Science.gov

Sample records for clinical oncology chemotherapy

  1. Implementation of the American Society of Clinical Oncology and Oncology Nursing Society chemotherapy safety standards.

    PubMed

    Vioral, Anna N; Kennihan, Heather K

    2012-12-01

    Chemotherapy involves an intricate, high-risk, multidisciplinary process of prescribing, dispensing, and administering complex multimedication regimens with narrow therapeutic indices. Chemotherapeutic agents also require safe-handling precautions for patients and healthcare providers. In addition, a number of chemotherapy and targeted therapies have expanded to nononcology populations. This complexity demands standardization of chemotherapy practice for all healthcare providers to ensure safe outcomes. This article describes one organization's multidisciplinary effort to standardize chemotherapy practice according to the American Society of Clinical Oncology and Oncology Nursing Society's 31 safety standards for chemotherapy administration. The article also describes how the organization integrated and developed standards of practice using interdisciplinary approaches. The educational processes used during implementation and the lessons learned are discussed to assist healthcare providers involved in standardizing chemotherapy administration. The article equips healthcare professionals with a multidisciplinary process for high-quality clinical standards of practice that may reduce errors and ensure safety.

  2. 2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology.

    PubMed

    Neuss, Michael N; Gilmore, Terry R; Belderson, Kristin M; Billett, Amy L; Conti-Kalchik, Tara; Harvey, Brittany E; Hendricks, Carolyn; LeFebvre, Kristine B; Mangu, Pamela B; McNiff, Kristen; Olsen, MiKaela; Schulmeister, Lisa; Von Gehr, Ann; Polovich, Martha

    2016-12-01

    Purpose To update the ASCO/Oncology Nursing Society (ONS) Chemotherapy Administration Safety Standards and to highlight standards for pediatric oncology. Methods The ASCO/ONS Chemotherapy Administration Safety Standards were first published in 2009 and updated in 2011 to include inpatient settings. A subsequent 2013 revision expanded the standards to include the safe administration and management of oral chemotherapy. A joint ASCO/ONS workshop with stakeholder participation, including that of the Association of Pediatric Hematology Oncology Nurses and American Society of Pediatric Hematology/Oncology, was held on May 12, 2015, to review the 2013 standards. An extensive literature search was subsequently conducted, and public comments on the revised draft standards were solicited. Results The updated 2016 standards presented here include clarification and expansion of existing standards to include pediatric oncology and to introduce new standards: most notably, two-person verification of chemotherapy preparation processes, administration of vinca alkaloids via minibags in facilities in which intrathecal medications are administered, and labeling of medications dispensed from the health care setting to be taken by the patient at home. The standards were reordered and renumbered to align with the sequential processes of chemotherapy prescription, preparation, and administration. Several standards were separated into their respective components for clarity and to facilitate measurement of adherence to a standard. Conclusion As oncology practice has changed, so have chemotherapy administration safety standards. Advances in technology, cancer treatment, and education and training have prompted the need for periodic review and revision of the standards. Additional information is available at http://www.asco.org/chemo-standards .

  3. 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)

  4. How Variable Is Our Delivery of Information? Approaches to Patient Education About Oral Chemotherapy in the Pediatric Oncology Clinic.

    PubMed

    Kahn, Justine M; Athale, Uma H; Clavell, Luis A; Cole, Peter D; Leclerc, Jean-Marie; Laverdiere, Caroline; Michon, Bruno; Schorin, Marshall A; Welch, Jennifer J G; Sallan, Stephen E; Silverman, Lewis B; Kelly, Kara M

    In pediatric patients with acute lymphoblastic leukemia, adherence to oral chemotherapy relies largely on a parent's comprehension of the drug's indication and administration guidelines. We assessed how pediatric oncology providers educate families about oral chemotherapy. We conducted a cross-sectional survey of 68 physicians and nurses from 9 institutions in the Dana-Farber Cancer Institute Acute Lymphoblastic Leukemia Consortium. The inter-individual approach to patient education is variable and may consist of handouts, treatment calendars, and discussions. The extent of teaching often varies depending on a provider's subjective assessment of a family's needs. Twenty-five percent of providers suggested standardizing patient teaching. When developing educational models, care teams should consider approaches that (a) objectively identify families in need of extensive teaching, (b) designate allotted teaching time by nursing staff during clinic visits, and (c) maintain the variation and dynamism that informs a successful provider-patient relationship.

  5. Side effects of chemotherapy in musculoskeletal oncology.

    PubMed

    Mavrogenis, Andreas F; Papagelopoulos, Panayiotis J; Romantini, Matteo; Angelini, Andrea; Ruggieri, Pietro

    2010-01-01

    With recent advances in medical and orthopedic oncology, radiation therapy and single- or multiple-agent perioperative chemotherapy are currently applied as an essential part of the multidisciplinary treatment to improve disease-free and overall survival of patients with primary and metastatic bone and soft tissue tumors. However, these treatments have led to unwanted complications. A better understanding of the effects of various antineoplastic agents on bone, soft tissue, and organs may provide the basis for the more efficacious use of antiproliferative drugs when fracture healing or allograft incorporation is required. This knowledge may also provide a rationale for concurrent treatment with drugs that protect against or compensate for adverse effects in osseous repair resulting from chemotherapy.

  6. 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.

  7. 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

  8. Clinical trials of interventional oncology.

    PubMed

    Arai, Yasuaki

    2012-08-01

    Interventional oncology has great potential to be a good treatment modality in the field of oncology, because its procedures are minimally invasive and fairly quick. However, except for a few procedures such as percutaneous radiofrequency ablation and trans-catheter arterial chemo-embolization that have been recognized as standard treatments for hepatocellular carcinoma, most procedures have not been established as the standard treatment modality due to the limited number of clinical trials with compelling evidence. There are several common problems when performing clinical trials of interventional oncology. The first is that the outcomes of clinical trials are greatly influenced by the level of technical skill of the physicians. The second is that equipment and devices vary widely in countries and regions, and they also influence the outcomes. The third is that the methodology of clinical trials for techniques such as interventional oncology has not yet been established. The fourth is the difficulty of setting appropriate endpoints; quality of life is suitable for evaluating interventional oncology in palliative care, but it is not easy to set as the endpoint. The fifth is the difficulty of employing a blinded design, because the procedure cannot be performed without the physician's awareness. Despite such difficult situations, many multi-institutional clinical trials of interventional oncology have been carried out in Japan, with some challenging results. Establishing evidence is critical to making interventional oncology the standard treatment. Interventional radiologists should know the importance of clinical trials, and should move ahead in this direction in a step-by-step manner.

  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. Design of oncology clinical trials: a review.

