 11 drugs presented at the American Society of Clinical Oncology meeting held in Chicago IL from May 30 to June 3rd 2008: BMS-663513, CT-322, CVX-045, GDC-0449, GRN163L, LY2181308, PF-00562271, RAV12, RTA 402, XL765, and the survivin vaccine. PMID:18959794

  9. Attitudes of Oncologists, Oncology Nurses, and Patients from a Women's Clinic Regarding Medical Decision Making for Older and Younger Breast Cancer Patients.

    ERIC Educational Resources Information Center

    Beisecker, Analee E.; And Others

    1994-01-01

    Administered Beisecker Locus of Authority in Decision Making: Breast Cancer survey to 67 oncologists, 94 oncology nurses, and 288 patients from women's clinic. All groups believed that physicians should have dominant role in decision making. Nurses felt that patients should have more input than patients or physicians felt they should. Physicians…

  10. Heterogeneous Optimization Framework: Reproducible Preprocessing of Multi-Spectral Clinical MRI for Neuro-Oncology Imaging Research.

    PubMed

    Milchenko, Mikhail; Snyder, Abraham Z; LaMontagne, Pamela; Shimony, Joshua S; Benzinger, Tammie L; Fouke, Sarah Jost; Marcus, Daniel S

    2016-07-01

    Neuroimaging research often relies on clinically acquired magnetic resonance imaging (MRI) datasets that can originate from multiple institutions. Such datasets are characterized by high heterogeneity of modalities and variability of sequence parameters. This heterogeneity complicates the automation of image processing tasks such as spatial co-registration and physiological or functional image analysis. Given this heterogeneity, conventional processing workflows developed for research purposes are not optimal for clinical data. In this work, we describe an approach called Heterogeneous Optimization Framework (HOF) for developing image analysis pipelines that can handle the high degree of clinical data non-uniformity. HOF provides a set of guidelines for configuration, algorithm development, deployment, interpretation of results and quality control for such pipelines. At each step, we illustrate the HOF approach using the implementation of an automated pipeline for Multimodal Glioma Analysis (MGA) as an example. The MGA pipeline computes tissue diffusion characteristics of diffusion tensor imaging (DTI) acquisitions, hemodynamic characteristics using a perfusion model of susceptibility contrast (DSC) MRI, and spatial cross-modal co-registration of available anatomical, physiological and derived patient images. Developing MGA within HOF enabled the processing of neuro-oncology MR imaging studies to be fully automated. MGA has been successfully used to analyze over 160 clinical tumor studies to date within several research projects. Introduction of the MGA pipeline improved image processing throughput and, most importantly, effectively produced co-registered datasets that were suitable for advanced analysis despite high heterogeneity in acquisition protocols. PMID:26910516

  11. Hyperthermia in Oncology

    NASA Astrophysics Data System (ADS)

    Mocna, Marta

    2007-11-01

    The aim of hyperthermia in oncology is destroy the cancer tissues by heat (so called non-ionizing form of the therapy). The cancer tissues is influenced by the temperature in the range of 40-44 °C. The article presents the most important facts connected with using hyperthermia in oncology and gives an overview of the current clinical investigation of this kind of thermotherapy in the treatment of cancer in Poznan.

  12. Improved survival rate in children with stage III and IV B cell non-Hodgkin's lymphoma and leukemia using multi-agent chemotherapy: results of a study of 114 children from the French Pediatric Oncology Society.

    PubMed

    Patte, C; Philip, T; Rodary, C; Bernard, A; Zucker, J M; Bernard, J L; Robert, A; Rialland, X; Benz-Lemoine, E; Demeocq, F

    1986-08-01

    Children with B cell non-Hodgkin's lymphoma who have not relapsed 1 year after diagnosis and treatment are generally cured. We report here the results of treatment in 114 children who all had a minimum follow-up of 20 months. The protocol LMB 0281 from the French Pediatric Oncology Society was used. This nine-drug intensive-pulsed chemotherapy was based on high-dose cyclophosphamide, high-dose methotrexate (HD MTX), and cytosine arabinoside (ara-C) in continuous infusion. CNS prophylaxis was with chemotherapy only. No local irradiation was performed. No debulking surgery was recommended. There were 72 patients with stage III lymphoma and 42 patients with stage IV lymphoma or B cell acute lymphocytic leukemia (B-ALL). Among those 42 patients, seven had CNS involvement alone, 21 had bone marrow alone, and 14 had both; 26 had greater than 25% blast cells in bone marrow, 14 of whom had blast cells in blood. The primary site of involvement was the abdomen in 90 patients, the Waldeyer Ring in nine, and various sites in eight; seven patients presented without tumor. Seventy-seven patients are alive with a median follow-up of 2 years and 8 months. Seven patients died due to initial treatment failure, 11 died from toxicity, and 19 died after relapse. Among the 93 patients without initial CNS involvement, only one isolated relapse in CNS occurred. Survival and disease-free survival rates reached 67% and 64%, respectively, for all patients, 75% and 73% for stage III patients and 54% and 48% for stage IV and B-ALL patients. Bone marrow involvement was not an adverse prognostic factor. Contrary initial CNS involvement indicated a bad prognosis with a disease-free survival rate of 19% compared with 76% without CNS disease. This study showed that CNS prophylaxis and local control of the primary tumor can be achieved by intensive chemotherapy alone, without radiotherapy or debulking surgery. PMID:3525767

  13. The National Cancer Institute–American Society of Clinical Oncology Cancer Trial Accrual Symposium: Summary and Recommendations

    PubMed Central

    Denicoff, Andrea M.; McCaskill-Stevens, Worta; Grubbs, Stephen S.; Bruinooge, Suanna S.; Comis, Robert L.; Devine, Peggy; Dilts, David M.; Duff, Michelle E.; Ford, Jean G.; Joffe, Steven; Schapira, Lidia; Weinfurt, Kevin P.; Michaels, Margo; Raghavan, Derek; Richmond, Ellen S.; Zon, Robin; Albrecht, Terrance L.; Bookman, Michael A.; Dowlati, Afshin; Enos, Rebecca A.; Fouad, Mona N.; Good, Marjorie; Hicks, William J.; Loehrer, Patrick J.; Lyss, Alan P.; Wolff, Steven N.; Wujcik, Debra M.; Meropol, Neal J.

    2013-01-01

    Introduction: Many challenges to clinical trial accrual exist, resulting in studies with inadequate enrollment and potentially delaying answers to important scientific and clinical questions. Methods: The National Cancer Institute (NCI) and the American Society of Clinical Oncology (ASCO) cosponsored the Cancer Trial Accrual Symposium: Science and Solutions on April 29-30, 2010 to examine the state of accrual science related to patient/community, physician/provider, and site/organizational influences, and identify new interventions to facilitate clinical trial enrollment. The symposium featured breakout sessions, plenary sessions, and a poster session including 100 abstracts. Among the 358 attendees were clinical investigators, researchers of accrual strategies, research administrators, nurses, research coordinators, patient advocates, and educators. A bibliography of the accrual literature in these three major areas was provided to participants in advance of the meeting. After the symposium, the literature in these areas was revisited to determine if the symposium recommendations remained relevant within the context of the current literature. Results: Few rigorously conducted studies have tested interventions to address challenges to clinical trials accrual. Attendees developed recommendations for improving accrual and identified priority areas for future accrual research at the patient/community, physician/provider, and site/organizational levels. Current literature continues to support the symposium recommendations. Conclusions: A combination of approaches addressing both the multifactorial nature of accrual challenges and the characteristics of the target population may be needed to improve accrual to cancer clinical trials. Recommendations for best practices and for future research developed from the symposium are provided. PMID:24130252

  14. Clinical Factors Associated with Response or Survival after Chemotherapy in Patients with Waldenström Macroglobulinemia in Korea

    PubMed Central

    Kim, Kihyun; Yoon, Dok Hyun; Kim, Jin Seok; Eom, Hyeon Seok; Kim, Inho; Lee, Won Sik; Kim, Se Hyung; Lee, Mark Hong; Lee, Jae Hoon; Shin, Ho-Jin; Lee, Ji Hyun; Mun, Yeung-Chul

    2014-01-01

    Waldenström's macroglobulinemia (WM) is a B-cell proliferative malignancy characterized by immunoglobulin M monoclonal gammopathy and bone marrow infiltration by lymphoplasmacytic cells. Clinical features and cytogenetics of WM in Asia including Republic of Korea remain unclear. Moreover, no study has reported treatment outcomes in patients with WM treated with novel agent combined with conventional chemotherapy. This study investigated clinical features and assessed treatment outcomes with novel agent and conventional chemotherapy in Republic of Korea. Data from all (n = 71) patients with newly diagnosed WM at 17 hospitals who received chemotherapy between January 2005 and December 2012 were collected retrospectively. The median age of patients was 66 years (range: 37–92 years) and male to female ratio was 5 : 1. Patients treated with novel agent combined chemotherapy displayed higher overall response rate (ORR) compared to conventional chemotherapy alone (92.9% versus 52.6%, P = 0.006). The 5-year overall survival rate was 62.6% (95% confidence interval: 34.73–111.07). Use of novel agents produced higher ORR but survival benefit was not apparent due to the small number of patients and short follow-up duration. Further studies are needed to confirm the efficacy of novel agents in patients with WM. PMID:24995279

  15. Biosimilar Epoetin Zeta in Oncology and Haematology: Development and Experience following 6 Years of Use.

    PubMed

    Michallet, Mauricette; Losem, Christoph

    2016-01-01

    Chemotherapy-induced anaemia is frequent in cancer patients, with severity depending on the extent of the disease and intensity of treatment. Clinical guidelines recommend erythropoietin therapy to treat or prevent anaemia in some oncology/haematology patients being treated with chemotherapy. The patent expiry of the first-generation erythropoietins has led to the development of biosimilar products, i.e. therapeutic proteins exhibiting comparable quality, safety and efficacy to an existing reference biological medicine, the patent of which has expired. This review summarises the available data set supporting the use of one such biosimilar product, epoetin zeta (Retacrit™) in oncology/haematology. The body of evidence supporting the use of epoetin zeta continues to grow, with post-marketing clinical studies underway to evaluate its longer-term clinical efficacy and safety. Biosimilar medicines have the potential to offer cost savings to health care providers, with the assurance of ongoing risk management programmes to ensure patient safety. PMID:26426164

  16. Factors influencing patients seeking oral health care in the oncology dental support clinic at an urban university dental school setting.

    PubMed

    Corrigan, Dale M; Walker, Mary P; Liu, Ying; Mitchell, Tanya Villalpando

    2014-01-01

    The purpose of this study was to identify predictors and/or factors associated with medically compromised patients seeking dental care in the oncology dental support clinic (ODSC) at the University of Missouri-Kansas City (UMKC) School of Dentistry. An 18-item survey was mailed to 2,541 patients who were new patients to the clinic from 2006 to 2011. The response rate was approximately 18% (n = 450). Analyses included descriptive statistics of percentages/frequencies as well as predictors based on correlations. Fifty percent of participants, 100 females and 119 males, identified their primary medical diagnosis as cancer. Total household income (p < .001) and the importance of receiving dental care (p < .001) were significant factors in relation to self-rated dental health. Perceived overall health (p < .001) also had a significant association with cancer status and the need for organ transplants. This study provided the ODSC at UMKC and other specialty clinics with vital information that can contribute to future planning efforts. PMID:24712504

  17. Clinical and histopathological evaluation of the effect of addition of immunotherapy with Mw vaccine to standard chemotherapy in borderline leprosy.

    PubMed

    Kamal, R; Natrajan, M; Katoch, K; Arora, M

    2012-01-01

    This study reports detailed analysis of clinical parameters and clearance of granuloma in borderline leprosy patients treated with immunotherapy and chemotherapy. It aims to assess the additive effect of immunotherapy (Mwvaccine) with standard MDT on clinical status of untreated borderline leprosy cases and on granuloma fraction of untreated borderline leprosy cases. Patients attending the OPD were serially recruited in two groups. A total of 150 cases in one treatment (trial) group (Mw vaccine plus MDT) and 120 cases in another treatment (control) group (MDT only) of border line leprosy have been included. After the formal written consent, detailed clinical examination, charting, smear examination of all untreated borderline patients of both groups was done, biopsies were taken from the active lesions of all patients of both groups at start of therapy and every six month thereafter till the completion of therapy. The same procedure was repeated every six months during the follow-up period. Standard MDT was given to all the patients of both groups according to type of disease. Mw vaccine 0.1 ml (0.5 x 10(9) bacilli) was injected intra-dermally at the start of therapy and every six months in addition to chemotherapy to the treatment group. The BT cases were followed up after 6 doses of MDT and 2 doses of Mw vaccine, and, the BB, BL cases were followed up after 24 doses of MDT plus 5 doses of Mw vaccine. Clinically, greater and faster improvement was observed in all the clinical parameters, faster attainment of smear negativity and two episodes of lepra reaction occurred in cases treated with combined chemotherapy and immunotherapy, as compared to controls (chemotherapy alone) wherein clinical improvement was slower in all parameters, slower attainment of smear negativity in bacillary index and seven showed the occurrence of reactions, histipathologically in addition to more rapid clearance of granuloma in immunotherapy treated group, a significant finding was an

  18. Multivisceral resections for rectal cancers: short-term oncological and clinical outcomes from a tertiary-care center in India

    PubMed Central

    Pai, Vishwas D.; Jatal, Sudhir; Ostwal, Vikas; Engineer, Reena; Arya, Supreeta; Patil, Prachi; Bal, Munita

    2016-01-01

    Background Locally advanced rectal cancers (LARCs) involve one or more of the adjacent organs in upto 10-20% patients. The cause of the adhesions may be inflammatory or neoplastic, and the exact causes cannot be determined pre- or intra-operatively. To achieve complete resection, partial or total mesorectal excision (TME) en bloc with the involved organs is essential. The primary objective of this study is to determine short-term oncological and clinical outcomes in these patients undergoing multivisceral resections (MVRs). Methods This is a retrospective review of a prospectively maintained database. Between 1 July 2013 and 31 May 2015, all patients undergoing MVRs for adenocarcinoma of the rectum were identified from this database. All patients who had en bloc resection of an adjacent organ or part of an adjacent organ were included. Those with unresectable metastatic disease after neoadjuvant therapy were excluded. Results Fifty-four patients were included in the study. Median age of the patients was 43 years. Mucinous histology was detected in 29.6% patients, and signet ring cell adenocarcinoma was found in 24.1% patients. Neoadjuvant therapy was given in 83.4% patients. R0 resection was achieved in 87% patients. Five-year overall survival (OS) was 70% for the entire cohort of population. Conclusions In Indian subcontinent, MVRs in young patients with high proportion of signet ring cell adenocarcinomas based on magnetic resonance imaging (MRI) of response assessment (MRI 2) is associated with similar circumferential resection margin (CRM) involvement and similar adjacent organ involvement as the western patients who are older and surgery is being planned on MRI 1 (baseline pelvis). However, longer follow-up is needed to confirm noninferiority of oncological outcomes. PMID:27284465

  19. A Bayesian Dose-finding Design for Oncology Clinical Trials of Combinational Biological Agents

    PubMed Central

    Cai, Chunyan; Yuan, Ying; Ji, Yuan

    2013-01-01

    Treating patients with novel biological agents is becoming a leading trend in oncology. Unlike cytotoxic agents, for which efficacy and toxicity monotonically increase with dose, biological agents may exhibit non-monotonic patterns in their dose-response relationships. Using a trial with two biological agents as an example, we propose a dose-finding design to identify the biologically optimal dose combination (BODC), which is defined as the dose combination of the two agents with the highest efficacy and tolerable toxicity. A change-point model is used to reflect the fact that the dose-toxicity surface of the combinational agents may plateau at higher dose levels, and a flexible logistic model is proposed to accommodate the possible non-monotonic pattern for the dose-efficacy relationship. During the trial, we continuously update the posterior estimates of toxicity and efficacy and assign patients to the most appropriate dose combination. We propose a novel dose-finding algorithm to encourage sufficient exploration of untried dose combinations in the two-dimensional space. Extensive simulation studies show that the proposed design has desirable operating characteristics in identifying the BODC under various patterns of dose-toxicity and dose-efficacy relationships. PMID:24511160

  20. A Bayesian Dose-finding Design for Oncology Clinical Trials of Combinational Biological Agents.

    PubMed

    Cai, Chunyan; Yuan, Ying; Ji, Yuan

    2014-01-01

    Treating patients with novel biological agents is becoming a leading trend in oncology. Unlike cytotoxic agents, for which efficacy and toxicity monotonically increase with dose, biological agents may exhibit non-monotonic patterns in their dose-response relationships. Using a trial with two biological agents as an example, we propose a dose-finding design to identify the biologically optimal dose combination (BODC), which is defined as the dose combination of the two agents with the highest efficacy and tolerable toxicity. A change-point model is used to reflect the fact that the dose-toxicity surface of the combinational agents may plateau at higher dose levels, and a flexible logistic model is proposed to accommodate the possible non-monotonic pattern for the dose-efficacy relationship. During the trial, we continuously update the posterior estimates of toxicity and efficacy and assign patients to the most appropriate dose combination. We propose a novel dose-finding algorithm to encourage sufficient exploration of untried dose combinations in the two-dimensional space. Extensive simulation studies show that the proposed design has desirable operating characteristics in identifying the BODC under various patterns of dose-toxicity and dose-efficacy relationships. PMID:24511160

  1. Monoclonal antibodies for medical oncology: a few critical perspectives.

    PubMed

    Belda-Iniesta, Cristóbal; Ibáñez de Cáceres, Inmaculada; de Castro, Javier

    2011-02-01

    Incorporation of antibodies as weapons for cancer therapy has meant a turning point in the survival, clinical and radiological response of many oncology patients. These drugs are effective, well designed missiles that either alone or in combination with chemotherapy are unavoidable weapons for breast, lung and colon cancer as well as for haematological tumours. In addition, incoming monoclonal antibodies (mAbs) and folder-like proteins will be incorporated into clinical practice in the near future. This review aims to discuss a few imminent indications of current mAbs that are used for solid tumours and to briefly introduce future mAbs to the reader. PMID:21324795

  2. Phase 1 Clinical Trial of Stereotactic Body Radiation Therapy Concomitant With Neoadjuvant Chemotherapy for Breast Cancer

    SciTech Connect

    Bondiau, Pierre-Yves; Courdi, Adel; Bahadoran, Phillipe; Chamorey, Emmanuel; Queille-Roussel, Catherine; Lallement, Michel; Birtwisle-Peyrottes, Isabelle; Chapellier, Claire; Pacquelet-Cheli, Sandrine; Ferrero, Jean-Marc

    2013-04-01

    Purpose: Stereotactic body radiation therapy (SBRT) allows stereotactic irradiation of thoracic tumors. It may have a real impact on patients who may not otherwise qualify for breast-conserving surgery. We conducted a phase 1 trial that tested 5 dose levels of SBRT concomitant with neoadjuvant chemotherapy (NACT) before to surgery. The purpose of the current dose escalation study was to determine the maximum tolerable dose of SBRT in the treatment of breast cancer. Methods and Materials: To define toxicity, we performed dermatologic examinations that included clinical examinations by 2 separate physicians and technical evaluations using colorimetry, dermoscopy, and skin ultrasonography. Dermatologic examinations were performed before NACT, 36 and 56 days after the beginning of NACT, and before surgery. Surgery was performed 4 to 8 weeks after the last chemotherapy session. Efficacy, the primary endpoint, was determined by the pathologic complete response (pCR) rate. Results: Maximum tolerable dose was not reached. Only 1 case of dose-limiting toxicity was reported (grade 3 dermatologic toxicity), and SBRT was overall well tolerated. The pCR rate was 36%, with none being observed at the first 2 dose levels, and the highest rate being obtained at dose level 3 (25.5 Gy delivered in 3 fractions). Furthermore, the breast-conserving surgery rate was up to 92% compared with an 8% total mastectomy rate. No surgical complications were reported. Conclusions: This study demonstrates that SBRT can be safely combined with NACT. Regarding the efficacy endpoints, this trial showed promising results in terms of pCR rate (36%) and breast-conserving rate (92%). The findings provide a strong rationale for extending the study into a phase 2 trial. In view of the absence of correlation between dose and pCR, and given that the data from dose level 3 met the statistical requirements, a dose of 25.5 Gy in 3 fractions should be used for the phase 2 trial.

  3. Cardiovascular safety monitoring during oncology drug development and therapy.

    PubMed

    Turner, J Rick; Panicker, Gopi Krishna; Karnad, Dilip R; Cabell, Christopher H; Lieberman, Ronald; Kothari, Snehal

    2014-01-01

    Assessments of cardiac and cardiovascular toxicity are prominent components of drug safety endeavors during drug development and clinical practice. Oncologic drugs bring several challenges to both domains. First, during drug development, it is necessary to adapt the ICH E14 "Thorough QT/QTc Study" because the cytotoxic nature of many oncologics precludes their being administered to healthy individuals. Second, appropriate benefit-risk assessments must be made by regulators: given the benefit these drugs provide in life-threatening illnesses, a greater degree of risk may be acceptable when granting marketing authorization than for drugs for less severe indications. Third, considerable clinical consideration is needed for patients who are receiving and have finished receiving pharmacotherapy. Paradoxically, although such therapy has proved very successful in many cases, with disease states going into remission and patients living for many years after cessation of treatment, cardiotoxicities can manifest themselves relatively soon or up to a decade later. Oncologic drugs have been associated with various off-target cardiovascular responses, including cardiomyopathy leading to heart failure, cardiac dysrhythmias, thromboembolic events, and hypertension. Follow-up attention and care are, therefore, critical. This article reviews the process of benefit-risk estimation, provides an overview of nonclinical and preapproval clinical assessment of cardiovascular safety of oncology drugs, and discusses strategies for monitoring and management of patients receiving drugs with known cardiotoxicity risk. These measures include cardiac function monitoring, limitation of chemotherapy dose, use of anthracycline analogs and cardioprotectants, and early detection of myocardial cell injury using biomarkers. PMID:24451296

  4. Species differences in tumour responses to cancer chemotherapy

    PubMed Central

    Lawrence, Jessica; Cameron, David; Argyle, David

    2015-01-01

    Despite advances in chemotherapy, radiotherapy and targeted drug development, cancer remains a disease of high morbidity and mortality. The treatment of human cancer patients with chemotherapy has become commonplace and accepted over the past 100 years. In recent years, and with a similar incidence of cancer to people, the use of cancer chemotherapy drugs in veterinary patients such as the dog has also become accepted clinical practice. The poor predictability of tumour responses to cancer chemotherapy drugs in rodent models means that the standard drug development pathway is costly, both in terms of money and time, leading to many drugs failing in Phase I and II clinical trials. This has led to the suggestion that naturally occurring cancers in pet dogs may offer an alternative model system to inform rational drug development in human oncology. In this review, we will explore the species variation in tumour responses to conventional chemotherapy and highlight our understanding of the differences in pharmacodynamics, pharmacokinetics and pharmacogenomics between humans and dogs. Finally, we explore the potential hurdles that need to be overcome to gain the greatest value from comparative oncology studies. PMID:26056373

  5. Species differences in tumour responses to cancer chemotherapy.

    PubMed

    Lawrence, Jessica; Cameron, David; Argyle, David

    2015-07-19

    Despite advances in chemotherapy, radiotherapy and targeted drug development, cancer remains a disease of high morbidity and mortality. The treatment of human cancer patients with chemotherapy has become commonplace and accepted over the past 100 years. In recent years, and with a similar incidence of cancer to people, the use of cancer chemotherapy drugs in veterinary patients such as the dog has also become accepted clinical practice. The poor predictability of tumour responses to cancer chemotherapy drugs in rodent models means that the standard drug development pathway is costly, both in terms of money and time, leading to many drugs failing in Phase I and II clinical trials. This has led to the suggestion that naturally occurring cancers in pet dogs may offer an alternative model system to inform rational drug development in human oncology. In this review, we will explore the species variation in tumour responses to conventional chemotherapy and highlight our understanding of the differences in pharmacodynamics, pharmacokinetics and pharmacogenomics between humans and dogs. Finally, we explore the potential hurdles that need to be overcome to gain the greatest value from comparative oncology studies. PMID:26056373

  6. Recent advances in the pharmacogenetics of cancer chemotherapy.

    PubMed

    Watters, James W; McLeod, Howard L

    2002-12-01

    Patient response to chemotherapy varies widely between individuals. Pharmacogenetics is the study of inherited DNA polymorphisms that influence drug disposition and effects, the goal of which is the individualization of drug treatment. As unpredictable efficacy and high levels of systemic toxicity are common in cancer chemotherapy, pharmacogenetics is particularly appealing for oncology. Recent studies have shown that polymorphisms in genes involved in drug metabolism, nucleotide synthesis and DNA repair contribute to inter-patient variability in the efficacy and toxicity of many chemotherapy agents. This review will discuss recent developments in the most clinically relevant examples of cancer pharmacogenetics, and how genetic differences among individuals are shaping the future of cancer chemotherapy. PMID:12596358

  7. The Business Case for Provider Participation in Clinical Trials Research: An Application to the National Cancer Institute's Community Clinical Oncology Program

    PubMed Central

    Song, Paula H.; Reiter, Kristin L.; Weiner, Bryan J.; Minasian, Lori; McAlearney, Ann Scheck

    2012-01-01

    Background Provider-based research networks (PBRNs) make clinical trials available in community-based practice settings, where most people receive their care, but provider participation requires both financial and in-kind contributions. Purpose This study explores whether providers believe there is a business case for participating in PBRNs and what factors contribute to the business case. Methodology/Approach We use a multiple case study methodology approach to examine the National Cancer Institute's Community Clinical Oncology Program, a longstanding federally funded PBRN. Interviews with 41 key informants across five sites, selected on the basis of organizational maturity, were conducted using a semi-structured interview guide. We analyzed interview transcripts using an iterative, deductive process to identify themes and subthemes in the data. Findings We found that a business case for provider participation in PBRNs may exist if both direct and indirect financial benefits are identified and included in the analysis, and if the time horizon is long enough to allow those benefits to be realized. We identified specific direct and indirect financial benefits that were perceived as important contributors to the business case and the perceived length of time required for a positive return to accrue. Practice Implications As the lack of a business case may result in provider reluctance to participate in PBRNs, knowledge of the benefits we identified may be crucial to encouraging and sustaining participation, thereby preserving patient access to innovative community-based treatments. The results are also relevant to federally-funded PBRNs outside of oncology or to providers considering participation in any clinical trials research. PMID:23044836

  8. A clinical exploration of neoadjuvant chemotherapy with tegafur, gimeracil, and oteracil potassium capsules combined with oxaliplatin for advanced gastric cancer

    PubMed Central

    Lv, Xinting; Zhang, Li; Huang, Renjun; Song, Weiyong

    2015-01-01

    Background: Advanced gastric cancer refers to tumor invasion into the gastric muscularis propria or even the layer beyond, and has low early gastric cancer diagnosis rate. Purpose: To determine the clinical efficacy and side effects of neoadjuvant chemotherapy with tegafur, gimeracil, and oteracil potassium capsules (TGOP) combined with oxaliplatin (SOX regimen) in patients with advanced gastric cancer. Methods: We evaluated 25 patients with advanced gastric cancer who were admitted and treated with neoadjuvant chemotherapy with the SOX regimen (intravenous injection of 130 mg/m2 oxaliplatin on day 1 followed by oral administration of 60 mg TGOP twice daily on days 1-14), every 3 weeks. The clinical efficacy and side effects of the SOX regimen were evaluated after two courses of treatment, before surgery. Results: Of the 25 patients enrolled in this study, 23 completed two courses of neoadjuvant chemotherapy, and of these, 12 achieved downstaging as determined by the clinical TNM stage, resulting in a total response rate of 52.2%. The 23 patients underwent surgery, with 22 receiving radical resection (95.7%). Among these 23 patients, R0 resection was achieved in 16 (69.6%) and pathological complete remission was observed in one. Conclusion: Neoadjuvant chemotherapy with TGOP combined with oxaliplatin was effective for advanced gastric cancer and had tolerable side effects. PMID:26770529

  9. The importance of pharmacist providing patient education in oncology.

    PubMed

    Avery, Mia; Williams, Felecia

    2015-02-01

    The world's increasing diversity requires health care professionals to adjust delivery methods of teaching to accommodate different cultural values and beliefs. The ability to communicate effectively across languages and various cultural practices directly affects patient education outcomes. Pharmacist should be aware of varying modalities and considerations when counseling a patient diagnosed with cancer and undergoing chemotherapy. In more recent years, the medical profession has seen an increase in patient outcomes due to using the multidisciplinary team approach and has benefited by implementing Medication Therapy Management (MTM) programs at various institutions. For the clinical pharmacist, this would mean documentation for these services should be precise and accurate based on the specific patients needs. There are several factors involved in the care and therapy of the patient with cancer. Clinical oncology pharmacist should be aware of the ever-changing role in oncology and be able to implement new practices at their facility for better patient outcomes. PMID:25540194

  10. Rolapitant for the treatment of chemotherapy-induced nausea and vomiting: a review of the clinical evidence.

    PubMed

    Chasen, Martin R; Rapoport, Bernardo L

    2016-03-01

    Chemotherapy-induced nausea and vomiting (CINV), both acute and delayed, has a dramatic effect on the well-being and quality of life of patients with cancer. Improved understanding of the mechanisms involved in CINV has led to the development of agents targeting the 5-HT3 receptor as well as the NK-1 receptor. Antiemetic prophylaxis given to patients receiving highly emetogenic chemotherapy combines agents blocking the 5-HT3 and NK-1 receptors along with corticosteroids given regularly and repeatedly. Rolapitant is a long-acting NK-1 receptor antagonist with proven efficacy in controlling CINV as part of the prophylaxis regimen. This review will detail the clinical efficacy and safety of rolapitant in the treatment of patients with cancer receiving highly or moderately emetogenic chemotherapy. PMID:26842387

  11. Anticancer chemotherapy

    SciTech Connect

    Weller, R.E.

    1988-10-01

    Despite troubled beginnings, anticancer chemotherapy has made significant contribution to the control of cancer in man, particularly within the last two decades. Early conceptual observations awakened the scientific community to the potentials of cancer chemotherapy. There are now more than 50 agents that are active in causing regression of clinical cancer. Chemotherapy's major conceptual contributions are two-fold. First, there is now proof that patients with overt metastatic disease can be cured, and second, to provide a strategy for control of occult metastases. In man, chemotherapy has resulted in normal life expectancy for some patients who have several types of metastatic cancers, including choriocarcinoma, Burkitt's lymphomas, Wilm's tumor, acute lymphocytic leukemia, Hodgkins disease, diffuse histiocytic lymphoma and others. Anticancer chemotherapy in Veterinary medicine has evolved from the use of single agents, which produce only limited remissions, to the concept of combination chemotherapy. Three basic principles underline the design of combination chemotherapy protocols; the fraction of tumor cell killed by one drug is independent of the fraction killed by another drug; drugs with different mechanisms of action should be chosen so that the antitumor effects will be additive; and since different classes of drugs have different toxicities the toxic effects will not be additive.

  12. A pilot study of tandem high-dose chemotherapy with stem cell rescue as consolidation for high-risk neuroblastoma: Children's Oncology Group study ANBL00P1.

    PubMed

    Seif, A E; Naranjo, A; Baker, D L; Bunin, N J; Kletzel, M; Kretschmar, C S; Maris, J M; McGrady, P W; von Allmen, D; Cohn, S L; London, W B; Park, J R; Diller, L R; Grupp, S A

    2013-07-01

    Increasing treatment intensity has improved outcomes for children with neuroblastoma. We performed a pilot study in the Children's Oncology Group to assess the feasibility and toxicity of a tandem myeloablative regimen without TBI supported by autologous CD34-selected peripheral blood stem cells. Forty-one patients with high-risk neuroblastoma were enrolled; eight patients did not receive any myeloablative consolidation procedure and seven received only one. Two patients out of 41 (4.9%) experienced transplant-related mortality. CD34 selection was discontinued after subjects were enrolled due to serious viral illness. From the time of study enrollment, the overall 3-year EFS and OS were 44.8 ± 9.6% and 59.2 ± 9.2% (N=41). These results demonstrate that tandem transplantation in the cooperative group setting is feasible and support a randomized comparison of single vs tandem myeloablative consolidation with PBSC support for high-risk neuroblastoma. PMID:23334272

  13. A critical appraisal of the clinical utility of proton therapy in oncology

    PubMed Central

    Wang, Dongxu

    2015-01-01

    Proton therapy is an emerging technology for providing radiation therapy to cancer patients. The depth dose distribution of a proton beam makes it a preferable radiation modality as it reduces radiation to the healthy tissue outside the tumor, compared with conventional photon therapy. While theoretically beneficial, its clinical values are still being demonstrated from the increasing number of patients treated with proton therapy, from several dozen proton therapy centers around the world. High equipment and facility costs are often the major obstacle for its wider adoption. Because of the high cost and lack of definite clinical evidence of its superiority, proton therapy treatment faces criticism on its cost-effectiveness. Technological development is causing a gradual lowering of costs, and research and clinical studies are providing further evidence on its clinical utility. PMID:26604838

  14. Nursing Application of Oral Chemotherapy Safety Standards:An Informal Survey.

    PubMed

    LeFebvre, Kristine B; Felice, Toni L

    2016-06-01

    As the use of oral chemotherapy continues to rise, new approaches are needed to ensure patient safety. To help address this issue, the American Society of Clinical Oncology/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards were expanded in 2013 to include additional measures addressing oral anticancer drugs (OACs). Because minimal data assessing the application of these standards exist, ONS conducted an independent survey of oncology nurses to evaluate the application of these standards in practice as they relate to several areas of OAC use: assessment, consent, patient education, drug verification, and monitoring. The data revealed that, although the standards are followed in many settings, a large number of settings do not have processes in place to support safety standards and ensure patient safety when administering OACs. Information gained in this informal survey can be used to guide additional research and educational initiatives. PMID:27206292

  15. Risk factors for Clostridium difficile infection in hemato-oncological patients: A case control study in 144 patients

    PubMed Central

    Fuereder, Thorsten; Koni, Danjel; Gleiss, Andreas; Kundi, Michael; Makristathis, Athanasios; Zielinski, Christoph; Steininger, Christoph

    2016-01-01

    Evidence on risk factors for Clostridium difficile infection (CDI) in hemato-oncologic patients is conflicting. We studied risk factors for CDI in a large, well-characterized cohort of hemato-oncological patients. 144 hemato-oncological patients were identified in this retrospective, single center study with a microbiologically confirmed CDI-associated diarrhea. Patients were compared with 144 age and sex matched hemato-oncologic patients with CDI negative diarrhea. Risk factors such as prior antimicrobial therapy, type of disease, chemotherapy and survival were evaluated. CDI-positive patients received more frequently any antimicrobial agent and antimicrobial combination therapy than CDI-negative patients (79% vs. 67%; OR = 2.26, p = 0.038 and OR = 2.62, p = 0.003, respectively). CDI positive patients were treated more frequently with antimicrobial agents active against C. difficile than CDI negative ones (25% vs. 13%; OR = 2.2, p = 0.039). The interval between last chemotherapy and onset of diarrhea was significantly shorter in patients without CDI (median, 17 days vs 36 days; p < 0.001). Our study demonstrates that chemotherapy is not a significant risk factor for CDI but for early onset CDI negative diarrhea. The predominant modifiable risk factor for CDI is in hemato-oncological patients antimicrobial treatment. These findings should be taken into account in the daily clinical practice to avoid CDI associated complications and excess health care costs. PMID:27510591

  16. Risk factors for Clostridium difficile infection in hemato-oncological patients: A case control study in 144 patients.

    PubMed

    Fuereder, Thorsten; Koni, Danjel; Gleiss, Andreas; Kundi, Michael; Makristathis, Athanasios; Zielinski, Christoph; Steininger, Christoph

    2016-01-01

    Evidence on risk factors for Clostridium difficile infection (CDI) in hemato-oncologic patients is conflicting. We studied risk factors for CDI in a large, well-characterized cohort of hemato-oncological patients. 144 hemato-oncological patients were identified in this retrospective, single center study with a microbiologically confirmed CDI-associated diarrhea. Patients were compared with 144 age and sex matched hemato-oncologic patients with CDI negative diarrhea. Risk factors such as prior antimicrobial therapy, type of disease, chemotherapy and survival were evaluated. CDI-positive patients received more frequently any antimicrobial agent and antimicrobial combination therapy than CDI-negative patients (79% vs. 67%; OR = 2.26, p = 0.038 and OR = 2.62, p = 0.003, respectively). CDI positive patients were treated more frequently with antimicrobial agents active against C. difficile than CDI negative ones (25% vs. 13%; OR = 2.2, p = 0.039). The interval between last chemotherapy and onset of diarrhea was significantly shorter in patients without CDI (median, 17 days vs 36 days; p < 0.001). Our study demonstrates that chemotherapy is not a significant risk factor for CDI but for early onset CDI negative diarrhea. The predominant modifiable risk factor for CDI is in hemato-oncological patients antimicrobial treatment. These findings should be taken into account in the daily clinical practice to avoid CDI associated complications and excess health care costs. PMID:27510591

  17. Cutaneous manifestations of nontargeted and targeted chemotherapies.

    PubMed

    Shi, Veronica J; Levy, Lauren L; Choi, Jennifer N

    2016-06-01

    Care of the oncologic patient requires an integral understanding of the adverse reactions of chemotherapy. With the advent of targeted agents and immunomodulating therapies, reactions to these newer treatments are of clinical interest. Cutaneous side effects of chemotherapeutic agents, including toxic erythema and mucositis, are common and may require cessation of treatment if associated with discomfort, superinfection, or negative impact on quality of life. This article reviews the cutaneous adverse reactions and treatment options of both conventional cytotoxic chemotherapeutic agents and newer targeted, multikinase inhibitors and immunomodulating therapies. An understanding of possible cutaneous reactions by all providers involved in the care of the oncologic patient is critical for prompt recognition, allowing for appropriate treatment and referral to dermatologists when necessary. PMID:27178698

  18. Is Radiotherapy an Option for Early Breast Cancers With Complete Clinical Response After Neoadjuvant Chemotherapy?

    SciTech Connect

    Daveau, Caroline; Savignoni, Alexia; Abrous-Anane, Soumya; Pierga, Jean-Yves; Reyal, Fabien; Gautier, Chantal; Kirova, Youlia M.; Dendale, Remi; Campana, Francois; Fourquet, Alain; Bollet, Marc A.

    2011-04-01

    Purpose: To determine whether the exclusive use of radiotherapy (ERT) could be a treatment option after complete clinical response (cCR) to neoadjuvant chemotherapy (NCT) for early breast cancer (EBC). Methods and Materials: Between 1985 and 1999, 1,477 patients received NCT for EBC considered too large for primary conservative surgery. Of 165 patients with cCR, 65 patients were treated with breast surgery (with radiotherapy) and 100 patients were treated with ERT. Results: The two groups were comparable in terms of baseline characteristics, except for larger initial tumor sizes in the ERT group. There were no significant differences in overall, disease-free and metastasis-free survival rates. Five-year and 10-year overall survival rates were 91% and 77% in the no-surgery group and 82% and 79% in the surgery group, respectively (p = 0.9). However, a nonsignificant trend toward higher locoregional recurrence rates (LRR) was observed in the no-surgery group (31% vs. 17% at 10 years; p = 0.06). In patients with complete responses on mammography and/or ultrasound, LRR were not significantly different (p = 0.45, 10-year LRR: 21% in surgery vs. 26% in ERT). No significant differences were observed in terms of the rate of cutaneous, cardiac, or pulmonary toxicities. Conclusions: Surgery is a key component of locoregional treatment for breast cancers that achieved cCR to NCT.

  19. Identifying clinically relevant drug resistance genes in drug-induced resistant cancer cell lines and post- chemotherapy tissues

    PubMed Central

    Tong, Mengsha; Zheng, Weicheng; Lu, Xingrong; Ao, Lu; Li, Xiangyu; Guan, Qingzhou; Cai, Hao; Li, Mengyao; Yan, Haidan; Guo, You; Chi, Pan; Guo, Zheng

    2015-01-01

    Until recently, few molecular signatures of drug resistance identified in drug-induced resistant cancer cell models can be translated into clinical practice. Here, we defined differentially expressed genes (DEGs) between pre-chemotherapy colorectal cancer (CRC) tissue samples of non-responders and responders for 5-fluorouracil and oxaliplatin-based therapy as clinically relevant drug resistance genes (CRG5-FU/L-OHP). Taking CRG5-FU/L-OHP as reference, we evaluated the clinical relevance of several types of genes derived from HCT116 CRC cells with resistance to 5-fluorouracil and oxaliplatin, respectively. The results revealed that DEGs between parental and resistant cells, when both were treated with the corresponding drug for a certain time, were significantly consistent with the CRG5-FU/L-OHP as well as the DEGs between the post-chemotherapy CRC specimens of responders and non-responders. This study suggests a novel strategy to extract clinically relevant drug resistance genes from both drug-induced resistant cell models and post-chemotherapy cancer tissue specimens. PMID:26515599

  20. Clinical Predictive Models for Chemotherapy-Induced Febrile Neutropenia in Breast Cancer Patients: A Validation Study

    PubMed Central

    Zhu, Liling; Su, Fengxi; Jia, Weijuan; Deng, Xiaogeng

    2014-01-01

    Background Predictive models for febrile neutropenia (FN) would be informative for physicians in clinical decision making. This study aims to validate a predictive model (Jenkin’s model) that comprises pretreatment hematological parameters in early-stage breast cancer patients. Patients and Methods A total of 428 breast cancer patients who received neoadjuvant/adjuvant chemotherapy without any prophylactic use of colony-stimulating factor were included. Pretreatment absolute neutrophil counts (ANC) and absolute lymphocyte counts (ALC) were used by the Jenkin’s model to assess the risk of FN. In addition, we modified the threshold of Jenkin’s model and generated Model-A and B. We also developed Model-C by incorporating the absolute monocyte count (AMC) as a predictor into Model-A. The rates of FN in the 1st chemotherapy cycle were calculated. A valid model should be able to significantly identify high-risk subgroup of patients with FN rate >20%. Results Jenkin’s model (Predicted as high-risk when ANC≦3.1*10∧9/L;ALC≦1.5*10∧9/L) did not identify any subgroups with significantly high risk (>20%) of FN in our population, even if we used different thresholds in Model-A(ANC≦4.4*10∧9/L;ALC≦2.1*10∧9/L) or B(ANC≦3.8*10∧9/L;ALC≦1.8*10∧9/L). However, with AMC added as an additional predictor, Model-C(ANC≦4.4*10∧9/L;ALC≦2.1*10∧9/L; AMC≦0.28*10∧9/L) identified a subgroup of patients with a significantly high risk of FN (23.1%). Conclusions In our population, Jenkin’s model, cannot accurately identify patients with a significant risk of FN. The threshold should be changed and the AMC should be incorporated as a predictor, to have excellent predictive ability. PMID:24945817

  1. Role of ERCC1 variants in response to chemotherapy and clinical outcome of advanced non-small cell lung cancer.

    PubMed

    Huang, Shao-jun; Wang, Yu-fei; Jin, Zhi-yong; Sun, Jia-yang; Guo, Zhan-lin

    2014-05-01

    Excision repair cross-complementation group 1 (ERCC1) and xeroderma pigmentosum-F (XPF) in the nucleotide excision repair pathway have been effectively repairing DNA damage induced by chemotherapeutic agents. We conducted a cohort study to assess the associations of ERCC1 and XPF polymorphisms with response to platinum-based chemotherapy and clinical outcome of non-small-cell lung cancer (NSCLC). One hundred eighty-seven NSCLC cases treated with platinum-based chemotherapy were prospectively analyzed. The predictive value of four SNPs in ERCC1 and two SNPs in XPF in patient's response and survival related to platinum-based chemotherapy were analyzed using χ(2) tests, Kaplan-Meier method, log-rank test, and Cox proportional hazards regression. The overall chemotherapy response rate for treatment was 51.18%. One hundred eighty-seven patients were followed up, and the median survival time is 17.6 months (ranged from 1 to 50 months). A total of 106 patients (56.68%) died from NSCLC during the follow-up period. Carriers of the rs3212986 AA and A allele had a borderline significantly lower response rate to the chemotherapy. In the Cox proportional hazards model, patients carrying the ERCC1 rs3212986 AA genotype were significantly associated with increased risk of death from NSCLC when compared with those with CC genotype as a reference variable. This study reported that variants in ERCC1 can be used as a prognostic maker to platinum-based chemotherapy in NSCLC patients. PMID:24370899

  2. [Communication in the context of phase I clinical trials in oncology: implementation and evaluation of training programs].

    PubMed

    Rouby, Pascal; Hollebecque, Antoine; Bahleda, Ratislav; Deutsch, Eric; Gomez-Rocca, Carlos; Angevin, Eric; de La Motte Rouge, Thibault; Soria, Jean-Charles; Dauchy, Sarah

    2015-02-01

    Communication training programs in oncology have demonstrated some efficacy to improve doctors' communication skills. The goal of our study was to evaluate the impact of such training in the particular context of phase I clinical trials. Self-satisfaction and self-efficacy scales evaluating doctor-patient communication was completed by 6 medical oncologists (3 juniors and 3 seniors) before and after their communication training for a total of sixty visits. Two types of visit have been distinguished: the visits between the oncologist and the patient alone (a dual situation) and those with a third party (a trilateral situation). For all the doctors in dual and trialateral situations, self-efficacy scores improved significantly after training. This improvement was more pronounced for juniors oncologists in trilateral situations. Before training, satisfactory scores were worst in duel versus trilateral situations (P=0.01). This was particularly pronounced for junior compared to senior doctors (P=0.035). After training, in trilateral situations, the satisfaction scores of junior doctors matched that of the senior doctors. The communication training programs appear to benefit junior oncologists to a greater extent in trilateral situations. PMID:25609484

  3. Early Benefit Assessments in Oncology in Germany: How Can a Clinically Relevant Endpoint Not Be Relevant to Patients?

    PubMed

    Ruof, Jörg; Flückiger, Olivier; Andre, Niko

    2015-09-01

    After 4 years of early benefit assessment (EBA) in Germany, it is becoming evident that the Federal Joint Committee (FJC) frequently considers well-established clinical endpoints as not being relevant to patients. Focusing on assessments of oncology medicines, we analysed the FJC's view on primary endpoints and compared it with the approach used by regulatory authorities. Mortality data were accepted by both stakeholders. Whereas regulatory authorities accepted primary morbidity endpoints such as progression-free survival and response rates, the FJC mostly excluded these from its assessments. Health-related quality of life (HRQoL) data have been poorly reflected in the approval process; for EBAs, those data have rarely impacted on benefit ratings. We argue that agreement between regulatory authorities and the FJC is required regarding primary study endpoints that are relevant to patients, and that clarification of acceptable endpoints by the FJC, especially in the morbidity domain, has to be provided. Moreover, in order to fully acknowledge the benefit of a new medicinal product, mortality, morbidity and HRQoL should be weighted differentially, according to the condition. PMID:26286202

  4. Elective Clinical Target Volumes for Conformal Therapy in Anorectal Cancer: A Radiation Therapy Oncology Group Consensus Panel Contouring Atlas

    SciTech Connect

    Myerson, Robert J. Garofalo, Michael C.; El Naqa, Issam; Abrams, Ross A.; Apte, Aditya; Bosch, Walter R.; Das, Prajnan; Gunderson, Leonard L.; Hong, Theodore S.; Kim, J.J. John; Willett, Christopher G.; Kachnic, Lisa A.

    2009-07-01

    Purpose: To develop a Radiation Therapy Oncology Group (RTOG) atlas of the elective clinical target volume (CTV) definitions to be used for planning pelvic intensity-modulated radiotherapy (IMRT) for anal and rectal cancers. Methods and Materials: The Gastrointestinal Committee of the RTOG established a task group (the nine physician co-authors) to develop this atlas. They responded to a questionnaire concerning three elective CTVs (CTVA: internal iliac, presacral, and perirectal nodal regions for both anal and rectal case planning; CTVB: external iliac nodal region for anal case planning and for selected rectal cases; CTVC: inguinal nodal region for anal case planning and for select rectal cases), and to outline these areas on individual computed tomographic images. The imaging files were shared via the Advanced Technology Consortium. A program developed by one of the co-authors (I.E.N.) used binomial maximum-likelihood estimates to generate a 95% group consensus contour. The computer-estimated consensus contours were then reviewed by the group and modified to provide a final contouring consensus atlas. Results: The panel achieved consensus CTV definitions to be used as guidelines for the adjuvant therapy of rectal cancer and definitive therapy for anal cancer. The most important difference from similar atlases for gynecologic or genitourinary cancer is mesorectal coverage. Detailed target volume contouring guidelines and images are discussed. Conclusion: This report serves as a template for the definition of the elective CTVs to be used in IMRT planning for anal and rectal cancers, as part of prospective RTOG trials.

  5. Do Oncologists Engage in Bereavement Practices? A Survey of the Israeli Society of Clinical Oncology and Radiation Therapy (ISCORT)

    PubMed Central

    Shabtai, Esther; Merimsky, Ofer; Inbar, Moshe; Rosenbaum, Eli; Meirovitz, Amichay; Wexler, Isaiah D.

    2010-01-01

    Purpose. We sought to determine the level of involvement of oncologists in bereavement rituals after a patient dies. Subjects and Methods. Members of the Israeli Society for Clinical Oncology and Radiation Therapy (ISCORT) were surveyed. The survey instrument consisted of questions regarding participation in bereavement rituals for patients in general and those with whom the oncologist had a special bond. Oncologists were queried as to the reasons for nonparticipation in bereavement rituals. Results. Nearly 70% of the ISCORT membership (126 of 182) completed the survey tool. Respondents included radiation, surgical, and medical oncologists. In general, oncologists rarely participated in bereavement rituals that involved direct contact with families such as funerals and visitations. Twenty-eight percent of physicians at least occasionally participated in rituals involving direct contact whereas 45% had indirect contact (e.g., letter of condolence) with the family on an occasional basis. There was significantly greater involvement in bereavement rituals when oncologists developed a special bond with the patient. In a stepwise linear regression model, the only factor significantly associated with greater participation in bereavement rituals was self-perceived spirituality in those claiming not to be religious. The major reasons offered for nonparticipation were time constraints, need to maintain appropriate boundaries between physicians and patients, and fear of burnout. Conclusion. Although many oncologists participate at least occasionally in some sort of bereavement ritual, a significant proportion of oncologists are not involved in these practices at all. PMID:20228130

  6. Dermatological Findings in Turkish Paediatric Haematology-Oncology Patients

    PubMed Central

    Uksal, Umit; Ozturk, Pinar; Colgecen, Emine; Taslidere, Nazan; Patiroglu, Turkan; Ozdemir, Mehmet Akif; Torun, Yasemin Altuner; Borlu, Murat

    2016-01-01

    Objective: Diagnoses of skin, mucosae, hair and nail manifestations in malignant diseases are often challenging because of life-threatening drug reactions, opportunistic infections or skin involvement of primary processes. Description of morphology, configuration and distribution of lesions is important in order to differentiate the self-healing eruptions from serious side effects of chemotherapy. There are case reports from Turkey including dermatological manifestations of malignancies and case series in adult patients but there are no published large group studies assessing all manifestations in children. The aim of this study was to evaluate the morphological features of dermatological findings in children with haemato-oncological diseases. Materials and Methods: The study was performed at the Erciyes University, Faculty of Medicine Pediatric Hematology-Oncology Clinic, Turkey. Three dermatologists daily consulted all patients admitted to the clinic during a one-year period. Results: The study group comprised of 157 children (79 female/78 male) aged 1–16 years (mean 7.19±4.63). Detailed dermatological examinations were performed, including oral-genital mucosae, hair and nails. Thorough skin examination revealed that 70% of the patients exhibited at least one dermatological finding. Generalized xerosis and hyperpigmentation were the most common findings among patients undergoing chemotherapy (24.19%). Multiple nevi on at least 10 covered areas were very frequent among patients undergoing long-term chemotherapy (18.47%). Three were identified as dysplastic nevus, but malignant transformation was not observed during the one-year study period. Conclusion: Regular dermatological consultation may help resolve the diagnostic and therapeutic problems in paediatric haemato-oncology clinics. PMID:27551173

  7. Applying PET to Broaden the Diagnostic Utility of the Clinically Validated CA19.9 Serum Biomarker for Oncology

    PubMed Central

    Viola-Villegas, Nerissa Therese; Rice, Samuel L.; Carlin, Sean; Wu, Xiaohong; Evans, Michael J.; Sevak, Kuntal K.; Drobjnak, Marija; Ragupathi, Govind; Sawada, Ritsuko; Scholz, Wolfgang W.; Livingston, Philip O.; Lewis, Jason S.

    2014-01-01

    Despite their considerable advantages, many circulating biomarkers have well-documented limitations. One prominent shortcoming in oncology is a high frequency of false-positive indications for malignant disease in upfront diagnosis. Because one common cause of false positivism is biomarker production from benign disorders in unrelated host tissues, we hypothesized that probing the sites of biomarker secretion with an imaging tool could be a broadly useful strategy to deconvolute the meaning of foreboding but inconclusive circulating biomarker levels. Methods In preparation to address this hypothesis clinically, we developed 89Zr-5B1, a fully human, antibody-based radiotracer targeting tumor-associated CA19.9 in the preclinical setting. Results 89Zr-5B1 localized to multiple tumor models representing diseases with undetectable and supraphysiologic serum CA19.9 levels. Among these, 89Zr-5B1 detected orthotopic models of pancreatic ductal adenocarcinoma, an elusive cancer for which the serum assay is measured in humans but with limited specificity in part because of the frequency of CA19.9 secretion from benign hepatic pathologies. Conclusion In this report, a general strategy to supplement some of the shortcomings of otherwise highly useful circulating biomarkers with immunoPET is described. To expedite the clinical validation of this model, a human monoclonal antibody to CA19.9 (a highly visible but partially flawed serum biomarker for several cancers) was radiolabeled and evaluated, and the compelling preclinical evidence suggests that the radiotracer may enhance the fidelity of diagnosis and staging of pancreatic ductal adenocarcinoma, a notoriously occult cancer. PMID:24029655

  8. Flow cytometric analysis of circulating endothelial cells and endothelial progenitors for clinical purposes in oncology: A critical evaluation

    PubMed Central

    DANOVA, MARCO; COMOLLI, GIUDITTA; MANZONI, MARIANGELA; TORCHIO, MARTINA; MAZZINI, GIULIANO

    2016-01-01

    Malignant tumors are characterized by uncontrolled cell growth and metastatic spread, with a pivotal importance of the phenomenon of angiogenesis. For this reason, research has focused on the development of agents targeting the vascular component of the tumor microenvironment and regulating the angiogenic switch. As a result, the therapeutic inhibition of angiogenesis has become an important component of anticancer treatment, however, its utility is partly limited by the lack of an established methodology to assess its efficacy in vivo. Circulating endothelial cells (CECs), which are rare in healthy subjects and significantly increased in different tumor types, represent a promising tool for monitoring the tumor clinical outcome and the treatment response. A cell population circulating into the blood also able to form endothelial colonies in vitro and to promote vasculogenesis is represented by endothelial progenitor cells (EPCs). The number of both of these cell types is extremely low and they cannot be identified using a single marker, therefore, in absence of a definite consensus on their phenotype, require discrimination using combinations of antigens. Multiparameter flow cytometry (FCM) is ideal for rapid processing of high numbers of cells per second and is commonly utilized to quantify CECs and EPCs, however, remains technically challenging since there is as yet no standardized protocol for the identification and enumeration of these rare events. Methodology in studies on CECs and/or EPCs as clinical biomarkers in oncology is heterogeneous and data have been obtained from different studies leading to conflicting conclusions. The present review presented a critical review of the issues that limit the comparability of results of the most significant studies employing FCM for CEC and/or EPC detection in patients with cancer. PMID:27284422

  9. Implementation of Remote 3-Dimensional Image Guided Radiation Therapy Quality Assurance for Radiation Therapy Oncology Group Clinical Trials

    SciTech Connect

    Cui Yunfeng; Galvin, James M.; Parker, William; Breen, Stephen; Yin Fangfang; Cai Jing; Papiez, Lech S.; Li, X. Allen; Bednarz, Greg; Chen Wenzhou; Xiao Ying

    2013-01-01

    Purpose: To report the process and initial experience of remote credentialing of three-dimensional (3D) image guided radiation therapy (IGRT) as part of the quality assurance (QA) of submitted data for Radiation Therapy Oncology Group (RTOG) clinical trials; and to identify major issues resulting from this process and analyze the review results on patient positioning shifts. Methods and Materials: Image guided radiation therapy datasets including in-room positioning CT scans and daily shifts applied were submitted through the Image Guided Therapy QA Center from institutions for the IGRT credentialing process, as required by various RTOG trials. A centralized virtual environment is established at the RTOG Core Laboratory, containing analysis tools and database infrastructure for remote review by the Physics Principal Investigators of each protocol. The appropriateness of IGRT technique and volumetric image registration accuracy were evaluated. Registration accuracy was verified by repeat registration with a third-party registration software system. With the accumulated review results, registration differences between those obtained by the Physics Principal Investigators and from the institutions were analyzed for different imaging sites, shift directions, and imaging modalities. Results: The remote review process was successfully carried out for 87 3D cases (out of 137 total cases, including 2-dimensional and 3D) during 2010. Frequent errors in submitted IGRT data and challenges in the review of image registration for some special cases were identified. Workarounds for these issues were developed. The average differences of registration results between reviewers and institutions ranged between 2 mm and 3 mm. Large discrepancies in the superior-inferior direction were found for megavoltage CT cases, owing to low spatial resolution in this direction for most megavoltage CT cases. Conclusion: This first experience indicated that remote review for 3D IGRT as part of QA

  10. Electronic nicotine delivery systems: a policy statement from the American Association for Cancer Research and the American Society of Clinical Oncology.

    PubMed

    Brandon, Thomas H; Goniewicz, Maciej L; Hanna, Nasser H; Hatsukami, Dorothy K; Herbst, Roy S; Hobin, Jennifer A; Ostroff, Jamie S; Shields, Peter G; Toll, Benjamin A; Tyne, Courtney A; Viswanath, Kasisomayajula; Warren, Graham W

    2015-03-10

    Combustible tobacco use remains the number-one preventable cause of disease, disability, and death in the United States. Electronic nicotine delivery systems (ENDS), which include electronic cigarettes, are devices capable of delivering nicotine in an aerosolized form. ENDS use by both adults and youth has increased rapidly, and some have advocated these products could serve as harm-reduction devices and smoking cessation aids. ENDS may be beneficial if they reduce smoking rates or prevent or reduce the known adverse health effects of smoking. However, ENDS may also be harmful, particularly to youth, if they increase the likelihood that nonsmokers or former smokers will use combustible tobacco products or if they discourage smokers from quitting. The American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO) recognize the potential ENDS have to alter patterns of tobacco use and affect the health of the public; however, definitive data are lacking. The AACR and ASCO recommend additional research on these devices, including assessing the health impacts of ENDS, understanding patterns of ENDS use, and determining what role ENDS have in cessation. Key policy recommendations include supporting federal, state, and local regulation of ENDS; requiring manufacturers to register with the US Food and Drug Administration and report all product ingredients, requiring childproof caps on ENDS liquids, and including warning labels on products and their advertisements; prohibiting youth-oriented marketing and sales; prohibiting child-friendly ENDS flavors; and prohibiting ENDS use in places where cigarette smoking is prohibited. This policy statement was developed by a joint writing group composed of members from the Tobacco and Cancer Subcommittee of the American Association for Cancer Research (AACR) Science Policy and Government Affairs (SPGA) Committee and American Society of Clinical Oncology (ASCO) Tobacco Cessation and Control

  11. Clinical verification of sensitivity to preoperative chemotherapy in cases of androgen receptor-expressing positive breast cancer

    PubMed Central

    Asano, Yuka; Kashiwagi, Shinichiro; Onoda, Naoyoshi; Kurata, Kento; Morisaki, Tamami; Noda, Satoru; Takashima, Tsutomu; Ohsawa, Masahiko; Kitagawa, Seiichi; Hirakawa, Kosei

    2016-01-01

    Background: Triple-negative breast cancer (TNBC) patients testing positive for androgen receptor (AR) expression are thought to be chemotherapy resistant, similar to other hormone receptor-positive breast cancers; however, this has not been substantially validated in the clinic. In this study, we investigated the association between chemotherapy sensitivity and AR expression in patients treated with neoadjuvant chemotherapy (NAC) using standardised chemotherapy criteria and regimens. Methods: A total of 177 patients with resectable early-stage breast cancer were treated with NAC. Oestrogen receptor, progesterone receptor, HER2, Ki67 and AR status were assessed immunohistochemically. Results: Sixty-one patients were diagnosed with TNBC; AR expression was identified in 23 (37.7%), which was significantly less common than that found in non-TNBC patients (103 of 116; 88.8% P<0.001). The rate of pathological complete response after NAC was significantly lower (P=0.001), and disease recurrence was more common (P=0.008) in patients with AR-positive compared with those with AR-negative TNBC. In TNBC cases, as expected, the non-recurrence period in cases that were negative for AR expression was significantly extended (P=0.006, log-rank). Conclusions: Androgen receptor expressions may be useful as biomarkers to predict treatment responses to NAC in TNBC. Moreover, induction of a change in subtype to the AR-negative phenotype was observed after NAC. PMID:26757422

  12. Gastrointestinal and liver infections in children undergoing antineoplastic chemotherapy in the years 2000

    PubMed Central

    Castagnola, Elio; Ruberto, Eliana; Guarino, Alfredo

    2016-01-01

    AIM: To review gastrointestinal and liver infections in children undergoing antineoplastic chemotherapy. To look at gut microflora features in oncology children. METHODS: We selected studies published after year 2000, excluding trials on transplanted pediatric patients. We searched English language publications in MEDLINE using the keywords: “gastrointestinal infection AND antineoplastic chemotherapy AND children”, “gastrointestinal infection AND oncology AND children”, “liver infection AND antineoplastic chemotherapy AND children”, “liver abscess AND chemotherapy AND child”, “neutropenic enterocolitis AND chemotherapy AND children”, “thyphlitis AND chemotherapy AND children”, “infectious diarrhea AND children AND oncology”, “abdominal pain AND infection AND children AND oncology”, “perianal sepsis AND children AND oncology”, “colonic pseudo-obstruction AND oncology AND child AND chemotherapy”, “microflora AND children AND malignancy”, “microbiota AND children AND malignancy”, “fungal flora AND children AND malignancy”. We also analysed evidence from several articles and book references. RESULTS: Gastrointestinal and liver infections represent a major cause of morbidity and mortality in children undergoing antineoplastic chemotherapy. Antineoplastic drugs cause immunosuppression in addition to direct toxicity, predisposing to infections, although the specific risk is variable according to disease and host features. Common pathogens potentially induce severe diseases whereas opportunistic microorganisms may attack vulnerable hosts. Clinical manifestations can be subtle and not specific. In addition, several conditions are rare and diagnostic process and treatments are not standardized. Diagnosis may be challenging, however early diagnosis is needed for quick and appropriate interventions. Interestingly, the source of infection in those children can be exogenous or endogenous. Indeed, mucosal damage may allow the

  13. Equivalence of intrathecal chemotherapy and radiotherapy as central nervous system prophylaxis in children with acute lymphatic leukemia: a pediatric oncology group study

    SciTech Connect

    Sullivan, M.P.; Chen, T.; Dyment, P.G.; Hvizdala, E.; Steuber, C.P.

    1982-10-01

    The efficacy of intrathecal (i.t.) chemoprophylaxis was compared with cranial radiotherapy plus i.t. methotrexate (MTX) in a Southwest Oncology Group (SWOG) study accessing 408 patients from September 10, 1974, to October 29, 1976. Randomization was stratified by prognostic groups (PGs) based on age and white blood cell count at diagnosis. All received induction therapy with vincristine and prednisone (Pred); maintenance therapy consisted of daily 6-mercaptopurine and weekly MTX. Consolidation for arm 1 employed cyclophosphamide and L-asparaginase followed by biwekly 5-day courses of parenteral MTX. The first dose of each course of MTX was given i.t. in triple chemoprophylaxis (MTX, hydrocortisone, and cytosine arabinoside). During maintenance, i.t. chemoprophylaxis was bimonthly and 28-day Pred ''pulses'' were given every 3 mo. Arm 2 i.t. chemoprophylaxis was initiated on achievement of remission, and arm 3 i.t. on treatment day 1; both continued 1 yr. Arm 4 induction included two doses of L-asparaginase. On achievement of remission, CNS prophylaxis (radiotherapy, 2400 rad plus i.t. MTX) was given. For all, therapy was discontinued after 3 yr of continuous complete remission. Survival and the incidence of extramedullary relapse were similar for the treatment employing either i.t. chemoprophylaxis or radiotherapy plus i.t. MTX upon achievement of remission. The study indicates that i.t. chemoprophylaxis may be substituted for cranial radiotherapy when utilizing effective systemic regimens. Additionally, chemoprophylaxis may be reduced from 3 to 1 yr in patients with good prognostic factors. (JMT)

  14. Emerging molecular targets in oncology: clinical potential of MET/hepatocyte growth-factor inhibitors

    PubMed Central

    Smyth, Elizabeth C; Sclafani, Francesco; Cunningham, David

    2014-01-01

    The MET/hepatocyte growth-factor (HGF) signaling pathway plays a key role in the processes of embryogenesis, wound healing, and organ regeneration. Aberrant activation of MET/HGF occurs through multiple mechanisms including gene amplification, mutation, protein overexpression, and abnormal gene splicing interrupting autocrine and paracrine regulatory feedback mechanisms. In many cancers including non-small-cell lung cancer, colorectal, gastric, renal, and hepatocellular cancer, dysregulation of MET may lead to a more aggressive cancer phenotype and may be a negative prognostic indicator. Successful therapeutic targeting of the MET/HGF pathway has been achieved using monoclonal antibodies against the MET receptor and its ligand HGF in addition to MET-specific and multitargeted small-molecule tyrosine-kinase inhibitors with several drugs in late-phase clinical trials including onartuzumab, rilotumumab, tivantinib, and cabozantinib. MET frequently interacts with other key oncogenic tyrosine kinases including epidermal growth-factor receptor (EGFR) and HER-3 and these interactions may be responsible for resistance to anti-EGFR therapies. Similarly, resistance to MET inhibition may be mediated through EGFR activation, or alternatively by increasing levels of MET amplification or acquisition of novel “gatekeeper” mutations. In order to optimize development of effective inhibitors of the MET/HGF pathway clinical trials must be enriched for patients with demonstrable MET-pathway dysregulation for which robustly standardized and validated assays are required. PMID:24959087

  15. A risk management approach for imaging biomarker-driven clinical trials in oncology.

    PubMed

    Liu, Yan; deSouza, Nandita M; Shankar, Lalitha K; Kauczor, Hans-Ulrich; Trattnig, Siegfried; Collette, Sandra; Chiti, Arturo

    2015-12-01

    Imaging has steadily evolved in clinical cancer research as a result of improved conventional imaging methods and the innovation of new functional and molecular imaging techniques. Despite this evolution, the design and data quality derived from imaging within clinical trials are not ideal and gaps exist with paucity of optimised methods, constraints of trial operational support, and scarce resources. Difficulties associated with integrating imaging biomarkers into trials have been neglected compared with inclusion of tissue and blood biomarkers, largely because of inherent challenges in the complexity of imaging technologies, safety issues related to new imaging contrast media, standardisation of image acquisition across multivendor platforms, and various postprocessing options available with advanced software. Ignorance of these pitfalls directly affects the quality of the imaging read-out, leading to trial failure, particularly when imaging is a primary endpoint. Therefore, we propose a practical risk-based framework and recommendations for trials driven by imaging biomarkers, which allow identification of risks at trial initiation to better allocate resources and prioritise key tasks. PMID:26678215

  16. Significance of PIK3CA Mutations in Patients with Early Breast Cancer Treated with Adjuvant Chemotherapy: A Hellenic Cooperative Oncology Group (HeCOG) Study

    PubMed Central

    Alexopoulou, Zoi; Kalogeras, Konstantine T.; Zagouri, Flora; Timotheadou, Eleni; Gogas, Helen; Pentheroudakis, George; Christodoulou, Christos; Koutras, Angelos; Bafaloukos, Dimitrios; Aravantinos, Gerasimos; Papakostas, Pavlos; Charalambous, Elpida; Papadopoulou, Kyriaki; Varthalitis, Ioannis; Efstratiou, Ioannis; Zaramboukas, Thomas; Patsea, Helen; Scopa, Chrisoula D.; Skondra, Maria; Kosmidis, Paris; Pectasides, Dimitrios; Fountzilas, George

    2015-01-01

    Background The PI3K-AKT pathway is frequently activated in breast cancer. PIK3CA mutations are most frequently found in the helical (exon 9) and kinase (exon 20) domains of this protein. The aim of the present study was to examine the role of different types of PIK3CA mutations in combination with molecular biomarkers related to PI3K-AKT signaling in patients with early breast cancer. Methods Tumor tissue samples from 1008 early breast cancer patients treated with adjuvant chemotherapy in two similar randomized trials of HeCOG were examined. Tumors were subtyped with immunohistochemistry (IHC) and FISH for ER, PgR, Ki67, HER2 and androgen receptor (AR). PIK3CA mutations were analyzed by Sanger sequencing (exon 20) and qPCR (exon 9) (Sanger/qPCR mutations). In 610 cases, next generation sequencing (NGS) PIK3CA mutation data were also available. PIK3CA mutations and PTEN protein expression (IHC) were analyzed in luminal tumors (ER and/or PgR positive), molecular apocrine carcinomas (MAC; ER/PgR negative / AR positive) and hormone receptor (ER/PgR/AR) negative tumors. Results PIK3CA mutations were detected in 235/1008 tumors (23%) with Sanger/qPCR and in 149/610 tumors (24%) with NGS. Concordance between the two methods was good with a Kappa coefficient of 0.76 (95% CI 0.69–0.82). Lobular histology, low tumor grade and luminal A tumors were associated with helical domain mutations (PIK3CAhel), while luminal B with kinase domain mutations (PIK3CAkin). The overall incidence of PIK3CA mutations was higher in luminal as compared to MAC and hormone receptor negative tumors (p = 0.004). Disease-free and overall survival did not significantly differ with respect to PIK3CA mutation presence and type. However, a statistically significant interaction between PIK3CA mutation status and PTEN low protein expression with regard to prognosis was identified. Conclusions The present study did not show any prognostic significance of specific PIK3CA mutations in a large group of

  17. Impact of obesity on chemotherapy management and outcomes in women with gynecologic malignancies

    PubMed Central

    Horowitz, Neil S.; Wright, Alexi A.

    2015-01-01

    Objective To describe the effects of obesity on the pharmacokinetics and dosing of chemotherapies and provide recommendations for chemotherapy management in obese women with gynecologic malignancies. Methods PubMEd and MEDLINE databases were searched for articles published before June 2014. Only English-language articles were considered. 84 manuscripts were reviewed and 66 were included. Search terms included: obesity, overweight, body mass index, body surface area, glomerular filtration rate, chemotherapy, ovarian cancer, endometrial cancer, inflammation, and pharmacokinetics, Results Obese cancer patients have worse clinical outcomes, compared with non-obese patients. This may be because of differences in pharmacokinetics, metabolic dysregulation, or physicians' decisions to reduce chemotherapy dose-intensity during treatment to minimize toxicities. A 2012 American Society of Clinical Oncology Clinical Practice Guideline recommends using actual body weight for chemotherapy dosing in all patients treated with curative intent, irrespective of obesity, to avoid compromising clinical outcomes, including progression free survival (PFS) and overall survival (OS). In women with gynecologic cancers most studies demonstrate no difference in PFS or OS when obese patients receive the same chemotherapy dose intensity as non-obese patients, except perhaps with bevacizumab. Conclusions Chemotherapy dose-intensity is a critical determinant of cancer outcomes and should be maintained in all patients, irrespective of obesity. Future studies should prospectively examine the impact of obesity on clinical outcomes (adverse events, survival) to improve the care of this growing population of patients who are at risk for inferior clinical outcomes. PMID:25870918

  18. Determining Chemotherapy Tolerance in Older Patients With Cancer

    PubMed Central

    Kim, Jerome; Hurria, Arti

    2014-01-01

    Older adults with cancer constitute a heterogeneous group of patients who pose unique challenges for oncology care. One major concern is how to identify patients who are at a higher risk for chemotherapy intolerance, because a standard oncology workup may not always be able to distinguish an older individual’s level of risk for treatment-related complications. Geriatric oncologists incorporate tools used in the field of geriatrics, and have developed the Comprehensive Geriatric Assessment to enhance the standard oncology workup. This assessment pinpoints problems with daily activities, comorbidities, medications, nutritional status, cognitive function, psychological state, and social support systems, all of which are risk factors for treatment vulnerability in older adults with cancer. Additional tools that also serve to predict chemotherapy toxicity in older patients with cancer are now available to identify patients at higher risk for morbidity and mortality. Together, these instruments complement the standard oncology workup by providing a global assessment, thereby guiding therapeutic interventions that may improve a patient’s quality of life and clinical outcomes. PMID:24335684

  19. Updates in oncology.

    PubMed

    Sculier, Jean-Paul; Meert, Anne-Pascale; Berghmans, Thierry

    2014-03-01

    The objective of this review is to report the Clinical Year in Review proceedings in the field of thoracic oncology that were presented at the 2013 European Respiratory Society Annual Congress in Barcelona, Spain. Various topics were reviewed, including: epidemiology, screening, histology, and treatment of nonsmall cell lung cancer and small cell lung cancer. PMID:24591664

  20. The clinical analysis of acute pancreatitis in colorectal cancer patients undergoing chemotherapy after operation

    PubMed Central

    Ji, Yanlei; Han, Zhen; Shao, Limei; Li, Yunling; Zhao, Long; Zhao, Yuehuan

    2015-01-01

    Acute pancreatitis is a rare complication in postoperative colorectal cancer patients after FOLFOX6 (oxaliplatin + calcium folinate +5-FU [5-fluorouracil]) chemotherapy. In this paper, a total of 62 patients with gastrointestinal cancer were observed after the burst of acute pancreatitis. Surgery of the 62 cases of colorectal cancer patients was completed successfully. But when they underwent FOLFOX6 chemotherapy, five patients got acute pancreatitis (8.06%), four (6.45%) had mild acute pancreatitis, and one (1.61%) had severe acute pancreatitis, of which two were males (3.23%) and three females (4.84%). No patients (0.00%) had acute pancreatitis on the 1st day after chemotherapy; one patient (1.61%) got it in the first 2 and 3 days after chemotherapy; and three others (4.83%) got it in the first 4 days after chemotherapy. In the 62 patients with malignant tumors, the body mass index (BMI) was less than 18 (underweight) in six of them, with two cases of acute pancreatitis (33.33%); the BMI was 18–25 (normal weight) in 34 cases, with one case (2.94%) of acute pancreatitis; the BMI was 25–30 (overweight) in 13 cases, with 0 cases (0.00%) of acute pancreatitis; and the BMI was ≥30 (obese) in nine patients, with two cases of acute pancreatitis (22.22%). After symptomatic treatment, four patients were cured and one died; the mortality rate was 1.61%. Most of them appeared in the first 4 days after chemotherapy; the probability of this complication is significantly higher in slim and obese patients than in normal weight patients. Postoperative colorectal cancer patients after FOLFOX6 chemotherapy have a sudden onset of acute pancreatitis occult, especially in patients with severe acute pancreatitis; the symptoms are difficult to control, there is high mortality and it is worthy of clinician’s attention. PMID:26392780

  1. The clinical analysis of acute pancreatitis in colorectal cancer patients undergoing chemotherapy after operation.

    PubMed

    Ji, Yanlei; Han, Zhen; Shao, Limei; Li, Yunling; Zhao, Long; Zhao, Yuehuan

    2015-01-01

    Acute pancreatitis is a rare complication in postoperative colorectal cancer patients after FOLFOX6 (oxaliplatin + calcium folinate +5-FU [5-fluorouracil]) chemotherapy. In this paper, a total of 62 patients with gastrointestinal cancer were observed after the burst of acute pancreatitis. Surgery of the 62 cases of colorectal cancer patients was completed successfully. But when they underwent FOLFOX6 chemotherapy, five patients got acute pancreatitis (8.06%), four (6.45%) had mild acute pancreatitis, and one (1.61%) had severe acute pancreatitis, of which two were males (3.23%) and three females (4.84%). No patients (0.00%) had acute pancreatitis on the 1st day after chemotherapy; one patient (1.61%) got it in the first 2 and 3 days after chemotherapy; and three others (4.83%) got it in the first 4 days after chemotherapy. In the 62 patients with malignant tumors, the body mass index (BMI) was less than 18 (underweight) in six of them, with two cases of acute pancreatitis (33.33%); the BMI was 18-25 (normal weight) in 34 cases, with one case (2.94%) of acute pancreatitis; the BMI was 25-30 (overweight) in 13 cases, with 0 cases (0.00%) of acute pancreatitis; and the BMI was ≥30 (obese) in nine patients, with two cases of acute pancreatitis (22.22%). After symptomatic treatment, four patients were cured and one died; the mortality rate was 1.61%. Most of them appeared in the first 4 days after chemotherapy; the probability of this complication is significantly higher in slim and obese patients than in normal weight patients. Postoperative colorectal cancer patients after FOLFOX6 chemotherapy have a sudden onset of acute pancreatitis occult, especially in patients with severe acute pancreatitis; the symptoms are difficult to control, there is high mortality and it is worthy of clinician's attention. PMID:26392780

  2. Influence of patient age on the frequency of occurrence and antimicrobial resistance patterns of isolates from hematology/oncology patients: report from the Chemotherapy Alliance for Neutropenics and the Control of Emerging Resistance Program (North America).