    PubMed

    Ananthakrishnan, Revathi; Menon, Sandeep

    2013-10-01

    Cancer is a disease that occurs due to the uncontrolled multiplication of cells that invade nearby tissues and can spread to other parts of the body. An increased incidence of cancer in the world has led to an increase in oncology research and in the number of oncology trials. Well designed oncology clinical trials are a key part of developing effective anti-cancer drugs. This review focuses on statistical considerations in the design and analysis of oncology clinical trials.

  12. American Society of Clinical Oncology

    MedlinePlus

    ... Conference Missouri Oncology Society State Affiliate View Event Neuroscience Update in Pediatric Neuro-Oncology Houston, Texas, United States April 22 Neuroscience Update in Pediatric Neuro-Oncology MD Anderson Informational; ...

  13. Best practice in nurse-led chemotherapy review: a position statement from the United Kingdom Oncology Nursing Society

    PubMed Central

    Lennan, E; Vidall, C; Roe, H; Jones, P; Smith, J; Farrell, C

    2012-01-01

    This position statement has been formulated by nurses from the United Kingdom Oncology Nursing Society (UKONS) to provide guidance on the provision of nurse-led chemotherapy review clinics for adult patients. For the purposes of this statement, a nurse-led chemotherapy clinic is defined as one that conducts formal review (in a consultation room) before the decision to proceed and prescribe the next cycle of chemotherapy. This statement does not address the toxicity checks that take place immediately prior to the administration of chemotherapy, although many of the same principles will apply to both settings. PMID:22879834

  14. 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.

  15. Japanese Society of Clinical Oncology clinical practice guidelines 2010 for antiemesis in oncology: executive summary.

    PubMed

    Takeuchi, Hideki; Saeki, Toshiaki; Aiba, Keisuke; Tamura, Kazuo; Aogi, Kenjiro; Eguchi, Kenji; Okita, Kenji; Kagami, Yoshikazu; Tanaka, Ryuhei; Nakagawa, Kazuhiko; Fujii, Hirofumi; Boku, Narikazu; Wada, Makoto; Akechi, Tatsuo; Udagawa, Yasuhiro; Okawa, Yutaka; Onozawa, Yusuke; Sasaki, Hidenori; Shima, Yasuo; Shimoyama, Naohito; Takeda, Masayuki; Nishidate, Toshihiko; Yamamoto, Akifumi; Ikeda, Tadashi; Hirata, Koichi

    2016-02-01

    The purpose of this article is to disseminate the standard of antiemetic therapy for Japanese clinical oncologists. On the basis of the Appraisal of Guidelines for Research and Evaluation II instrument, which reflects evidence-based clinical practice guidelines, a working group of the Japanese Society of Clinical Oncology (JSCO) reviewed clinical practice guidelines for antiemesis and performed a systematic review of evidence-based domestic practice guidelines for antiemetic therapy in Japan. In addition, because health-insurance systems in Japan are different from those in other countries, a consensus was reached regarding standard treatments for chemotherapy that induce nausea and vomiting. Current evidence was collected by use of MEDLINE, from materials from meetings of the American Society of Clinical Oncology National Comprehensive Cancer Network, and from European Society of Medical Oncology/Multinational Association of Supportive Care in Cancer guidelines for antiemesis. Initially, 21 clinical questions (CQ) were selected on the basis of CQs from other guidelines. Patients treated with highly emetic agents should receive a serotonin (5-hydroxytryptamine; 5HT3) receptor antagonist, dexamethasone, and a neurokinin 1 receptor antagonist. For patients with moderate emetic risk, 5HT3 receptor antagonists and dexamethasone were recommended, whereas for those receiving chemotherapy with low emetic risk dexamethasone only is recommended. Patients receiving high-emetic-risk radiation therapy should also receive a 5HT3 receptor antagonist. In this paper the 2010 JSCO clinical practice guidelines for antiemesis are presented in English; they reveal high concordance of Japanese medical circumstances with other antiemetic guidelines that are similarly based on evidence.

  16. 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

  17. 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.

  18. Chemotherapy for elderly patients with advanced cancer: A pilot study in Institute of Oncology Bucharest

    PubMed Central

    Grigorescu, Alexandru C.

    2015-01-01

    Objectives First objective was better understanding of the indications of chemotherapy in elderly with advanced cancer, tolerability and toxicity of chemotherapy in this age group. The second objective was to define current practice in chemotherapy for elderly people with advanced cancer for a selected group of patients treated in Institute of Oncology Bucharest (IOB). Materials and Methods The study makes a clinical analysis of medical records of 27 patients from the archive of Institute of Oncology Bucharest treated by the same doctor. Patients were selected according to: age ≥ 65 years, ECOG performance status 0–1, normal blood counts and blood biochemistry, histological confirmation of the diagnosis of cancer, patients should received at least 3 cycles of chemotherapy. We extract characteristics of the patients to see if they were a homogeneous group of patients and to compare them with data from the literature. Overall survival was calculated by the Kaplan Meyer curve. Results 295 patients more then 65 years were treated in our site in 2 years 2011, 2012. 93 patients received chemotherapy and only 27 patients were enrolled in this study following inclusion criteria. Common sites of cancer were lung and breast. The most used cytostatics for lung cancer was gemcitabine and carboplatine and cyclophosphamide, metotrexat and 5 fluorouracil for breast cancer. Toxicity was mild with the prevalence of hematologic toxicity. Overall survival without taking into account the type of cancer was 27.7 month. Conclusions For selected patients, chemotherapy was well tolerated and appears to prolong survival regardless of the location of cancer. The relatively small number of elderly patients who received chemotherapy is probably due to lack of compliance to treatment, the increased number of co-morbidities and evaluation of performance status only by the ECOG index known not to be good enough to establish the indication of chemotherapy. PMID:27847881

  19. 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…

  20. 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

  1. Postmastectomy Radiotherapy: An American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Focused Guideline Update.

    PubMed

    Recht, Abram; Comen, Elizabeth A; Fine, Richard E; Fleming, Gini F; Hardenbergh, Patricia H; Ho, Alice Y; Hudis, Clifford A; Hwang, E Shelley; Kirshner, Jeffrey J; Morrow, Monica; Salerno, Kilian E; Sledge, George W; Solin, Lawrence J; Spears, Patricia A; Whelan, Timothy J; Somerfield, Mark R; Edge, Stephen B

    A joint American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology panel convened to develop a focused update of the American Society of Clinical Oncology guideline concerning use of postmastectomy radiotherapy (PMRT).

  2. 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.

  3. Veterinary oncology clinical trials: design and implementation.

    PubMed

    Thamm, Douglas H; Vail, David M

    2015-08-01

    There has been a recent increase in interest among veterinarians and the larger biomedical community in the evaluation of novel cancer therapies in client-owned (pet) animals with spontaneous cancer. This includes novel drugs designed to be veterinary therapeutics, as well as agents for which data generated in animals with tumors may inform human clinical trial design and implementation. An understanding of the process involved in moving a therapeutic agent through the stages of clinical evaluation is critical to the successful implementation of clinical investigations, as well as interpretation of the veterinary oncology literature. This review outlines considerations in the design and conduct of the various phases of oncology clinical trials, along with recent adaptations/modifications of these basic designs that can enhance the generation of timely and meaningful clinical data.

  4. [Quality management in oncology supported by clinical cancer registries].

    PubMed

    Klinkhammer-Schalke, Monika; Gerken, Michael; Barlag, Hagen; Tillack, Anett

    2015-01-01

    Efforts in nationwide quality management for oncology have so far failed to comprehensively document all levels of care. New organizational structures such as population-based clinical cancer registries or certified organ cancer centers were supposed to solve this problem more sufficiently, but they have to be accompanied by valid trans-sectoral documentation and evaluation of clinical data. To measure feasibility and qualitative effectiveness of guideline implementation we approached this problem with a nationwide investigation from 2000 to 2011. The rate of neoadjuvant radio/chemotherapy in stage UICC II/III rectum cancer, cut-off point 80% for separating good from insufficient quality, was used as a quality indicator. The nationwide analysis indicates an increase from 45% to 70%, but only with the implementation strategy of CME. The combination of new structures, evidence-based quality indicators, organ cancer center and clinical cancer registries has shown good feasibility and seems promising.

  5. A randomized Phase II trial of systemic chemotherapy with and without trastuzumab followed by surgery in HER2-positive advanced gastric or esophagogastric junction adenocarcinoma with extensive lymph node metastasis: Japan Clinical Oncology Group study JCOG1301 (Trigger Study).

    PubMed

    Kataoka, Kozo; Tokunaga, Masanori; Mizusawa, Junki; Machida, Nozomu; Katayama, Hiroshi; Shitara, Kohei; Tomita, Toshihiko; Nakamura, Kenichi; Boku, Narikazu; Sano, Takeshi; Terashima, Masanori; Sasako, Mitsuru

    2015-11-01

    Pre-operative chemotherapy with S-1 plus cisplatin is considered to be acceptable as one of the standard treatment options for gastric cancer patients with extensive lymph node metastases in Japan. Addition of trastuzumab to chemotherapy is shown to be effective for HER2-positive advanced gastric cancer patients, and we have commenced a randomized Phase II trial in March 2015 to evaluate S-1 plus cisplatin plus trastuzumab compared with S-1 plus cisplatin alone in the neoadjuvant setting for HER2-positive gastric cancer patients with ELM, which are followed by adjuvant chemotherapy with S-1 for 1 year. A total of 130 patients will be accrued from 41 Japanese institutions over 3 years. The primary endpoint is overall survival. The secondary endpoints are progression-free survival, response rate of pre-operative chemotherapy, proportion of patients with R0 resection, proportion of patients who complete the pre-operative chemotherapy and surgery, proportion of patients who complete the protocol treatment including post-operative chemotherapy, pathological response rate and adverse events. This trial has been registered in the UMIN Clinical Trials Registry as UMIN 000016920.

  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.

  7. Kinase inhibitors and monoclonal antibodies in oncology: clinical implications.

    PubMed

    Gharwan, Helen; Groninger, Hunter

    2016-04-01

    Molecularly targeted cancer therapies, such as small-molecule kinase inhibitors and monoclonal antibodies, constitute a rapidly growing and an important part of the oncology armamentarium. Unlike conventional (cytotoxic) chemotherapeutics, targeted therapies were designed to disrupt cancer cell pathogenesis at specific biological points essential for the development and progression of the tumour. These agents were developed to disrupt specific targets with the aim of minimizing treatment burden compared with conventional chemotherapy. Nevertheless the increasingly common use of targeted therapies has revealed some unanticipated, often clinically significant toxic effects, as well as compromising effective palliative and end-of-life management approaches. Although patients and clinicians welcome improvements in cancer prognosis, these changes can also impact patient quality-of-life. Therefore, as demand for oncology expertise increases, physicians need to apprise themselves of targeted therapies and their clinical implications, including drug-specific side effects, impact on quality of life, and cost issues, especially in relation to end-of-life care. This Review provides a useful summary and guide for professionals treating patients with malignant diseases.

  8. A Phase II/III randomized controlled trial comparing perioperative versus postoperative chemotherapy with mFOLFOX6 for lower rectal cancer with suspected lateral pelvic node metastasis: Japan Clinical Oncology Group Study JCOG1310 (PRECIOUS study).

    PubMed

    Ohue, Masayuki; Iwasa, Satoru; Kanemitsu, Yukihide; Hamaguchi, Tetsuya; Shiozawa, Manabu; Ito, Masaaki; Yasui, Masayoshi; Katayama, Hiroshi; Mizusawa, Junki; Shimada, Yasuhiro

    2017-01-01

    A randomized phase II/III trial was started in May 2015 comparing perioperative versus postoperative chemotherapy with modified infusional fluorouracil and folinic acid with oxaliplatin for lower rectal cancer patients with suspected lateral pelvic node metastasis. The standard arm is total mesorectal excision or tumor-specific mesorectal excision with lateral pelvic node dissection (LND) followed by postoperative chemotherapy (modified infusional fluorouracil and folinic acid with oxaliplatin; 12 cycles). The experimental (perioperative chemotherapy) arm is six courses of modified infusional fluorouracil and folinic acid with oxaliplatin before and six courses after total mesorectal excision with lateral pelvic node dissection. The aim of this trial is to confirm the superiority of perioperative chemotherapy. A total of 330 patients will be enrolled over 7 years. The primary endpoint in Phase II part is proportion of R0 resection and that in Phase III part is overall survival. Secondary endpoints are progression-free survival, local progression-free survival, etc. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000017603 [http://www.umin.ac.jp/ctr/index-j.htm].