    PubMed

    Kirby, Jeffrey T; Fritsche, Thomas R; Jones, Ronald N

    2006-09-01

    The Chemotherapy Alliance for Neutropenics and the Control of Emerging Resistance Program (CANCER) monitored the susceptibility of pathogens recovered in hematology/oncology centers from 2000 to 2002. A total of 3970 isolates from 32 hospitals (26 United States, 6 Canada) were analyzed at a central location (JMI Laboratories, North Liberty, IA) for trends in pathogen occurrence and reference antimicrobial susceptibility profiles. The top 5 ranking pathogens were Staphylococcus aureus (19.3%), coagulase-negative staphylococci (CoNS) (14.1%), Escherichia coli (13.4%), Enterococcus spp. (10.2%), and Klebsiella spp. (9.5%). A total of 35.5% of S. aureus and 78.8% of CoNS were resistant to oxacillin, whereas 22.0% of Enterococcus spp. were resistant to vancomycin. E. coli and Klebsiella spp. were highly susceptible (>90%) to piperacillin/tazobactam, 3rd-generation cephalosporins, and ciprofloxacin, but 3.9% and 2.4% of these species, respectively, met screening criteria for extended spectrum beta-lactamase production. Enterobacter spp. were less susceptible to piperacillin/tazobactam, ceftazidime, and ceftriaxone (83.7-88.2%) because of Amp C production and were most inhibited by cefepime and imipenem. Amikacin and polymyxin B were very active against Pseudomonas aeruginosa (97.4-97.7% susceptible). Prevalence of S. aureus, E. coli, Enterobacter spp., and Klebsiella spp. increased significantly (+48% to 98%) with age, whereas CoNS and viridans group streptococci decreased markedly (-62% to 69%) with advancing age. The isolation of Gram-positive pathogens declined (55% to 47%) with age (< or =14 to > or =65 years). Fluoroquinolones generally exhibited decreased susceptibility with increased age against nearly all listed pathogens. Oxacillin resistance rates for S. aureus increased with age (6-46%) as did vancomycin resistance rates for enterococci (nil in < or =14 years group to 18-24% in adults). Pathogens infecting neutropenic patients did not reflect greater

  3. Determination of Spatial Distribution of Children Treated in Children Oncology Clinic with the Aid of Geographic Information Systems.

    PubMed

    Topan, Aysel; Bayram, Dilek; Özendi, Mustafa; Cam, Ali; Öztürk, Özlem; Ayyıldız, Tülay Kuzlu; Kulakçı, Hülya; Veren, Funda

    2016-10-01

    The main objective of this research is to examine child cancer cases in Zonguldak/Turkey descriptively in epidemiological aspect with the help of GIS. Universe of the study is composed of 60 children between 1 and 19 years old who were treated in Children Oncology Clinic with a diagnosis of cancer. Whole universe was reached without selecting a sample in the study. Data were collected by using a form prepared by obtaining expert advice and they were applied to children and their parents at study dates. Results were expressed as percentages. Chi-Square test was used in intergroup comparisons, results were assessed within 95 % confidence interval and p < 0.05 was considered as statistically significant. Variables that were used in the study were assessed, recorded in prepared data collection form and distribution maps were produced. When disease diagnosis of the children participated in the study were evaluated, the most observed three types are ALL with 33.3 % (n = 20), Medullablastoma with 13.3 % (n = 8) and Hodgkin-nonHodgkin Lymphoma with 11.7 % (n = 7). Kdz. Eregli with 31.7 % (n = 19), Center with 31.7 % (n = 19), and Caycuma with 18.3 % (n = 11) are the first-three counties where the cases were mostly observed. Statistically significant difference was found (p = 0.016) comparing disease diagnosis with living place, and distribution maps of the number of cancer cases were produced. PMID:27624492

  4. Acute gastroduodenal mucosal injury after cisplatin plus etoposide chemotherapy. Clinical and endoscopic study.

    PubMed

    Sartori, S; Nielsen, I; Maestri, A; Beltrami, D; Trevisani, L; Pazzi, P

    1991-01-01

    The effects on gastric and duodenal mucosa induced by cisplatin plus etoposide (PE) chemotherapy were investigated in 32 patients with lung cancer. They were submitted to gastroduodenoscopy before receiving cisplatin 100 mg/m2 (day 1) plus etoposide at a mean dose of 107 mg/m2 (days 1, 3 and 5). Endoscopic examination was repeated on day 8. Before chemotherapy, 22 patients showed normal endoscopic appearance and 10 minimal lesions (3 or fewer erosions). After chemotherapy, 16 remained normal, 1 had minimal lesions and 15 developed major lesions: 11 gastric or duodenal multiple erosions, 1 diffuse erosive gastritis, 2 gastric and 1 duodenal ulcer (p less than 0.001). No difference was observed in the number of vomiting episodes nor in severity of upper gastrointestinal symptoms between the patients who remained normal and those who developed mucosal injury. We conclude that PE chemotherapy can have a properly called gastroduodenal toxicity, leaving nausea and vomiting out which are rather due to central than peripheral mechanisms. Some trials are necessary to investigate which kind of drugs (H2-receptor blockers, sucralfate, prostaglandin E analogues) may be useful in preventing acute gastroduodenal mucosal injury induced by PE chemotherapy. PMID:1745480

  5. Clinical cancer advances 2007: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology.

    PubMed

    Gralow, Julie; Ozols, Robert F; Bajorin, Dean F; Cheson, Bruce D; Sandler, Howard M; Winer, Eric P; Bonner, James; Demetri, George D; Curran, Walter; Ganz, Patricia A; Kramer, Barnett S; Kris, Mark G; Markman, Maurie; Mayer, Robert J; Raghavan, Derek; Ramsey, Scott; Reaman, Gregory H; Sawaya, Raymond; Schuchter, Lynn M; Sweetenham, John W; Vahdat, Linda T; Davidson, Nancy E; Schilsky, Richard L; Lichter, Allen S

    2008-01-10

    A MESSAGE FROM ASCO'S PRESIDENT: For the third year, the American Society of Clinical Oncology (ASCO) is publishing Clinical Cancer Advances: Major Research Advances in Cancer Treatment, Prevention, and Screening, an annual review of the most significant cancer research presented or published over the past year. ASCO publishes this report to demonstrate the important progress being made on the front lines of clinical cancer research today. The report is intended to give all those with an interest in cancer care-the general public, cancer patients and organizations, policymakers, oncologists, and other medical professionals-an accessible summary of the year's most important cancer research advances. These pages report on the use of magnetic resonance imaging for breast cancer screening, the association between hormone replacement therapy and breast cancer incidence, the link between human papillomavirus and head and neck cancers, and the use of radiation therapy to prevent lung cancer from spreading. They also report on effective new targeted therapies for cancers that have been historically difficult to treat, such as liver cancer and kidney cancer, among many others. A total of 24 advances are featured in this year's report. These advances and many more over the past several years show that the nation's long-term investment in cancer research is paying off. But there are disturbing signs that progress could slow. We are now in the midst of the longest sustained period of flat government funding for cancer research in history. The budgets for the National Institutes of Health and the National Cancer Institute (NCI) have been unchanged for four years. When adjusted for inflation, cancer research funding has actually declined 12% since 2004. These budget constraints limit the NCI's ability to fund promising cancer research. In the past several years the number of grants that the NCI has been able to fund has significantly decreased; this year, in response to just the

  6. Comparing Analytic Methods for Longitudinal GWAS and a Case-Study Evaluating Chemotherapy Course Length in Pediatric AML. A Report from the Children's Oncology Group.

    PubMed

    Vujkovic, Marijana; Aplenc, Richard; Alonzo, Todd A; Gamis, Alan S; Li, Yimei

    2016-01-01

    Regression analysis is commonly used in genome-wide association studies (GWAS) to test genotype-phenotype associations but restricts the phenotype to a single observation for each individual. There is an increasing need for analytic methods for longitudinally collected phenotype data. Several methods have been proposed to perform longitudinal GWAS for family-based studies but few methods are described for unrelated populations. We compared the performance of three statistical approaches for longitudinal GWAS in unrelated subjectes: (1) principal component-based generalized estimating equations (PC-GEE); (2) principal component-based linear mixed effects model (PC-LMEM); (3) kinship coefficient matrix-based linear mixed effects model (KIN-LMEM), in a study of single-nucleotide polymorphisms (SNPs) on the duration of 4 courses of chemotherapy in 624 unrelated children with de novo acute myeloid leukemia (AML) genotyped on the Illumina 2.5 M OmniQuad from the COG studies AAML0531 and AAML1031. In this study we observed an exaggerated type I error with PC-GEE in SNPs with minor allele frequencies < 0.05, wheras KIN-LMEM produces more than expected type II errors. PC-MEM showed balanced type I and type II errors for the observed vs. expected P-values in comparison to competing approaches. In general, a strong concordance was observed between the P-values with the different approaches, in particular among P < 0.01 where the between-method AUCs exceed 99%. PC-LMEM accounts for genetic relatedness and correlations among repeated phenotype measures, shows minimal genome-wide inflation of type I errors, and yields high power. We therefore recommend PC-LMEM as a robust analytic approach for GWAS of longitudinal data in unrelated populations. PMID:27547214

  7. Comparing Analytic Methods for Longitudinal GWAS and a Case-Study Evaluating Chemotherapy Course Length in Pediatric AML. A Report from the Children's Oncology Group

    PubMed Central

    Vujkovic, Marijana; Aplenc, Richard; Alonzo, Todd A.; Gamis, Alan S.; Li, Yimei

    2016-01-01

    Regression analysis is commonly used in genome-wide association studies (GWAS) to test genotype-phenotype associations but restricts the phenotype to a single observation for each individual. There is an increasing need for analytic methods for longitudinally collected phenotype data. Several methods have been proposed to perform longitudinal GWAS for family-based studies but few methods are described for unrelated populations. We compared the performance of three statistical approaches for longitudinal GWAS in unrelated subjectes: (1) principal component-based generalized estimating equations (PC-GEE); (2) principal component-based linear mixed effects model (PC-LMEM); (3) kinship coefficient matrix-based linear mixed effects model (KIN-LMEM), in a study of single-nucleotide polymorphisms (SNPs) on the duration of 4 courses of chemotherapy in 624 unrelated children with de novo acute myeloid leukemia (AML) genotyped on the Illumina 2.5 M OmniQuad from the COG studies AAML0531 and AAML1031. In this study we observed an exaggerated type I error with PC-GEE in SNPs with minor allele frequencies < 0.05, wheras KIN-LMEM produces more than expected type II errors. PC-MEM showed balanced type I and type II errors for the observed vs. expected P-values in comparison to competing approaches. In general, a strong concordance was observed between the P-values with the different approaches, in particular among P < 0.01 where the between-method AUCs exceed 99%. PC-LMEM accounts for genetic relatedness and correlations among repeated phenotype measures, shows minimal genome-wide inflation of type I errors, and yields high power. We therefore recommend PC-LMEM as a robust analytic approach for GWAS of longitudinal data in unrelated populations. PMID:27547214

  8. [Factitious diseases in oncology].

    PubMed

    Reich, Michel; Clermont, Amélie; Amela, Éric; Kotecki, Nuria

    2015-12-01

    Factitious diseases and pathomimias and particularly Munchausen's syndrome, due to their rarity, are poorly diagnosed by medical teams working in oncology. Consequences can be serious and result in unadapted surgery or non justified implementation of chemotherapy and radiotherapy regimens. These patients simulate diseases in order to attract medical attention. They might become belligerent and are likely to promptly discharge themselves from hospital if they do not get the desired attention or are unmasked. With two following case reports and literature review, we would like to alert clinicians about difficulties encountered in diagnosis and management of factitious disorders. When faced with this diagnosis, the patient will tend to deny reality and break contact with the medical team who exposed him. Medical peregrinating behavior surrounded by conflicts with medical team, past psychiatric illness, history of working in the medical and paramedical field and social isolation can guide the diagnosis. Somaticians and especially surgeons working in the oncologic field must remain vigilant about this diagnosis and collaborate with either the psycho-oncologic team or the consultation-liaison psychiatric team. Some recommendations for medical professionals how to cope with these patients will be suggested. PMID:26597474

  9. Performance in quasi-firms: an example from the Community Clinical Oncology Program.

    PubMed

    Lacey, L M; Hynes, D M; Kaluzny, A D

    1992-01-01

    In this analysis, the authors examined the effects of different sets of process, structure, and environmental variables on the performance of the CCOP as a quasi-firm. Specifically, they distinguished between internal organizational processes, structural, and size characteristics of the CCOP and the organizational environment created by prior NCI program experience and the relationship within the quasi-firm. The analysis revealed that these sets of organizational and environmental characteristics have differential effects on treatment accrual. The strongest predictors are those associated with the quasi-firm relationship between the CCOP and its chosen research bases. Any definitive policy implications for the design of organizational network relationships--especially the CCOPs--will require further analysis. Particular attention needs to be given to the longitudinal nature of the relationships and the ability of these organizational and environmental factors to affect other aspects of performance. Several points have been made within this initial assessment. First, the structural character of the CCOP and its relationship to its organizational environment are important factors affecting accrual performance. The subtleties of this multivariate model are not as important as simply demonstrating that the various internal and external characteristics of these organizations as quasi-firms simultaneously affect their ability to accrue patients to clinical trials. Secondly, the importance of research base relations, and particularly the significant role of nurses, needs to be emphasized. While CCOPs were originally designed as a network of physicians and hospitals, it appears that an infrastructure of professionally active nurses working within a larger organizational environment is critical to success--at least as defined by accrual to treatment protocols. Finally, the failure of prior experience with other NCI community programs to affect CCOP accrual performance

  10. Results of the 2005-2008 Association of Residents in Radiation Oncology Survey of Chief Residents in the United States: Clinical Training and Resident Working Conditions

    SciTech Connect

    Gondi, Vinai; Bernard, Johnny Ray; Jabbari, Siavash; Keam, Jennifer; Amorim Bernstein, Karen L. de; Dad, Luqman K.; Li, Linna; Poppe, Matthew M.; Strauss, Jonathan B.; Chollet, Casey T.

    2011-11-15

    Purpose: To document clinical training and resident working conditions reported by chief residents during their residency. Methods and Materials: During the academic years 2005 to 2006, 2006 to 2007, and 2007 to 2008, the Association of Residents in Radiation Oncology conducted a nationwide survey of all radiation oncology chief residents in the United States. Chi-square statistics were used to assess changes in clinical training and resident working conditions over time. Results: Surveys were completed by representatives from 55 programs (response rate, 71.4%) in 2005 to 2006, 60 programs (75.9%) in 2006 to 2007, and 74 programs (93.7%) in 2007 to 2008. Nearly all chief residents reported receiving adequate clinical experience in commonly treated disease sites, such as breast and genitourinary malignancies; and commonly performed procedures, such as three-dimensional conformal radiotherapy and intensity-modulated radiotherapy. Clinical experience in extracranial stereotactic radiotherapy increased over time (p < 0.001), whereas clinical experience in endovascular brachytherapy (p <0.001) decreased over time. The distribution of gynecologic and prostate brachytherapy cases remained stable, while clinical case load in breast brachytherapy increased (p = 0.006). A small but significant percentage of residents reported receiving inadequate clinical experience in pediatrics, seeing 10 or fewer pediatric cases during the course of residency. Procedures involving higher capital costs, such as particle beam therapy and intraoperative radiotherapy, and infrequent clinical use, such as head and neck brachytherapy, were limited to a minority of institutions. Most residency programs associated with at least one satellite facility have incorporated resident rotations into their clinical training, and the majority of residents at these programs find them valuable experiences. The majority of residents reported working 60 or fewer hours per week on required clinical duties

  11. Clinical benefits of combined chemotherapy with S-1, oxaliplatin, and docetaxel in advanced gastric cancer patients with palliative surgery

    PubMed Central

    Liu, Yan; Feng, Ye; Gao, Yongjian; Hou, Ruizhi

    2016-01-01

    Background and aim Advanced gastric cancer accounts for a substantial portion of cancer-related mortality worldwide. Surgical intervention is the curative therapeutic approach, but patients with advanced gastric cancer are not eligible for the radical resection. The present work aimed to investigate the efficacy and safety of palliative surgery combined with S-1, oxaliplatin, and docetaxel chemotherapy in the treatment of patients with advanced gastric cancer. Method A total of 20 patients who underwent palliative resection of gastric cancer in China–Japan Union Hospital of Jilin University from 2010 to 2011 were evaluated. Days 20–30 postoperative, these patients started to receive chemotherapy of S-1 (40 mg/m2, oral intake twice a day) and intravenous infusion of oxaliplatin (135 mg/m2) and docetaxel (75 mg/m2). After three cycles of chemotherapy (21 days/cycle), patients were evaluated, and only those who responded toward the treatment continued to receive six to eight cycles of the treatment and were included in end point evaluation. Patients’ survival time and adverse reactions observed along the treatment were compared with those treated with FOLFOX. Results Out of 20 patients evaluated, there was one case of complete response, nine cases of partial response, six cases of stable disease, and four cases of progressive disease. The total efficacy (complete response + partial response) and clinical benefit rates were 50% and 80%, respectively. Of importance, the treatment achieved a significantly longer survival time compared to FOLFOX, despite the fact that both regimens shared common adverse reactions. The adverse reactions were gastrointestinal reaction, reduction in white blood cells, and peripheral neurotoxicity. All of them were mild, having no impact on the treatment. Conclusion Combination therapy of S-1, oxaliplatin, and docetaxel improves the survival of gastric cancer patients treated with palliative resection, with adverse reactions being

  12. Treatment of early clinically staged Hodgkin's disease with a combination of ABVD chemotherapy plus limited field radiotherapy.

    PubMed

    Karmiris, T D; Grigoriou, E; Tsantekidou, M; Spanou, E; Mihalakeas, H; Baltadakis, J; Apostolidis, J; Pagoni, M; Karakasis, D; Bakiri, M; Mitsouli, C; Harhalakis, N; Nikiforakis, E

    2003-09-01

    The current management of early stage Hodgkin's disease (HD) is usually based on clinical staging, combined modality therapy and the use of less toxic chemotherapy regimens. This approach entails high cure rates, while ensures less long term toxicity with avoidance of laparotomy. The aim of this study was to assess the efficacy of a brief course of Adriamycin, Bleomycin, Vinblastine, Dacarbazine (ABVD) chemotherapy followed by limited field radiotherapy (RT) in favorable clinical stage (CS) I and IIA HD. Forty patients, aged 17-68 (median 34) years, with favorable CS I and IIA HD, without bulky mediastinal disease, have been treated with 4-6 (median 4) cycles of ABVD plus limited field RT. Twenty seven (67%) patients received 4 cycles of chemotherapy, while 13 received 5-6 cycles. Thirty five (87%) patients received limited field RT with dose 24-36 Gy and five (13%) received extended field with 36-46 Gy. All patients responded completely to chemotherapy. One patient experienced a relapse two months after the end of therapy. All patients are alive; 39 in continuous complete remission. With a median follow-up period of 44 months (range 18-101) the actuarial overall and progress free survival was 100 and 97% at 5 years. We did not observe any case of secondary leukemia or solid tumor. Pulmonary toxicity was mild in cases of mediastinal irradiation. Considering the short follow-up time and the small number of patients, the combination of a brief course of ABVD plus regional RT is a very efficacious treatment of favorable CS I and IIA HD with mild toxicity. However, long term survival data are needed, which could give confident answers regarding the risk of late therapy related complications, particularly second malignancies. PMID:14565654

  13. A Comparison of Proposed Biosimilar LA-EP2006 and Reference Pegfilgrastim for the Prevention of Neutropenia in Patients With Early-Stage Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2), a Phase III, Randomized, Double-Blind Trial

    PubMed Central

    Donskih, Roman; Jones, C. Michael; Nixon, Allen; Vidal, Maria J.; Nakov, Roumen; Singh, Pritibha; Schaffar, Gregor; Gascón, Pere; Harbeck, Nadia

    2016-01-01

    granulocyte colony-stimulating factor pegfilgrastim is widely used for the prevention of chemotherapy-induced neutropenia. Biosimilars are biologics with similar quality, safety, and efficacy to a reference product that may increase the affordability of treatment compared with their reference compounds. There are currently no approved biosimilars of pegfilgrastim in highly regulated markets. No previous phase III studies have been performed with LA-EP2006. PROTECT-2 was conducted to confirm the similarity of the proposed biosimilar LA-EP2006 to pegfilgrastim. Biosimilar pegfilgrastim (LA-EP2006) may benefit oncology patients by offering increased access to biological treatments that may improve clinical outcomes. This means that patients could potentially be treated prophylactically with biologics rather than only after complications have occurred. PMID:27091420

  14. Shared Risk Factors for Cardiovascular Disease and Cancer: Implications for Preventive Health and Clinical Care in Oncology Patients.

    PubMed

    Johnson, Christopher B; Davis, Margot K; Law, Angeline; Sulpher, Jeffrey

    2016-07-01

    The cardiovascular toxicity of cancer therapy has raised awareness of the importance of heart disease in cancer care among oncologists and cardiologists, leading to the new interdisciplinary field of cardio-oncology. Evidence is accumulating to suggest that risk factors associated with cardiovascular disease are also related to an increased incidence of cancer and excess cancer mortality. We review the epidemiologic evidence that smoking, obesity, poor diet, and inactivity can cause both heart disease and cancer. The importance of cardiovascular disease and cardiovascular risk factors in adversely affecting oncological outcomes and leading to increased cancer mortality is discussed. Cardiotoxicity prediction tools that incorporate cardiac disease and risk factors are described. Raising awareness about shared risk factors for cancer and heart disease may result in more effective advocacy to promote healthy lifestyle changes through the combined efforts of the historically separate specialties of cardiology and oncology. PMID:27343745

  15. Initial clinical experience with a radiation oncology dedicated open 1.0T MR-simulation.

    PubMed

    Glide-Hurst, Carri K; Wen, Ning; Hearshen, David; Kim, Joshua; Pantelic, Milan; Zhao, Bo; Mancell, Tina; Levin, Kenneth; Movsas, Benjamin; Chetty, Indrin J; Siddiqui, M Salim

    2015-01-01

    < 0.001) and ~fourfold acquisition time increase was measured for ten-phase versus two-phase. Superior-inferior object extent was underestimated 8% (6 mm) for two-phase as compared to ten-phase MIPs, although < 2% difference was obtained for ≥ 4 phases. 4D MRI for a patient demonstrated acceptable image quality in ~ 7 min. MR-SIM was integrated into our workflow and QA procedures were developed. Clinical applicability was demonstrated for 4D MRI and UTE imaging to support MR-SIM for single modality treatment planning. PMID:26103190

  16. Systemic Therapy in Men With Metastatic Castration-Resistant Prostate Cancer: American Society of Clinical Oncology and Cancer Care Ontario Clinical Practice Guideline

    PubMed Central

    Basch, Ethan; Loblaw, D. Andrew; Oliver, Thomas K.; Carducci, Michael; Chen, Ronald C.; Frame, James N.; Garrels, Kristina; Hotte, Sebastien; Kattan, Michael W.; Raghavan, Derek; Saad, Fred; Taplin, Mary-Ellen; Walker-Dilks, Cindy; Williams, James; Winquist, Eric; Bennett, Charles L.; Wootton, Ted; Rumble, R. Bryan; Dusetzina, Stacie B.; Virgo, Katherine S.

    2014-01-01

    Purpose To provide treatment recommendations for men with metastatic castration-resistant prostate cancer (CRPC). Methods The American Society of Clinical Oncology and Cancer Care Ontario convened an expert panel to develop evidence-based recommendations informed by a systematic review of the literature. Results When added to androgen deprivation, therapies demonstrating improved survival, improved quality of life (QOL), and favorable benefit-harm balance include abiraterone acetate/prednisone, enzalutamide, and radium-223 (223Ra; for men with predominantly bone metastases). Improved survival and QOL with moderate toxicity risk are associated with docetaxel/prednisone. For asymptomatic/minimally symptomatic men, improved survival with unclear QOL impact and low toxicity are associated with sipuleucel-T. For men who previously received docetaxel, improved survival, unclear QOL impact, and moderate to high toxicity risk are associated with cabazitaxel/prednisone. Modest QOL benefit (without survival benefit) and high toxicity risk are associated with mitoxantrone/prednisone after docetaxel. No benefit and excess toxicity are observed with bevacizumab, estramustine, and sunitinib. Recommendations Continue androgen deprivation (pharmaceutical or surgical) indefinitely. Abiraterone acetate/prednisone, enzalutamide, or 223Ra should be offered; docetaxel/prednisone should also be offered, accompanied by discussion of toxicity risk. Sipuleucel-T may be offered to asymptomatic/minimally symptomatic men. For men who have experienced progression with docetaxel, cabazitaxel may be offered, accompanied by discussion of toxicity risk. Mitoxantrone may be offered, accompanied by discussion of limited clinical benefit and toxicity risk. Ketoconazole or antiandrogens (eg, bicalutamide, flutamide, nilutamide) may be offered, accompanied by discussion of limited known clinical benefit. Bevacizumab, estramustine, and sunitinib should not be offered. There is insufficient evidence to

  17. Pharmacological foundations of cardio-oncology.

    PubMed

    Minotti, Giorgio; Salvatorelli, Emanuela; Menna, Pierantonio

    2010-07-01

    Anthracyclines and many other antitumor drugs induce cardiotoxicity that occurs "on treatment" or long after completing chemotherapy. Dose reductions limit the incidence of early cardiac events but not that of delayed sequelae, possibly indicating that any dose level of antitumor drugs would prime the heart to damage from sequential stressors. Drugs targeted at tumor-specific moieties raised hope for improving the cardiovascular safety of antitumor therapies; unfortunately, however, many such drugs proved unable to spare the heart, aggravated cardiotoxicity induced by anthracyclines, or were safe in selected patients of clinical trials but not in the general population. Cardio-oncology is the discipline aimed at monitoring the cardiovascular safety of antitumor therapies. Although popularly perceived as a clinical discipline that brings oncologists and cardiologists working together, cardio-oncology is in fact a pharmacology-oriented translational discipline. The cardiovascular performance of survivors of cancer will only improve if clinicians joined pharmacologists in the search for new predictive models of cardiotoxicity or mechanistic approaches to explain how a given drug might switch from causing systolic failure to inducing ischemia. The lifetime risk of cardiotoxicity from antitumor drugs needs to be reconciled with the identification of long-lasting pharmacological signatures that overlap with comorbidities. Research on targeted drugs should be reshaped to appreciate that the terminal ballistics of new "magic bullets" might involve cardiomyocytes as innocent bystanders. Finally, the concepts of prevention and treatment need to be tailored to the notion that late-onset cardiotoxicity builds on early asymptomatic cardiotoxicity. The heart of cardio-oncology rests with such pharmacological foundations. PMID:20335321

  18. Effect of increase in duration of aprepitant consumption from 3 to 6 days on the prevention of nausea and vomiting in women receiving combination of anthracycline/cyclophosphamide chemotherapy: A randomized, crossover, clinical trial

    PubMed Central

    Ahvazi, Negah Chaabi; Hemati, Simin; Mohamadianpanah, Mohamad

    2015-01-01

    Background: Aprepitant is one of the effective antiemetic drugs that usually used for a period of 3 days for prevention of anthracycline/cyclophosphamide (AC) induced nausea and vomiting. However, many patients still experience nausea and vomiting on days 3–5. The aim of this study was to evaluate the effect of an increase in duration of aprepitant consumption from 3 to 6 days on the prevention of nausea and vomiting in women receiving AC chemotherapy. Materials and Methods: It was a randomized, crossover, controlled clinical trial. Women with breast cancer and scheduled to receive AC regimens were enrolled in this study. Enrolled patients were randomized into two groups. Group I received 3 days regimen of aprepitant in the first course of AC regimen chemotherapy and 6 days regimen of aprepitant in the second course; Group II received 6 days regimen followed by 3 days regimen. For nausea and vomiting assessment, we used Eastern Cooperative Oncology Group questionnaire. Results: Forty-nine patients were enrolled in this study. Sixty-three percent achieved a complete response with 6 days aprepitant regimen compared with 39% with 3 days regimen (P < 0.001). Ten percent had at least one vomiting episode during the 6 days regimen versus 15% with 3 days regimen (P = 0.034). Nausea was significantly more severe in 3 days regimen of aprepitant than in 6 days regimen. Conclusion: Increase in the duration of aprepitant consumption through 6 days resulted in significantly better prevention of nausea and vomiting than 3 days consumption for women receiving AC chemotherapy. PMID:26682204

  19. Adjuvant chemotherapy in elderly patients with breast cancer: key challenges.

    PubMed

    Pondé, Noam; Dal Lago, Lissandra; Azim, Hatem A

    2016-06-01

    Elderly women with early breast cancer (BC) form a heterogeneous and large subgroup (41.8% of women with BC are over 65). Decision making in this subgroup is made more difficult by lack of familiarity with their physical, cognitive and social issues. Adequate management depends on biological factors and accurate clinical evaluation through comprehensive geriatric assessment (CGA). CGA can help to better select and determine potential risks factors for patients who are candidates for adjuvant chemotherapy. It is still recently introduced in geriatric oncology and there is a lack of awareness of its importance. Available data on adjuvant chemotherapy for BC is limited but suggests it can be of benefit for well selected patients, though the risk of short and long-term toxicity is significant. Here we provide a discussion of the key practical issues in decision making in the setting of adjuvant chemotherapy for elderly BC patients. PMID:27010772

  20. The role of palliative chemotherapy in hospitalized patients

    PubMed Central

    Wheatley–Price, P.; Ali, M.; Balchin, K.; Spencer, J.; Fitzgibbon, E.; Cripps, C.

    2014-01-01

    Background Hospitalized patients with advanced cancer often have a poor performance status, which is considered a relative contraindication to cytotoxic chemotherapy. We investigated outcomes in hospitalized solid tumour oncology patients who received palliative chemotherapy (pct). Methods With ethics approval, we performed a single-institution chart review of all patients hospitalized on our oncology unit who received pct between April 2008 and January 2010. Patient demographics, reasons for admission, cancer type, prior therapy, and administered chemotherapy were recorded. The primary endpoint was median survival from date of inpatient chemotherapy until death or last known follow up. We also investigated place of discharge and whether patients received additional therapy. Results During the study period, 199 inpatients received pct. Median age was 61 years; 59% of the patients were women. Most had been admitted with dyspnea (31%) or pain (29%) as the dominant symptom. Common cancers represented were breast (23%), small-cell lung cancer (sclc, 22%), non-small-cell lung cancer (nsclc, 16%), and colorectal cancer (9%). Most patients (67%) were receiving first-line chemotherapy. Median overall survival duration was 4.5 months, and the 6-month survival rate was 41%. The longest and shortest survivals were seen in the sclc and nsclc groups (7.3 and 2.5 months respectively). Factors significantly associated with shorter survival were baseline hypoalbuminemia and therapy beyond the first line. In this cohort, 77% of patients were discharged home, and 72% received further chemotherapy. Conclusions Despite a short median survival, many patients are well enough to be discharged home and to receive further chemotherapy. The development of risk models to predict a higher chance of efficacy will have practical clinical utility. PMID:25089101

  1. Response Assessment in Neuro-Oncology working group and European Association for Neuro-Oncology recommendations for the clinical use of PET imaging in gliomas.

    PubMed

    Albert, Nathalie L; Weller, Michael; Suchorska, Bogdana; Galldiks, Norbert; Soffietti, Riccardo; Kim, Michelle M; la Fougère, Christian; Pope, Whitney; Law, Ian; Arbizu, Javier; Chamberlain, Marc C; Vogelbaum, Michael; Ellingson, Ben M; Tonn, Joerg C

    2016-09-01

    This guideline provides recommendations for the use of PET imaging in gliomas. The review examines established clinical benefit in glioma patients of PET using glucose ((18)F-FDG) and amino acid tracers ((11)C-MET, (18)F-FET, and (18)F-FDOPA). An increasing number of studies have been published on PET imaging in the setting of diagnosis, biopsy, and resection as well radiotherapy planning, treatment monitoring, and response assessment. Recommendations are based on evidence generated from studies which validated PET findings by histology or clinical course. This guideline emphasizes the clinical value of PET imaging with superiority of amino acid PET over glucose PET and provides a framework for the use of PET to assist in the management of patients with gliomas. PMID:27106405

  2. [Chemotherapy for tuberculosis; yesterday, today, and tomorrow--basic and clinical studies].

    PubMed

    Aoyagi, T

    1998-07-01

    The discovery of streptomycin in 1944 had given rise to great flowering of chemotherapy for tuberculosis. The times which triple treatment of SM.PAS.INH after the temporal time of SM.PAS had been standard regimens on initial treatment had continued for more than twenty years. The shortening of duration for chemotherapy had become possible by the introduction of RFP, and the duration had reduced to one fourth compared with that of the regimens till then by the addition of PZA for two months at the beginning of treatment on the initial treatment cases. In this paper, historical aspects of early and present-day chemotherapy of tuberculosis and the reports of main studies have been summarized, and pharmacokinetics of INH, action of antituberculous drugs in short-course chemotherapy, MDR-TB and biological response modifiers for treatment of tuberculosis, etc. has been reviewed. It is urgently awaited that more new drugs without cross resistance to previous drugs will be developed for the more shortening of the duration and the improvement of the treatment for MDR-TB. PMID:9739578

  3. Efficacy of Adding Bevacizumab in the First-Line Chemotherapy of Metastatic Colorectal Cancer: Evidence from Seven Randomized Clinical Trials

    PubMed Central

    Chen, Yan-xian; Yang, Qiong; Kuang, Jun-jie; Chen, Shi-yu; Wei, Ying; Jiang, Zhi-min; Xie, De-rong

    2014-01-01

    Background. Efficacy of adding bevacizumab in first-line chemotherapy of metastatic colorectal cancer (mCRC) has been controversial. The aim of this study is to gather current data to analyze efficacy of adding bevacizumab to the most used combination first-line chemotherapy in mCRC, based on the 2012 meta-analysis reported by Macedo et al.  Methods. Medline, EMBASE and Cochrane library, meeting presentations and abstracts were searched. Eligible studies were randomized controlled trials (RCTs) which evaluated first-line chemotherapy with or without bevacizumab in mCRC. The extracting data were included and examined in the meta-analysis according to the type of chemotherapy regimen. Results. Seven trials, totaling 3436 patients, were analyzed. Compared with first-line chemothery alone, the adding of bevacizumab did not show clinical benefit for OS both in first-line therapy and the most used combination chemotherapy (HR = 0.89; 95% CI = 0.78–1.02; P = 0.08; HR = 0.93; 95% CI = 0.83–1.05; P = 0.24). In contrast with OS, the addition of bevacizumab resulted in significant improvement for PFS (HR = 0.68; 95% CI = 0.59–0.78; P < 0.00001). Moreover, it also demonstrated statistical benefit for PFS in the most used combination first-line chemotherapy (HR = 0.84; 95% CI = 0.75–0.94; P = 0.002). And the subgroup analysis indicated only capacitabine-based regimens were beneficial. Conclusions. This meta-analysis shows that the addition of bevacizumab to FOLFOX/FOLFIRI/XELOX regimens might not be beneficial in terms of OS. Benefit has been seen when PFS has been taken into account. In subgroup analysis, benefit adding bevacizumab has been seen when capecitabine-based regimens are used. Further studies are warranted to explore the combination with bevacizumab. PMID:24971091

  4. [Postoperative Adjuvant Chemotherapy for Stage III Colon Cancer - Drug Selection, Tolerability, and Safety in Clinical Practice].