  9. 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

  10. Knowledge Level on Administration of Chemotherapy through Peripheral and Central Venous Catheter among Oncology Nurses

    PubMed Central

    Kapucu, Sevgisun; Özkaraman, Ayşe Özaydın; Uysal, Neşe; Bagcivan, Gulcan; Şeref, Ferhan Çetin; Elöz, Aygül

    2017-01-01

    Objective: The aim of this study is to determine the knowledge levels of oncology nurses about peripheral and central venous catheter during their chemotherapy administration. Methods: Data collection of this descriptive study was started on April 15, 2015–July 15, 2015. The data presented in this summary belong to 165 nurses. Data were collected with data collection form including questions related to sociodemographic qualifications and knowledge levels of nurses. Data collection forms were E-mailed to the members of Turkish Oncology Nursing Society. Data presented with numbers, percentages, and mean ± standard deviation. Results: The mean age of nurses was 33.60 ± 7.34 years and mean duration for oncology nursing experience was 2.65 ± 0.91 years. Nurses had correct information about the importance of selecting peripheral venous catheter and choosing the placement area for chemotherapy administration (63.6%), control of catheter before the administration (93.9%), influence of chemotherapeutic agent on length of catheter (40.6%), and management of extravasation (75.7%). Nurses also had correct information about the first use of port catheter (67.3%) and checking the catheter whether it is working properly or not (75.8%). Conclusions: In General, nurses’ level of knowledge related to catheter is 50% and higher. It is recommended to increase the knowledge of nurses about evidence-based information for catheter care as a step to safe chemotherapy practice. PMID:28217732

  11. 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)

  12. [Hospital information systems ineffectiveness in costing ambulatory chemotherapy in pulmonary oncology].

    PubMed

    Thomas, P; Raholimina, V; Ferri-Dessens, R M; Pibarot, M; Penot Ragon, C; Gregoire, R; Kleisbauer, J P

    2000-06-01

    The real cost of medical consumption was compared with the proportion of medication consumption of (the) GHM n(o) 681 (homogeneous group of patients, chemotherapy for cancer in day care) in the French case mix system (PMSI). For those patients in our thoracic oncology unit (Sainte-Marguerite Hospital, Marseille, France), the real medication cost was calculated from prices paid by the hospital, then compared to the expected expenditures for the medication consumption of the GHM 681, i.e. 678 French francs (24.1% of the 225 ISA points (synthetic activity index)). Over a period of 2 months in 1998, 87 patients (mean age 63 +/- 11) had 194 chemotherapy sessions in day care, with multi-drug therapy in 38 cases. Vinorelbine or gemcitabine represented 81% of the single drug chemotherapy. In 84% of the single drug and 76% of the multi-drug chemotherapy, the real cost of medication consumption was above the allocated budget. The mean cost for single drug chemotherapy was 1722 FF and 2920 FF for multi-drug chemotherapy. The budget allocated by the PMSI shows a deficit in the most cases. To avoid a restriction in the use of some drugs, it appears that the French system of budget evaluation needs to be improved.

  13. 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

  14. Selenium in oncology: from chemistry to clinics.

    PubMed

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

    2009-10-12

    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

  15. Protection behaviors for cytotoxic drugs in oncology nurses of chemotherapy centers in Shiraz hospitals, South of Iran

    PubMed Central

    Abbasi, Khadijeh; Hazrati, Maryam; Mohammadbeigi, Abolfazl; Ansari, Jasem; Sajadi, Mahboubeh; Hosseinnazzhad, Azam; Moshiri, Esmail

    2016-01-01

    Context: The use of antineoplastic agents for the treatment of cancer is an increasingly common practice in hospitals. As a result, workers involved with handling antineoplastic drugs may be accidentally exposed to these agents, placing them at potential risk for long-term adverse effects. This study aimed to determine the occupational protection status of clinical nursing staff exposed to cytotoxic drugs. Subjects and Methods: The study was designed as an analytic descriptive survey. The research settings took place in six centers of chemotherapy in Shiraz, Iran. The participants were 86 nurses who worked in oncology units and administered cytotoxic drugs. Data were collected using a questionnaire and a checklist which was developed by the investigators to determine occupational protection status of clinical nursing staff exposed to cytotoxic drugs. Percentage calculations and the independent samples t-test were used to see the general distribution and analysis of data. To statistically analyze of the data, SPSS software (version 16) was applied. Results: The mean age of participants was 30.52 ± 6.50 years and 66.27% of the nurses worked on inpatient oncology wards. The mean practice score was 21.1 ± 3.76 that ranged from 12.5 to 31. The independent samples t-test showed the outpatient nurses were weaker in practice (17.2 ± 2.52) in comparison with university hospitals (23.35 ± 3.02, P < 0.001). Occupational protection status of clinical nursing staff exposed to cytotoxic drugs especially during administration and disposal of medicines was poor and rarely trained with this subject and was observed under the standard conditions. Conclusions: There is deficiency in the understanding and related protection practices of clinical nursing staff vocationally exposed to cytotoxic drugs. It is recommended that all clinical nursing staff should receive full occupational protection training about these matters and the authorities provide standard conditions of oncology

  16. 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 patent's age…

  17. 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

  18. How to Develop a Cardio-Oncology Clinic.

    PubMed

    Snipelisky, David; Park, Jae Yoon; Lerman, Amir; Mulvagh, Sharon; Lin, Grace; Pereira, Naveen; Rodriguez-Porcel, Martin; Villarraga, Hector R; Herrmann, Joerg

    2017-04-01

    Cardiovascular demands to the care of cancer patients are common and important given the implications for morbidity and mortality. As a consequence, interactions with cardiovascular disease specialists have intensified to the point of the development of a new discipline termed cardio-oncology. As an additional consequence, so-called cardio-oncology clinics have emerged, in most cases staffed by cardiologists with an interest in the field. This article addresses this gap and summarizes key points in the development of a cardio-oncology clinic.

  19. American Society of Clinical Oncology National Census of Oncology Practices: preliminary report.

    PubMed

    Forte, Gaetano J; Hanley, Amy; Hagerty, Karen; Kurup, Anupama; Neuss, Michael N; Mulvey, Therese M

    2013-01-01

    In response to reports of increasing financial and administrative burdens on oncology practices and a lack of systematic information related to these issues, American Society of Clinical Oncology (ASCO) leadership started an effort to collect key practice-level data from all oncology practices in the United States. The result of the effort is the ASCO National Census of Oncology Practices (Census) launched in June 2012. The initial Census work involved compiling an inventory of oncology practices from existing lists of oncology physicians in the United States. A comprehensive, online data collection instrument was developed, which covered a number of areas, including practice characteristics (staffing configuration, organizational structure, patient mix and volume, types of services offered); organizational, staffing, and service changes over the past 12 months; and an assessment of the likelihood that the practice would experience organizational, staffing, and service changes in the next 12 months. More than 600 practices participated in the Census by providing information. In this article, we present preliminary highlights from the data gathered to date. We found that practice size was related to having experienced practice mergers, hiring additional staff, and increasing staff pay in the past 12 months, that geographic location was related to having experienced hiring additional staff, and that practices in metropolitan areas were more likely to have experienced practice mergers in the past 12 months than those in nonmetropolitan areas. We also found that practice size and geographic location were related to higher likelihoods of anticipating practice mergers, sales, and purchases in the future.

  20. [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.

  1. 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

  2. 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.

  3. 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.

  4. 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

    2016-01-01

    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.

  5. 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.

  6. Platinum-based Chemotherapy in Primary Advanced Seminoma—a Retrospective Analysis: Treatment Results at the Northern Israel Oncology Center (1989–2010)

    PubMed Central

    Stein, Moshe E.; Drumea, Karen; Charas, Tomer; Gershuny, Anthony; Ben-Yosef, Rahamim

    2014-01-01

    Objective: Over the past 30 years, great strides have been made in the treatment of disseminated testicular tumors. Despite the low number of patients and the rarity of studies concerning primary advanced seminoma, the efficacy of chemotherapy is clear, mainly 3–4-cisplatin-based chemotherapy. Aiming to contribute to the understanding and implementation of proper chemotherapeutic management in advanced seminoma patients, we retrospectively summarized our experience with 26 patients who were referred for platinum-based chemotherapy, post-orchiectomy to the Northern Israel Oncology Center between 1989 and 2010. Response rate, side effects, and long-term outcome were investigated. Methods: Before chemotherapy, meticulous staging was done, including tumor markers (B-human chorionic gonadotropin (B-HCG), alpha-fetoprotein (AFP), and lactic dehydrogenase (LDH)), and abdominal and pelvic computerized tomography (CT) scans were carried out. Results: All 26 treated patients achieved complete remission, clinically and symptomatically, with normalization of their CT scans. At a median follow-up of 120 months (range, 24–268 months) all patients are alive, without evidence of recurrent disease. One patient whose disease recurred twice achieved a third complete remission following salvage treatment with high-dose chemotherapy and autologous peripheral stem cell transplantation. Another patient, who preferred surveillance, relapsed abdominally after 9 months but achieved long-standing complete remission with cisplatin-based chemotherapy. Both these patients are alive with no evidence of disease. Three patients recovered uneventfully from bleomycin-induced pneumonitis. Conclusions: Advanced seminoma is a highly curable disease using platinum-based chemotherapy. Our study confirms the efficacy and safety of cisplatin-based chemotherapy in the treatment of advanced seminoma. PMID:24498512

  7. Induction chemotherapy-based larynx preservation program for locally advanced hypopharyngeal cancer: oncologic and functional outcomes and prognostic factors.

    PubMed

    Bozec, Alexandre; Benezery, Karen; Ettaiche, Marc; Chamorey, Emmanuel; Vandersteen, Clair; Dassonville, Olivier; Poissonnet, Gilles; Riss, Jean-Christophe; Hannoun-Lévi, Jean-Michel; Chand, Marie-Eve; Leysalle, Axel; Saada, Esma; Guigay, Joël; Sudaka, Anne; Demard, François; Santini, José; Peyrade, Frédéric

    2016-10-01

    To evaluate oncologic and functional outcomes and prognostic factors in patients with locally advanced hypopharyngeal cancer included in an induction chemotherapy (ICT)-based larynx preservation program in daily clinical practice. All patients with locally advanced (T3/4, N0-3, M0) hypopharyngeal squamous cell carcinoma, technically suitable for total pharyngo-laryngectomy, treated by docetaxel (75 mg/m(2), day 1), cisplatin (75 mg/m(2), day 1) and 5-fluorouracil (750 mg/m(2)/day, day 1-5) (TPF)-ICT (2-3 cycles) for larynx preservation at our institution between 2004 and 2013, were included in this retrospective study. Prognostic factors of oncologic (overall, cause-specific and recurrence-free survival: OS, SS and RFS) and functional (dysphagia outcome and severity scale, permanent enteral nutrition, larynx preservation) outcomes were assessed in univariate and multivariate analyses. A total of 53 patients (42 men and 11 women, mean age 58.6 ± 8.2 years) were included in this study. Grade 3-4 toxicities were experienced by 17 (32 %) patients during ICT. The rate of poor response (response <50 % without larynx remobilization) to ICT was 10 %. At 5 years, OS, SS and RFS rates were 56, 60 and 54 %, respectively. Four patients required definitive enteral nutrition (permanent enteral tube feeding). The rate of patients alive, disease-free and with a functional larynx at 2 years was 58 %. T4 tumor stage (p = 0.005) and response to ICT <50 % (p = 0.02) were independent prognostic factors of OS. Response to ICT was significantly associated with the risk of permanent enteral nutrition (p = 0.04) and larynx preservation (p = 0.01). In daily clinical practice, a TPF-ICT-based larynx preservation protocol can be used in patients with locally advanced hypopharyngeal cancer with satisfactory results in terms of tolerance, efficacy and oncologic and functional outcomes.

  8. Antidrug Antibody Formation in Oncology: Clinical Relevance and Challenges.

    PubMed

    van Brummelen, Emilie M J; Ros, Willeke; Wolbink, Gertjan; Beijnen, Jos H; Schellens, Jan H M

    2016-10-01

    : In oncology, an increasing number of targeted anticancer agents and immunotherapies are of biological origin. These biological drugs may trigger immune responses that lead to the formation of antidrug antibodies (ADAs). ADAs are directed against immunogenic parts of the drug and may affect efficacy and safety. In other medical fields, such as rheumatology and hematology, the relevance of ADA formation is well established. However, the relevance of ADAs in oncology is just starting to be recognized, and literature on this topic is scarce. In an attempt to fill this gap in the literature, we provide an up-to-date status of ADA formation in oncology. In this focused review, data on ADAs was extracted from 81 clinical trials with biological anticancer agents. We found that most biological anticancer drugs in these trials are immunogenic and induce ADAs (63%). However, it is difficult to establish the clinical relevance of these ADAs. In order to determine this relevance, the possible effects of ADAs on pharmacokinetics, efficacy, and safety parameters need to be investigated. Our data show that this was done in fewer than 50% of the trials. In addition, we describe the incidence and consequences of ADAs for registered agents. We highlight the challenges in ADA detection and argue for the importance of validating, standardizing, and describing well the used assays. Finally, we discuss prevention strategies such as immunosuppression and regimen adaptations. We encourage the launch of clinical trials that explore these strategies in oncology.