    PubMed

    Okada, Kazutake; Sadahiro, Sotaro; Saito, Gota; Tanaka, Akira; Suzuki, Toshiyuki

    2016-05-01

    In the National Comprehensive Cancer Network(NCCN)guidelines, oxaliplatin(L-OHP)-based chemotherapeutic regimens, including 5-fluorouracil, Leucovorin(LV), and L-OHP(FOLFOX); capecitabine and L-OHP(CapeOX); , and 5-fluorouracil, folinic acid, and L-OHP(FLOX)are designated as category 1 recommendations for postoperative adjuvant chemotherapy in Stage III colon cancer, followed by capecitabine and 5-fluorouracil plus LV as category 2A recommendations. We studied the selection of drugs for adjuvant chemotherapy and assessed the tolerability and safety of CapeOX and tegafur- uraci(l UFT)plus LV(UFT/LV)in patients with Stage III colon cancer. The study group included 104 consecutive patients with Stage III colon cancer who underwent curative surgery. One patient changed hospitals immediately after surgery. Among the remaining 103 patients, 82(80%)received adjuvant chemotherapy and 21(20%)did not. CapeOX was administered to 32 patients(31%), UFT/LV to 49 patients(48%), and capecitabine to 1 patient(1%). In 59 patients, the treatment choice was determined according to the patient's preference; 32 patient(s 54%)selected CapeOX, 26(44%)selected UFT/LV, and 1(2%) selected no chemotherapy. The treatment completion rate was 80% for CapeOX and 84% for UFT/LV. Among patients who completed chemotherapy, dose reduction and drug withdrawal were not required in 22% of patients who received CapeOX and 80% of those who received UFT/LV. Neither CapeOX nor UFT/LV was associated with any serious adverse events. The tolerability and safety of CapeOX and UFT/LV were acceptable. However, CapeOX dose had to be carefully adjusted according to each patient's condition. PMID:27210088

  5. The Clinical Outcomes of Proton Beam Radiation Therapy for Retinoblastomas That Were Resistant to Chemotherapy and Focal Treatment

    PubMed Central

    Chang, Ji Woong; Kim, Joo Young; Shin, Dong Ho; Choi, Jin; Kim, Jeong Hun; Kim, Seong-Joon

    2011-01-01

    Purpose To evaluate the clinical results of proton beam radiation therapy (PBRT) for treatment of retinoblastoma. Methods Children with retinoblastoma who were treated with chemotherapy and focal treatment such as brachytherapy and thermotherapy but showed no response or developed recurrences later received PBRT. The PBRT strategy was designed to concentrate the radiation energy to the retinoblastoma and spare the surrounding healthy tissue or organs. Results There were three patients who received PBRT. The first patient received PBRT because of an initial lack of tumor regression with chemotherapy and brachytherapy. This patient showed regression after PBRT. The second patient who developed recurrence of retinoblastoma as diffuse infiltrating subretinal seeding was taken PBRT. After complete regression, there was recurrence of tumor and the eye was enucleated. The third patient had unilateral extensively advanced retinoblastoma. Initial chemotherapy failed and tumor recurred. The tumor responded to PBRT and regressed significantly. However, the eye developed sudden multiple recurrences, so we had to perform enucleation. Conclusions PBRT for retinoblastoma was effective in cases of showing no response to other treatment modalities. However, it should be carefully applied when there was recurrence of diffuse infiltrating subretinal seeding or extensively advanced retinoblastoma initially. PMID:22131775

  6. Concepts and mechanisms underlying chemotherapy induced immunogenic cell death: impact on clinical studies and considerations for combined therapies

    PubMed Central

    Gebremeskel, Simon; Johnston, Brent

    2015-01-01

    Chemotherapy has historically been thought to induce cancer cell death in an immunogenically silent manner. However, recent studies have demonstrated that therapeutic outcomes with specific chemotherapeutic agents (e.g. anthracyclines) correlate strongly with their ability to induce a process of immunogenic cell death (ICD) in cancer cells. This process generates a series of signals that stimulate the immune system to recognize and clear tumor cells. Extensive studies have revealed that chemotherapy-induced ICD occurs via the exposure/release of calreticulin (CALR), ATP, chemokine (C–X–C motif) ligand 10 (CXCL10) and high mobility group box 1 (HMGB1). This review provides an in-depth look into the concepts and mechanisms underlying CALR exposure, activation of the Toll-like receptor 3/IFN/CXCL10 axis, and the release of ATP and HMGB1 from dying cancer cells. Factors that influence the impact of ICD in clinical studies and the design of therapies combining chemotherapy with immunotherapy are also discussed. PMID:26486085

  7. Clinical effects of immunotherapy of DC-CIK combined with chemotherapy in treating patients with metastatic breast cancer.

    PubMed

    Mao, Qixin; Li, Lianfang; Zhang, Chongjian; Sun, Yadong; Liu, Shanqing; Cui, Shude

    2015-05-01

    This study aimed to analyze the clinical effects of dendritic cell (DC) and cytokine-induced killer (CIK) immunotherapy combined with chemotherapy on patients with metastatic breast cancer. Twenty patients were included into this study who were diagnosed as metastatic breast cancer (MBC). DC and CIK were augmented by in vitro culture and then rein fused into body through vein.The pain relief rate (RR), toxic and side effects of chemotherapy, immunity functions and living quality of patients were observed. DC and CIK cells were induced by the autologous peripheral blood mononuclear cells (PBMC). Meanwhile, flow cytometry was used to measure T cell subsets and natural killer T (NKT) cells in patients in the two groups before and after the biological treatment. After DC and CIK were rein fused into the patients body, no severe side-effect was found. It was also found that cellular immunotherapy combined with chemotherapy the immunotherapy of cells improved the immunity, the living quality of patients and the disease control rate (DCR). In conclusion, cellular immunotherapy produces small side effects; it combined with chemotherapyis able to improve the DCR and living quality of patients and prolong their lives. PMID:26051718

  8. Locally Advanced Rectal Cancer Patients Receiving Radio-Chemotherapy: A Novel Clinical-Pathologic Score Correlates With Global Outcome

    SciTech Connect

    Berardi, Rossana; Mantello, Giovanna; Scartozzi, Mario; Del Prete, Stefano; Luppi, Gabriele; Martinelli, Roberto; Fumagalli, Marco; Grillo-Ruggieri, Filippo; Bearzi, Italo; Mandolesi, Alessandra; Marmorale, Cristina; Cascinu, Stefano

    2009-12-01

    Purpose: To determine the importance of downstaging of locally advanced rectal cancer after neoadjuvant treatment. Methods and Materials: The study included all consecutive patients with locally advanced rectal cancer who underwent neoadjuvant treatment (chemotherapy and/or radiotherapy) in different Italian centers from June 1996 to December 2003. A novel score was used, calculated as the sum of numbers obtained by giving a negative or positive point, respectively, to each degree of increase or decrease in clinical to pathologic T and N status. Results: A total of 317 patients were eligible for analysis. Neoadjuvant treatments performed were as follows: radiotherapy alone in 75 of 317 patients (23.7%), radiotherapy plus chemotherapy in 242 of 317 patients (76.3%). Worse disease-free survival was observed in patients with a lower score (Score 1 = -3 to +3 vs. Score 2 = +4 to +7; p = 0.04). Conclusions: Our results suggest that a novel score, calculated from preoperative and pathologic tumor and lymph node status, could represent an important parameter to predict outcome in patients receiving neoadjuvant treatment for rectal cancer. The score could be useful to select patients for adjuvant chemotherapy after neoadjuvant treatment and surgery.

  9. Screening, Assessment, and Management of Fatigue in Adult Survivors of Cancer: An American Society of Clinical Oncology Clinical Practice Guideline Adaptation

    PubMed Central

    Bower, Julienne E.; Bak, Kate; Berger, Ann; Breitbart, William; Escalante, Carmelita P.; Ganz, Patricia A.; Schnipper, Hester Hill; Lacchetti, Christina; Ligibel, Jennifer A.; Lyman, Gary H.; Ogaily, Mohammed S.; Pirl, William F.; Jacobsen, Paul B.

    2014-01-01

    Purpose This guideline presents screening, assessment, and treatment approaches for the management of adult cancer survivors who are experiencing symptoms of fatigue after completion of primary treatment. Methods A systematic search of clinical practice guideline databases, guideline developer Web sites, and published health literature identified the pan-Canadian guideline on screening, assessment, and care of cancer-related fatigue in adults with cancer, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines In Oncology (NCCN Guidelines) for Cancer-Related Fatigue and the NCCN Guidelines for Survivorship. These three guidelines were appraised and selected for adaptation. Results It is recommended that all patients with cancer be evaluated for the presence of fatigue after completion of primary treatment and be offered specific information and strategies for fatigue management. For those who report moderate to severe fatigue, comprehensive assessment should be conducted, and medical and treatable contributing factors should be addressed. In terms of treatment strategies, evidence indicates that physical activity interventions, psychosocial interventions, and mind-body interventions may reduce cancer-related fatigue in post-treatment patients. There is limited evidence for use of psychostimulants in the management of fatigue in patients who are disease free after active treatment. Conclusion Fatigue is prevalent in cancer survivors and often causes significant disruption in functioning and quality of life. Regular screening, assessment, and education and appropriate treatment of fatigue are important in managing this distressing symptom. Given the multiple factors contributing to post-treatment fatigue, interventions should be tailored to each patient's specific needs. In particular, a number of nonpharmacologic treatment approaches have demonstrated efficacy in cancer survivors. PMID:24733803

  10. Chemotherapy and molecular targeting therapy for recurrent cervical cancer.

    PubMed

    Tsuda, Naotake; Watari, Hidemichi; Ushijima, Kimio

    2016-04-01

    For patients with primary stage ⅣB, persistent, or recurrent cervical cancer, chemotherapy remains the standard treatment, although it is neither curative nor associated with long-term disease control. In this review, we summarized the history of treatment of recurrent cervical cancer, and the current recommendation for chemotherapy and molecular targeted therapy. Eligible articles were identified by a search of the MEDLINE bibliographical database for the period up to November 30, 2014. The search strategy included the following any or all of the keywords: "uterine cervical cancer", "chemotherapy", and "targeted therapies". Since cisplatin every 21 days was considered as the historical standard treatment for recurrent cervical cancer, subsequent trials have evaluated and demonstrated activity for other agents including paclitaxel, gemcitabine, topotecan and vinorelbine among others. Accordingly, promising agents were incorporated into phase Ⅲ trials. To examine the best agent to combine with cisplatin, several landmark phase Ⅲ clinical trials were conducted by Gynecologic Oncology Group (GOG) and Japan Clinical Oncology Group (JCOG). Through, GOG204 and JCOG0505, paclitaxel/cisplatin (TP) and paclitaxel/carboplatin (TC) are now considered to be the recommended therapies for recurrent cervical cancer patients. However, the prognosis of patients who are already resistant to chemotherapy, are very poor. Therefore new therapeutic strategies are urgently required. Molecular targeted therapy will be the most hopeful candidate of these strategies. From the results of GOG240, bevacizumab combined with TP reached its primary endpoint of improving overall survival (OS). Although, the prognosis for recurrent cervical cancer patients is still poor, the results of GOG240 shed light on the usefulness of molecular target agents to chemotherapy in cancer patients. Recurrent cervical cancer is generally considered incurable and current chemotherapy regiments offer only

  11. [Surgical oncology: historical development and current status].

    PubMed

    Granados García, Martín; Beltrán Ortega, Arturo; Soto Sánchez, Beatriz Lucero; León Takahashi, Alberto Mitsuo

    2011-01-01

    The surgical oncology remains an essential part in the multidisciplinary management for patients with cancer, even though the current progress in field of radiotherapy, chemotherapy, systemic therapies, including therapies directed to molecular targets. Their role impact in several moments during the management of an oncological patient: prevention, diagnosis, assessment of the spread of the disease, curative treatment, management of the sequels, complications by the treatment and not less important, the palliation. The current state of the surgical oncology as a result of a constant development, inspired by skillful hands with creative and restless minds, have achieved to mark the history of the medicine in an area which currently has a great transcendence and an accelerated growth in a short period of time. Under this argument, we have decided to present an updated overview about the role of the surgical oncology, from the evolution through the history until all their applications in the different areas of the oncology. PMID:22116189

  12. The opinion of clinical staff regarding painfulness of procedures in pediatric hematology-oncology: an Italian survey

    PubMed Central

    2011-01-01

    Background Beliefs of caregivers about patient's pain have been shown to influence assessment and treatment of children's pain, now considered an essential part of cancer treatment. Painful procedures in hematology-oncology are frequently referred by children as the most painful experiences during illness. Aim of this study was to evaluate professionals' beliefs about painfulness of invasive procedures repeatedly performed in Pediatric Hemato-Oncology Units. Methods Physicians, nurses, psychologists and directors working in Hemato-Oncology Units of the Italian Association of Pediatric Hematology-Oncology (AIEOP) were involved in a wide-nation survey. The survey was based on an anonymous questionnaire investigating beliefs of operators about painfulness of invasive procedures (lumbar puncture, bone marrow aspirate and bone marrow biopsy) and level of pain management. Results Twenty-four directors, 120 physicians, 248 nurses and 22 psychologists responded to the questionnaire. The score assigned to the procedural pain on a 0-10 scale was higher than 5 in 77% of the operators for lumbar puncture, 97.5% for bone marrow aspiration, and 99.5% for bone marrow biopsy. The scores assigned by nurses differed statistically from those of the physicians and directors for the pain caused by lumbar puncture and bone marrow aspiration. Measures adopted for procedural pain control were generally considered good. Conclusions Invasive diagnostic-therapeutic procedures performed in Italian Pediatric Hemato-Oncology Units are considered painful by all the caregivers involved. Pain management is generally considered good. Aprioristically opinions about pain depend on invasiveness of the procedure and on the professional role. PMID:21663631

  13. CT-Based Evaluation of Tumor Volume After Intra-Arterial Chemotherapy of Locally Advanced Carcinoma of the Oral Cavity: Comparison with Clinical Remission Rates

    SciTech Connect

    Rohde, Stefan Turowski, Bernd; Berkefeld, Joachim; Kovacs, Adorjan F.

    2007-02-15

    Purpose. To assess the volume of locally advanced tumors of the oral cavity and the oropharynx before and after intra-arterial (i.a.) chemotherapy by means of computed tomography and to compare these data with clinically determined treatment response of the same patient population. Methods. Eighty-eight patients with histologically proven, advanced carcinoma of the oral cavity and/or the oropharynx (local tumor stages T3/4) received neoadjuvant i.a. chemotherapy with cisplatin as part of a multimodal therapeutic regimen, comprising (1) local chemotherapy, (2) surgery, and (3) combined radio-chemotherapy. Three weeks after the intervention, residual disease was evaluated radiologically by measurement of the tumor volume and clinically by inspection and palpation of the primary tumor according to WHO criteria. Results. Comparison of treatment response according to radiological and clinical criteria respectively revealed complete remission in 5% vs. 8% (p < 0.05), partial remission in 30% vs. 31%, stable disease in 61% vs. 58%, and tumor progression in 5% vs. 2%. Conclusion. Radiological volumetry and clinical evaluation found comparable response rates after local chemotherapy. However, in patients with good response after local treatment, volumetric measurement with CT may help to distinguish between partial and complete remission. Thus, radiological tumor volumetry provides precise and differentiated information about tumor response and should be used as an additional tool in treatment monitoring after local chemotherapy.

  14. PD-L1 polymorphism can predict clinical outcomes of non-small cell lung cancer patients treated with first-line paclitaxel-cisplatin chemotherapy

    PubMed Central

    Lee, Shin Yup; Jung, Deuk Kju; Choi, Jin Eun; Jin, Cheng Cheng; Hong, Mi Jeong; Do, Sook Kyung; Kang, Hyo-Gyoung; Lee, Won Kee; Seok, Yangki; Lee, Eung Bae; Jeong, Ji Yun; Shin, Kyung Min; Yoo, Seung Soo; Lee, Jaehee; Cha, Seung Ick; Kim, Chang Ho; Park, Jae Yong

    2016-01-01

    This study was conducted to investigate whether polymorphisms of genes involved in immune checkpoints can predict the clinical outcomes of patients with advanced stage non-small cell lung cancer (NSCLC) after 1st line paclitaxel-cisplatin chemotherapy. A total of 379 NSCLC patients were enrolled. Twelve single nucleotide polymorphisms (SNPs) of PD-1, PD-L1, and CTLA-4 genes were selected and genotyped. The associations of SNPs with chemotherapy response and overall survival (OS) were analyzed. Among the 12 SNPs investigated, PD-L1 rs2297136T > C and rs4143815C > G were significantly associated with clinical outcomes after chemotherapy. The rs2297136T > C was significantly associated with both better chemotherapy response and better OS, and the rs4143815C > G had a significantly better response to chemotherapy. Consistent with the individual genotype analyses, rs2297136C-rs4143815G haplotype (ht4) carrying variant alleles at both loci was significantly associated with better chemotherapy response and OS compared with combined other haplotypes. Patients with at least one ht4 had significantly better chemotherapy response and OS compared to those without ht4. PD-L1 rs2297136T > C and rs4143815C > G polymorphisms may be useful for the prediction of clinical outcome of 1st line paclitaxel-cisplatin chemotherapy in NSCLC. Further studies are needed to confirm our findings and to understand the role of PD-L1 in the chemotherapy outcome of NSCLC patients. PMID:27181838

  15. PD-L1 polymorphism can predict clinical outcomes of non-small cell lung cancer patients treated with first-line paclitaxel-cisplatin chemotherapy.

    PubMed

    Lee, Shin Yup; Jung, Deuk Kju; Choi, Jin Eun; Jin, Cheng Cheng; Hong, Mi Jeong; Do, Sook Kyung; Kang, Hyo-Gyoung; Lee, Won Kee; Seok, Yangki; Lee, Eung Bae; Jeong, Ji Yun; Shin, Kyung Min; Yoo, Seung Soo; Lee, Jaehee; Cha, Seung Ick; Kim, Chang Ho; Park, Jae Yong

    2016-01-01

    This study was conducted to investigate whether polymorphisms of genes involved in immune checkpoints can predict the clinical outcomes of patients with advanced stage non-small cell lung cancer (NSCLC) after 1st line paclitaxel-cisplatin chemotherapy. A total of 379 NSCLC patients were enrolled. Twelve single nucleotide polymorphisms (SNPs) of PD-1, PD-L1, and CTLA-4 genes were selected and genotyped. The associations of SNPs with chemotherapy response and overall survival (OS) were analyzed. Among the 12 SNPs investigated, PD-L1 rs2297136T > C and rs4143815C > G were significantly associated with clinical outcomes after chemotherapy. The rs2297136T > C was significantly associated with both better chemotherapy response and better OS, and the rs4143815C > G had a significantly better response to chemotherapy. Consistent with the individual genotype analyses, rs2297136C-rs4143815G haplotype (ht4) carrying variant alleles at both loci was significantly associated with better chemotherapy response and OS compared with combined other haplotypes. Patients with at least one ht4 had significantly better chemotherapy response and OS compared to those without ht4. PD-L1 rs2297136T > C and rs4143815C > G polymorphisms may be useful for the prediction of clinical outcome of 1(st) line paclitaxel-cisplatin chemotherapy in NSCLC. Further studies are needed to confirm our findings and to understand the role of PD-L1 in the chemotherapy outcome of NSCLC patients. PMID:27181838

  16. American Society of Clinical Oncology policy statement update: tobacco control--reducing cancer incidence and saving lives. 2003.

    PubMed

    2003-07-15

    As an international medical society dedicated to cancer prevention, the American Society of Clinical Oncology (ASCO) advocates a fundamental reform of United States and international policy toward addictive tobacco products. ASCO's goal is the immediate reduction of tobacco use and ultimate achievement of a tobacco-free world. The centerpiece of ASCO's policy is the recommendation for an independent commission to study the tobacco problem in all of its dimensions: social, medical, legal, and economic (both domestically and globally). The commission membership should include broad-based representation and expertise on tobacco issues. In ASCO's view, tobacco control efforts to date have been less than successful because they are too fragmented and incremental, leaving many important issues unaddressed. A more comprehensive solution could flow from this study, including input from a variety of government agencies involved with public health, agriculture, First Amendment and other legal considerations, and international trade. The study, within defined time limits, should culminate in a report that outlines a strategy for achieving immediate reduction of tobacco use and ultimate achievement of a tobacco-free world, including explicit plans and a timetable for implementation. Although this comprehensive approach to tobacco control will take many years to implement even under the best of circumstances, there are certain measures that could be undertaken immediately with meaningful impact on tobacco usage. These include: Increasing efforts to discourage tobacco use, particularly among the young Raising federal excise taxes by at least $2 per pack and encouraging states to consider tobacco taxes as a first resort in revenue enhancement Ensuring that tobacco settlement funds be devoted only to health-related projects, including medical treatment, biomedical research, and tobacco prevention efforts Requiring disclosure of all ingredients in tobacco products Comprehensively

  17. Multicriteria decision analysis in oncology

    PubMed Central

    Adunlin, Georges; Diaby, Vakaramoko; Montero, Alberto J.; Xiao, Hong

    2015-01-01

    Background There has been a growing interest in the development and application of alternative decision-making frameworks within health care, including multicriteria decision analysis (MCDA). Even though the literature includes several reviews on MCDA methods, applications of MCDA in oncology are lacking. Aim The aim of this paper is to discuss a rationale for the use of MCDA in oncology. In this context, the following research question emerged: How can MCDA be used to develop a clinical decision support tool in oncology? Methods In this paper, a brief background on decision making is presented, followed by an overview of MCDA methods and process. The paper discusses some applications of MCDA, proposes research opportunities in the context of oncology and presents an illustrative example of how MCDA can be applied to oncology. Findings Decisions in oncology involve trade-offs between possible benefits and harms. MCDA can help analyse trade-off preferences. A wide range of MCDA methods exist. Each method has its strengths and weaknesses. Choosing the appropriate method varies depending on the source and nature of information used to inform decision making. The literature review identified eight studies. The analytical hierarchy process (AHP) was the most often used method in the identified studies. Conclusion Overall, MCDA appears to be a promising tool that can be used to assist clinical decision making in oncology. Nonetheless, field testing is desirable before MCDA becomes an established decision-making tool in this field. PMID:24635949

  18. A report from the 47th Annual Meeting of the American Society of Clinical Oncology (June 3-7, 2011 - Chicago, Illinois, USA).

    PubMed

    Rabasseda, X; Gómez-Zaera, M

    2011-09-01

    Improving survival, as well as the quality of life and functioning of survivors, is the main objective of cancer therapy, for which a very large number of drugs are currently available or under development as therapeutic candidates. Information on many of these compounds was discussed during the 2011 American Society of Clinical Oncology (ASCO) meeting in Chicago. The number of news presentations discussed during the meeting was incredibly high, with plenary, oral abstract, poster discussion and general poster sessions filling room upon room. The following report provides a quick review of major new research into drug and support therapies for cancer as presented at the meeting. PMID:21971543

  19. Cytotoxic chemotherapy: Still the mainstay of clinical practice for all subtypes metastatic breast cancer.

    PubMed

    Twelves, Chris; Jove, Maria; Gombos, Andrea; Awada, Ahmad

    2016-04-01

    Cytotoxic chemotherapy remains central to the treatment of all subtypes of metastatic breast cancer (MBC). We review evidence-based chemotherapy options for women with MBC after an anthracycline and a taxane including re-challenge with anthracycline or taxane, capecitabine, eribulin and ixabepilone as a single agent or combination with capecitabine (not approved in the EU); and the vinca alkaloid vinflunine as single agent or combined with either capecitabine/gemcitabine (also not approved EU or USA). Etirinotecan pegol, comprising irinotecan bound to polyethylene glycol by a biodegradable linker, is a new cytotoxic agent for patients with MBC that has achieved encouraging response rates in phase II studies; it has been further evaluated in the phase III BEACON trial. New cytotoxics should address novel targets or modes of delivery, achieve meaningful improvements in outcomes and seek to identify predictive biomarker(s). PMID:26857987

  20. Regional hyperthermia combined with chemotherapy in paediatric, adolescent and young adult patients: current and future perspectives.

    PubMed

    Seifert, Georg; Budach, Volker; Keilholz, Ulrich; Wust, Peter; Eggert, Angelika; Ghadjar, Pirus

    2016-01-01

    Here we evaluate the current status of clinical research on regional hyperthermia (RHT) in combination with chemotherapy or radiation therapy in paediatric oncology.Data were identified in searches of MEDLINE, Current Contents, PubMed, and references from relevant articles using medical subject headings including hyperthermia, cancer, paediatric oncology, children, radiation therapy and chemotherapy. Currently, only two RHT centres exist in Europe which treat children. Clinical RHT research in paediatric oncology has as yet been limited to children with sarcomas and germ cell tumours that respond poorly to or recur after chemotherapy. RHT is a safe and effective treatment delivering local thermic effects, which may also stimulate immunological processes via heat-shock protein reactions. RHT is used chiefly in children and adolescents with sarcomas or germ cell tumours located in the abdomino-pelvic region, chest wall or extremities to improve operability or render the tumour operable. It could potentially be combined with radiation therapy in a post-operative R1 setting where more radical surgery is not possible or combined with chemotherapy instead of radiation therapy in cases where the necessary radiation dose is impossible to achieve or would have mutilating consequences. RHT might also be an option for chemotherapy intensification in the neoadjuvant first-line treatment setting for children and adolescents, as was recently reflected in the promising long-term outcome data in adults with high-risk soft tissue sarcomas (EORTC 62961/ESHO trial).The limited data available indicate that combining RHT with chemotherapy is a promising option to treat germ cell tumours and, potentially, sarcomas. RHT may also be beneficial in first-line therapy in children, adolescents and young adults. The research should focus on optimising necessary technical demands and then initiate several clinical trials incorporating RHT into interdisciplinary treatment of children

  1. Highlights from the 42nd annual meeting of the American Society of Clinical Oncology Atlanta, GA, USA, 2-6 June 2006.

    PubMed

    Puglisi, Fabio; Andreetta, Claudia; Fasola, Gianpiero

    2006-11-01

    The results of approximately 3700 preclinical and clinical studies were presented at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO) held 2-6 June 2006, in Atlanta, Georgia. The annual ASCO meeting is the largest forum in which oncology professionals from around the world report the latest advances in cancer research, encompassing a wide spectrum of subjects on molecular biology, prevention, diagnosis and therapy of tumours. The present report summarises some of the more important results of the studies presented at the meeting. In particular, the authors focused on findings from randomised Phase III trials that, in their opinion, are most likely to have an immediate effect on clinical practice. The top advances were grouped into four major themes (breast cancer, colorectal cancer, non-small cell lung cancer and selected presentations from the plenary session). In addition, selected Phase I and II studies on promising novel therapeutic agents were briefly described. Finally, a 'question and answer' format was adopted to report results of interesting studies on some hot topics. PMID:17059386

  2. Imaging Opportunities in Radiation Oncology

    SciTech Connect

    Balter, James M.; Haffty, Bruce G.; Dunnick, N. Reed; Siegel, Eliot L.

    2011-02-01

    Interdisciplinary efforts may significantly affect the way that clinical knowledge and scientific research related to imaging impact the field of Radiation Oncology. This report summarizes the findings of an intersociety workshop held in October 2008, with the express purpose of exploring 'Imaging Opportunities in Radiation Oncology.' Participants from the American Society for Radiation Oncology (ASTRO), National Institutes of Health (NIH), Radiological Society of North America (RSNA), American Association of physicists in Medicine (AAPM), American Board of Radiology (ABR), Radiation Therapy Oncology Group (RTOG), European Society for Therapeutic Radiology and Oncology (ESTRO), and Society of Nuclear Medicine (SNM) discussed areas of education, clinical practice, and research that bridge disciplines and potentially would lead to improved clinical practice. Findings from this workshop include recommendations for cross-training opportunities within the allowed structured of Radiology and Radiation Oncology residency programs, expanded representation of ASTRO in imaging related multidisciplinary groups (and reciprocal representation within ASTRO committees), increased attention to imaging validation and credentialing for clinical trials (e.g., through the American College of Radiology Imaging Network (ACRIN)), and building ties through collaborative research as well as smaller joint workshops and symposia.

  3. Altered glycometabolism affects both clinical features and prognosis of triple-negative and neoadjuvant chemotherapy-treated breast cancer.

    PubMed

    Dong, Tieying; Kang, Xinmei; Liu, Zhaoliang; Zhao, Shu; Ma, Wenjie; Xuan, Qijia; Liu, Hang; Wang, Zhipeng; Zhang, Qingyuan

    2016-06-01

    Glycometabolism is a distinctive aspect of energy metabolism in breast cancer, and key glycometabolism enzymes/pathways (glycolysis, hexosamine biosynthetic pathway, and pentose phosphate pathway) may directly or indirectly affect the clinical features. In this study, we analyzed the particular correlation between the altered glycometabolism and clinical features of breast cancer to instruct research and clinical treatment. Tissue microarrays containing 189 hollow needle aspiration samples and 295 triple-negative breast cancer tissues were used to test the expression of M2 isoform of pyruvate kinase (PKM2), glutamine-fructose-6-phosphate transaminase 1 (GFPT1), glucose-6-phosphate dehydrogenase (G6PD), and p53 by immunohistochemistry and the intensity of these glycometabolism-related protein was evaluated. Chi-square test, Kaplan-Meier estimates, and Cox proportional hazards model were used to analyze the relationship between the expression of these factors and major clinical features. PKM2, GFPT1, and G6PD affect the pathologic complete response rate of neoadjuvant chemotherapy patients in different ways; pyruvate kinase muscle isozyme 2 (PKM2) and G6PD are closely associated with the molecular subtypes, whereas GFPT1 is correlated with cancer size. All these three factors as well as p53 have impacts on the progression-free survival and overall survival of triple-negative breast cancer patients. Cancer size shows significant association with PKM2 and GFPT1 expression, while the pN stage and grade are associated with PKM2 and G6PD expression. Our study support that clinical characteristics are reflections of specific glycometabolism pathways, so their relationships may shed light on the orientation of research or clinical treatment. The expression of PKM2, GFPT1, and G6PD are hazardous factors for prognosis: high expression of these proteins predict worse progression-free survival and overall survival in triple-negative breast cancer, as well as worse pathologic

  4. PTEN polymorphisms contribute to clinical outcomes of advanced lung adenocarcinoma patients treated with platinum-based chemotherapy.

    PubMed

    Yang, Yang; Xu, Wen; Liu, Di; Ding, Xi; Su, Bo; Sun, Yifeng; Gao, Wen

    2016-06-01

    This study aimed to elucidate the impact of PTEN single nucleotide polymorphism (SNP) on clinical outcomes for advanced lung adenocarcinoma (LAC) patients treated with platinum-based chemotherapy. Three functional SNPs (rs11202607 G>A, rs701848 A>G, and rs11202592 G>C) of PTEN gene were genotyped by using DNA from blood samples of 618 advanced LAC patients, and their relationships with clinical outcomes were analyzed. The carriers of homozygous mutant of rs701848 and rs11202592 polymorphisms revealed significantly worse overall survival (OS) than those with heterozygote or wild-type homozygote (18.83 vs. 21.47 vs. 24.37 months, P = 0.034 and 13.40 vs. 19.03 vs. 21.90 months, P = 0.025, respectively). Subgroup analysis revealed that this association was particularly significant in tumor-lymph-node metastasis (TNM) stage III patients. The objective response rates (ORR) and disease control rates (DCR) of patients with genotype AA, AG, and GG in PTEN rs701848 polymorphism were statistically different (24.1 vs 16.6 vs 12.2 %, P = 0.017 and 82.7 vs 76.0 vs 70.2 %, P = 0.029, respectively). Haplotype analysis revealed a protective effect of the haplotype G-A-A (in the order of rs11202592, rs701848, and rs11202607) on chemotherapy efficacy and survival. Taken together, PTEN polymorphisms may contribute to survival and chemotherapy efficacy of advanced LAC patients treated with platinum-based agents. PMID:26695147

  5. Establishing a minority-based community clinical oncology program: the University of Medicine and Dentistry of New Jersey, New Jersey Medical School-university Hospital Cancer Center experience.

    PubMed

    Wieder, Robert; Teal, Randall; Saunders, Tracie; Weiner, Bryan J

    2013-03-01

    The Minority-Based Community Clinical Oncology Program (MB-CCOP) at University of Medicine and Dentistry of New Jersey, New Jersey Medical School-University Hospital Cancer Center was established to serve an unmet need in a medically, educationally, and socioeconomically underserved community of primarily African American and Latino patients in Newark and Essex County, New Jersey. The MB-CCOP was built on an existing infrastructure of multidisciplinary teams of cancer specialists who collaborated in patient care and an existing clinical research program, which included multilingual staff and a breast cancer navigator. This article highlights some of the unique opportunities and challenges involved in the startup of an MB-CCOP specifically relevant to an academic setting. We present a guide to the necessary infrastructure and institutional support that must be in place before considering such a program and some of the steps an institution can take to overcome barriers preventing successful enrollment of patients onto clinical trials. PMID:23814524

  6. Definitive radiotherapy with or without chemotherapy for clinical stage T4N0-1 non-small cell lung cancer

    PubMed Central

    Kim, Yeon Joo; Jeong, Seong-Yun; Kim, Sang We; Lee, Jung-Shin; Kim, Su Ssan; Choi, Wonsik; Choi, Eun Kyung

    2015-01-01

    Purpose To determine failure patterns and survival outcomes of T4N0-1 non-small cell lung cancer (NSCLC) treated with definitive radiotherapy. Materials and Methods Ninety-five patients with T4N0-1 NSCLC who received definitive radiotherapy with or without chemotherapy from May 2003 to October 2014 were retrospectively reviewed. The standard radiotherapy scheme was 66 Gy in 30 fractions. The main concurrent chemotherapy regimen was 50 mg/m2 weekly paclitaxel combined with 20 mg/m2 cisplatin or AUC 2 carboplatin. The primary outcome was overall survival (OS). Secondary outcomes were failure patterns and toxicities. Results The median age was 64 years (range, 34 to 90 years). Eighty-eight percent of patients (n = 84) had an Eastern Cooperative Oncology Group performance status of 0-1, and 42% (n = 40) experienced pretreatment weight loss. Sixty percent of patients (n = 57) had no metastatic regional lymph nodes. The median radiation dose was EQD2 67.1 Gy (range, 56.9 to 83.3 Gy). Seventy-one patients (75%) were treated with concurrent chemotherapy; of these, 13 were also administered neoadjuvant chemotherapy. At a median follow-up of 21 months (range, 1 to 102 months), 3-year OS was 44%. The 3-year cumulative incidences of local recurrence and distant recurrence were 48.8% and 36.3%, respectively. Pretreatment weight loss and combined chemotherapy were significant factors for OS. Acute esophagitis over grade 3 occurred in three patients and grade 3 chronic esophagitis occurred in one patient. There was no grade 3-4 radiation pneumonitis. Conclusion Definitive radiotherapy for T4N0-1 NSCLC results in favorable survival with acceptable toxicity rates. Local recurrence is the major recurrence pattern. Intensity modulated radiotherapy and radio-sensitizing agents would be needed to improve local tumor control. PMID:26756028

  7. Improved efficiency in clinical workflow of reporting measured oncology lesions via PACS-integrated lesion tracking tool.

    PubMed

    Sevenster, Merlijn; Travis, Adam R; Ganesh, Rajiv K; Liu, Peng; Kose, Ursula; Peters, Joost; Chang, Paul J

    2015-03-01

    OBJECTIVE. Imaging provides evidence for the response to oncology treatment by the serial measurement of reference lesions. Unfortunately, the identification, comparison, measurement, and documentation of several reference lesions can be an inefficient process. We tested the hypothesis that optimized workflow orchestration and tight integration of a lesion tracking tool into the PACS and speech recognition system can result in improvements in oncologic lesion measurement efficiency. SUBJECTS AND METHODS. A lesion management tool tightly integrated into the PACS workflow was developed. We evaluated the effect of the use of the tool on measurement reporting time by means of a prospective time-motion study on 86 body CT examinations with 241 measureable oncologic lesions with four radiologists. RESULTS. Aggregated measurement reporting time per lesion was 11.64 seconds in standard workflow, 16.67 seconds if readers had to register measurements de novo, and 6.36 seconds for each subsequent follow-up study. Differences were statistically significant (p < 0.05) for each reader, except for one difference for one reader. CONCLUSION. Measurement reporting time can be reduced by using a PACS workflow-integrated lesion management tool, especially for patients with multiple follow-up examinations, reversing the onetime efficiency penalty at baseline registration. PMID:25714288

  8. [Oncology PET imaging].

    PubMed

    Inubushi, Masayuki

    2014-01-01

    At the beginning of this article, likening medical images to "Where is Waldo?" I indicate the concept of diagnostic process of PET/CT imaging, so that medical physics specialists could understand the role of each imaging modality and infer our distress for image diagnosis. Then, I state the present situation of PET imaging and the basics (e.g. health insurance coverage, clinical significance, principle, protocol, and pitfall) of oncology FDG-PET imaging which accounts for more than 99% of all clinical PET examinations in Japan. Finally, I would like to give a wishful prospect of oncology PET that will expand to be more cancer-specific in order to assess therapeutic effects of emerging molecular targeted drugs targeting the "hallmarks of cancer". PMID:25199271

  9. Escalating costs for cancer chemotherapy.

    PubMed

    Nyman, J V; Dorr, R T; Hall, G R

    1981-08-01

    The annual costs of chemotherapeutic agents from 1975 to 1980 were determined, and the impact on a hospital's budget of new chemotherapeutic agents marketed during this period was evaluated. Pharmacy purchasing records for the antineoplastics were reviewed retrospectively to determine fiscal year (FY) costs. Statistics from the Consumer Price Index report and hospital patient load were used to project an adjusted annual cost for cancer chemotherapy. The annual expenditures for seven agents marketed in the past five years were expressed as a percentage of the pharmacy's budget. In addition, the oncology clinic records for the past four years were reviewed to assess trends in the number of visits and quantity of drugs prescribed. Analysis indicated that the costs of antineoplastic drugs have risen from $10,156 for FY 1973-1974 to $296,914 for FY 1979-1980. Antineoplastic drug costs have risen from 5.74 to 16.74% of the total drug budget during the same period. Only a portion of the increase in costs could be attributed to increased patient load and inflation. The percentage of patients receiving chemotherapy has reached a plateau, and the quantity of agents being prescribed was not found to be increasing. It was concluded that the rise in cost tends to follow the recent commercial availability of several new antineoplastics, especially doxorubicin. Cancer drug costs will continue to represent a large portion of the total hospital budget in the future and budgets must be planned accordingly. PMID:7270558

  10. Clinical Benefits of Systemic Chemotherapy for Patients with Metastatic Pheochromocytomas or Sympathetic Extra-Adrenal Paragangliomas: Insights from the Largest Single Institutional Experience

    PubMed Central

    Ayala-Ramirez, Montserrat; Feng, Lei; Habra, Mouhammed A.; Rich, Thereasa; Dickson, Paxton V.; Perrier, Nancy; Phan, Alexandria; Waguespack, Steven; Patel, Shreyaskumar; Jimenez, Camilo

    2013-01-01

    Background The purpose of this study was to evaluate the clinical benefits of systemic chemotherapy for patients with metastatic pheochromocytomas or sympathetic paragangliomas by assessing reduction in tumor size, blood pressure, and improvement in overall survival. Methods We retrospectively reviewed the medical records of patients with metastatic pheochromocytomas-sympathetic paragangliomas who had received chemotherapy at The University of Texas MD Anderson Cancer Center Results Clinical benefit and overall survival (OS) were assessed. Of fifty-four patients treated with chemotherapy, fifty-two were evaluable for response. Seventeen (33%) experienced a response, defined as decreased or normalized blood pressure/decreased number and dosage of antihypertensive medications and/or reduced tumor size after the first chemotherapy regimen. The median OS time was 6.4 years (95 confidence interval (CI): 5.2–16.4) for responders and 3.7 (95% CI: 3.0–7.5) years for non-responders. Of patients who had synchronous metastatic disease, a positive response at 1 year after the start of chemotherapy was associated with a trend toward a longer overall survival (log-rank test, P-value =0.095). In a multivariate Cox proportional hazards model, the effect of response to chemotherapy on overall survival was significant (hazard ratio=0.22, 95% confidence interval: 0.05–1.0; P-value = 0.05). All responders had been treated with dacarbazine and cyclophosphamide. Vincristine was included for 14 responders and doxorubicin was included for 12 responders. We could not identify clinical factors that predicted response to chemotherapy. Conclusion Chemotherapy may decrease tumor size and facilitate blood pressure control in about 33% of patients with metastatic pheochromocytoma-sympathetic paraganglioma. These patients exhibit a longer survival. PMID:22006217

  11. Eva Between Anxiety and Hope: Integrating Anthroposophic Music Therapy in Supportive Oncology Care.

    PubMed

    Ben-Arye, Eran; Ben-Arye, Yotam; Barak, Yael

    2015-11-30

    Music therapy is a significant modality in the treatment of patients with cancer, who suffer emotional and spiritual distress as well as chemotherapy side effects that impair their quality of life. In this article, we present a case study of a patient challenged with recurrent ovarian cancer who received, concomitant with chemotherapy, a special form of music therapy based on anthroposophic medicine (AM) aimed at alleviating anxiety and improving her general well-being. AM-centered music therapy goals are discussed in regard to two modes of treatment: receptive listening and clinical composition. Next, these two treatment modes are discussed in a broader context by reviewing conventional music therapy interventions during chemotherapy on two axes: a. standardized vs. individualized treatment; b. patient's involvement on a passive to active continuum. In conclusion, psycho-oncology care can be enriched by adding anthroposophic medicine-oriented music therapy integrated within patients' supportive care. PMID:26973967

  12. Eva Between Anxiety and Hope: Integrating Anthroposophic Music Therapy in Supportive Oncology Care

    PubMed Central

    Ben-Arye, Eran; Ben-Arye, Yotam; Barak, Yael

    2015-01-01

    Music therapy is a significant modality in the treatment of patients with cancer, who suffer emotional and spiritual distress as well as chemotherapy side effects that impair their quality of life. In this article, we present a case study of a patient challenged with recurrent ovarian cancer who received, concomitant with chemotherapy, a special form of music therapy based on anthroposophic medicine (AM) aimed at alleviating anxiety and improving her general well-being. AM-centered music therapy goals are discussed in regard to two modes of treatment: receptive listening and clinical composition. Next, these two treatment modes are discussed in a broader context by reviewing conventional music therapy interventions during chemotherapy on two axes: a. standardized vs. individualized treatment; b. patient’s involvement on a passive to active continuum. In conclusion, psycho-oncology care can be enriched by adding anthroposophic medicine-oriented music therapy integrated within patients’ supportive care. PMID:26973967

  13. Computerized Provider Order Entry in Pediatric Oncology: Design, Implementation, and Outcomes

    PubMed Central

    Chen, Allen R.; Lehmann, Christoph U.