  9. Potentially Curable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update.

    PubMed

    Khorana, Alok A; Mangu, Pamela B; Berlin, Jordan; Engebretson, Anitra; Hong, Theodore S; Maitra, Anirban; Mohile, Supriya G; Mumber, Matthew; Schulick, Richard; Shapiro, Marc; Urba, Susan; Zeh, Herbert J; Katz, Matthew H G

    2017-04-11

    Purpose To update the Potentially Curable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline published on May 31, 2016. The October 2016 update focuses solely on new evidence that pertains to clinical question 4 of the guideline: What is the appropriate adjuvant regimen for patients with pancreatic cancer who have undergone an R0 or R1 resection of their primary tumor? Methods The recently published results of a randomized phase III study prompted an update of this guideline. The high quality of the reported evidence and the potential for its clinical impact prompted the Expert Panel to revise one of the guideline recommendations. Results The ESPAC-4 study, a multicenter, international, open-label randomized controlled phase III trial of adjuvant combination chemotherapy compared gemcitabine and capecitabine with gemcitabine monotherapy in 730 evaluable patients with resected pancreatic ductal adenocarcinoma. Median overall survival was improved in the doublet arm to 28.0 months (95% CI, 23.5 to 31.5 months) versus 25.5 months (95% CI, 22.7 to 27.9 months) for gemcitabine alone (hazard ratio, 0.82; 95% CI, 0.68 to 0.98; P = .032). Grade 3 and 4 adverse events were similar in both arms, although higher rates of hand-foot syndrome and diarrhea occurred in patients randomly assigned to the doublet arm. Recommendations All patients with resected pancreatic cancer who did not receive preoperative therapy should be offered 6 months of adjuvant chemotherapy in the absence of medical or surgical contraindications. The doublet regimen of gemcitabine and capecitabine is preferred in the absence of concerns for toxicity or tolerance; alternatively, monotherapy with gemcitabine or fluorouracil plus folinic acid can be offered. Adjuvant treatment should be initiated within 8 weeks of surgical resection, assuming complete recovery. The remaining recommendations from the original 2016 ASCO guideline are unchanged.

  10. Clinical Trials and the Role of the Oncology Clinical Trials Nurse.

    PubMed

    Ness, Elizabeth A; Royce, Cheryl

    2017-03-01

    Clinical trials are paramount to improving human health. New trial designs and informed consent issues are emerging as a result of genomic profiling and the development of molecularly targeted agents. Many groups and individuals are responsible for ensuring the protection of research participants and the quality of the data produced. The specialty role of the clinical trials nurse (CTN) is critical to clinical trials. Oncology CTNs have competencies that can help guide their practice; however, not all oncology clinical trials are supervised by a nurse. Using the process of engagement, one organization has restructured oncology CTNs under a nurse-supervised model.

  11. 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

  12. Optimizing the Design of Preprinted Orders for Ambulatory Chemotherapy: Combining Oncology, Human Factors, and Graphic Design

    PubMed Central

    Jeon, Jennifer; White, Rachel E.; Hunt, Richard G.; Cassano-Piché, Andrea L.; Easty, Anthony C.

    2012-01-01

    Purpose: To establish a set of guidelines for developing ambulatory chemotherapy preprinted orders. Methods: Multiple methods were used to develop the preprinted order guidelines. These included (A) a comprehensive literature review and an environmental scan; (B) analyses of field study observations and incident reports; (C) critical review of evidence from the literature and the field study observation analyses; (D) review of the draft guidelines by a clinical advisory group; and (E) collaboration with graphic designers to develop sample preprinted orders, refine the design guidelines, and format the resulting content. Results: The Guidelines for Developing Ambulatory Chemotherapy Preprinted Orders, which consist of guidance on the design process, content, and graphic design elements of ambulatory chemotherapy preprinted orders, have been established. Conclusion: Health care is a safety critical, dynamic, and complex sociotechnical system. Identifying safety risks in such a system and effectively addressing them often require the expertise of multiple disciplines. This study illustrates how human factors professionals, clinicians, and designers can leverage each other's expertise to uncover commonly overlooked patient safety hazards and to provide health care professionals with innovative, practical, and user-centered tools to minimize those hazards. PMID:23077436

  13. Clinical oncologic applications of PET/MRI: a new horizon

    PubMed Central

    Partovi, Sasan; Kohan, Andres; Rubbert, Christian; Vercher-Conejero, Jose Luis; Gaeta, Chiara; Yuh, Roger; Zipp, Lisa; Herrmann, Karin A; Robbin, Mark R; Lee, Zhenghong; Muzic, Raymond F; Faulhaber, Peter; Ros, Pablo R

    2014-01-01

    Positron emission tomography/magnetic resonance imaging (PET/MRI) leverages the high soft-tissue contrast and the functional sequences of MR with the molecular information of PET in one single, hybrid imaging technology. This technology, which was recently introduced into the clinical arena in a few medical centers worldwide, provides information about tumor biology and microenvironment. Studies on indirect PET/MRI (use of positron emission tomography/computed tomography (PET/CT) images software fused with MRI images) have already generated interesting preliminary data to pave the ground for potential applications of PET/MRI. These initial data convey that PET/MRI is promising in neuro-oncology and head & neck cancer applications as well as neoplasms in the abdomen and pelvis. The pediatric and young adult oncology population requiring frequent follow-up studies as well as pregnant woman might benefit from PET/MRI due to its lower ionizing radiation dose. The indication and planning of therapeutic interventions and specifically radiation therapy in individual patients could be and to a certain extent are already facilitated by performing PET/MRI. The objective of this article is to discuss potential clinical oncology indications of PET/MRI. PMID:24753986

  14. MRI Biomarkers in Oncology Clinical Trials

    PubMed Central

    Abramson, Richard G.; Arlinghaus, Lori; Dula, Adrienne; Quarles, C. Chad; Stokes, Ashley; Weis, Jared; Whisenant, Jennifer; Chekmenev, Eduard Y.; Zhukov, Igor; Williams, Jason; Yankeelov, Thomas

    2015-01-01

    Quantitative magnetic resonance imaging (MRI) techniques have the ability to quantitatively report various pathophysiological processes associated with cancer. These measures have been shown to provide complementary information to that typically obtained from standard morphologically based criteria (e.g., size) and, furthermore, have been shown to outperform sized based measures in certain applications. In this review, we discuss eight areas of quantitative MRI that are either currently employed in clinical trials, or are emerging as promising techniques for both diagnosing cancer as well as assessing—or even predicting—the response of cancer to various therapies. The currently employed methods include the response evaluation criteria in solid tumors (RECIST), dynamic susceptibility MRI (DSC-MRI), dynamic contrast enhanced MRI (DCE-MRI), and diffusion weighted imaging (DWI). The emerging techniques covered are chemical exchange saturation transfer MRI (CEST-MRI), elastography, hyperpolarized MRI, and multi-parameter MRI. After a brief introduction to each technique, we present a small number of illustrative applications before noting the existing limitations of each method and what must be done to move each to more routine clinical application. PMID:26613873

  15. Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology Clinical Practice Guideline Update.