    2011-01-01

    Purpose: Pediatric oncology is a challenging environment for computerized provider order entry (CPOE). Our goal was to build on the proven safety features of CPOE and facilitate input of expert clinicians. Methods: A standard, commercially available CPOE system was implemented throughout the hospital. The design of the pediatric oncology implementation was a collaborative effort by a multidisciplinary team of clinicians and information technology experts. Results: During 9 months of configuration effort, 30 medical logic modules and 110 order sets were developed to support pediatric oncology. The proportion of chemotherapy orders submitted using specific research protocol or standard-of-care order sets increased from 57% to 84% as the number of active order sets grew to 200. The number of medication-related patient safety events decreased 39% after implementation of CPOE in pediatric oncology. Acceptance of the system is high in all clinical disciplines. Conclusion: Implementation of CPOE required extensive customization but improved patient safety in this highly complex pediatric oncology environment. PMID:22043183

  14. Approach to fever assessment in ambulatory cancer patients receiving chemotherapy: a clinical practice guideline

    PubMed Central

    Krzyzanowska, M.K.; Walker-Dilks, C.; Atzema, C.; Morris, A.; Gupta, R.; Halligan, R.; Kouroukis, T.; McCann, K.

    2016-01-01

    Background This guideline was prepared by the Fever Assessment Guideline Development Group, a group organized by the Program in Evidence-Based Care at the request of the Cancer Care Ontario Systemic Treatment Program. The mandate was to develop a standardized approach (in terms of definitions, information, and education) for the assessment of fever in cancer patients receiving chemotherapy. Methods The guideline development methods included a search for existing guidelines, literature searches in medline and embase for systematic reviews and primary studies, internal review by content and methodology experts, and external review by targeted experts and intended users. Results The search identified eight guidelines that had partial relevance to the topic of the present guideline and thirty-eight primary studies. The studies were mostly noncomparative prospective or retrospective studies. Few studies directly addressed the topic of fever except as one among many symptoms or adverse effects associated with chemotherapy. The recommendations concerning fever definition are supported mainly by other existing guidelines. No evidence was found that directly pertained to the assessment of fever before a diagnosis of febrile neutropenia was made. However, some studies evaluated approaches to symptom management that included fever among the symptoms. Few studies directly addressed information needs and resources for managing fever in cancer patients. Conclusions Fever in patients with cancer who are receiving systemic therapy is a common and potentially serious symptom that requires prompt assessment, but currently, evidence to inform best practices concerning when, where, and by whom that assessment is done is very limited. PMID:27536179

  15. Novel Drug Therapies for Fertility Preservation in Men Undergoing Chemotherapy: Clinical Relevance of Protector Agents.

    PubMed

    Rabaça, A; Sousa, M; Alves, M G; Oliveira, P F; Sá, R

    2015-01-01

    Cancer has been affecting a growing number of children, adolescents and adult males in reproductive age. Male reproductive potential is adversely affected by chemotherapeutic drugs and patients are at risk for prolonged infertility. Fertility recovery is related to the chemotherapeutic agent and dosage used, being thus difficult to predict. As a result, there is a strong need to identify a natural or synthetic compound that is able to preserve male fertility without interfering with the efficacy of the chemotherapeutic regimen. New procedures, as well as several drugs, are being investigated to assess their efficiency in protecting male reproductive functions from the chemotherapy side-effects. This review provides an overview of the wide range of chemotherapeutic drugs regularly used in cancer treatment and their detrimental effects on male fertility. In addition, it also assesses the existing protector agents for male fertility and their usefulness in preserving and protecting male reproductive functions exposed to chemotherapeutics. Several protector agents for male fertility are being studied, and results are promising. Nonetheless, further research must be implemented to identify a supplemental therapy that addresses the multiple side effects of chemotherapy on male reproductive function. Until such therapy is discovered, it is fundamental that all fertility preservation options are discussed with patients, before treatment is initiated, to assure parenthood. PMID:26295467

  16. Chemotherapy and molecular targeting therapy for recurrent cervical cancer

    PubMed Central

    Tsuda, Naotake; Watari, Hidemichi; Ushijima, Kimio

    2016-01-01

    For patients with primary stage ⅣB, persistent, or recurrent cervical cancer, chemotherapy remains the standard treatment, although it is neither curative nor associated with long-term disease control. In this review, we summarized the history of treatment of recurrent cervical cancer, and the current recommendation for chemotherapy and molecular targeted therapy. Eligible articles were identified by a search of the MEDLINE bibliographical database for the period up to November 30, 2014. The search strategy included the following any or all of the keywords: “uterine cervical cancer”, “chemotherapy”, and “targeted therapies”. Since cisplatin every 21 days was considered as the historical standard treatment for recurrent cervical cancer, subsequent trials have evaluated and demonstrated activity for other agents including paclitaxel, gemcitabine, topotecan and vinorelbine among others. Accordingly, promising agents were incorporated into phase Ⅲ trials. To examine the best agent to combine with cisplatin, several landmark phase Ⅲ clinical trials were conducted by Gynecologic Oncology Group (GOG) and Japan Clinical Oncology Group (JCOG). Through, GOG204 and JCOG0505, paclitaxel/cisplatin (TP) and paclitaxel/carboplatin (TC) are now considered to be the recommended therapies for recurrent cervical cancer patients. However, the prognosis of patients who are already resistant to chemotherapy, are very poor. Therefore new therapeutic strategies are urgently required. Molecular targeted therapy will be the most hopeful candidate of these strategies. From the results of GOG240, bevacizumab combined with TP reached its primary endpoint of improving overall survival (OS). Although, the prognosis for recurrent cervical cancer patients is still poor, the results of GOG240 shed light on the usefulness of molecular target agents to chemotherapy in cancer patients. Recurrent cervical cancer is generally considered incurable and current chemotherapy regiments

  17. Clinical experience with irradiation of inflammatory carcinoma of the breast with and without elective chemotherapy. [. gamma. rays; effects of chemotherapy on incidence of late complications

    SciTech Connect

    Barker, J.L.; Montague, E.D.; Peters, L.J.

    1980-02-15

    From 1948 to 1972, 69 patients with inflammatory carcinoma of the breast were treated with irradiation alone. Because of a 46% incidence of local-regional failure, twice daily fractionated irradiation was given in 1972 to 11 patients; a decrease in local-regional failures (27%) was achieved. From 1973 through December 1976, preirradiation multidrug chemotherapy was added to the twice daily fractionated irradiation of 31 patients. Analysis of all patients with a minimum two-year follow-up demonstrates that chemotherapy does not improve local-regional control or freedom from disease rates, but does delay appearance of distant metastases.

  18. Efficacy of IP6 + inositol in the treatment of breast cancer patients receiving chemotherapy: prospective, randomized, pilot clinical study

    PubMed Central

    2010-01-01

    Background Prospective, randomized, pilot clinical study was conducted to evaluate the beneficial effects of inositol hexaphosphate (IP6) + Inositol in breast cancer patients treated with adjuvant therapy. Patients and methods Patients with invasive ductal breast cancer where polychemotherapy was indicated were monitored in the period from 2005-2007. Fourteen patients in the same stage of ductal invasive breast cancer were involved in the study, divided in two randomized groups. One group was subjected to take IP6 + Inositol while the other group was taking placebo. In both groups of patients the same laboratory parameters were monitored. When the treatment was finished, all patients have filled questionnaires QLQ C30 and QLQ-BR23 to determine the quality of life. Results Patients receiving chemotherapy, along with IP6 + Inositol did not have cytopenia, drop in leukocyte and platelet counts. Red blood cell counts and tumor markers were unaltered in both groups. However, patients who took IP6 + Inositol had significantly better quality of life (p = 0.05) and functional status (p = 0.0003) and were able to perform their daily activities. Conclusion IP6 + Inositol as an adjunctive therapy is valuable help in ameliorating the side effects and preserving quality of life among the patients treated with chemotherapy. PMID:20152024

  19. Emerging clinical applications of PET based molecular imaging in oncology: the promising future potential for evolving personalized cancer care

    PubMed Central

    Dhingra, Vandana K; Mahajan, Abhishek; Basu, Sandip

    2015-01-01

    This review focuses on the potential of advanced applications of functional molecular imaging in assessing tumor biology and cellular characteristics with emphasis on positron emission tomography (PET) applications with both 18-fluorodeoxyglucose (FDG) and non-FDG tracers. The inherent heterogeneity of cancer cells with their varied cellular biology and metabolic and receptor phenotypic expression in each individual patient and also intra-and inter-lesionally in the same individual mandates for transitioning from a generalized “same-size-fits-all” approach to personalized medicine in oncology. The past two decades have witnessed improvement of oncological imaging through CT, MR imaging, PET, subsequent movement through hybrid or fusion imaging with PET/CT and single-photon emission computerized tomography (SPECT-CT), and now toward the evolving PET/MR imaging. These recent developments have proven invaluable in enhancing oncology care and have the potential to help image the tumor biology at the cellular level, followed by providing a tailored treatment. Molecular imaging, integrated diagnostics or Radiomics, biology-driven interventional radiology and theranostics, all hold immense potential to serve as a guide to give “start and stop” treatment for a patient on an individual basis. This will likely have substantial impact on both treatment costs and outcomes. In this review, we bring forth the current trends in molecular imaging with established techniques (PET/CT), with particular emphasis on newer molecules (such as amino acid metabolism and hypoxia imaging, somatostatin receptor based imaging, and hormone receptor imaging) and further potential for FDG. An introductory discussion on the novel hybrid imaging techniques such as PET/MR is also made to understand the futuristic trends. PMID:26752813

  20. [ASCO-update 2015 - highlights of the 51. meeting of the american society of clinical oncology/ASCO 2015].

    PubMed

    Lorenzen, S; Arnold, D; Fottner, C; Leichsenring, J; Moehler, M; Seufferlein, T; Vogel, A; Weber, M M; Reinacher-Schick, A

    2016-02-01

    The field of gastrointestinal oncology is rapidly developing, on the one hand through the identification of novel molecular targets and therapeutic principles, on the other hand through the establishment and improvement of multidisciplinary treatment strategies. The following manuscript summarizes the most important trial results of the ASCO Meeting 2015 for gastrointestinal cancers. Besides trials on perioperative treatment of esophageal-, pancreatic- and colon cancer, we will present impressive data on new therapeutic strategies such as immunotherapy in gastric-, liver and microsatellite instable colorectal cancer. The trials will be put into context by the authors. PMID:26854837

  1. Red Blood Cell Antibodies in Hematology/Oncology Patients: Interpretation of Immunohematologic Tests and Clinical Significance of Detected Antibodies.

    PubMed

    Hendrickson, Jeanne E; Tormey, Christopher A

    2016-06-01

    Red blood cell (RBC) transfusion is a cornerstone of the management of patients with hematology/oncology disorders. However, a potentially deleterious consequence of transfusion is the development of alloantibodies against blood group antigens present on RBCs. Such alloantibodies can be an obstacle in providing compatible units for transfusion. Providers in this arena must fully understand the testing performed by blood banks, as well as the consequences of detected antibodies. This article reviews immunohematologic tests, describes how autoimmune hemolytic anemia is classified by autoantibodies; outlines RBC alloimmunization rates, and presents strategies to prevent/mitigate the impact of RBC alloimmunization. PMID:27113001

  2. Non-surgical management of early breast cancer in the United Kingdom: the role and practice of radiotherapy. Clinical Audit Sub-committee of the Faculty of Clinical Oncology, Royal College of Radiologists, and the Joint Council for Clinical Oncology.

    PubMed

    Price, P; Yarnold, J R

    1995-01-01

    This paper reports on the delivery of radiotherapy to the primary site and lymphatic pathways in the management of early stage breast cancer. Radiotherapists were clear that their aim of locoregional radiotherapy was to reduce local recurrence. However, variation in policies for delivery were seen: 80% of radiotherapists did not always give radiotherapy routinely following wide local excision as part of breast conserving management; instead they withheld it selectively for a number of reasons. Only 66% routinely used breast boosts. There was a range of indications for giving radiotherapy to the lymphatic pathways; there was also variation in the management of incompletely or marginally excised primary tumours. Most sources of variation in the practice of radiotherapy in the management of women with early stage breast cancer appeared to arise from scientific uncertainty. However, organizational issues influenced many decisions. These scientific uncertainties and organizational issues are best addressed in the context of multidisciplinary breast clinics. PMID:8845315

  3. Ethical issues at the interface of clinical care and research practice in pediatric oncology: a narrative review of parents' and physicians' experiences

    PubMed Central

    2011-01-01

    Background Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences of the unprecedented integration of research and care in pediatric oncology from the perspective of parents and physicians. Methodology An empirical ethical approach, combining (1) a narrative review of (primarily) qualitative studies on parents' and physicians' experiences of the pediatric oncology research practice, and (2) comparison of these experiences with existing theoretical ethical concepts about (pediatric) research. The use of empirical evidence enriches these concepts by taking into account the peculiarities that ethical challenges pose in practice. Results Analysis of the 22 studies reviewed revealed that the integration of research and care has consequences for the informed consent process, the promotion of the child's best interests, and the role of the physician (doctor vs. scientist). True consent to research is difficult to achieve due to the complexity of research protocols, emotional stress and parents' dependency on their child's physician. Parents' role is to promote their child's best interests, also when they are asked to consider enrolling their child in a trial. Parents are almost never in equipoise on trial participation, which leaves them with the agonizing situation of wanting to do what is best for their child, while being fearful of making the wrong decision. Furthermore, a therapeutic misconception endangers correct assessment of participation, making parents inaccurately attribute therapeutic intent to research procedures. Physicians prefer the perspective of a therapist over a researcher. Consequently they may truly believe that in the research setting they promote the child's best interests, which maintains the existence of a therapeutic

  4. The correlation between LDH serum levels and clinical outcome in advanced biliary tract cancer patients treated with first line chemotherapy

    PubMed Central

    Faloppi, Luca; Del Prete, Michela; Gardini, Andrea Casadei; Santini, Daniele; Silvestris, Nicola; Bianconi, Maristella; Giampieri, Riccardo; Valgiusti, Martina; Brunetti, Oronzo; Bittoni, Alessandro; Andrikou, Kalliopi; Lai, Eleonora; Dessì, Alessandra; Cascinu, Stefano; Scartozzi, Mario

    2016-01-01

    LDH may represent an indirect marker of neo-angiogenesis and worse prognosis in many tumour types. We assessed the correlation between LDH and clinical outcome for biliary tract cancer (BTC) patients treated with first-line chemotherapy. Overall, 114 advanced BTC patients treated with first-line gemcitabine and cisplatin were included. Patients were divided into two groups (low vs. high LDH), according to pre-treatment LDH values. Patients were also classified according to pre- and post-treatment variation in LDH serum levels (increased vs. decreased). Median progression free survival (PFS) was 5.0 and 2.6 months respectively in patients with low and high pre-treatment LDH levels (p = 0.0042, HR = 0.56, 95% CI: 0.37–0.87). Median overall survival (OS) was 7.7 and 5.6 months (low vs. high LDH) (p = 0.324, HR = 0.81, 95% CI: 0.54–1.24). DCR was 71% vs. 43% (low vs. high LDH) (p = 0.002). In 38 patients with decreased LDH values after treatment, PFS and OS were respectively 6.2 and 12.1 months, whereas in 76 patients with post-treatment increased LDH levels, PFS and OS were respectively 3.0 and 5.1 months (PFS: p = 0.0009; HR = 0.49; 95% IC: 0.33–0.74; OS: p < 0.0001; HR = 0.42; 95% IC: 0.27–0.63). Our data seem to suggest that LDH serum level may predict clinical outcome in BTC patients receiving first-line chemotherapy. PMID:27063994

  5. Mastectomy With Immediate Expander-Implant Reconstruction, Adjuvant Chemotherapy, and Radiation for Stage II-III Breast Cancer: Treatment Intervals and Clinical Outcomes

    SciTech Connect

    Wright, Jean L.; Cordeiro, Peter G.; Ben-Porat, Leah; Van Zee, Kimberly J.; Hudis, Clifford; Beal, Kathryn; McCormick, Beryl

    2008-01-01

    Purpose: To determine intervals between surgery and adjuvant chemotherapy and radiation in patients treated with mastectomy with immediate expander-implant reconstruction, and to evaluate locoregional and distant control and overall survival in these patients. Methods and Materials: Between May 1996 and March 2004, 104 patients with Stage II-III breast cancer were routinely treated at our institution under the following algorithm: (1) definitive mastectomy with axillary lymph node dissection and immediate tissue expander placement, (2) tissue expansion during chemotherapy, (3) exchange of tissue expander for permanent implant, (4) radiation. Patient, disease, and treatment characteristics and clinical outcomes were retrospectively evaluated. Results: Median age was 45 years. Twenty-six percent of patients were Stage II and 74% Stage III. All received adjuvant chemotherapy. Estrogen receptor staining was positive in 77%, and 78% received hormone therapy. Radiation was delivered to the chest wall with daily 0.5-cm bolus and to the supraclavicular fossa. Median dose was 5040 cGy. Median interval from surgery to chemotherapy was 5 weeks, from completion of chemotherapy to exchange 4 weeks, and from exchange to radiation 4 weeks. Median interval from completion of chemotherapy to start of radiation was 8 weeks. Median follow-up was 64 months from date of mastectomy. The 5-year rate for locoregional disease control was 100%, for distant metastasis-free survival 90%, and for overall survival 96%. Conclusions: Mastectomy with immediate expander-implant reconstruction, adjuvant chemotherapy, and radiation results in a median interval of 8 weeks from completion of chemotherapy to initiation of radiation and seems to be associated with acceptable 5-year locoregional control, distant metastasis-free survival, and overall survival.

  6. Chemotherapy in Prostate Cancer.

    PubMed

    Hurwitz, Michael

    2015-10-01

    For approximately a decade, chemotherapy has been shown to prolong life in patients with metastatic castration-resistant prostate cancer (mCRPC). Since that time, however, only two agents have proven to prolong life (docetaxel and cabazitaxel). However, in the last year, the addition of chemotherapy to primary hormonal therapy became a standard of care for high-volume castration-sensitive metastatic disease. Here I will review current prostate cancer chemotherapies, mechanisms of resistance to those therapies, and ongoing clinical studies of chemotherapy combinations and novel chemotherapeutics. PMID:26216506

  7. Histopathological Changes and Clinical Responses of Buruli Ulcer Plaque Lesions during Chemotherapy: A Role for Surgical Removal of Necrotic Tissue?

    PubMed Central

    Brun, Luc Valère; Dossou, Ange Dodji; Barogui, Yves Thierry; Johnson, Roch Christian; Pluschke, Gerd

    2011-01-01

    Background Buruli ulcer (BU) caused by Mycobacterium ulcerans is a necrotizing skin disease usually starting with a subcutaneous nodule or plaque, which may ulcerate and progress, if untreated, over months and years. During the currently recommended antibiotic treatment with rifampicin/streptomycin plaque lesions tend to ulcerate, often associated with retarded wound healing and prolonged hospital stays. Methodology/Principal Findings Included in this study were twelve laboratory reconfirmed, HIV negative BU patients presenting with plaque lesions at the CDTUB in Allada, Benin. Punch biopsies for histopathological and immunohistochemical analysis were taken before start of treatment and after four to five weeks of treatment. Where excision or wound debridement was clinically indicated, the removed tissue was also analyzed. Based on clinical judgment, nine of the twelve patients enrolled in this study received limited surgical excision seven to 39 days after completion of chemotherapy, followed by skin grafting. Lesions of three patients healed without further intervention. Before treatment, plaque lesions were characterized by a destroyed subcutis with extensive necrosis without major signs of infiltration. After completion of antibiotic treatment partial infiltration of the affected tissue was observed, but large necrotic areas remained unchanged. Conclusion/Significance Our histopathological analyses show that ulceration of plaque lesions during antibiotic treatment do not represent a failure to respond to antimycobacterial treatment. Based on our results we suggest formal testing in a controlled clinical trial setting whether limited surgical excision of necrotic tissue favours wound healing and can reduce the duration of hospital stays. PMID:21980547

  8. Malignant astrocytoma: hyperfractionated and standard radiotherapy with chemotherapy in a randomized prospective clinical trial

    SciTech Connect

    Payne, D.G.; Simpson, W.J.; Keen, C.; Platts, M.E.

    1982-12-01

    A prospective randomized trial of 157 patients with malignant astrocytomas (Grade III or IV) was carried out at a single institution. The minimization technique ensured balanced distribution of prognostic factors between the treatment groups. All received oral lomustine (CCNU, 80 mg/m/sup 2/) six weekly and hydroxyurea (HU, 3.5 gm/m/sup 2/ over 5 days) three weekly, for one year or until recurrence, with doses adjusted for myelosuppression. Patients were randomized to daily (5000 rad in 25 fractions (fr) in 5 weeks) or Q3h (every 3 hours) Cobalt 60 irradiation (3600-4000 rad in 36-40 fr of 100 rad each, given 4 fr per day at 3-hour intervals over two weeks). Steroid therapy (up to 16 mg day dexamethasone) was permitted. Complications were moderate and equivalent in the two groups. No significant survival or toxicity differences were seen between the two groups. Age, initial performance status, and extent of surgical resection were found to be significant (P<0.01) prognostic factors for survival. Median survival of the whole group was 48 weeks with a minimum follow-up of one year. There was no advantage to large radiation fields. The hyperfractionation and daily regimes had similar efficacy and toxicity. Hyperfractionation with chemotherapy offers a useful alternative approach in the management of this disease.

  9. Clinical use of photodynamic antimicrobial chemotherapy for the treatment of deep carious lesions

    NASA Astrophysics Data System (ADS)

    Guglielmi, Camila De Almeida B.; Simionato, Maria Regina L.; Ramalho, Karen Müller; Imparato, José Carlos P.; Pinheiro, Sérgio Luiz; Luz, Maria A. A. C.

    2011-08-01

    The purpose of this study was to assess photodynamic antimicrobial chemotherapy (PACT) via irradiation, using a low power laser associated with a photosensitization dye, as an alternative to remove cariogenic microorganisms by drilling. Remaining dentinal samples in deep carious lesions on permanent molars (n = 26) were treated with 0.01% methylene blue dye and irradiated with a low power laser (InGaAIP - indium gallium aluminum phosphide; λ = 660 nm; 100 mW; 320 Jcm-2 90 s; 9J). Samples of dentin from the pulpal wall region were collected with a micropunch before and immediately after PACT and kept in a transport medium for microbiological analysis. Samples were cultured in plates of Brucella blood agar, Mitis Salivarius Bacitracin agar and Rogosa SL agar to determine the total viable bacteria, mutans streptococci and Lactobacillus spp. counts, respectively. After incubation, colony-forming units were counted and microbial reduction was calculated for each group of bacteria. PACT led to statistically significant reductions in mutans streptococci (1.38 log), Lactobacillus spp. (0.93 log), and total viable bacteria (0.91 log). This therapy may be an appropriate approach for the treatment of deep carious lesions using minimally invasive procedures.

  10. Long lasting clinical response to chemotherapy for advanced uterine leiomyosarcoma: a case report

    PubMed Central

    2013-01-01

    Introduction Uterine leiomyosarcoma is one of the most frequent uterine sarcomas. In the metastatic setting it is sensitive to doxorubicin, ifosfamide, gemcitabine, docetaxel and a few other drugs, but time to progression is generally short. For this reason prognosis is often poor and there are few reports in the literature of long responders. Case presentation We report a case of a 40-year-old Caucasian woman with metastatic uterine leiomyosarcoma who began treatment six years before the presentation of this case report and for the following six years underwent ten lines of chemotherapy, achieving excellent results and a good quality of life. Among the treatments administered we observed a long response to temolozomide, an unconventional drug for this kind of disease. Conclusion Although there are few chemotherapeutic options for the management of metastatic uterine leiomyosarcoma, a small number of patients have an unexpected long lasting response to treatment. For this reason further research is needed to identify new therapeutic agents and the predictive factors for the achievement of response. PMID:23347560

  11. Association between the ERCC1 rs11615 polymorphism and clinical outcomes of oxaliplatin-based chemotherapies in gastrointestinal cancer: a meta-analysis

    PubMed Central

    Ma, Shou-Cheng; Zhao, Yue; Zhang, Tao; Ling, Xiao-Ling; Zhao, Da

    2015-01-01

    Purpose The relationship between the excision repair cross-complementing 1 (ERCC1) rs11615 polymorphism (C/T) and responses to oxaliplatin-based chemotherapy for gastric cancer (GC) and colorectal cancer (CRC) patients is controversial. Therefore, we performed a meta-analysis to assess this relationship. Method Relevant studies were retrieved by searching the PubMed database. A systematic review and meta-analysis was performed to evaluate the predictive value of the ERCC1 rs11615 polymorphism for the clinical outcomes of GC and CRC patients receiving oxaliplatin-based chemotherapy. Therapeutic response to chemotherapy, progression-free survival (PFS), and overall survival (OS) were analyzed. Results A total of 22 studies were included in this meta-analysis, including 1,242 cases of GC and 1,772 cases of CRC. For the ERCC1 rs11615 polymorphism, the T allele was associated with a reduced response to chemotherapy in Asians and GC patients (P<0.05). On the other hand, the T allele was associated with a significant increase in the risk for shorter PFS and OS in all patients (PFS: hazard ratio [HR] =1.22, P<0.001, 95% confidence interval [CI] =0.93–1.51 and OS: HR =1.12, P<0.001, 95% CI =0.85–1.40). Conclusion The ERCC1 rs11615 polymorphism was closely associated with the clinical outcomes of GC and CRC patients treated with oxaliplatin-based chemotherapy. PMID:25834456

  12. Whole-body FDG PET-MR oncologic imaging: pitfalls in clinical interpretation related to inaccurate MR-based attenuation correction.

    PubMed

    Attenberger, Ulrike; Catana, Ciprian; Chandarana, Hersh; Catalano, Onofrio A; Friedman, Kent; Schonberg, Stefan A; Thrall, James; Salvatore, Marco; Rosen, Bruce R; Guimaraes, Alexander R

    2015-08-01

    Simultaneous data collection for positron emission tomography and magnetic resonance imaging (PET/MR) is now a reality. While the full benefits of concurrently acquiring PET and MR data and the potential added clinical value are still being evaluated, initial studies have identified several important potential pitfalls in the interpretation of fluorodeoxyglucose (FDG) PET/MRI in oncologic whole-body imaging, the majority of which being related to the errors in the attenuation maps created from the MR data. The purpose of this article was to present such pitfalls and artifacts using case examples, describe their etiology, and discuss strategies to overcome them. Using a case-based approach, we will illustrate artifacts related to (1) Inaccurate bone tissue segmentation; (2) Inaccurate air cavities segmentation; (3) Motion-induced misregistration; (4) RF coils in the PET field of view; (5) B0 field inhomogeneity; (6) B1 field inhomogeneity; (7) Metallic implants; (8) MR contrast agents. PMID:26025348

  13. American Society of Clinical Oncology policy statement: opportunities in the patient protection and affordable care act to reduce cancer care disparities.

    PubMed

    Moy, Beverly; Polite, Blase N; Halpern, Michael T; Stranne, Steven K; Winer, Eric P; Wollins, Dana S; Newman, Lisa A

    2011-10-01

    Patients in specific vulnerable population groups suffer disproportionately from cancer. The elimination of cancer disparities is critically important for lessening the burden of cancer. The Patient Protection and Affordable Care Act provides both opportunities and challenges for addressing cancer care disparities and access to care. The American Society of Clinical Oncology (ASCO) advocates for policies that ensure access to cancer care for the underserved. Such policies include insurance reform and the reduction of economic barriers to quality health care. Building on ASCO's prior statement on disparities in cancer care (2009), this article summarizes elements of the health care law that are relevant to cancer disparities and provides recommendations for addressing major provisions in the law. It outlines specific strategies to address insurance reform, access to care, quality of care, prevention and wellness, research on health care disparities, and diversity in the health care workforce. ASCO is committed to leading efforts toward the improvement of cancer care among the most vulnerable patients. PMID:21810680

  14. Bioimpedance-based respiratory gating method for oncologic positron emission tomography (PET) imaging with first clinical results

    NASA Astrophysics Data System (ADS)

    Koivumäki, T.; Vauhkonen, M.; Teuho, J.; Teräs, M.; Hakulinen, M. A.

    2013-04-01

    Respiratory motion may cause significant image artefacts in positron emission tomography/computed tomography (PET/CT) imaging. This study introduces a new bioimpedance-based gating method for minimizing respiratory artefacts. The method was studied in 12 oncologic patients by evaluating the following three parameters: maximum metabolic activity of radiopharmaceutical accumulations, the size of these targets as well as their target-to-background ratio. The bioimpedance-gated images were compared with non-gated images and images that were gated with a reference method, chest wall motion monitoring by infrared camera. The bioimpedance method showed clear improvement as increased metabolic activity and decreased target volume compared to non-gated images and produced consistent results with the reference method. Thus, the method may have great potential in the future of respiratory gating in nuclear medicine imaging.

  15. Towards secondary use of heterogeneous radio-oncological data for retrospective clinical trials: service-oriented connection of a central research database with image analysis tools

    NASA Astrophysics Data System (ADS)

    Bougatf, Nina; Bendl, Rolf; Debus, Jürgen

    2015-03-01

    Our overall objective is the utilization of heterogeneous and distributed radio-oncological data in retrospective clinical trials. Previously, we have successfully introduced a central research database for collection of heterogeneous data from distributed systems. The next step is the integration of image analysis tools in the standard retrieval process. Hence, analyses for complex medical questions can be processed automatically and facilitated immensely. In radiation oncology recurrence analysis is a central approach for the evaluation of therapeutic concepts. However, various analysis steps have to be performed like image registration, dose transformation and dose statistics. In this paper we show the integration of image analysis tools in the standard retrieval process by connecting them with our central research database using a service-oriented approach. A concrete problem from recurrence analysis has been selected to prove our concept exemplarily. We implemented service-oriented data collection and analysis tools to use them in a central analysis platform, which is based on a work flow management system. An analysis work flow has been designed that, at first, identifies patients in the research database fulfilling the inclusion criteria. Then the relevant imaging data is collected. Finally the imaging data is analyzed automatically. After the successful work flow execution, the results are available for further evaluation by a physician. As a result, the central research database has been connected successfully with automatic data collection and image analysis tools and the feasibility of our service-oriented approach has been demonstrated. In conclusion, our approach will simplify retrospective clinical trials in our department in future.

  16. Hybrid Imaging in Oncology.

    PubMed

    Fatima, Nosheen; Zaman, Maseeh uz; Gnanasegaran, Gopinath; Zaman, Unaiza; Shahid, Wajeeha; Zaman, Areeba; Tahseen, Rabia

    2015-01-01

    In oncology various imaging modalities play a crucial role in diagnosis, staging, restaging, treatment monitoring and follow up of various cancers. Stand-alone morphological imaging like computerized tomography (CT) and magnetic resonance imaging (MRI) provide a high magnitude of anatomical details about the tumor but are relatively dumb about tumor physiology. Stand-alone functional imaging like positron emission tomography (PET) and single photon emission tomography (SPECT) are rich in functional information but provide little insight into tumor morphology. Introduction of first hybrid modality PET/CT is the one of the most successful stories of current century which has revolutionized patient care in oncology due to its high diagnostic accuracy. Spurred on by this success, more hybrid imaging modalities like SPECT/CT and PET/MR were introduced. It is the time to explore the potential applications of the existing hybrid modalities, developing and implementing standardized imaging protocols and train users in nuclear medicine and radiology. In this review we discuss three existing hybrid modalities with emphasis on their technical aspects and clinical applications in oncology. PMID:26320423

  17. Pilot of three objective markers of physical health and chemotherapy toxicity in older adults

    PubMed Central

    Hsu, T.; Chen, R.; Lin, S.C.X.; Djalalov, S.; Horgan, A.; Le, L.W.; Leighl, N.

    2015-01-01

    Background Patient function is a key part of the clinical decision to offer chemotherapy and has, in earlier studies, been associated with chemotherapy toxicity. Objective testing might be more accurate than patient-reported or physician-assessed physical function, and thus might be a stronger predictor of chemotherapy toxicity in older adults. Methods Patients, 70 years of age and older, with thoracic or colorectal cancer were recruited. Three physical tests were performed before commencement of a new line of chemotherapy: grip strength, 4-m walk test, and the Timed Up and Go (tug). Our pilot study explored the association between those tests and chemotherapy toxicity. Results The 24 patients recruited had a median age of 74.5 years (range: 70–84 years), and 54.2% had an Eastern Cooperative Oncology Group performance status of 0 or 1. Median score on the Charlson comorbidity index was 1 (range: 0–4). Almost two thirds had metastatic disease, 70% were chemonaïve, and 83.3% were about to receive polychemotherapy. Patients had a mean tug of 13.2 ± 5.7 s and a mean gait speed of 0.74 ± 0.24 m/s; 50% had a grip strength test in the lowest 20th percentile. Grades 3–5 chemotherapy toxicities occurred in 34.7% of the patients; two thirds required a dose reduction or delay; and one third discontinued chemotherapy because of toxicity. Hospitalization attributable to chemotherapy was uncommon (12.5%). A trend toward increased severe chemotherapy toxicity with slower gait speed was observed (p = 0.049). Conclusions Abnormalities in objective markers of physical function are common in older adults with cancer, even in those deemed fit for chemotherapy. However, those abnormalities were not associated with an increased likelihood of chemotherapy toxicity in the population included in this small pilot study. PMID:26715870

  18. First Clinical Experience with a High-Capacity Implantable Infusion Pump for Continuous Intravenous Chemotherapy

    SciTech Connect

    Damascelli, Bruno; Patelli, Gianluigi; Frigerio, Laura F.; Lanocita, Rodolfo; Di Tolla, Giuseppe; Marchiano, Alfonso; Spreafico, Carlo; Garbagnati, Francesco; Bonalumi, Maria G.; Monfardini, Lorenzo; Ticha, Vladimira; Prino, Aurelio

    1999-01-15

    Purpose: To evaluate the efficiency of a new high-capacity pump for systemic venous chemotherapy and to verify the quality of implantation by interventional radiology staff. Methods: A total of 47 infusion pumps with a 60-ml reservoir and variable flow rates (2, 6, 8, or 12 ml/24 hr) were implanted by radiologists in 46 patients with solid tumor metastases requiring treatment with a single, continuously infused cytostatic agent. The reservoir was refilled transcutaneously, usually once weekly. The flow accuracy of the pump was assessed from actual drug delivery recorded on 34 patients over a minimum observation period of 180 days. Results: No early complications occurred in any of the 47 implants in 46 patients. A total of 12 (25.53%) complications occurred between 3 and 24 months after implantation. Seven (14.90%) of these were due to the external design of the pump, while five (10.63%) were related to the central venous catheter. In the 34 patients available for pump evaluation (follow-up of at least 180 days), the system was used for a total of 14,191 days (range 180-911 days, mean 417.38 days), giving an overall complication rate of 0.84 per 1000 days of operation. The mean flow rate accuracy was 90.26%. Conclusion: The new implantable pump showed good flow rate accuracy and reliable operation. The pump-related complications were related to its external design and have now been corrected by appropriate modifications. From a radiologic and surgical viewpoint, the venous implantation procedure is identical to that of conventional vascular access devices and can be performed by radiologists familiar with these techniques. The current limitations lie in the high cost of the pump and, for certain drugs, the short time between refills.

  19. Severe Tumor Lysis Syndrome and Acute Pulmonary Edema Requiring Extracorporeal Membrane Oxygenation Following Initiation of Chemotherapy for Metastatic Alveolar Rhabdomyosarcoma.

    PubMed

    Sanford, Ethan; Wolbrink, Traci; Mack, Jennifer; Grant Rowe, R

    2016-05-01

    We present an 8-year-old male with metastatic alveolar rhabdomyosarcoma (ARMS) who developed precipitous cardiopulmonary collapse with severe tumor lysis syndrome (TLS) 48 hr after initiation of chemotherapy. Despite no detectable pulmonary metastases, acute hypoxemic respiratory failure developed, requiring extracorporeal membrane oxygenation (ECMO). Although TLS has been reported in disseminated ARMS, this singular case of life-threatening respiratory deterioration developing after initiation of chemotherapy presented unique therapeutic dilemmas. We review the clinical aspects of this case, including possible mechanisms of respiratory failure, and discuss the role of ECMO utilization in pediatric oncology. PMID:26713672

  20. Chemotherapy-Related Neurotoxicity.

    PubMed

    Taillibert, Sophie; Le Rhun, Emilie; Chamberlain, Marc C

    2016-09-01

    Chemotherapy may have detrimental effects on either the central or peripheral nervous system. Central nervous system neurotoxicity resulting from chemotherapy manifests as a wide range of clinical syndromes including acute, subacute, and chronic encephalopathies, posterior reversible encephalopathy, acute cerebellar dysfunction, chronic cognitive impairment, myelopathy, meningitis, and neurovascular syndromes. These clinical entities vary by causative agent, degree of severity, evolution, and timing of occurrence. In the peripheral nervous system, chemotherapy-induced peripheral neuropathy (CIPN) and myopathy are the two main complications of chemotherapy. CIPN is the most common complication, and the majority manifest as a dose-dependent length-dependent sensory axonopathy. In severe cases of CIPN, the dose of chemotherapy is reduced, the administration delayed, or the treatment discontinued. Few treatments are available for CIPN and based on meta-analysis, duloxetine is the preferred symptomatic treatment. Myopathy due to corticosteroid use is the most frequent cause of muscle disorders in patients with cancer. PMID:27443648

  1. Factors affecting receipt of chemotherapy in women with breast cancer

    PubMed Central

    Morimoto, Libby; Coalson, Jenna; Mowat, Fionna; O’Malley, Cynthia

    2010-01-01

    Aims: To review literature describing factors associated with receipt of chemotherapy for breast cancer, to better understand what factors are most relevant to women’s health and whether health disparities are apparent, and to assess how these factors might affect observational studies and outcomes research. Patterns of care for metastatic breast cancer, for which no standard-of-care exists, were of particular interest. Methods: Relevant studies written in English, Italian, French, or Spanish, published in 2000 or later, were identified through MEDLINE and reviewed. Review articles and clinical trials were excluded; all observational studies and surveys were considered. Articles were reviewed for any discussion of patient characteristics, hospital/physician/insurance characteristics, psychosocial characteristics, and clinical characteristics affecting receipt of chemotherapy by breast cancer patients. Results: In general, factors associated with increased likelihood of receiving chemotherapy included younger age, being Caucasian, having good general health and few co-morbidities, having more severe clinical disease, having responded well to previous treatment, and having breast cancer that is estrogen- or progesterone-receptor-negative. Many of the clinical factors found to increase the likelihood of receiving chemotherapy were consistent with current oncology guidelines. Of the relevant 19 studies identified, only six (32%) reported data specific to metastatic cancer; most studies aggregated women with stage I–IV for purposes of analysis. Conclusion: Studies of patterns of care in breast cancer treatment can help identify challenges in health care provided to particular subgroups of women and can aid researchers in designing studies that account for such factors in clinical and outcomes research. Although scarce, studies evaluating only women with metastatic breast cancer indicate that factors affecting decisions related to receipt of chemotherapy are similar

  2. Chemotherapy tolerance after radioimmunotherapy with 90Y-CC49 monoclonal antibody in patients with advanced non-small cell lung cancer: clinical effects and hematologic toxicity.

    PubMed

    Robert, Francisco; Busby, Elizabeth M; LoBuglio, Albert F

    2003-06-01

    The purpose of this retrospective analysis was to evaluate the hematologic toxicity and clinical outcome of salvage chemotherapy following (90)Y-CC49 radioimmunotherapy (RIT) in patients with non-small cell lung cancer (NSCLC). Sixteen patients from a total of 37 who were enrolled in a phase I trial of (90)Y-CC49 monoclonal therapy were treated with post-RIT salvage chemotherapy at our institution. Five patients had received chest radiation therapy prior to RIT, and seven patients had prior chemotherapy. The majority of these patients were treated with doses of (90)Y of >/= 14 mCi/m(2) (8-20 mCi/m(2)), and four of them received concurrent 96-hour taxol infusion. The maximum tolerated dose of this study was exceeded at 17 mCi/m(2), and grade 4 thrombocytopenia/neutropenia were the dose-limiting toxicities. Twelve patients received one chemotherapy regimen as salvage therapy, and four patients had more than one regimen. Four patients (25%) experienced reversible grade 4 neutropenia, but no grade 4 thrombocytopenia was observed. Five patients had stable disease. The median survival from start of salvage therapy was 5.5 months. Our data suggest that therapy with RIT did not significantly affect survival of these patients. Taking into consideration the potential clinical relevance of integration of RIT with other treatment modalities, it is important to expand this clinical experience in order to support combined modality strategies. PMID:12954119

  3. Therapeutic Usefulness of Postoperative Adjuvant Chemotherapy with Tegafur–Uracil (UFT) in Patients with Breast Cancer: Focus on the Results of Clinical Studies in Japan

    PubMed Central

    Noguchi, Shinzaburo

    2010-01-01

    In Japan, the history of postoperative chemotherapy for breast cancer started with 5-fluorouracil (5-FU), launched in the 1980s. Currently, oral fluoropyrimidine–based regimens indicated for the treatment of breast cancer in Japan include tegafur plus uracil (UFT); tegafur, gimeracil, and oteracil (TS-1); doxifluridine; and capecitabine. In particular, UFT represents an important option for long-term treatment because of minimal adverse events and the potential for long-term maintenance of effective plasma concentrations of 5-FU to inhibit micrometastasis after surgery. Therefore, various clinical studies of postoperative adjuvant chemotherapy with UFT have been conducted in patients with completely resected tumors. Recent studies have shown that UFT prolongs survival after tumor resection in patients with gastric cancer, colorectal cancer, and lung cancer. In patients with breast cancer, large clinical trials of UFT-based postoperative chemotherapy conducted in Japan have shown that UFT is useful for the treatment of intermediate-risk patients with no lymph node metastasis. This paper reviews the results of clinical studies of UFT conducted in Japan to assess the therapeutic usefulness of this oral 5-FU. The types of patients most likely to benefit from UFT are discussed on the basis of currently available evidence and a global consensus of treatment recommendations. The optimal timing of endocrine therapy and strategies for postoperative adjuvant chemotherapy with UFT in patients with breast cancer are also discussed. PMID:20080863

  4. Co-clinical trials demonstrate superiority of crizotinib to chemotherapy in ALK-rearranged non-small cell lung cancer and predict strategies to overcome resistance

    PubMed Central

    Tupper, Tanya; Cheng, Katherine; Wang, Yuchuan; Tan, Xiaohong; Altabef, Abigail; Woo, Sue-Ann; Chen, Liang; Reibel, Jacob B.; Janne, Pasi A.; Sharpless, Norman E.; Engelman, Jeffrey A.; Shapiro, Geoffrey I.; Kung, Andrew L.; Wong, Kwok-Kin

    2014-01-01

    Purpose To extend the results of a phase III trial in non-small cell lung cancer patients with adenocarcinomas harboring EML4-ALK fusion. Experimental Design we performed a co-clinical trial in a mouse model comparing the ALK inhibitor crizotinib to the standard-of-care cytotoxic agents docetaxel or pemetrexed. Results Concordant with the clinical outcome in humans, crizotinib produced a substantially higher response rate compared to chemotherapy, associated with significantly longer progression-free survival. Overall survival was also prolonged in crizotinib- compared to chemotherapy-treated mice. Pemetrexed produced superior overall survival compared to docetaxel, suggesting that this agent may be the preferred chemotherapy in the ALK population. Additionally, in the EML4-ALK-driven mouse lung adenocarcinoma model, HSP90 inhibition can overcome both primary and acquired crizotinib resistance. Furthermore, HSP90 inhibition, as well as the second-generation ALK inhibitor TAE684, demonstrated activity in newly developed lung adenocarcinoma models driven by crizotinib-insensitive EML4-ALK L1196M or F1174L. Conclusions Our findings suggest that crizotinib is superior to standard chemotherapy in ALK inhibitor-naïve disease and support further clinical investigation of HSP90 inhibitors and second-generation ALK inhibitors in tumors with primary or acquired crizotinib resistance. PMID:24327273

  5. Assessment of adherence to the guidelines for the management of nausea and vomiting induced by chemotherapy

    PubMed Central

    França, Monique Sedlmaier; Usón, Pedro Luiz Serrano; Antunes, Yuri Philippe Pimentel Vieira; Prado, Bernard Lobato; Donnarumma, Carlos del Cistia; Mutão, Taciana Sousa; Rodrigues, Heloisa Veasey; del Giglio, Auro

    2015-01-01

    ABSTRACT Objective: To assess adherence of the prescribing physicians in a private cancer care center to the American Society of Clinical Oncology guideline for antiemetic prophylaxis, in the first cycle of antineoplastic chemotherapy. Methods: A total of 139 chemotherapy regimens, of 105 patients, were evaluated retrospectively from 2011 to 2013. Results: We observed 78% of non-adherence to the guideline rate. The main disagreements with the directive were the prescription of higher doses of dexamethasone and excessive use of 5-HT3 antagonist for low risk emetogenic chemotherapy regimens. On univariate analysis, hematological malignancies (p=0.005), the use of two or more chemotherapy (p=0.05) and high emetogenic risk regimes (p=0.012) were factors statistically associated with greater adherence to guidelines. Treatment based on paclitaxel was the only significant risk factor for non-adherence (p=0.02). By multivariate analysis, the chemotherapy of high emetogenic risk most correlated with adherence to guideline (p=0.05). Conclusion: We concluded that the adherence to guidelines is greater if the chemotherapy regime has high emetogenic risk. Educational efforts should focus more intensely on the management of chemotherapy regimens with low and moderate emetogenic potential. Perhaps the development of a computer generated reminder may improve the adherence to guidelines. PMID:26154543

  6. Prospective multicenter study of combined treatment with chemotherapy and radiotherapy in breast cancer women with the rare clinical scenario of ipsilateral supraclavicular node recurrence without distant metastases

    SciTech Connect

    Pergolizzi, Stefano . E-mail: Stefano.Pergolizzi@unime.it; Adamo, Vincenzo; Russi, Elvio; Santacaterina, Anna; Maisano, Roberto; Numico, Gianmauro; Palazzolo, Carmela; Ferrau, Francesco; Settineri, Nicola; Altavilla, Giuseppe; Girlando, Andrea; Spadaro, Pietro; Cascinu, Stefano

    2006-05-01

    Purpose: To evaluate the role of chemotherapy combined with curative radiotherapy in breast cancer patients who presented with recurrent ipsilateral supraclavicular lymph node metastases (ISLM) without 'nonregional disease,' we designed an observational study performed prospectively. Patients and Methods: Forty-four consecutive patients with ISLM from breast cancer as part of recurrent regional disease without distant metastases were included in this study. All patients received chemotherapy with doxorubicin-based schema or paclitaxel for six courses and curative radiotherapy (60 Gy/30 fractions of 2 Gy/5 days a week). An 'involved field' radiation was delivered during the interval between the third and fourth chemotherapy course; hormonal therapy was given based on receptor status. Results: The rate of overall clinical response after chemotherapy and radiotherapy was 94.9%. Median time to progression and overall survival were 28 and 40 months, respectively; the 5-year actuarial overall survival and disease-free survival rates were 35% (95% confidence interval, 19-51) and 20% (95% confidence interval, 6-34), respectively. Conclusion: A curative course of intravenous chemotherapy and radical irradiation is feasible in patients with ISLM. All patients presenting recurrence in supraclavicular nodes should be treated with definitive locoregional treatments and systemic therapy because the outcomes are better than might be historically assumed.

  7. Dicycloplatin, a novel platinum analog in chemotherapy: synthesis of chinese pre-clinical and clinical profile and emerging mechanistic studies.

    PubMed

    Yu, Jing Jie; Yang, Xuqing; Song, Qinhua; Mueller, Michael D; Remick, Scot C

    2014-01-01

    Dicycloplatin (DCP) has better solubility and stability than both cisplatin and carboplatin. Pre-clinical and phase I studies demonstrated significant antitumor activity and fewer adverse events than carboplatin. Phase II clinical trials in advanced non-small cell lung cancer found efficacy and safety of DCP-plus-paclitaxel comparable to carboplatin-plus-paclitaxel but better tolerability. This article summarizes and reviews pre-clinical and clinical data for dicycloplatin from the Chinese medical literature. We also report on new mechanistic findings in our laboratory in West Virginia, USA. Patient blood samples were collected for DCP-prototype determination by liquid chromatography mass spectrometry (LC-MS/MS). Molecular studies of ovarian cancer cells treated with DCP or cisplatin were carried out for gene-signature profiling using immunoblotting. Pharmacokinetic mass-spectrometry showed different spectrum profiles of DCP and carboplatin in plasma. Plasma concentration of DCP prototype was 17.1 μg/ml 2h after administration, with a peak concentration of 26.9 μg/ml at 0.5 h. Immunoblotting showed DCP-induced activation of DNA damage pathways, including double-phosphorylated checkpoint kinase 2 (CHK2) and breast cancer 1 (BRCA1) and triple-phosphorylated p53, compared to controls. Cisplatin produced a similar profile, with increased p53 protein. DCP and cisplatin activate DNA-damage response through similar pathways. DCP may be more soluble and stable, and better-tolerated. PMID:24403501

  8. Risk of Infectious Complications in Hemato-Oncological Patients Treated with Kinase Inhibitors

    PubMed Central

    Reinwald, Mark; Boch, Tobias; Hofmann, Wolf-Karsten; Buchheidt, Dieter

    2015-01-01

    Infectious complications are a major cause of morbidity and mortality in patients with hemato-oncological diseases. Although disease-related immunosuppression represents one factor, aggressive treatment regimens, such as chemotherapy, stem cell transplantation, or antibody treatment, account for a large proportion of infectious side effects. With the advent of targeted therapies affecting specific kinases in malignant diseases, the outcome of patients has further improved. Nonetheless, dependent on the specific pathway targeted or off-target activity of the kinase inhibitor, therapy-associated infectious complications may occur. We review the most common and approved kinase inhibitors targeting a variety of hemato-oncological malignancies for their immunosuppressive potential and evaluate their risk of infectious side effects based on preclinical evidence and clinical data in order to raise awareness of the potential risks involved. PMID:27127405

  9. Different Clinical Utility of Oropharyngeal Bacterial Screening prior to Percutaneous Endoscopic Gastrostomy in Oncological and Neurological Patients

    PubMed Central

    Dastych, Milan; Senkyrik, Michal; Pavlik, Tomas; Prokesova, Jitka; Jecmenova, Marketa; Dolina, Jiri; Hep, Ales

    2014-01-01

    Background. The aim of this study was to monitor oropharyngeal bacterial colonization in patients indicated for percutaneous endoscopic gastronomy (PEG). Methods. Oropharyngeal swabs were obtained from patients prior to PEG placement. A development of peristomal infection was evaluated. The analysis of oropharyngeal and peristomal site pathogens was done. Results. Consecutive 274 patients referred for PEG due to neurological disorder or cancer completed the study. Oropharyngeal colonization with pathogens was observed in 69% (190/274), dominantly in the neurologic subgroup of patients (P < 0.001). Peristomal infection occurred in 30 (10.9%) of patients and in 57% of them the correlation between oropharyngeal and peristomal agents was present. The presence of oropharyngeal pathogens was assessed as an important risk factor for the development of peristomal infection only in oncological patients (OR = 8.33, 95% CI: 1.66–41.76). Despite a high prevalence of pathogens in neurological patients, it did not influence the risk of peristomal infection with the exception for methicillin resistant Staphylococcus aureus (MRSA) carriers (OR 4.5, 95% CI: 1.08–18.76). Conclusion. During oropharyngeal microbial screening prior to the PEG insertion, the detection of pathogens may be a marker of the increased risk of peristomal infection in cancer patients only. In neurological patients the benefit of the screening is limited to the detection of MRSA carriers. PMID:25243153

  10. Pharmacogenetic prediction of clinical outcome in advanced colorectal cancer patients receiving oxaliplatin/5-fluorouracil as first-line chemotherapy.

    PubMed

    Paré, L; Marcuello, E; Altés, A; del Río, E; Sedano, L; Salazar, J; Cortés, A; Barnadas, A; Baiget, M

    2008-10-01

    To determine whether molecular parameters could be partly responsible for resistance or sensitivity to oxaliplatin (OX)-based chemotherapy used as first-line treatment in advanced colorectal cancer (CRC). We studied the usefulness of the excision repair cross-complementing 1 (ERCC1), xeroderma pigmentosum group D (XPD), XRCC1 and GSTP1 polymorphisms as predictors of clinical outcome in these patients. We treated 126 CRC patients with a first-line OX/5-fluorouracil chemotherapeutic regimen. Genetic polymorphisms were determined by real-time PCR on an ABI PRISM 7000, using DNA from peripheral blood. Clinical response (CR), progression-free survival (PFS) and overall survival (OS) were evaluated according to each genotype. In the univariate analysis for CR, ERCC1-118 and XPD 751 polymorphisms were significant (P=0.02 and P=0.05, respectively). After adjustment for the most relevant clinical variables, only ERCC1-118 retained significance (P=0.008). In the univariate analysis for PFS, ERCC1-118 and XPD 751 were significant (P=0.003 and P=0.009, respectively). In the multivariant analysis, only the XPD 751 was significant for PFS (P=0.02). Finally, ERCC1-118 and XPD 751 polymorphisms were significant in the univariate analysis for OS (P=0.006 and P=0.015, respectively). Both genetic variables remained significant in the multivariate Cox survival analysis (P=0.022 and P=0.03). Our data support the hypothesis that enhanced DNA repair diminishes the benefit of platinum-based treatments. PMID:18797464

  11. Pharmacogenetic prediction of clinical outcome in advanced colorectal cancer patients receiving oxaliplatin/5-fluorouracil as first-line chemotherapy

    PubMed Central

    Paré, L; Marcuello, E; Altés, A; Río, E del; Sedano, L; Salazar, J; Cortés, A; Barnadas, A; Baiget, M

    2008-01-01

    To determine whether molecular parameters could be partly responsible for resistance or sensitivity to oxaliplatin (OX)-based chemotherapy used as first-line treatment in advanced colorectal cancer (CRC). We studied the usefulness of the excision repair cross-complementing 1 (ERCC1), xeroderma pigmentosum group D (XPD), XRCC1 and GSTP1 polymorphisms as predictors of clinical outcome in these patients. We treated 126 CRC patients with a first-line OX/5-fluorouracil chemotherapeutic regimen. Genetic polymorphisms were determined by real-time PCR on an ABI PRISM 7000, using DNA from peripheral blood. Clinical response (CR), progression-free survival (PFS) and overall survival (OS) were evaluated according to each genotype. In the univariate analysis for CR, ERCC1-118 and XPD 751 polymorphisms were significant (P=0.02 and P=0.05, respectively). After adjustment for the most relevant clinical variables, only ERCC1-118 retained significance (P=0.008). In the univariate analysis for PFS, ERCC1-118 and XPD 751 were significant (P=0.003 and P=0.009, respectively). In the multivariant analysis, only the XPD 751 was significant for PFS (P=0.02). Finally, ERCC1-118 and XPD 751 polymorphisms were significant in the univariate analysis for OS (P=0.006 and P=0.015, respectively). Both genetic variables remained significant in the multivariate Cox survival analysis (P=0.022 and P=0.03). Our data support the hypothesis that enhanced DNA repair diminishes the benefit of platinum-based treatments. PMID:18797464

  12. Preoperative bevacizumab combined with letrozole and chemotherapy in locally advanced ER- and/or PgR-positive breast cancer: clinical and biological activity

    PubMed Central

    Torrisi, R; Bagnardi, V; Cardillo, A; Bertolini, F; Scarano, E; Orlando, L; Mancuso, P; Luini, A; Calleri, A; Viale, G; Goldhirsch, A; Colleoni, M

    2008-01-01

    The antiangiogenic agent bevacizumab showed synergistic effects when combined with chemotherapy in advanced breast cancer. We presently investigated the activity of bevacizumab in combination with chemotherapy, including capecitabine and vinorelbine, and endocrine therapy, including letrozole (+triptorelin in premenopausal women), as primary therapy for patients with ER and/or PgR ⩾10% T2–T4a-c, N0–N2, M0 breast cancer. Biological end point included the proliferative activity (Ki67), whereas clinical end points were clinical response rate, pathological complete response (pCR) and tolerability. Circulating endothelial cells (CECs) and their progenitors, as surrogate markers of antiangiogenic activity, were measured at baseline and at surgery.Thirty-six women are evaluable. A clinical response rate of 86% (95% CI, 70–95) and no pCR were observed; Ki67 was significantly decreased by 71% (interquartile range, −82%, −62%). Toxicity was manageable: two grade 3 hypertension, four grade 3 deep venous thrombosis and no grade >2 proteinuria were observed. Treatment significantly decreased the percentage of viable CECs and prevented the chemotherapy-induced mobilisation of circulating progenitors. Basal circulating progenitors were positively associated with clinical response. In conclusion, bevacizumab is feasible and active in association with primary chemoendocrine therapy for ER-positive tumours in terms of proliferation inhibition, clinical response and antiangiogenic activity. PMID:18941458

  13. Towards using a full spectrum of early clinical trial data: a retrospective analysis to compare potential longitudinal categorical models for molecular targeted therapies in oncology.

    PubMed

    Colin, Pierre; Micallef, Sandrine; Delattre, Maud; Mancini, Pierre; Parent, Eric

    2015-09-30

    Following the pattern of phase I clinical trials for cytotoxic drugs, dose-finding clinical trials in oncology of molecularly targeted agents (MTA) aim at determining the maximum tolerated dose (MTD). In classical phase I clinical trials, MTD is generally defined by the number of patients with short-term major treatment toxicities (usually called dose-limiting toxicities, DLT), occurring during the first cycle of study treatment (e.g. within the first 3weeks of treatment). However, S. Postel-Vinay (2011) highlighted that half of grade 3 to 4 toxicities, usually considered as DLT, occur after the first cycle of MTA treatment. In addition, MTAs could induce other moderate (e.g. grade 2) toxicities which could be taken into account depending on their clinical importance, chronic nature and duration. Ignoring these late toxicities may lead to an underestimation of the drug toxicity and to wrong dose recommendations for phase II and III clinical trials. Some methods have been proposed, such as the time-to-event continuous reassessment method (Cheung 2000 and Mauguen 2011), to take into account the late toxicities. We suggest approaches based on longitudinal models (Doussau 2013). We compare several models for longitudinal data, such as transitional or marginal models, to take into account all relevant toxicities occurring during the entire length of the patient treatment (and not just the events within a predefined short-term time-window). These models allow the statistician to benefit from a larger amount of safety data which could potentially improve that accuracy in MTD assessment. PMID:26059319

  14. Predicting Ovarian Cancer Patients' Clinical Response to Platinum-Based Chemotherapy by Their Tumor Proteomic Signatures.

    PubMed

    Yu, Kun-Hsing; Levine, Douglas A; Zhang, Hui; Chan, Daniel W; Zhang, Zhen; Snyder, Michael

    2016-08-01

    Ovarian cancer is the deadliest gynecologic malignancy in the United States with most patients diagnosed in the advanced stage of the disease. Platinum-based antineoplastic therapeutics is indispensable to treating advanced ovarian serous carcinoma. However, patients have heterogeneous responses to platinum drugs, and it is difficult to predict these interindividual differences before administering medication. In this study, we investigated the tumor proteomic profiles and clinical characteristics of 130 ovarian serous carcinoma patients analyzed by the Clinical Proteomic Tumor Analysis Consortium (CPTAC), predicted the platinum drug response using supervised machine learning methods, and evaluated our prediction models through leave-one-out cross-validation. Our data-driven feature selection approach indicated that tumor proteomics profiles contain information for predicting binarized platinum response (P < 0.0001). We further built a least absolute shrinkage and selection operator (LASSO)-Cox proportional hazards model that stratified patients into early relapse and late relapse groups (P = 0.00013). The top proteomic features indicative of platinum response were involved in ATP synthesis pathways and Ran GTPase binding. Overall, we demonstrated that proteomic profiles of ovarian serous carcinoma patients predicted platinum drug responses as well as provided insights into the biological processes influencing the efficacy of platinum-based therapeutics. Our analytical approach is also extensible to predicting response to other antineoplastic agents or treatment modalities for both ovarian and other cancers. PMID:27312948

  15. The impact of a new acute oncology service in acute hospitals: experience from the Clatterbridge Cancer Centre and Merseyside and Cheshire Cancer Network.

    PubMed

    Neville-Webbe, H L; Carser, J E; Wong, H; Andrews, J; Poulter, T; Smith, R; Marshall, E

    2013-12-01

    The 2008 National Confidential Enquiry into Patient Outcomes and Death highlighted an urgent need to improve the quality, safety and efficiency of care for cancer patients following emergency presentation to acute general hospitals. A network-wide acute oncology service (AOS) was therefore commissioned and implemented on the basis of recommendations from the National Chemotherapy Advisory Group (NCAG). Through a continuous programme of raising awareness regarding both the role of the AOS and the necessity of early patient referral to acute oncology teams, we have been able to establish an AOS across all acute trusts in our cancer network. The network-wide AOS has improved communication across clinical teams, enabled rapid review of over 3,000 patients by oncology staff, reduced hospital stay, increased understanding of oncology emergencies and their treatment, and enhanced pathways for rapid diagnosis and appropriate referrals for patients presenting with malignancy of undefined origin (MUO). These achievements have been made by developing a network protocol book for managing common oncology emergencies, by introducing local pathways for managing MUO and by collaborating with palliative care teams to introduce local acute oncology (AO) multi-disciplinary team (MDT) meetings. PMID:24298102

  16. Clinical Outcomes with First-line Endocrine Therapy or Chemotherapy in Postmenopausal HR+/HER2− Metastatic Breast Cancer

    PubMed Central

    Song, Yan; Hao, Yanni; Macalalad, Alexander R.; Lin, Peggy L.; Signorovitch, James E.; Wu, Eric Q.

    2015-01-01

    OBJECTIVE To describe patient profiles and clinical outcomes associated with first-line endocrine monotherapy (ET) and chemotherapy (CT) for postmenopausal HR+/HER2− metastatic breast cancer (mBC) patients. METHODS This is a retrospective chart review of 139 postmenopausal HR+/HER2− mBC patients initiating first-line ET monotherapy or CT. Overall survival (OS) was described using Kaplan–Meier curves. Exploratory comparative proportional hazards regression was conducted. RESULTS Patients on first-line CT had significantly more frequent liver metastases than patients on first-line ET monotherapy at baseline. The median OS was 35.5 months [95% confidence interval (CI), 22.7–41.2 months] for patients on first-line ET monotherapy and 22.2 months (95% CI, 13.6–25.9 months) for those on first-line CT (P = 0.021). Adjusting for baseline characteristics, the OS between first-line ET monotherapy and CT was not significantly different. CONCLUSIONS Patients who were prescribed CT as first-line treatment had evidence of more advanced disease at baseline and shorter OS than those who received ET monotherapy as first-line treatment, suggesting a need for additional safe and effective treatment options for these patients. PMID:26380551

  17. Clinical benefits of alpharadin in castrate-chemotherapy-resistant prostate cancer: case report and literature review

    PubMed Central

    Croke, Jennifer; Leung, Eugene; Segal, Roanne; Malone, Shawn

    2012-01-01

    Prostate cancer has the second-highest mortality worldwide in men. The most common site of metastasis is bone. Bone metastases and their resulting complications represent a significant source of morbidity. Radioisotopes have been used for treatment of painful bony metastases. Although shown to decrease pain and analgesia use, this has not improved outcomes. The following case report describes a patient with castrate-resistant prostate cancer who was treated with the radioisotope radium-223 as part of the phase III clinical trial Alpharadin in Patients with Symptomatic Hormone Refractory Prostate Cancer with Skeletal Metastases (ALSYMPCA). He responded to radium-223 with pain relief, bone scan response, stabilisation of prostate specific antigen (PSA) and normalisation of alkaline phosphatase. Interim analysis of this trial has shown that radium-223 significantly prolongs overall survival, time to first skeletal-related event and is well tolerated. Alpharadin is a new treatment option for men with castrate-resistant prostate cancer and symptomatic bone metastases. PMID:23125297

  18. [Immunostimulatory properties of mistletoe extracts and their application in oncology].

    PubMed

    Wrotek, Sylwia; Skawiński, Robert; Kozak, Wiesław

    2014-01-01

    For a long time cancer immunotherapy was overshadowed by chemotherapy and radiotherapy. Recently, "Science", one of the world's top scientific journals, named the stimulation of the body's own immune system to fight cancer cells as the "breakthrough of the year". In Germany, Switzerland and Austria, extracts derived from mistletoe (Viscum album L.) such as Iscador, Abnobaviscum, Helixor, Iscar, Iscucin and Isorel have been used in oncology for many years. These extracts have immunomodulating and immunostimulating properties, as demonstrated by experimental studies as well as in clinical trials. The aim of our paper is to present immunological disorders associated with cancer, which can be counteracted by treatment with extracts derived from mistletoe. Although these drugs cannot replace conventional cancer treatment, they may improve the patient's quality and length of life. PMID:25380204

  19. Introduction of online adaptive radiotherapy for bladder cancer through a multicentre clinical trial (Trans-Tasman Radiation Oncology Group 10.01): Lessons learned

    PubMed Central

    Pham, Daniel; Roxby, Paul; Kron, Tomas; Rolfo, Aldo; Foroudi, Farshad

    2013-01-01

    Online adaptive radiotherapy for bladder cancer is a novel radiotherapy technique that was found feasible in a pilot study at a single academic institution. In September 2010 this technique was opened as a multicenter study through the Trans-Tasman Radiation Oncology Group (TROG 10.01 bladder online adaptive radiotherapy treatment). Twelve centers across Australia and New-Zealand registered interest into the trial. A multidisciplinary team of radiation oncologists, radiation therapists and medical physicists represented the trial credentialing and technical support team. To provide timely activation and proper implementation of the adaptive technique the following key areas were addressed at each site: Staff education/training; Practical image guided radiotherapy assessment; provision of help desk and feedback. The trial credentialing process involved face-to-face training and technical problem solving via full day site visits. A dedicated “help-desk” team was developed to provide support for the clinical trial. 26% of the workload occurred at the credentialing period while the remaining 74% came post-center activation. The workload was made up of the following key areas; protocol clarification (36%), technical problems (46%) while staff training was less than 10%. Clinical trial credentialing is important to minimizing trial deviations. It should not only focus on site activation quality assurance but also provide ongoing education and technical support. PMID:23776308

  20. Introduction of online adaptive radiotherapy for bladder cancer through a multicentre clinical trial (Trans-Tasman Radiation Oncology Group 10.01): Lessons learned.

    PubMed

    Pham, Daniel; Roxby, Paul; Kron, Tomas; Rolfo, Aldo; Foroudi, Farshad

    2013-04-01

    Online adaptive radiotherapy for bladder cancer is a novel radiotherapy technique that was found feasible in a pilot study at a single academic institution. In September 2010 this technique was opened as a multicenter study through the Trans-Tasman Radiation Oncology Group (TROG 10.01 bladder online adaptive radiotherapy treatment). Twelve centers across Australia and New-Zealand registered interest into the trial. A multidisciplinary team of radiation oncologists, radiation therapists and medical physicists represented the trial credentialing and technical support team. To provide timely activation and proper implementation of the adaptive technique the following key areas were addressed at each site: Staff education/training; Practical image guided radiotherapy assessment; provision of help desk and feedback. The trial credentialing process involved face-to-face training and technical problem solving via full day site visits. A dedicated "help-desk" team was developed to provide support for the clinical trial. 26% of the workload occurred at the credentialing period while the remaining 74% came post-center activation. The workload was made up of the following key areas; protocol clarification (36%), technical problems (46%) while staff training was less than 10%. Clinical trial credentialing is important to minimizing trial deviations. It should not only focus on site activation quality assurance but also provide ongoing education and technical support. PMID:23776308

  1. American Society of Clinical Oncology/College of American Pathologists Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer

    PubMed Central

    Hammond, M. Elizabeth H.; Hayes, Daniel F.; Dowsett, Mitch; Allred, D. Craig; Hagerty, Karen L.; Badve, Sunil; Fitzgibbons, Patrick L.; Francis, Glenn; Goldstein, Neil S.; Hayes, Malcolm; Hicks, David G.; Lester, Susan; Love, Richard; Mangu, Pamela B.; McShane, Lisa; Miller, Keith; Osborne, C. Kent; Paik, Soonmyung; Perlmutter, Jane; Rhodes, Anthony; Sasano, Hironobu; Schwartz, Jared N.; Sweep, Fred C. G.; Taube, Sheila; Torlakovic, Emina Emilia; Valenstein, Paul; Viale, Giuseppe; Visscher, Daniel; Wheeler, Thomas; Williams, R. Bruce; Wittliff, James L.; Wolff, Antonio C.

    2011-01-01

    Purpose To develop a guideline to improve the accuracy of immunohistochemical (IHC) estrogen receptor (ER) and progesterone receptor (PgR) testing in breast cancer and the utility of these receptors as predictive markers. Methods The American Society of Clinical Oncology and the College of American Pathologists convened an international Expert Panel that conducted a systematic review and evaluation of the literature in partnership with Cancer Care Ontario and developed recommendations for optimal IHC ER/PgR testing performance. Results Up to 20% of current IHC determinations of ER and PgR testing worldwide may be inaccurate (false negative or false positive). Most of the issues with testing have occurred because of variation in preanalytic variables, thresholds for positivity, and interpretation criteria. Recommendations The Panel recommends that ER and PgR status be determined on all invasive breast cancers and breast cancer recurrences. A testing algorithm that relies on accurate, reproducible assay performance is proposed. Elements to reliably reduce assay variation are specified. It is recommended that ER and PgR assays be considered positive if there are at least 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal (normal epithelial elements) and external controls. The absence of benefit from endocrine therapy for women with ER-negative invasive breast cancers has been confirmed in large overviews of randomized clinical trials. PMID:20524868

  2. Cancer Chemotherapy

    MedlinePlus

    ... controlled way. Cancer cells keep growing without control. Chemotherapy is drug therapy for cancer. It works by killing the cancer ... It depends on the type and amount of chemotherapy you get and how your body reacts. Some ...

  3. Cancer Chemotherapy

    MedlinePlus

    ... cells grow and die in a controlled way. Cancer cells keep forming without control. Chemotherapy is drug ... Your course of therapy will depend on the cancer type, the chemotherapy drugs used, the treatment goal ...

  4. Personality types of oncology nurses.

    PubMed

    Bean, C A; Holcombe, J K

    1993-12-01

    Personality type influences the choice of occupation. The breadth of specialty areas within oncology nursing allows for divergent activities and relationships and, thus, the accommodation of different personality characteristics. This exploratory study examined personality types for a convenience sample of oncology nurses predominantly employed in hospitals. According to the personality typology defined by Carl Jung, a person demonstrates a preference among four dimensions, i.e., extraversion/introversion, sensory/intuition, thinking/feeling, and judging/perceiving. The type with the strongest self-selection for these oncology nurses was ISFJ, where feeling is introverted and perception is practical, so that helping others is both a responsibility and a pleasure. The discussion relates the personality types to Jung's theory and their impact in clinical practice. Strengths and weaknesses of each personality type are described. PMID:8111753

  5. Association between dynamic features of breast DCE-MR imaging and clinical response of neoadjuvant chemotherapy: a preliminary analysis

    NASA Astrophysics Data System (ADS)

    Huang, Lijuan; Fan, Ming; Li, Lihua; Zhang, Juan; Shao, Guoliang; Zheng, Bin

    2016-03-01

    Neoadjuvant chemotherapy (NACT) is being used increasingly in the management of patients with breast cancer for systemically reducing the size of primary tumor before surgery in order to improve survival. The clinical response of patients to NACT is correlated with reduced or abolished of their primary tumor, which is important for treatment in the next stage. Recently, the dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) is used for evaluation of the response of patients to NACT. To measure this correlation, we extracted the dynamic features from the DCE- MRI and performed association analysis between these features and the clinical response to NACT. In this study, 59 patients are screened before NATC, of which 47 are complete or partial response, and 12 are no response. We segmented the breast areas depicted on each MR image by a computer-aided diagnosis (CAD) scheme, registered images acquired from the sequential MR image scan series, and calculated eighteen features extracted from DCE-MRI. We performed SVM with the 18 features for classification between patients of response and no response. Furthermore, 6 of the 18 features are selected to refine the classification by using Genetic Algorithm. The accuracy, sensitivity and specificity are 87%, 95.74% and 50%, respectively. The calculated area under a receiver operating characteristic (ROC) curve is 0.79+/-0.04. This study indicates that the features of DCE-MRI of breast cancer are associated with the response of NACT. Therefore, our method could be helpful for evaluation of NACT in treatment of breast cancer.

  6. Phase II clinical trial of palonosetron combined with tropisetron in preventing chemotherapy-induced nausea and vomiting

    PubMed Central

    Ma, Yuan; Su, Lei; Liu, Liyan; Xie, Chao; Zhang, Xia; Song, Bao; Cheng, Sensen; Liu, Jie

    2015-01-01

    The purpose of the study was to evaluate the efficacy and toxicity of palonosetron combined with tropisetron in preventing chemotherapy-induced nausea and vomiting. A total of 82 non-small cell lung cancer patients undergoing Docetaxel combined with Cisplatin were randomly divided into group A and group B. The patients were received palonosetron combined with tropisetron (group A, n = 42) or tropisetron alone (group B, n = 40) before initiation of chemotherapy. The nausea degree, antiemetic efficacy and safety after chemotherapy were evaluated. Patients were administered for rescue therapy if needed. Results showed no significant difference in complete remission rate (CRR) during acute phase (0-24 h post chemotherapy) between group A and group B (90.48% versus 75%, P > 0.05). The CRR of group A during delayed (24-120 h post chemotherapy) and overall phases (0-120 h post chemotherapy) were 83.33% and 78.57%, higher than group B (50% and 42.50%, P < 0.05). AS for the improvement rate of nausea during delayed phase, group A is better than group B (57.14% versus 35%, P < 0.05). The adverse drug reactions of two groups were mild and generally well tolerated, including headache, constipation and abdominal distension, and no statistically significant differences were observed. In conclusions, compared to tropisetron alone, the therapy of palonosetron plus tropisetron is more effective and safer in controlling of nausea and vomiting induced by high emetic risk chemotherapy. PMID:26221359

  7. Phase II clinical trial of palonosetron combined with tropisetron in preventing chemotherapy-induced nausea and vomiting.