    PubMed

    Ferrell, Betty R; Temel, Jennifer S; Temin, Sarah; Alesi, Erin R; Balboni, Tracy A; Basch, Ethan M; Firn, Janice I; Paice, Judith A; Peppercorn, Jeffrey M; Phillips, Tanyanika; Stovall, Ellen L; Zimmermann, Camilla; Smith, Thomas J

    2017-01-01

    Purpose To provide evidence-based recommendations to oncology clinicians, patients, family and friend caregivers, and palliative care specialists to update the 2012 American Society of Clinical Oncology (ASCO) provisional clinical opinion (PCO) on the integration of palliative care into standard oncology care for all patients diagnosed with cancer. Methods ASCO convened an Expert Panel of members of the ASCO Ad Hoc Palliative Care Expert Panel to develop an update. The 2012 PCO was based on a review of a randomized controlled trial (RCT) by the National Cancer Institute Physicians Data Query and additional trials. The panel conducted an updated systematic review seeking randomized clinical trials, systematic reviews, and meta-analyses, as well as secondary analyses of RCTs in the 2012 PCO, published from March 2010 to January 2016. Results The guideline update reflects changes in evidence since the previous guideline. Nine RCTs, one quasiexperimental trial, and five secondary analyses from RCTs in the 2012 PCO on providing palliative care services to patients with cancer and/or their caregivers, including family caregivers, were found to inform the update. Recommendations Inpatients and outpatients with advanced cancer should receive dedicated palliative care services, early in the disease course, concurrent with active treatment. Referral of patients to interdisciplinary palliative care teams is optimal, and services may complement existing programs. Providers may refer family and friend caregivers of patients with early or advanced cancer to palliative care services.

  16. 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.

  17. 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

  18. Chemotherapy

    MedlinePlus

    ... the cancer cells. This is called palliative chemotherapy. Chemotherapy for conditions other than cancer Some chemotherapy drugs ... you'll receive. Side effects that occur during chemotherapy treatment Common side effects of chemotherapy drugs include: ...

  19. [Refining the French system of cost assessment for oncology patients following chemotherapy].

    PubMed

    Lévy-Piedbois, Christine; Borella, Laurent; Bergerot, Philippe; Peuvrel, Patrick; Erard, Cristel; Parmentier, Gérard; Ravaud, Alain; Trombert Paviot, Béatrice; Armand, Jean-Pierre; Rodrigues, Jean-Marie

    2003-11-01

    The aim of this study was to check the clinical predictive variables of the variance of the total cost by GHM for patients undergoing chemotherapy. 10 different hospitals registered 537 hospital stays and 1,535 day care sessions. The initial disease, metastases, other pathologies, participation to randomised trial were recorded. Each day health status, pain, stage of the protocol and the drugs, use of catheter, pump or chamber implant were noted. Work was measured separately for physicians and nurses per 24 hours using a visual analogy scale. Lab tests and drugs were recorded for each patient. The cost of the drugs explain 98% of the variance of the total cost for the day care and 50% for the hospitalisations. For the latter, beside the cost of drugs, the length of stay, labor, initial disease, age, pain and associated pathology are predictive variables. According to this results, we conclude that the drugs for chemotherapy should be paid separately. No other change should be made for day care. DRG for hospitalized patients should take into account initial disease, age and pain.

  20. Updates in Gastrointestinal Oncology – insights from the 2008 44th annual meeting of the American Society of Clinical Oncology

    PubMed Central

    Javle, Milind; Hsueh, Chung-Tsen

    2009-01-01

    We have reviewed the pivotal presentations rcelated to colorectal cancer (CRC) and other gastrointestinal malignancies from 2008 annual meeting of the American Society of Clinical Oncology (ASCO). We have discussed the scientific findings and the impact on practice guidelines and ongoing clinical trials. The report on KRAS status in patients with metastatic CRC receiving epidermal growth factor receptor (EGFR) targeted antibody treatment has led to a change in National Comprehensive Cancer Network guideline that recommends only patients with wild-type KRAS tumor should receive this treatment. The results of double biologics (bevacizumab and anti-EGFR antibody) plus chemotherapy as first-line treatment in patients with metastatic CRC has shown a worse outcome than bevacizumab-based regimen. Microsatellite Instability has again been confirmed to be an important predictor in patients with stage II colon cancer receiving adjuvant treatment. Adjuvant gemcitabine therapy for pancreatic cancer was investigated by the CONKO-001 study; this resulted in superior survival as compared with observation and can be regarded as an acceptable option, without the addition of radiotherapy. The addition of bevacizumab to gemcitabine and erlotinib was not supior to gemcitabine and erlotinib for advanced disease. Second-line therapy for advanced pancreatic cancer with 5-fluorouracil and oxaliplatin resulted in a survival benefit. Irinotecan plus cisplatin and paclitaxel plus cisplatin result in similar survival when combined with radiotherapy for esophageal cancer. The novel fluoropyrimidine S1 appears to be active in gastric cancer, as a single agent or as combination therapy. Adjuvant intraperitoneal mitomycin-C may decrease the incidence of peritoneal recurrence of gastric cancer. Sorafenib is an effective agent in Asian patients with hepatocellular carcinoma secondary to hepatitis B; its utility in child's B cirrhosis remains to be proven. Sunitinib is also an active agent in

  1. Chemotherapy

    MedlinePlus

    Cancer chemotherapy; Cancer drug therapy; Cytotoxic chemotherapy ... Philadelphia, PA: Elsevier Saunders; 2016:chap 179. National Cancer Institute. Chemotherapy and you: support for people who have cancer. ...

  2. The use of combinations of monoclonal antibodies in clinical oncology.

    PubMed

    Henricks, Linda M; Schellens, Jan H M; Huitema, Alwin D R; Beijnen, Jos H

    2015-12-01

    Treatment with monoclonal antibodies is becoming increasingly important in clinical oncology. These antibodies specifically inhibit signaling pathways in tumor growth and/or induce immunological responses against tumor cells. By combining monoclonal antibodies several pathways may be targeted simultaneously, potentially leading to additive or synergistic effects. Theoretically, antibodies are very suitable for use in combination therapy, because of limited overlapping toxicity and lack of pharmacokinetic interactions. In this article an overview is given of preclinical and clinical data on twenty-five different combinations of antibodies in oncology. Some of these combinations have proven clinical benefit, for example the combination of trastuzumab and pertuzumab in HER2-positive breast cancer, which exemplifies an additive or synergistic effect on antitumor activity in clinical studies and the combination of nivolumab and ipilimumab, which results in significant increases in progression-free and overall survival in patients with advanced melanoma. However, other combinations may lead to unfavorable results, such as bevacizumab with cetuximab or panitumumab in advanced colorectal cancer. These combinations result in shorter progression-free survival and increased toxicity compared to therapy with a single antibody. In summary, the different published studies showed widely varying results, depending on the combination of antibodies, indication and patient population. More preclinical and clinical studies are necessary to unravel the mechanisms behind synergistic or antagonistic effects of combining monoclonal antibodies. Most research on combination therapies is still in an early stage, but it is expected that for several tumor types the use of combination therapy of antibodies will become standard of care in the near future.