    PubMed

    Ma, Yuan; Su, Lei; Liu, Liyan; Xie, Chao; Zhang, Xia; Song, Bao; Cheng, Sensen; Liu, Jie

    2015-01-01

    The purpose of the study was to evaluate the efficacy and toxicity of palonosetron combined with tropisetron in preventing chemotherapy-induced nausea and vomiting. A total of 82 non-small cell lung cancer patients undergoing Docetaxel combined with Cisplatin were randomly divided into group A and group B. The patients were received palonosetron combined with tropisetron (group A, n = 42) or tropisetron alone (group B, n = 40) before initiation of chemotherapy. The nausea degree, antiemetic efficacy and safety after chemotherapy were evaluated. Patients were administered for rescue therapy if needed. Results showed no significant difference in complete remission rate (CRR) during acute phase (0-24 h post chemotherapy) between group A and group B (90.48% versus 75%, P > 0.05). The CRR of group A during delayed (24-120 h post chemotherapy) and overall phases (0-120 h post chemotherapy) were 83.33% and 78.57%, higher than group B (50% and 42.50%, P < 0.05). AS for the improvement rate of nausea during delayed phase, group A is better than group B (57.14% versus 35%, P < 0.05). The adverse drug reactions of two groups were mild and generally well tolerated, including headache, constipation and abdominal distension, and no statistically significant differences were observed. In conclusions, compared to tropisetron alone, the therapy of palonosetron plus tropisetron is more effective and safer in controlling of nausea and vomiting induced by high emetic risk chemotherapy. PMID:26221359

  8. The Role of Nutraceuticals in Chemoprevention and Chemotherapy and Their Clinical Outcomes

    PubMed Central

    Saldanha, Sabita N.; Tollefsbol, Trygve O.

    2012-01-01

    The genesis of cancer is often a slow process and the risk of developing cancer increases with age. Altering a diet that includes consumption of beneficial phytochemicals can influence the balance and availability of dietary chemopreventive agents. In chemopreventive approaches, foods containing chemicals that have anticancer properties can be supplemented in diets to prevent precancerous lesions from occurring. This necessitates further understanding of how phytochemicals can potently maintain healthy cells. Fortunately there is a plethora of plant-based phytochemicals although few of them are well studied in terms of their application as cancer chemopreventive and therapeutic agents. In this analysis we will examine phytochemicals that have strong chemopreventive and therapeutic properties in vitro as well as the design and modification of these bioactive compounds for preclinical and clinical applications. The increasing potential of combinational approaches using more than one bioactive dietary compound in chemoprevention or cancer therapy will also be evaluated. Many novel approaches to cancer prevention are on the horizon, several of which are showing great promise in saving lives in a cost-effective manner. PMID:22187555

  9. Oncologic Outcomes After Transoral Robotic Surgery

    PubMed Central

    Magnuson, J. Scott; Smith, Richard V.; Moore, Eric; Lawson, Georges; Remacle, Marc; Ganly, Ian; Kraus, Dennis H.; Teng, Marita S.; Miles, Brett A.; White, Hilliary; Duvvuri, Umamaheswar; Ferris, Robert L.; Mehta, Vikas; Kiyosaki, Krista; Damrose, Edward J.; Wang, Steven J.; Kupferman, Michael E.; Koh, Yoon Woo; Genden, Eric M.; Holsinger, F. Christopher

    2016-01-01

    IMPORTANCE Large patient cohorts are necessary to validate the efficacy of transoral robotic surgery (TORS) in the management of head and neck cancer. OBJECTIVES To review oncologic outcomes of TORS from a large multi-institutional collaboration and to identify predictors of disease recurrence and disease-specific mortality. DESIGN, SETTING, AND PARTICIPANTS A retrospective review of records from 410 patients undergoing TORS for laryngeal and pharyngeal cancers from January 1, 2007, through December 31, 2012, was performed. Pertinent data were obtained from 11 participating medical institutions. INTERVENTIONS Select patients received radiation therapy and/or chemotherapy before or after TORS. MAIN OUTCOMES AND MEASURES Locoregional control, disease-specific survival, and overall survival were calculated. We used Kaplan-Meier survival analysis with log-rank testing to evaluate individual variable association with these outcomes, followed by multivariate analysis with Cox proportional hazards regression modeling to identify independent predictors. RESULTS Of the 410 patients treated with TORS in this study, 364 (88.8%) had oropharyngeal cancer. Of these 364 patients, information about post-operative adjuvant therapy was known about 338: 106 (31.3) received radiation therapy alone, and 72 (21.3%) received radiation therapy with concurrent chemotherapy. Neck dissection was performed in 323 patients (78.8%). Mean follow-up time was 20 months. Local, regional, and distant recurrence occurred in 18 (4.4%), 15 (3.7%), and 10 (2.4%) of 410 patients, respectively. Seventeen (4.1%) died of disease, and 13 (3.2%) died of other causes. The 2-year locoregional control rate was 91.8% (95% CI, 87.6%-94.7%), disease-specific survival 94.5% (95% CI, 90.6%-96.8%), and overall survival 91% (95% CI, 86.5%-94.0%). Multivariate analysis identified improved survival among women (P = .05) and for patients with tumors arising in tonsil (P = .01). Smoking was associated with worse overall

  10. Virtual Oncological Networks--IT Support for an Evidence-based, Oncological Health Care Management.

    PubMed

    Heiden, Katja; Sinha, Monika; Böckmann, Britta

    2015-01-01

    An interdisciplinary and intersectoral coordinated therapy management along Clinical Practice Guidelines can ensure that all patients receive adequate diagnostic, treatment, and supportive services that lead most likely to optimal outcomes. Within the research project "Virtual Oncological Networks", guideline-compliant pathways are defined and enacted within a Health Care Management Platform to support treatment planning and ongoing care of oncological diseases. PMID:26262255

  11. Micronutrients in Oncological Intervention

    PubMed Central

    Gröber, Uwe; Holzhauer, Peter; Kisters, Klaus; Holick, Michael F.; Adamietz, Irenäus A.

    2016-01-01

    Nutritional supplements are widely used among patients with cancer who perceive them to be anticancer and antitoxicity agents. Depending on the type of malignancy and the gender 30%–90% of the cancer patients supplement their diets with antioxidant and immuno-stabilizing micronutrients, such as selenium, vitamin C, and vitamin D, often without the knowledge of the treating physician. From the oncological viewpoint, there are justifiable concerns that dietary supplements decrease the effectiveness of chemotherapy and radiotherapy. Recent studies, however, have provided increasing evidence that treatment is tolerated better—with an increase in patient compliance and a lower rate of treatment discontinuations—when micronutrients, such as selenium, are added as appropriate to the patient’s medication. Nutritional supplementation tailored to an individual’s background diet, genetics, tumor histology, and treatments may yield benefits in subsets of patients. Clinicians should have an open dialogue with patients about nutritional supplements. Supplement advice needs to be individualized and come from a credible source, and it is best communicated by the physician. PMID:26985904

  12. Micronutrients in Oncological Intervention.

    PubMed

    Gröber, Uwe; Holzhauer, Peter; Kisters, Klaus; Holick, Michael F; Adamietz, Irenäus A

    2016-03-01

    Nutritional supplements are widely used among patients with cancer who perceive them to be anticancer and antitoxicity agents. Depending on the type of malignancy and the gender 30%-90% of the cancer patients supplement their diets with antioxidant and immuno-stabilizing micronutrients, such as selenium, vitamin C, and vitamin D, often without the knowledge of the treating physician. From the oncological viewpoint, there are justifiable concerns that dietary supplements decrease the effectiveness of chemotherapy and radiotherapy. Recent studies, however, have provided increasing evidence that treatment is tolerated better-with an increase in patient compliance and a lower rate of treatment discontinuations-when micronutrients, such as selenium, are added as appropriate to the patient's medication. Nutritional supplementation tailored to an individual's background diet, genetics, tumor histology, and treatments may yield benefits in subsets of patients. Clinicians should have an open dialogue with patients about nutritional supplements. Supplement advice needs to be individualized and come from a credible source, and it is best communicated by the physician. PMID:26985904

  13. Effectiveness of chemotherapy in rhabdomyosarcoma: example of orbital primary.

    PubMed

    Orbach, Daniel; Brisse, Hervé; Helfre, Sylvie; Freneaux, Paul; Husseini, Khaled; Aerts, Isabelle; Desjardins, Laurence; Fattet, Sarah

    2003-12-01

    The survival of patients with rhabdomyosarcoma has been progressively improved with successive protocols due to the development of multidisciplinary management and the data accumulated by international groups. Orbital rhabdomyosarcoma represents 10% of all cases and affects young children (median age: 6.8 years). It is a chemosensitive and radiosensitive tumour. Chemotherapy is designed to decrease the indications for local therapy (mainly radiotherapy) responsible for a high rate of sequelae (cosmetic, functional or secondary cancer). According to the International Society of Paediatric Oncology guidelines, local therapy is not indicated as first-line treatment in case of complete remission after chemotherapy. The 10-year survival of children with non-parameningeal orbital rhabdomyosarcoma is currently 87% and identical survivals are reported by the various collaborative groups despite the use of different treatments. Despite clinical trials demonstrating the efficacy of many types of chemotherapy (cisplatin, etoposide, doxorubicin, dacarbazine), the value of adding these drugs to combination chemotherapy comprising of an alkylating agent (cyclophosphamide or ifosfamide), vincristine and dactinomycin has not been formally demonstrated in terms of survival benefit for children with rhabdomyosarcoma. The authors review these various results and compare the current guidelines for the management of orbital rhabdomyosarcoma recommended by North American and European groups. PMID:14640915

  14. Effects of a self-management program on antiemetic-induced constipation during chemotherapy among breast cancer patients: a randomized controlled clinical trial.

    PubMed

    Hanai, Akiko; Ishiguro, Hiroshi; Sozu, Takashi; Tsuda, Moe; Arai, Hidenori; Mitani, Akira; Tsuboyama, Tadao

    2016-01-01

    Research on patient-reported outcomes indicates that constipation is a common adverse effect of chemotherapy, and the use of 5-hydroxytryptamine (serotonin; 5HT3) receptor antagonists aggravates this condition. As cancer patients take multiple drugs as a part of their clinical management, a non-pharmacological self-management (SM) of constipation would be recommended. We aimed to evaluate the effectiveness of a SM program on antiemetic-induced constipation in cancer patients. Thirty patients with breast cancer, receiving 5HT3 receptor antagonists to prevent emesis during chemotherapy were randomly assigned to the intervention or control group. The SM program consisted of abdominal massage, abdominal muscle stretching, and education on proper defecation position. The intervention group started the program before the first chemotherapy cycle, whereas patients in the wait-list control group received the program on the day before their second chemotherapy cycle. The primary outcome was constipation severity, assessed by the constipation assessment scale (CAS, sum of eight components). The secondary outcome included each CAS component (0-2 points) and mood states. A self-reported assessment of satisfaction with the program was performed. The program produced a statistically and clinically significant alleviation of constipation severity (mean difference in CAS, -3.00; P = 0.02), decrease in the likelihood of a small volume of stool (P = 0.03), and decrease in depression and dejection (P = 0.02). With regards to program satisfaction, 43.6 and 26.4 % patients rated the program as excellent and good, respectively. Our SM program is effective for mitigating the symptoms of antiemetic-induced constipation during chemotherapy. PMID:26650825

  15. The effect of casein phosphopeptide amorphous calcium phosphate fluoride paste (CPP-ACPF) on oral and salivary conditions of patients undergoing chemotherapy: A randomized controlled clinical trial

    PubMed Central

    Banava, Sepideh; Houshyari, Mohammad; Safaie, Tahmineh

    2015-01-01

    Background Oral and saliva conditions of patients undergoing chemotherapy is often affected by the medication they receive. Up to now, no appropriate medication that possesses the positive effects of chemotherapy without presenting oral complications has been introduced. Objective The aim of this study was to assess the clinical effects of CPP-ACPF paste on the oral and salivary status of patients undergoing chemotherapy. Methods From October 2013 to April 2014, 20 patients in chemotherapy treatment plans and who met the inclusion criteria enrolled in this randomized parallel single-blind controlled clinical trial in Shohada-e-Tajrish Hospital in Tehran, Iran. Patients were divided into two groups: 1) patients received their daily medication of cancer therapy center (group 1, control); 2) patients applied CPP-ACPF Crème (MI paste plus, GC USA) twice a day as instructed (group 2). The baseline status of oral conditions of patients (mucositis, dry mouth, infection, diminished tasting sense, difficulty in food intake, burning sensation of mucosa, saliva and dental plaque pH, rest and stimulated saliva, buffering capacity of saliva) were recorded and reevaluated after 21 and 42 days. The data were analyzed with a Mann-Whitney U-test. Results A total of 20 patients were allocated randomly to groups 1 and 2. The Mann-Whitney U-test showed that application of CPP-ACPF paste twice daily did not cause any significant difference in oral complication of the subject group compared with the control group (p>0.05). Among salivary signs, resting and stimulated saliva rates and saliva buffering capacity had significantly altered in the CPP-ACPF group in day 21 and 42 in comparison with those of the control group (p<0.05). Conclusion Application of CPP-ACPF paste before and during chemotherapy can improve the salivary status of patients undergoing this treatment. PMID:26767110

  16. Comparison of In-Patient Costs for Children Treated on the AAML0531 Clinical Trial: A Report From the Children’s Oncology Group

    PubMed Central

    Getz, Kelly D.; Li, Yimei; Alonzo, Todd A.; Hall, Matthew; Gerbing, Robert B.; Sung, Lillian; Huang, Yuan-Shung; Arnold, Staci; Seif, Alix E.; Miller, Tamara P.; Bagatell, Rochelle; Fisher, Brian T.; Adamson, Peter C.; Gamis, Alan; Keren, Ron; Aplenc, Richard

    2015-01-01

    Background A better understanding of drivers of treatment costs may help identify effective cost containment strategies and prioritize resources. We aimed to develop a method for estimating inpatient costs for pediatric patients with acute myeloid leukemia (AML) enrolled on NCI-funded Phase III trials, compare costs between AAML0531 treatment arms (standard chemotherapy ± gemtuzumab ozogamicin (GMTZ)), and evaluate primary drivers of costs for newly diagnosed pediatric AML. Procedure Patients from the AAML0531 trial were matched on hospital, sex, and dates of birth and diagnosis to the Pediatric Health Information Systems (PHIS) database to obtain daily billing data. Inpatient treatment costs were calculated as adjusted charges multiplied by hospital-specific cost-to-charge ratios. Generalized linear models were used to compare costs between treatment arms and courses, and by patient characteristics. Results Inpatient costs did not differ by randomized treatment arm. Costs varied by course with stem cell transplant being most expensive, followed by Intensification II (cytarabine/mitoxantrone) and Induction I (cytarabine/daunorubicin/etoposide). Room/board and pharmacy were the largest contributors to inpatient treatment cost, representing 74% of the total cost. Higher AML risk group (P = 0.0003) and older age (P < 0.0001) were associated with significantly higher daily inpatient cost. Conclusions Costs from external data sources can be successfully integrated into NCI-funded Phase III clinical trials. Inpatient treatment costs did not differ by GMTZ exposure but varied by chemotherapy course. Variation in cost by course was driven by differences in duration of hospitalization through room/board charges as well as increased clinical and pharmacy charges in specific courses. Pediatr Blood Cancer PMID:25946708

  17. [Biosimilar drugs in oncology].

    PubMed

    Levêque, Dominique

    2016-03-01

    Biosimilar drugs are biologic drugs clinically similar to the reference products. They correspond to a generic approach applied to biologic agents. Biosimilars are aimed to provide cheaper drugs by enhancing the concurrency. The approval of biosimilars is abbreviated when compared to that of the reference biologics but includes clinical trials (distinguishing them from the generics). Current available biosimilars in oncology are filgrastim and epoietin alpha. In the next future, will be launched rituximab and trastuzumab. In France, the development of biosimilars is faced with many hurdles that necessitates a better information of physicians and a greater price discount in the out-patient setting. More globally, harmonisation of recommendations particularly concerning extrapolation of indications and nomenclature are needed for a better acceptance. PMID:26832422

  18. [Clinical Investigation of the Effects of Filgrastim BS1 on Neutropenia Following Oral Cancer Chemotherapy (TPF Therapy)].

    PubMed

    Uchiyama, Kimio; Yamada, Manabu; Tamate, Shusuke; Iwasaki, Konomi; Mitomo, Keisuke; Nakayama, Seiichi

    2015-09-01

    The time for the neutrophil count to recover after subcutaneous injection of filgrastim BS1 or lenograstim was studied in patients suffering from neutropenia following preoperative combined chemotherapy using docetaxel, nedaplatin, or cisplatin (in divided doses for 5 days)and 5-fluorouracil for oral cancer. 1. There was no significant difference in the minimum leukocyte and neutrophil counts after chemotherapy. 2. There was no significant difference in the maximum leukocyte and neutrophil counts after chemotherapy. 3. Time for leukocytes to recover from their minimum count(>4,000/mm3)or for neutrophils to recover from their minimum count(>2,000/mm3)and the number of days on which treatment was administered tended to be shorter in the filgrastim BS1 group. Thus, it was concluded that filgrastim BS1 is just as effective as other prior G-CSF agents in treating patients suffering from neutropenia following chemotherapy(TPF therapy). PMID:26469162

  19. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS).

    PubMed

    Cherny, N I; Sullivan, R; Dafni, U; Kerst, J M; Sobrero, A; Zielinski, C; de Vries, E G E; Piccart, M J

    2015-08-01

    The value of any new therapeutic strategy or treatment is determined by the magnitude of its clinical benefit balanced against its cost. Evidence for clinical benefit from new treatment options is derived from clinical research, in particular phase III randomised trials, which generate unbiased data regarding the efficacy, benefit and safety of new therapeutic approaches. To date, there is no standard tool for grading the magnitude of clinical benefit of cancer therapies, which may range from trivial (median progression-free survival advantage of only a few weeks) to substantial (improved long-term survival). Indeed, in the absence of a standardised approach for grading the magnitude of clinical benefit, conclusions and recommendations derived from studies are often hotly disputed and very modest incremental advances have often been presented, discussed and promoted as major advances or 'breakthroughs'. Recognising the importance of presenting clear and unbiased statements regarding the magnitude of the clinical benefit from new therapeutic approaches derived from high-quality clinical trials, the European Society for Medical Oncology (ESMO) has developed a validated and reproducible tool to assess the magnitude of clinical benefit for cancer medicines, the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS). This tool uses a rational, structured and consistent approach to derive a relative ranking of the magnitude of clinically meaningful benefit that can be expected from a new anti-cancer treatment. The ESMO-MCBS is an important first step to the critical public policy issue of value in cancer care, helping to frame the appropriate use of limited public and personal resources to deliver cost-effective and affordable cancer care. The ESMO-MCBS will be a dynamic tool and its criteria will be revised on a regular basis. PMID:26026162

  20. Prevalence and Clinical Impact of Anaplasia in Childhood Rhabdomyosarcoma: A Report from the Soft Tissue Sarcoma Committee for the Children’s Oncology Group

    PubMed Central

    Qualman, Stephen; Lynch, James; Bridge, Julia; Parham, David; Teot, Lisa; Meyer, William; Pappo, Alberto

    2009-01-01

    Background Anapalsia is rare in childhood rhabdomyosarcoma and has not been included in the International Classification of Rhabdomyosarcoma (ICR). A recent review of cases from the Soft Tissue Sarcoma Committee of the Children’s Oncology Group (COG) suggests that anaplasia might be more common than previously reported and may impact clinical outcome. Materials and Methods The prevalence of anaplasia (focal or diffuse) was prospectively assessed in 546 eligible cases who were registered in an Intergroup Rhabdomyosarcoma Study Group (IRSG) or COG therapeutic trial from 1995–1998. The incidence of anaplasia in tumor samples and its impact in predicting clinical outcome was assessed. Results Overall 71 (13%) of all samples analyzed had anaplasia. Anaplasia was more common in patients with tumors in favorable sites and was less commonly seen in younger patients and in those with stage 2, 3 or clinical Group III disease. Regardless of its distribution (focal or diffuse), on univariate analysis the presence of anaplasia had a significant negative impact for both failure-free survival (FFS: 63% vs 77% at 5 years) and survival (S: 68% vs 82% at 5 years) in patients with embryonal rhabdomyosarcoma. This effect was most pronounced in children with intermediate risk disease. Using multivariate analysis, the hazard ratio was 1.6 for FFS (p=0.085) and 1.7 for overall survival (p=0.081). Anaplasia did not affect outcome in patients with alveolar tumors. Conclusion The incidence of anaplasia in rhabdomyosarcoma is higher than previously described and may be of prognostic significance in children with intermediate risk embryonal rhabdomyosarcoma. PMID:18985676

  1. Additional Therapy with a Mistletoe Product during Adjuvant Chemotherapy of Breast Cancer Patients Improves Quality of Life: An Open Randomized Clinical Pilot Trial.

    PubMed

    Tröger, Wilfried; Zdrale, Zdravko; Tišma, Nevena; Matijašević, Miodrag

    2014-01-01

    Background. Breast cancer patients receiving adjuvant chemotherapy often experience a loss of quality of life. Moreover chemotherapy may induce neutropenia. Patients report a better quality of life when additionally treated with mistletoe products during chemotherapy. Methods. In this prospective randomized open-label pilot study 95 patients were randomized into three groups. All patients were treated with an adjuvant chemotherapy. The primary objective of the study was quality of life, the secondary objective was neutropenia. Here we report the comparison of HxA (n = 34) versus untreated control (n = 31). Results. In the explorative analysis ten of 15 scores of the EORTC QLQ-C30 showed a better quality of life in the HxA group compared to the control group (P < 0.001 to P = 0.038 in Dunnett-T3 test). The difference was clinically relevant (difference of at least 5 points, range 5.4-12.2) in eight of the ten scores. Neutropenia occurred in 7/34 HxA patients and in 8/31 control patients (P = 0.628). Conclusions. This pilot study showed an improvement of quality of life by treating breast cancer patients with HxA additionally to CAF. Although the open design may be a limitation, the findings show the feasibility of a confirmatory study using the methods described here. PMID:24701238

  2. Increased Expression of TGFβR2 Is Associated with the Clinical Outcome of Non-Small Cell Lung Cancer Patients Treated with Chemotherapy

    PubMed Central

    Yu, Fei; Cai, Haidong; Fang, Suyun; Cai, Li; Yang, Huiqiong; Sun, Yu; Li, Dan; Liu, Jin; Xie, Ruting; Yuan, Xueyu; Zhong, Xiaoming; Li, Ming; Wei, Qing; Lv, Zhongwei; Fu, Da; Ma, Yushui

    2015-01-01

    To investigate the prognostic significance of TGFβR2 expression and chemotherapy in Chinese non-small cell lung cancer (NSCLC) patients, TGFβR2 expression NSCLC was analyzed in silico using the Oncomine database, and subsequently analyzed with quantitative RT-PCR in 308 NSCLC biopsies, 42 of which were paired with adjacent non-neoplastic tissues. Our results show that TGFβR2 expression was also increased in NSCLC biopsies relative to normal tissue samples and correlated with poor prognosis. TGFβR2 expression was also significantly correlated with other clinical parameters such as tumor differentiation, invasion of lung membrane, and chemotherapy. Moreover, overall survival (OS) and disease free survival (DFS) was increased in patients with low TGFβR2 expressing NSCLC and who had undergone chemotherapy. Thus, high expression of TGFβR2 is a significant risk factor for decreased OS and DFS in NSCLC patients. Thus, TGFβR2 is a potential prognostic tumor biomarker for chemotherapy. PMID:26252213

  3. Prognostic Role of BRAF Mutation in Stage II/III Colorectal Cancer Receiving Curative Resection and Adjuvant Chemotherapy: A Meta-Analysis Based on Randomized Clinical Trials

    PubMed Central

    Cao, Ying; Fang, Xuefeng; Zhong, Chenhan; Li, Dan; Yuan, Ying

    2016-01-01

    Background and Objective Studies examining the prognostic value of the BRAF mutation on relapse-free survival (RFS), disease-free survival (DFS) and overall survival (OS) in stage II/III colorectal cancer (CRC) patients receiving curative resection and adjuvant chemotherapy so far showed discrepant results. Therefore, a meta-analysis of relevant studies was performed for clarification. Methods Randomized trials of stage II/III colorectal cancer treated with curative resection followed by adjuvant chemotherapy were selected to conduct a meta-analysis. The necessary descriptive and statistical information such as hazard ratios (HRs) and 95% confidence intervals (CIs) were derived from published survival data. Results Seven phase III randomized clinical trials (RCTs) including 1,035 BRAF mutation stage II/III CRC patients receiving curative resection and adjuvant chemotherapy were analyzed. Overall, BRAF mutation resulted in poorer OS (HR = 1.42, 95% CI: 1.25–1.60; P < 0.00001), and poorer DFS (HR = 1.26, 95% CI: 1.07–1.48, P = 0.006) compared with BRAF wild-type CRC. The prognostic role on RFS could not be elucidated in the meta-analysis because of limited data. Conclusions BRAF mutation was significantly related with shorter DFS and OS among stage II/III CRC patients receiving adjuvant chemotherapy after curative resection. Its prognostic role for RFS needs to be further analyzed when more data is available. PMID:27138801

  4. Additional Therapy with a Mistletoe Product during Adjuvant Chemotherapy of Breast Cancer Patients Improves Quality of Life: An Open Randomized Clinical Pilot Trial

    PubMed Central

    Tröger, Wilfried; Ždrale, Zdravko; Tišma, Nevena; Matijašević, Miodrag

    2014-01-01

    Background. Breast cancer patients receiving adjuvant chemotherapy often experience a loss of quality of life. Moreover chemotherapy may induce neutropenia. Patients report a better quality of life when additionally treated with mistletoe products during chemotherapy. Methods. In this prospective randomized open-label pilot study 95 patients were randomized into three groups. All patients were treated with an adjuvant chemotherapy. The primary objective of the study was quality of life, the secondary objective was neutropenia. Here we report the comparison of HxA (n = 34) versus untreated control (n = 31). Results. In the explorative analysis ten of 15 scores of the EORTC QLQ-C30 showed a better quality of life in the HxA group compared to the control group (P < 0.001 to P = 0.038 in Dunnett-T3 test). The difference was clinically relevant (difference of at least 5 points, range 5.4–12.2) in eight of the ten scores. Neutropenia occurred in 7/34 HxA patients and in 8/31 control patients (P = 0.628). Conclusions. This pilot study showed an improvement of quality of life by treating breast cancer patients with HxA additionally to CAF. Although the open design may be a limitation, the findings show the feasibility of a confirmatory study using the methods described here. PMID:24701238

  5. Outcomes of Positron Emission Tomography-Staged Clinical N3 Breast Cancer Treated With Neoadjuvant Chemotherapy, Surgery, and Radiotherapy

    SciTech Connect

    Park, Hae Jin; Shin, Kyung Hwan; Cho, Kwan Ho; Park, In Hae; Lee, Keun Seok; Ro, Jungsil; Jung, So-Youn; Lee, Seeyoun; Kim, Seok Won; Kang, Han-Sung; Chie, Eui Kyu; Ha, Sung Whan

    2011-12-01

    Purpose: To evaluate the treatment outcome and efficacy of regional lymph node irradiation after neoadjuvant chemotherapy (NCT) and surgery in positron emission tomography (PET)-positive clinical N3 (cN3) breast cancer patients. Methods and Materials: A total of 55 patients with ipsilateral infraclavicular (ICL), internal mammary (IMN), or supraclavicular (SCL) lymph node involvement in the absence of distant metastases, as revealed by an initial PET scan, were retrospectively analyzed. The clinical nodal stage at diagnosis (2002 AJCC) was cN3a in 14 patients (26%), cN3b in 12 patients (22%), and cN3c in 29 patients (53%). All patients were treated with NCT, followed by mastectomy or breast-conserving surgery and subsequent radiotherapy (RT) with curative intent. Results: At the median follow-up of 38 months (range, 9-80 months), 20 patients (36%) had developed treatment failures, including distant metastases either alone or combined with locoregional recurrences that included one ipsilateral breast recurrence (IBR), six regional failures (RF), and one case of combined IBR and RF. Only 3 patients (5.5%) exhibited treatment failure at the initial PET-positive clinical N3 lymph node. The 5-year locoregional relapse-free survival, disease-free survival (DFS), and overall survival rates were 80%, 60%, and 79%, respectively. RT delivered to PET-positive IMN regions in cN3b patients and at higher doses ({>=}55 Gy) to SCL regions in cN3c patients was not associated with improved 5-year IMN/SCL relapse-free survival or DFS. Conclusion: NCT followed by surgery and RT, including the regional lymph nodes, resulted in excellent locoregional control for patients with PET-positive cN3 breast cancer. The primary treatment failure in this group was due to distant metastasis rather than RF. Neither higher-dose RT directed at PET-positive SCL nodes nor coverage of PET-positive IMN nodes was associated with additional gains in locoregional control or DFS.

  6. [Clinical availability of the herbal medicine, SYOUSAIKOTOU, as a gargling agent for prevention and treatment of chemotherapy-induced stomatitis].

    PubMed

    Matsuoka, Hitoshi; Mizushima, Yuki; Kawano, Masako; Tachibana, Naoko; Sawada, Yoshiko; Kato, Sachiko; Nagakura, Hiromi; Tanaka, Miyuki; Suzuki, Keiko; Tadanobu, Kuribayashi

    2004-11-01

    The stomatitis accompanying chemotherapy reduces a patient's QOL. Many reports have suggested that some kinds of gargling agents for oral mucositis shorten the duration and severity of symptoms. This study tested the prevention and efficacy against stomatitis of a herbal medicine (Syousaikotou) as a gargling agent for patients receiving chemotherapy. Compared to gargling with providone-iodine and amphotericin B, the Syousaikotou gargle showed a significantly decreased incidence of stomatitis, and a painkilling effect. Stomatitis occurred in about 17.4% among 23 chemotherapy cycles with the Syousaikotou gargle, against about 40.8% among 71 chemotherapy cycles without the Syousaikotou gargle. Among the patients suffering stomatitis pain after 22 chemotherapy cycles, the painkilling effect was seen to be 76.2%, and continues for about 2 hours. Critical side effects were not seen, but in 4 cases there were complaints about foul smells, such as oil and grass smells. Syousaikotou gargle was considered to be one of the useful methods against the stomatitis prevention and sharp pain mitigation from the chemotherapy. PMID:15570931

  7. [History of Oncology in Slovakia].

    PubMed

    Ondruš, D; Kaušitz, J

    2016-01-01

    The history of oncology in Slovakia is closely linked to the history of St. Elizabeth Hospital, which was set up in the mid-18th century by nuns of the St. Elizabeth Order in Bratislava. In the first half of the 20th century, a unit was set up in the hospital dedicated to diagnosis and treatment of cancer. Shortly after World War II, the unit was turned into the Institute for Cancer Research and Treatment. In 1950, St. Elizabeth Hospital was nationalized, and the Cancer Research Institute of the Slovak Academy of Science and the Institute of Clinical Oncology were located there as centers for oncological diagnosis and treatment. After the restitution of church property in the early 1990s, the hospital was returned to the Order of St. Elizabeth, which set up the St. Elisabeth Cancer Institute in the hospital premises in January of 1996. This year marks the 20th anniversary of this institute in its new premises and the 85th anniversary of the Institute of Radiumtherapy founded in Bratislava, and thus the establishment of institutional healthcare for cancer patients in Slovakia is the reason for balancing. We present a view of the consecutive changes in the organization, space and staff of the Institute and evaluate the impact of celebrities on medicine who developed oncology as a clinical, scientific and educational discipline in Bratislava and in other cities and regions of Slovakia. PMID:27296401

  8. Dose-dense sequential adjuvant chemotherapy followed, as indicated, by trastuzumab for one year in patients with early breast cancer: first report at 5-year median follow-up of a Hellenic Cooperative Oncology Group randomized phase III trial

    PubMed Central

    2014-01-01

    Background Dose-dense sequential chemotherapy including anthracyclines and taxanes has been established in the adjuvant setting of high-risk operable breast cancer. However, the preferable taxane and optimal schedule of administration in a dose-dense regimen have not been defined yet. Methods From July 2005 to November 2008, 1001 patients (990 eligible) were randomized to receive, every 2 weeks, 3 cycles of epirubicin 110 mg/m2 followed by 3 cycles of paclitaxel 200 mg/m2 followed by 3 cycles of intensified CMF (Arm A; 333 patients), or 3 cycles of epirubicin followed by 3 cycles of CMF, as in Arm A, followed 3 weeks later by 9 weekly cycles of docetaxel 35 mg/m2 (Arm B; 331), or 9 weekly cycles of paclitaxel 80 mg/m2 (Arm C; 326). Trastuzumab was administered for one year to HER2-positive patients post-radiation. Results At a median follow-up of 60.5 months, the 3-year disease-free survival (DFS) rate was 86%, 90% and 88%, for Arms A, B and C, respectively, while the 3-year overall survival (OS) rate was 96% in all arms. No differences were found in DFS or OS between the combined B and C Arms versus Arm A (DFS: HR = 0.81, 95% CI: 0.59-1.11, P = 0.20; OS: HR = 0.84, 95% CI: 0.55-1.30, P = 0.43). Among the 255 patients who received trastuzumab, 189 patients (74%) completed 1 year of treatment uneventfully. In all arms, the most frequently reported severe adverse events were neutropenia (30% vs. 27% vs. 26%) and leucopenia (12% vs. 13% vs. 12%), while febrile neutropenia occurred in fifty-one patients (6% vs. 4% vs. 5%). Patients in Arm A experienced more often severe pain (P = 0.002), neurological complications (P = 0.004) and allergic reactions (P = 0.004), while patients in Arm B suffered more often from severe skin reactions (P = 0.020). Conclusions No significant differences in survival between the regimens were found in the present phase III trial. Taxane scheduling influenced the type of severe toxicities. HER2

  9. Electronic nicotine delivery systems: a policy statement from the American Association for Cancer Research and the American Society of Clinical Oncology.

    PubMed

    Brandon, Thomas H; Goniewicz, Maciej L; Hanna, Nasser H; Hatsukami, Dorothy K; Herbst, Roy S; Hobin, Jennifer A; Ostroff, Jamie S; Shields, Peter G; Toll, Benjamin A; Tyne, Courtney A; Viswanath, Kasisomayajula; Warren, Graham W

    2015-02-01

    Combustible tobacco use remains the number one preventable cause of disease, disability, and death in the United States. Electronic nicotine delivery systems (ENDS), which include e-cigarettes, are devices capable of delivering nicotine in an aerosolized form. ENDS use by both adults and youth has increased rapidly, and some have advocated these products could serve as harm-reduction devices and smoking cessation aids. ENDS may be beneficial if they reduce smoking rates or prevent or reduce the known adverse health effects of smoking. However, ENDS may also be harmful, particularly to youth, if they increase the likelihood that nonsmokers or formers smokers will use combustible tobacco products or if they discourage smokers from quitting. The American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO) recognize the potential ENDS have to alter patterns of tobacco use and affect the public's health; however, definitive data are lacking. AACR and ASCO recommend additional research on these devices, including assessing the health impacts of ENDS, understanding patterns of ENDS use, and determining what role ENDS have in cessation. Key policy recommendations include supporting federal, state, and local regulation of ENDS; requiring manufacturers to register with the FDA and report all product ingredients, requiring childproof caps on ENDS liquids, and including warning labels on products and their advertisements; prohibiting youth-oriented marketing and sales; prohibiting child-friendly ENDS flavors; and prohibiting ENDS use in places where cigarette smoking is prohibited. PMID:25573384

  10. Radiation Therapy Oncology Group Consensus Panel Guidelines for the Delineation of the Clinical Target Volume in the Postoperative Treatment of Pancreatic Head Cancer

    SciTech Connect

    Goodman, Karyn A.; Regine, William F.; Dawson, Laura A.; Ben-Josef, Edgar; Haustermans, Karin; Bosch, Walter R.; Turian, Julius; Abrams, Ross A.

    2012-07-01

    Purpose: To develop contouring guidelines to be used in the Radiation Therapy Oncology Group protocol 0848, a Phase III randomized trial evaluating the benefit of adjuvant chemoradiation in patients with resected head of pancreas cancer. Methods and Materials: A consensus committee of six radiation oncologists with expertise in gastrointestinal radiotherapy developed stepwise contouring guidelines and an atlas for the delineation of the clinical target volume (CTV) in the postoperative treatment of pancreas cancer, based on identifiable regions of interest and margin expansions. Areas at risk for subclinical disease to be included in the CTV were defined, including nodal regions, anastomoses, and the preoperative primary tumor location. Regions of interest that could be reproducibly contoured on postoperative imaging after a pancreaticoduodenectomy were identified. Standardized expansion margins to encompass areas at risk were developed after multiple iterations to determine the optimal margin expansions. Results: New contouring recommendations based on CT anatomy were established. Written guidelines for the delineation of the postoperative CTV and normal tissues, as well as a Web-based atlas, were developed. Conclusions: The postoperative abdomen has been a difficult area for effective radiotherapy. These new guidelines will help physicians create fields that better encompass areas at risk and minimize dose to normal tissues.

  11. Portable, parallel 9-wavelength near-infrared spectral tomography (NIRST) system for efficient characterization of breast cancer within the clinical oncology infusion suite.

    PubMed

    Zhao, Yan; Pogue, Brian W; Haider, Steffen J; Gui, Jiang; diFlorio-Alexander, Roberta M; Paulsen, Keith D; Jiang, Shudong

    2016-06-01

    A portable near-infrared spectral tomography (NIRST) system was developed with simultaneous frequency domain (FD) and continuous-wave (CW) optical measurements for efficient characterization of breast cancer in a clinical oncology setting. Simultaneous FD and CW recordings were implemented to speed up acquisition to 3 minutes for all 9 wavelengths, spanning a range from 661nm to 1064nm. An adjustable interface was designed to fit various breast sizes and shapes. Spatial images of oxy- and deoxy-hemoglobin, water, lipid, and scattering components were reconstructed using a 2D FEM approach. The system was tested on a group of 10 normal subjects, who were examined bilaterally and the recovered optical images were compared to radiographic breast density. Significantly higher total hemoglobin and water were estimated in the high density relative to low density groups. One patient with invasive ductal carcinoma was also examined and the cancer region was characterized as having a contrast ratio of 1.4 in total hemoglobin and 1.2 in water. PMID:27375937

  12. Portable, parallel 9-wavelength near-infrared spectral tomography (NIRST) system for efficient characterization of breast cancer within the clinical oncology infusion suite

    PubMed Central

    Zhao, Yan; Pogue, Brian W.; Haider, Steffen J.; Gui, Jiang; diFlorio-Alexander, Roberta M.; Paulsen, Keith D.; Jiang, Shudong

    2016-01-01

    A portable near-infrared spectral tomography (NIRST) system was developed with simultaneous frequency domain (FD) and continuous-wave (CW) optical measurements for efficient characterization of breast cancer in a clinical oncology setting. Simultaneous FD and CW recordings were implemented to speed up acquisition to 3 minutes for all 9 wavelengths, spanning a range from 661nm to 1064nm. An adjustable interface was designed to fit various breast sizes and shapes. Spatial images of oxy- and deoxy-hemoglobin, water, lipid, and scattering components were reconstructed using a 2D FEM approach. The system was tested on a group of 10 normal subjects, who were examined bilaterally and the recovered optical images were compared to radiographic breast density. Significantly higher total hemoglobin and water were estimated in the high density relative to low density groups. One patient with invasive ductal carcinoma was also examined and the cancer region was characterized as having a contrast ratio of 1.4 in total hemoglobin and 1.2 in water. PMID:27375937

  13. Discovery and Delivery of Synergistic Chemotherapy Drug Combinations to Tumors

    NASA Astrophysics Data System (ADS)

    Camacho, Kathryn Militar

    Chemotherapy combinations for cancer treatments harbor immense therapeutic potentials which have largely been untapped. Of all diseases, clinical studies of drug combinations are the most prevalent in oncology, yet their effectiveness is disputable, as complete tumor regressions are rare. Our research has been devoted towards developing delivery vehicles for combinations of chemotherapy drugs which elicit significant tumor reduction yet limit toxicity in healthy tissue. Current administration methods assume that chemotherapy combinations at maximum tolerable doses will provide the greatest therapeutic effect -- a presumption which often leads to unprecedented side effects. Contrary to traditional administration, we have found that drug ratios rather than total cumulative doses govern combination therapeutic efficacy. In this thesis, we have developed nanoparticles to incorporate synergistic ratios of chemotherapy combinations which significantly inhibit cancer cell growth at lower doses than would be required for their single drug counterparts. The advantages of multi-drug incorporation in nano-vehicles are many: improved accumulation in tumor tissue via the enhanced permeation and retention effect, limited uptake in healthy tissue, and controlled exposure of tumor tissue to optimal synergistic drug ratios. To exploit these advantages for polychemotherapy delivery, two prominent nanoparticles were investigated: liposomes and polymer-drug conjugates. Liposomes represent the oldest class of nanoparticles, with high drug loading capacities and excellent biocompatibility. Polymer-drug conjugates offer controlled drug incorporations through reaction stoichiometry, and potentially allow for delivery of precise ratios. Here, we show that both vehicles, when armed with synergistic ratios of chemotherapy drugs, significantly inhibit tumor growth in an aggressive mouse breast carcinoma model. Furthermore, versatile drug incorporation methods investigated here can be broadly

  14. Trends in Twitter Use by Physicians at the American Society of Clinical Oncology Annual Meeting, 2010 and 2011

    PubMed Central

    Chaudhry, Aafia; Glodé, L. Michael; Gillman, Matt; Miller, Robert S.

    2012-01-01

    Purpose: Social media channels such as Twitter are gaining increasing acceptance as mechanisms for instantaneous scientific dialogue. Professional medical societies such as ASCO are using social media to expand the reach of scientific communications at and around their scientific meetings. This article examines the how Twitter use by oncologists expanded at the ASCO Annual Meetings from 2010 to 2011. Methods: In both years, tweets that were specifically generated by physicians and that incorporated the official meeting hashtag were harvested from the public domain, and a discourse analysis was performed by three independent raters. Follow-up surveys were conducted to assess physician attitudes toward Twitter and its potential role in clinical practice. Results: A combined total of 12,644 tweets were analyzed for 2010 and 2011. Although the number of physicians authoring tweets was small (14 in 2010, 34 in 2011), this group generated nearly 29% of the total meeting dialogue examined in this analysis in 2010 and 23% in 2011. Physicians used Twitter for reporting clinical news from scientific sessions, for discussions of treatment issues, for promotion, and to provide social commentary. The tangible impact of Twitter discussions on clinical practice remains unclear. Conclusion: Despite the 140-character limit, Twitter was successfully used by physicians at the 2010 and 2011 ASCO Annual Meetings to engage in clinical discussions, whether or not an author was on site as a live attendee. Twitter usage grew significantly from 2010 to 2011. Professional societies should monitor these phenomena to enhance annual meeting attendee user experience. PMID:22942812

  15. A Comparison of Patient Controlled Epidural Analgesia With Intravenous Patient Controlled Analgesia for Postoperative Pain Management After Major Gynecologic Oncologic Surgeries: A Randomized Controlled Clinical Trial

    PubMed Central

    Moslemi, Farnaz; Rasooli, Sousan; Baybordi, Ali; Golzari, Samad E.J.

    2015-01-01

    Background: Postoperative pain after major open gynecologic surgeries requires appropriate pain management. Objectives: This study aimed at comparing perioperative patient controlled epidural analgesia (PCEA) and patient controlled intravenous analgesia (PCA) after gynecologic oncology surgeries. Patients and Methods: In this clinical trial study, 90 patients with American society of anesthesiologists (ASA) class I or II scheduled for gynecologic oncologic surgeries were randomly allocated to two groups (45 patients each group) to receive: patient-controlled epidural analgesia with bupivacaine and fentanyl (PCEA group), or patient controlled intravenous analgesia (IV PCA group) with fentanyl, pethidine and ondansetron. Postoperative pain was assessed over 48 hours using the visual analog scale (VAS). The frequency of rescue analgesia was recorded. Occurrence of any concomitant events such as nausea, vomiting, ileus, purities, sedation and respiratory complications were recorded postoperatively. Results: There were no statistically significant differences in demographic data including; age, weight, ASA physical status, duration of surgery, intraoperative bleeding, and the amount of blood transfusion (P > 0.05), between the two studied groups. Severity of postoperative pain was not significantly different between the two groups (P > 0.05); however, after first patient mobilization, pain was significantly lower in the epidural group than the IV group (P < 0.001). There was no significant difference between the two groups regarding the incidence of complications such as nausea, vomiting, purities or ileus (P > 0.05). Nevertheless, the incidence and severity of sedation was significantly higher in the IV group (P < 0.001). Respiratory depression was higher in the IV group than the epidural group; this difference, however, was not significant (P = 0.11). In the epidural group, only 10 patients (22.2%) had mild and transient lower extremities parenthesis. Conclusions

  16. Clinical evaluation with 18 months follow-up of new PTTM enhanced dental implants in maxillo-facial post-oncological patients

    PubMed Central

    Papi, Piero; Jamshir, Sara; Brauner, Edoardo; Di Carlo, Stefano; Ceci, Antonio; Piccoli, Luca; Pompa, Giorgio

    2014-01-01

    Summary Aim The aim of this study is to present 18 months follow-up results of porous tantalum trabecular metal-enhanced titanium dental implant (PTTM) in implant supported prosthesis in post-oncological patients. Materials and methods A total of 25 PTTM implants were placed in each jaw of 6 patients that met specific inclusion and exclusion criteria. Resonance Frequency Analysis (RFA) was conducted and Implant stability was recorded in ISQ values (Osstell ISQ, Osstell AB, Goteborg, Sweden) at implant placement and after 2,4,6,12 and 18 months of functional loading. Mean bone loss was also evaluated at the same interval of time on each periapical radiographs, bone levels were calculated by measuring the distance from the implant shoulder to the first bone to implant contact. Results Cumulative implant survival rate is 100% (n=25/25) to date and mean ISQ values recorded were: 72.14±5.61 (range= 50–81) at surgery, 64.39±8.12 (range=44–74) after 2 months, 74.26±7.14 (range=44–74) after 4 months, 76.84±7.65 (range=60–83) after 6 months, 78.13±4.14 (range=64–84) after 12 months and 80.22±6.23 (range=68–89) after 18 months of functional loading. Mean crestal marginal bone loss was 0.19±0.25 mm after 2 months of functional loading on periapical radiographs, 0.22±0.4 mm at 4 months, 0.3±0.46 mm at 6 months, 0.57±0.62 at 1 year and 0.64±0.60 mm after 18 months. Conclusions The results of this study, even if limited by the number of implants placed indicate that PTTM dental implants have a clinical efficacy in prosthetic rehabilitation of post-oncological patients, due to trabecular structure of the porous Ta metal that increases bone-implant connection values. PMID:25774249

  17. Excellent clinical outcomes and retention in care for adults with HIV-associated Kaposi sarcoma treated with systemic chemotherapy and integrated antiretroviral therapy in rural Malawi

    PubMed Central

    Herce, Michael E; Kalanga, Noel; Wroe, Emily B; Keck, James W; Chingoli, Felix; Tengatenga, Listern; Gopal, Satish; Phiri, Atupere; Mailosi, Bright; Bazile, Junior; Beste, Jason A; Elmore, Shekinah N; Crocker, Jonathan T; Rigodon, Jonas

    2015-01-01

    Introduction HIV-associated Kaposi sarcoma (HIV-KS) is the most common cancer in Malawi. In 2008, the non-governmental organization, Partners In Health, and the Ministry of Health established the Neno Kaposi Sarcoma Clinic (NKSC) to treat HIV-KS in rural Neno district. We aimed to evaluate 12-month clinical outcomes and retention in care for HIV-KS patients in the NKSC, and to describe our implementation model, which featured protocol-guided chemotherapy, integrated antiretroviral therapy (ART) and psychosocial support delivered by community health workers. Methods We conducted a retrospective cohort study using routine clinical data from 114 adult HIV-KS patients who received ART and ≥1 chemotherapy cycle in the NKSC between March 2008 and February 2012. Results At enrolment 97% of patients (n/N=103/106) had advanced HIV-KS (stage T1). Most patients were male (n/N=85/114, 75%) with median age 36 years (interquartile range, IQR: 29–42). Patients started ART a median of 77 days prior to chemotherapy (IQR: 36–252), with 97% (n/N=105/108) receiving nevirapine/lamivudine/stavudine. Following standardized protocols, we treated 20 patients (18%) with first-line paclitaxel and 94 patients (82%) with bleomycin plus vincristine (BV). Of the 94 BV patients, 24 (26%) failed to respond to BV requiring change to second-line paclitaxel. A Division of AIDS grade 3/4 adverse event occurred in 29% of patients (n/N=30/102). Neutropenia was the most common grade 3/4 event (n/N=17/102, 17%). Twelve months after chemotherapy initiation, 83% of patients (95% CI: 74–89%) were alive, including 88 (77%) retained in care. Overall survival (OS) at 12 months did not differ by initial chemotherapy regimen (p=0.6). Among patients with T1 disease, low body mass index (BMI) (adjusted hazard ratio, aHR=4.10, 95% CI: 1.06–15.89) and 1 g/dL decrease in baseline haemoglobin (aHR=1.52, 95% CI: 1.03–2.25) were associated with increased death or loss to follow-up at 12 months. Conclusions

  18. African American Participation in Oncology Clinical Trials--Focus on Prostate Cancer: Implications, Barriers, and Potential Solutions.

    PubMed

    Ahaghotu, Chiledum; Tyler, Robert; Sartor, Oliver

    2016-04-01

    In the United States, the incidence and mortality rates of many cancers, especially prostate cancer, are disproportionately high among African American men compared with Caucasian men. Recently, mortality rates for prostate cancer have declined more rapidly in African American versus Caucasian men, but prostate cancer is still the most common cancer and the second leading cause of cancer deaths in African American men in the United States. Compared with Caucasian men, prostate cancer occurs at younger ages, has a higher stage at diagnosis, and is more likely to progress after definitive treatments in African American men. Reasons for racial discrepancies in cancer are multifactorial and potentially include socioeconomic, cultural, nutritional, and biologic elements. In addition to improving access to novel therapies, clinical trial participation is essential to adequately establish the risks and benefits of treatments in African American populations. Considering the disproportionately high mortality rates noted in these groups, our understanding of the natural history and responses to therapies is limited. This review will explore African American underrepresentation in clinical trials with a focus on prostate cancer, and potentially effective strategies to engage African American communities in prostate cancer research. Solutions targeting physicians, investigators, the community, and health care systems are identified. Improvement of African American participation in prostate cancer clinical trials will benefit all stakeholders. PMID:26786562

  19. Role of nuclear medicine in chemotherapy of malignant lesions

    SciTech Connect

    Kim, E.E.; Haynie, T.P.

    1985-01-01

    The major role of nuclear medicine in clinical oncology is in tumor imaging, which includes evaluating specific organs or the entire body for the presence of tumor. Nuclear medicine studies have been used clinically in the initial evaluation of the tumor extent and in the subsequent management of the cancer patient to assess response to treatment, to detect early relapse, and to assist in making decisions concerning follow-up treatment. Technetium-99m macroaggregated albumin perfusion study for intraarterial chemotherapy has been helpful in monitoring the catheter tip, providing a map of regional perfusion at the capillary level (tumor vascularity), evaluating the degree of arteriovenous shunt in tumor bed, and optimizing division of the dose of chemotherapeutic agent when bilateral arterial catheters are used. Quantitative and serial radionuclide angiocardiography has been useful in assessing doxorubicin (Adriamycin, Adria Laboratories, Columbus, Ohio) toxicity, and /sup 67/Ga-citrate imaging has been used to monitor chemotherapy effect on lungs and kidneys. Radionuclide venography can demonstrate suspected thrombus, and the delineation of the vascular anatomy also allows proper placement of another catheter for continuous effective chemotherapy. Serial bone scans have been the primary modality to assess the response of bone metastasis to systemic therapy in breast cancer patients, and nuclear hepatic imaging may show tumor response, hepatocellular dysfunction, and cholecystitis related to chemotherapeutic agents. 41 references.

  20. Evaluation of a cloud-based local-read paradigm for imaging evaluations in oncology clinical trials for lung cancer

    PubMed Central

    Kobayashi, Naomi; Bonnard, Eric; Charbonnier, Colette; Yamamichi, Junta; Mizobe, Hideaki; Kimura, Shinya

    2015-01-01

    Background Although tumor response evaluated with radiological imaging is frequently used as a primary endpoint in clinical trials, it is difficult to obtain precise results because of inter- and intra-observer differences. Purpose To evaluate usefulness of a cloud-based local-read paradigm implementing software solutions that standardize imaging evaluations among international investigator sites for clinical trials of lung cancer. Material and Methods Two studies were performed: KUMO I and KUMO I Extension. KUMO I was a pilot study aiming at demonstrating the feasibility of cloud implementation and identifying issues regarding variability of evaluations among sites. Chest CT scans at three time-points from baseline to progression, from 10 patients with lung cancer who were treated with EGFR tyrosine kinase inhibitors, were evaluated independently by two oncologists (Japan) and one radiologist (France), through a cloud-based software solution. The KUMO I Extension was performed based on the results of KUMO I. Results KUMO I showed discordance rates of 40% for target lesion selection, 70% for overall response at the first time-point, and 60% for overall response at the second time-point. Since the main reason for the discordance was differences in the selection of target lesions, KUMO I Extension added a cloud-based quality control service to achieve a consensus on the selection of target lesions, resulting in an improved rate of agreement of response evaluations. Conclusion The study shows the feasibility of imaging evaluations at investigator sites, based on cloud services for clinical studies involving multiple international sites. This system offers a step forward in standardizing evaluations of images among widely dispersed sites. PMID:26668754

  1. KRAS and Colorectal Cancer: Ethical and Pragmatic Issues in Effecting Real-Time Change in Oncology Clinical Trials and Practice

    PubMed Central

    Goldberg, Richard M.; Grothey, Axel; Mooney, Margaret; Roach, Nancy; Saltz, Leonard B.; Welch, John J.; Wood, William A.; Meropol, Neal J.

    2011-01-01

    Systemic therapy has led to a median survival time for patients with advanced colorectal cancer (CRC) almost fourfold longer than that expected with best supportive care, an outcome achieved through combining chemotherapeutic and targeted biologic agents. Although the latter can include anti–epidermal growth factor receptor antibodies, such as cetuximab and panitumumab, we now have strong evidence that patients whose tumors harbor mutated KRAS will not benefit from this class of agent. Acceptance of the reliability and importance of the KRAS data took several years to evolve, however, for a variety of reasons. The timeline from the presentation and publication of small, retrospective phase II studies to widespread acceptance of the KRAS predictive value and changes in behavior—specifically, modifications of ongoing national trials in advanced/metastatic CRC, changes in national guidelines and practice patterns, and adjustments to the labeled indications for the monoclonal antibodies—was lengthy. In this commentary, we discuss whether or not the process of data disclosure regarding KRAS status and treatment of advanced CRC patients was effective in permitting timely decisions regarding ongoing publicly funded clinical trials and whether or not such decisions were rational and ethical. The overall goals are to highlight lessons learned regarding early disclosure of clinical trial results, as well as vetting and adoption of new scientific data, and to propose modifications for handling similar situations in the future. PMID:21737577

  2. Phase II Clinical Trial of Neoadjuvant Alternating Doublet Chemotherapy With Ifosfamide/Doxorubicin and Etoposide/Cisplatin in Small-Cell Urothelial Cancer

    PubMed Central

    Siefker-Radtke, Arlene O.; Kamat, Ashish M.; Grossman, H. Barton; Williams, Dallas L.; Qiao, Wei; Thall, Peter F.; Dinney, Colin P.; Millikan, Randall E.

    2009-01-01

    Purpose Currently, treatment recommendations for small-cell urothelial cancer (SCUC) are based on anecdotal case reports and small retrospective series. We now report results from the first phase II clinical trial developed exclusively for SCUC, to our knowledge. Patients and Methods From 2001 to 2006, 30 patients with SCUC provided consent and were treated with alternating doublet chemotherapy. Patients with surgically resectable disease (≤ cT4aN0M0) received a total of four cycles of neoadjuvant chemotherapy, whereas those with unresectable disease (≥ cT4b, N+, or M+) received two cycles beyond maximal response. Results Eighteen patients with surgically resectable SCUC received neoadjuvant treatment with a median overall survival (OS) of 58 months; 13 of these patients remain alive and cancer free. For patients with cT2N0M0 SCUC, the 5-year OS rate is 80%; only one of four patients with cT3b-4aN0M0 remains alive (median OS, 37.8 months). For 12 patients with unresectable or metastatic SCUC, the median OS was 13.3 months. Chemotherapy was well tolerated, with transfusion, neutropenic fever, and infection remaining the most frequent grade 3 and 4 toxicities. There was only one postsurgical death. Brain metastases were strongly associated with more advanced-stage disease, developing in eight of 16 patients with either bulky tumors (≥ cT3b) or metastatic disease (P = .004). Conclusion These clinical trial results are consistent with previously reported retrospective data demonstrating long-term survival with four cycles of neoadjuvant chemotherapy for surgically resectable SCUC. Once metastases develop, the prognosis remains poor. The strong positive association between disease stage and brain metastases highlights a patient subset that may potentially benefit from prophylactic cranial irradiation. PMID:19414678

  3. Intraarterial pelvic infusion chemotherapy in advanced gynecologic cancer.

    PubMed

    Lifshitz, S; Railsback, L D; Buchsbaum, H J

    1978-10-01

    Fourteen patients with advanced localized gynecologic cancer were treated with 44 courses of intraarterial pelvic infusion chemotherapy. All patients received methotrexate with folinic acid rescue; 9 patients also received vincristine. Tumor regression was observed in 3 of 14 patients (21.4%). In 5 patients there were major complications related to 28 intraarterial catheter placements. Two patients developed leukopenia following chemotherapy. The value of intraarterial infusion chemotherapy in gynecologic cancer is limited. Its use in gynecologic oncology is discussed. PMID:309571

  4. Immuno-Positron Emission Tomography with Zirconium-89-Labeled Monoclonal Antibodies in Oncology: What Can We Learn from Initial Clinical Trials?

    PubMed

    Jauw, Yvonne W S; Menke-van der Houven van Oordt, C Willemien; Hoekstra, Otto S; Hendrikse, N Harry; Vugts, Danielle J; Zijlstra, Josée M; Huisman, Marc C; van Dongen, Guus A M S

    2016-01-01

    Selection of the right drug for the right patient is a promising approach to increase clinical benefit of targeted therapy with monoclonal antibodies (mAbs). Assessment of in vivo biodistribution and tumor targeting of mAbs to predict toxicity and efficacy is expected to guide individualized treatment and drug development. Molecular imaging with positron emission tomography (PET) using zirconium-89 ((89)Zr)-labeled monoclonal antibodies also known as (89)Zr-immuno-PET, visualizes and quantifies uptake of radiolabeled mAbs. This technique provides a potential imaging biomarker to assess target expression, as well as tumor targeting of mAbs. In this review we summarize results from initial clinical trials with (89)Zr-immuno-PET in oncology and discuss technical aspects of trial design. In clinical trials with (89)Zr-immuno-PET two requirements should be met for each (89)Zr-labeled mAb to realize its full potential. One requirement is that the biodistribution of the (89)Zr-labeled mAb (imaging dose) reflects the biodistribution of the drug during treatment (therapeutic dose). Another requirement is that tumor uptake of (89)Zr-mAb on PET is primarily driven by specific, antigen-mediated, tumor targeting. Initial trials have contributed toward the development of (89)Zr-immuno-PET as an imaging biomarker by showing correlation between uptake of (89)Zr-labeled mAbs on PET and target expression levels in biopsies. These results indicate that (89)Zr-immuno-PET reflects specific, antigen-mediated binding. (89)Zr-immuno-PET was shown to predict toxicity of RIT, but thus far results indicating that toxicity of mAbs or mAb-drug conjugate treatment can be predicted are lacking. So far, one study has shown that molecular imaging combined with early response assessment is able to predict response to treatment with the antibody-drug conjugate trastuzumab-emtansine, in patients with human epithelial growth factor-2 (HER2)-positive breast cancer. Future studies would benefit from a

  5. Immuno-Positron Emission Tomography with Zirconium-89-Labeled Monoclonal Antibodies in Oncology: What Can We Learn from Initial Clinical Trials?

    PubMed Central

    Jauw, Yvonne W. S.; Menke-van der Houven van Oordt, C. Willemien; Hoekstra, Otto S.; Hendrikse, N. Harry; Vugts, Danielle J.; Zijlstra, Josée M.; Huisman, Marc C.; van Dongen, Guus A. M. S.

    2016-01-01

    Selection of the right drug for the right patient is a promising approach to increase clinical benefit of targeted therapy with monoclonal antibodies (mAbs). Assessment of in vivo biodistribution and tumor targeting of mAbs to predict toxicity and efficacy is expected to guide individualized treatment and drug development. Molecular imaging with positron emission tomography (PET) using zirconium-89 (89Zr)-labeled monoclonal antibodies also known as 89Zr-immuno-PET, visualizes and quantifies uptake of radiolabeled mAbs. This technique provides a potential imaging biomarker to assess target expression, as well as tumor targeting of mAbs. In this review we summarize results from initial clinical trials with 89Zr-immuno-PET in oncology and discuss technical aspects of trial design. In clinical trials with 89Zr-immuno-PET two requirements should be met for each 89Zr-labeled mAb to realize its full potential. One requirement is that the biodistribution of the 89Zr-labeled mAb (imaging dose) reflects the biodistribution of the drug during treatment (therapeutic dose). Another requirement is that tumor uptake of 89Zr-mAb on PET is primarily driven by specific, antigen-mediated, tumor targeting. Initial trials have contributed toward the development of 89Zr-immuno-PET as an imaging biomarker by showing correlation between uptake of 89Zr-labeled mAbs on PET and target expression levels in biopsies. These results indicate that 89Zr-immuno-PET reflects specific, antigen-mediated binding. 89Zr-immuno-PET was shown to predict toxicity of RIT, but thus far results indicating that toxicity of mAbs or mAb-drug conjugate treatment can be predicted are lacking. So far, one study has shown that molecular imaging combined with early response assessment is able to predict response to treatment with the antibody-drug conjugate trastuzumab-emtansine, in patients with human epithelial growth factor-2 (HER2)-positive breast cancer. Future studies would benefit from a standardized criterion

  6. Case management in oncology rehabilitation (CAMON): The effect of case management on the quality of life in patients with cancer after one year of ambulant rehabilitation. A study protocol for a randomized controlled clinical trial in oncology rehabilitation

    PubMed Central

    2011-01-01

    Background Cancer diseases and their therapies have negative effects on the quality of life. The aim of this study is to assess the effectiveness of case management in a sample of oncological outpatients with the intent of rehabilitation after cancer treatment. Case management wants to support the complex information needs of the patients in addition to the segmented structure of the health care system. Emphasis is put on support for self-management in order to enhance health - conscious behaviour, learning to deal with the burden of the illness and providing the opportunity for regular contacts with care providers. We present a study protocol to investigate the efficacy of a case management in patients following oncology rehabilitation after cancer treatment. Methods The trial is a multicentre, two-arm randomised controlled study. Patients are randomised parallel in either 'usual care' plus case management or 'usual care' alone. Patients with all types of cancer can be included in the study, if they have completed the therapy with chemo- and/or radiotherapy/surgery with curative intention and are expected to have a survival time >1 year. To determine the health-related quality of life the general questionnaire FACT G is used. The direct correlation between self-management and perceived self-efficacy is measured with the Jerusalem & Schwarzer questionnaire. Patients satisfaction with the care received is measured using the Patient Assessment of Chronic Illness Care 5 As (PACIC-5A). Data are collected at the beginning of the trial and after 3, 6 and 12 months. The power analysis revealed a sample size of 102 patients. The recruitment of the centres began in 2009. The inclusion of patients began in May 2010. Discussion Case management has proved to be effective regarding quality of life of patients with chronic diseases. When it comes to oncology, case management is mainly used in cancer treatment, but it is not yet common in the rehabilitation of cancer patients

  7. Phase III Randomized Clinical Trial Comparing Tremelimumab With Standard-of-Care Chemotherapy in Patients With Advanced Melanoma

    PubMed Central

    Ribas, Antoni; Kefford, Richard; Marshall, Margaret A.; Punt, Cornelis J.A.; Haanen, John B.; Marmol, Maribel; Garbe, Claus; Gogas, Helen; Schachter, Jacob; Linette, Gerald; Lorigan, Paul; Kendra, Kari L.; Maio, Michele; Trefzer, Uwe; Smylie, Michael; McArthur, Grant A.; Dreno, Brigitte; Nathan, Paul D.; Mackiewicz, Jacek; Kirkwood, John M.; Gomez-Navarro, Jesus; Huang, Bo; Pavlov, Dmitri; Hauschild, Axel

    2013-01-01

    Purpose In phase I/II trials, the cytotoxic T lymphocyte–associated antigen-4–blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients with advanced melanoma treated with tremelimumab or standard-of-care chemotherapy. Patients and Methods Patients with treatment-naive, unresectable stage IIIc or IV melanoma were randomly assigned at a ratio of one to one to tremelimumab (15 mg/kg once every 90 days) or physician's choice of standard-of-care chemotherapy (temozolomide or dacarbazine). Results In all, 655 patients were enrolled and randomly assigned. The test statistic crossed the prespecified futility boundary at second interim analysis after 340 deaths, but survival follow-up continued. At final analysis with 534 events, median OS by intent to treat was 12.6 months (95% CI, 10.8 to 14.3) for tremelimumab and 10.7 months (95% CI, 9.36 to 11.96) for chemotherapy (hazard ratio, 0.88; P = .127). Objective response rates were similar in the two arms: 10.7% in the tremelimumab arm and 9.8% in the chemotherapy arm. However, response duration (measured from date of random assignment) was significantly longer after tremelimumab (35.8 v 13.7 months; P = .0011). Diarrhea, pruritus, and rash were the most common treatment-related adverse events in the tremelimumab arm; 7.4% had endocrine toxicities. Seven deaths in the tremelimumab arm and one in the chemotherapy arm were considered treatment related by either investigators or sponsor. Conclusion This study failed to demonstrate a statistically significant survival advantage of treatment with tremelimumab over standard-of-care chemotherapy in first-line treatment of patients with metastatic melanoma. PMID:23295794

  8. Clinical Significance of CA125 Level after the First Cycle of Chemotherapy on Survival of Patients with Advanced Ovarian Cancer

    PubMed Central

    Lee, Maria; Chang, Min Young; Yoo, Hanna; Lee, Kyung Eun; Chay, Doo Byung; Cho, Hanbyoul; Kim, Young Tae

    2016-01-01

    Purpose To determine the most powerful cancer antigen 125 (CA125)-related prognostic factor for advanced epithelial ovarian cancer (EOC) and to identify cut-off values that distinguish patients with a poor prognosis from those with a good prognosis. Materials and Methods We included 223 patients who received staging laparotomy and were diagnosed with stage IIC–IV serous EOC. Cox regression analysis was used to determine the most significant prognostic factor among the following variables: serum CA125 before surgery and after the first, second, and sixth cycles of chemotherapy; the nadir CA125 value; the relative percentage change in CA125 levels after the first and second cycles of chemotherapy compared to baseline CA125; CA125 half-life; time to nadir; and time to normalization of the CA125 level. Results The CA125 level after the first chemotherapy cycle was the most significant independent prognostic factor for overall survival (OS). Time to normalization (p=0.028) and relative percentage change between CA125 levels at baseline and after the first chemotherapy cycle (p=0.021) were additional independent prognostic factors in terms of OS. The CA125 level after the first chemotherapy cycle (p=0.001) and time to normalization (p<0.001) were identified as independent prognostic factors for progression free survival (PFS). Conclusion Among well-established CA125-related prognostic factors, serum CA125 levels after the first cycle of chemotherapy and time to normalization were the most significant prognostic factors for both OS and PFS. PMID:26996555

  9. Demystified … Molecular pathology in oncology

    PubMed Central

    Crocker, J

    2002-01-01

    In the past 10 years, molecular biology has found major applications in pathology, particularly in oncology. This has been a field of enormous expansion, where pure science has found a place in clinical practice and is now of everyday use in any academic unit. This demystified review will discuss the techniques used in molecular pathology and then provide examples of how these can be used in oncology. PMID:12456768

  10. Comparison of Quality Oncology Practice Initiative (QOPI) Measure Adherence Between Oncology Fellows, Advanced Practice Providers, and Attending Physicians.

    PubMed

    Zhu, Jason; Zhang, Tian; Shah, Radhika; Kamal, Arif H; Kelley, Michael J

    2015-12-01

    Quality improvement measures are uniformly applied to all oncology providers, regardless of their roles. Little is known about differences in adherence to these measures between oncology fellows, advance practice providers (APP), and attending physicians. We investigated conformance across Quality Oncology Practice Initiative (QOPI) measures for oncology fellows, advance practice providers, and attending physicians at the Durham Veterans Affairs Medical Center (DVAMC). Using data collected from the Spring 2012 and 2013 QOPI cycles, we abstracted charts of patients and separated them based on their primary provider. Descriptive statistics and the chi-square test were calculated for each QOPI measure between fellows, advanced practice providers (APPs), and attending physicians. A total of 169 patients were reviewed. Of these, 31 patients had a fellow, 39 had an APP, and 99 had an attending as their primary oncology provider. Fellows and attending physicians performed similarly on 90 of 94 QOPI metrics. High-performing metrics included several core QOPI measures including documenting consent for chemotherapy, recommending adjuvant chemotherapy when appropriate, and prescribing serotonin antagonists when prescribing emetogenic chemotherapies. Low-performing metrics included documentation of treatment summary and taking action to address problems with emotional well-being by the second office visit. Attendings documented the plan for oral chemotherapy more often (92 vs. 63%, P=0.049). However, after the chart audit, we found that fellows actually documented the plan for oral chemotherapy 88% of the time (p=0.73). APPs and attendings performed similarly on 88 of 90 QOPI measures. The quality of oncology care tends to be similar between attendings and fellows overall; some of the significant differences do not remain significant after a second manual chart review, highlighting that the use of manual data collection for QOPI analysis is an imperfect system, and there may

  11. Outbreak of Tsukamurella spp. Bloodstream Infections among Patients of an Oncology Clinic—West Virginia, 2011–2012

    PubMed Central

    See, Isaac; Nguyen, Duc B.; Chatterjee, Somu; Shwe, Thein; Scott, Melissa; Ibrahim, Sherif; Moulton-Meissner, Heather; McNulty, Steven; Noble-Wang, Judith; Price, Cindy; Schramm, Kim; Bixler, Danae; Guh, Alice Y.

    2015-01-01

    Objective To determine the source and identify control measures of an outbreak of Tsukamurella species bloodstream infections at an outpatient oncology facility. Design Epidemiologic investigation of the outbreak with a case control study. Methods A case was an infection in which Tsukamurella spp. was isolated from a blood or catheter tip culture during January 2011–June 2012 from a patient of the oncology clinic. Laboratory records of area hospitals and patient charts were reviewed. A case-control study was conducted among clinic patients to identify risk factors for Tsukamurella spp. bloodstream infection. Clinic staff were interviewed and infection control practices were assessed. Results Fifteen cases of Tsukamurella (T. pulmonis or T. tyrosinosolvens) bloodstream infection were identified, all in patients with underlying malignancy and indwelling central lines. Median age of case-patients was 68 years; 47% were male. The only significant risk factor for infection was receipt of saline flush from the clinic during September–October 2011 (P=0.03), when the clinic had been preparing saline flush from a common-source bag of saline. Other infection control deficiencies that were identified at the clinic included suboptimal procedures for central line access and preparation of chemotherapy. Conclusion Although multiple infection control lapses were identified, the outbreak was likely caused by improper preparation of saline flush syringes by the clinic. The outbreak demonstrates that bloodstream infections among oncology patients can result from improper infection control practices and highlights the critical need for increased attention to and oversight of infection control in outpatient oncology settings. PMID:24521597

  12. Mutually exclusive mutations in NOTCH1 and PIK3CA associated with clinical prognosis and chemotherapy responses of esophageal squamous cell carcinoma in China

    PubMed Central

    Song, Bin; Cui, Heyang; Li, Yaoping; Cheng, Caixia; Yang, Bin; Wang, Fang; Kong, Pengzhou; Li, Hongyi; Zhang, Ling; Jia, Zhiwu; Bi, Yanghui; Wang, Jiaqian; Zhou, Yong; Liu, Jing; Wang, Juan; Zhao, Zhenxiang; Zhang, Yanyan; Hu, Xiaoling; Shi, Ruyi; Yang, Jie; Liu, Haiyan; Yan, Ting; Li, Yike; Xu, Enwei; Qian, Yu; Xi, Yanfeng; Guo, Shiping; Chen, Yunqing; Wang, Jinfen; Li, Guodong; Liang, Jianfang; Jia, Junmei; Chen, Xing; Guo, Jiansheng; Wang, Tong; Zhang, Yanbo; Li, Qingshan; Wang, Chuangui; Cheng, Xiaolong; Zhan, Qimin; Cui, Yongping

    2016-01-01

    Background Recurrent genetic abnormalities that correlate with clinical features could be used to determine patients' prognosis, select treatments and predict responses to therapy. Esophageal squamous cell carcinoma (ESCC) contains genomic alterations of undefined clinical significance. We aimed to identify mutually exclusive mutations that are frequently detected in ESCCs and characterized their associations with clinical variables. Methods We analyzed next-generation-sequencing data from 104 ESCCs from Taihang Mountain region of China; 96 pairs were selected for deep target-capture-based validation and analysis of clinical and pathology data. We used model proposed by Szczurek to identify exclusive mutations and to associate these with pathology findings. Univariate and multivariate analyses with Cox proportional hazards model were used to examine the association between mutations and overall survival and response to chemotherapy. Findings were validated in an analysis of samples from 89 patients with ESCC from Taihang Mountain. Results We identified statistically significant mutual exclusivity between mutations in NOTCH1 and PIK3CA in ESCC samples. Mutations in NOTCH1 were associated with well-differentiated, early-stage malignancy and less metastasis to regional lymph nodes. Nonetheless, patients with NOTCH1 mutations had shorter survival times than patients without NOTCH1 mutations, and failed to respond to chemotherapy. In contrast, patients with mutations in PIK3CA had better responses to chemotherapy and longer survival times than patients without PIK3CA mutations. Conclusions In a genetic analysis of ESCCs from patients in China, we identified mutually exclusive mutations in NOTCH1 and PIK3CA. These findings might increase our understanding of ESCC development and be used as prognostic factors. PMID:26528858

  13. How to use molecular markers when caring for a patient with brain cancer: 1P/19Q as a predictive and prognostic marker in the neuro-oncology clinic.

    PubMed

    van den Bent, M J

    2013-01-01

    Although the central role of 1p/19q codeletion in oligodendroglioma was established almost two decades ago, apart from clear prognostic significance the implications for clinical care have been less clear. This has changed with the long-term follow-up analysis of the EORTC and RTOG trials on procarbazine, lomustine, and vincristine (PCV) chemotherapy in anaplastic oligodendroglioma. These have shown that 1p/19q loss in these tumors is predictive of overall survival benefit of the addition of PCV chemotherapy to radiotherapy. PMID:23714473

  14. Adjuvant chemotherapy for soft-tissue sarcoma: review and meta-analysis of the published results of randomised clinical trials.

    PubMed Central

    Tierney, J. F.; Mosseri, V.; Stewart, L. A.; Souhami, R. L.; Parmar, M. K.

    1995-01-01

    Fifteen published randomised trials comparing adjuvant chemotherapy with no chemotherapy in soft-tissue sarcoma (STS) were identified (1546 patients). A qualitative review and a meta-analysis of this published literature were performed. With the qualitative review it was not possible to synthesise the apparently conflicting results of individual trials. The meta-analysis of the published data suggests an improvement in survival at 2 years (OR = 0.73, 95% CI = 0.53-0.99, P = 0.044) and at 5 years (OR = 0.59, 95% CI = 0.45-0.78, P = 0.0002) in favour of chemotherapy. However, the assumptions and approximations required to conduct this quantitative summary demand that the results are interpreted with caution. The only reliable means of assessing the current evidence on whether adjuvant chemotherapy has a role in the treatment of patients with STS, is to collect, check and reanalyse individual patients data (IPD) from each trial centrally, and formally combine the results in a stratified time-to-event analysis. Such an IPD analysis is currently being undertaken by an international collaborative group. PMID:7640234

  15. Polymeric nanoparticles for targeted treatment in oncology: current insights

    PubMed Central

    Prabhu, Rashmi H; Patravale, Vandana B; Joshi, Medha D

    2015-01-01

    Chemotherapy, a major strategy for cancer treatment, lacks the specificity to localize the cancer therapeutics in the tumor site, thereby affecting normal healthy tissues and advocating toxic adverse effects. Nanotechnological intervention has greatly revolutionized the therapy of cancer by surmounting the current limitations in conventional chemotherapy, which include undesirable biodistribution, cancer cel