  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. Toward a science of tumor forecasting for clinical oncology.

    PubMed

    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. 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.

  5. Towards a Science of Tumor Forecasting for Clinical Oncology

    PubMed Central

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

    2015-01-01

    We propose that the quantitative cancer biology community make 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 exam or imaging methods. This fundamental practice within clinical oncology limits optimization of atreatment 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. With a successful methodology towards tumor forecasting, it should be possible to integrate large tumor specific datasets of varied types, and effectively defeat cancer one patient at a time. PMID:25592148

  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 PAGES

    Yankeelov, Thomas E.; Quaranta, Vito; Evans, Katherine J.; ...

    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

    2016-06-02

    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.

  9. Chemotherapy-induced peripheral neuropathy: a review and implications for oncology nursing practice.

    PubMed

    Wickham, Rita

    2007-06-01

    Advances in supportive care have increased the likelihood that previously less common adverse effects of chemotherapy will be more evident. The incidence of chemotherapy-induced peripheral neuropathy (CIPN) is increasing because more neurotoxic drugs have been developed and because patients are living longer and receiving multiple chemotherapy regimens. This article reviews the anatomy of the peripheral nervous system, the proposed mechanisms of CIPN, and manifestations of CIPN from vinca alkaloids, taxanes, and platinum analogs. Major topics of this article are evidence-based data regarding symptom management, a review of medical management, and a synthesis of nursing care for patients at risk for or experiencing CIPN.

  10. 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

    Martín, Andrés J Muñoz; Alfonso, Pilar García; Rupérez, Ana B; Jiménez, Miguel Martín

    2016-07-01

    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.

  11. Hereditary Colorectal Cancer Syndromes: American Society of Clinical Oncology Clinical Practice Guideline Endorsement of the Familial Risk–Colorectal Cancer: European Society for Medical Oncology Clinical Practice Guidelines

    PubMed Central

    Stoffel, Elena M.; Mangu, Pamela B.; Gruber, Stephen B.; Hamilton, Stanley R.; Kalady, Matthew F.; Lau, Michelle Wan Yee; Lu, Karen H.; Roach, Nancy; Limburg, Paul J.

    2015-01-01

    Purpose To provide recommendations on prevention, screening, genetics, treatment, and management for people at risk for hereditary colorectal cancer (CRC) syndromes. The American Society of Clinical Oncology (ASCO) has a policy and set of procedures for endorsing clinical practice guidelines that have been developed by other professional organizations. Methods The Familial Risk–Colorectal Cancer: European Society for Medical Oncology Clinical Practice Guideline published in 2013 on behalf of the European Society for Medical Oncology (ESMO) Guidelines Working Group in Annals of Oncology was reviewed for developmental rigor by methodologists, with content and recommendations reviewed by an ASCO endorsement panel. Results The ASCO endorsement panel determined that the recommendations of the ESMO guidelines are clear, thorough, and based on the most relevant scientific evidence. The ASCO panel endorsed the ESMO guidelines and added a few qualifying statements. Recommendations Approximately 5% to 6% of patient cases of CRC are associated with germline mutations that confer an inherited predisposition for cancer. The possibility of a hereditary cancer syndrome should be assessed for every patient at the time of CRC diagnosis. A diagnosis of Lynch syndrome, familial adenomatous polyposis, or another genetic syndrome can influence clinical management for patients with CRC and their family members. Screening for hereditary cancer syndromes in patients with CRC should include review of personal and family histories and testing of tumors for DNA mismatch repair deficiency and/or microsatellite instability. Formal genetic evaluation is recommended for individuals who meet defined criteria. PMID:25452455

  12. Phase 0 clinical trials in oncology new drug development

    PubMed Central

    Gupta, Umesh Chandra; Bhatia, Sandeep; Garg, Amit; Sharma, Amit; Choudhary, Vaibhav

    2011-01-01

    Research focus of pharmaceutical industry has expanded to a larger extent in last few decades putting many more new molecules, particularly targeted agents, for the clinical development. On the other hand, researchers are facing serious challenges due to high failure rates of new molecules in clinical studies. The United States Food and Drug Administration (FDA) in combination with academia and industry experts identified many factors responsible for failures of new molecules, and with a vision of taking traditional drug development model toward an innovative paradigm shift, issued regulatory guidance on conduct of exploratory investigational new drug (exploratory IND) studies, often called as phase 0 clinical trials, requiring reduced preclinical testing, which has special relevance to life-threatening diseases such as cancer. Phase 0 trials, utilizing much lower drug doses, provide an opportunity to explore the clinical behavior of new molecules very early in the drug development pathway, helping to identify the promising candidates and eliminating non-promising molecules, thus improving the efficiency of overall drug development with significant savings of resources. Being non-therapeutic in nature, these studies, however, pose certain ethical challenges requiring careful study designing and informed consent process. This article reviews the insights and perspectives for the feasibility, utility, planning, designing and conduct of phase 0 clinical trials, in addition to ethical issues and industrial perspective focused at oncology new drug development. PMID:21584177

  13. Phase 0 clinical trials in oncology new drug development.

    PubMed

    Gupta, Umesh Chandra; Bhatia, Sandeep; Garg, Amit; Sharma, Amit; Choudhary, Vaibhav

    2011-01-01

    Research focus of pharmaceutical industry has expanded to a larger extent in last few decades putting many more new molecules, particularly targeted agents, for the clinical development. On the other hand, researchers are facing serious challenges due to high failure rates of new molecules in clinical studies. The United States Food and Drug Administration (FDA) in combination with academia and industry experts identified many factors responsible for failures of new molecules, and with a vision of taking traditional drug development model toward an innovative paradigm shift, issued regulatory guidance on conduct of exploratory investigational new drug (exploratory IND) studies, often called as phase 0 clinical trials, requiring reduced preclinical testing, which has special relevance to life-threatening diseases such as cancer. Phase 0 trials, utilizing much lower drug doses, provide an opportunity to explore the clinical behavior of new molecules very early in the drug development pathway, helping to identify the promising candidates and eliminating non-promising molecules, thus improving the efficiency of overall drug development with significant savings of resources. Being non-therapeutic in nature, these studies, however, pose certain ethical challenges requiring careful study designing and informed consent process. This article reviews the insights and perspectives for the feasibility, utility, planning, designing and conduct of phase 0 clinical trials, in addition to ethical issues and industrial perspective focused at oncology new drug development.

  14. [Report of the 10th Annual Meeting of the Chinese society of Clinical Oncology].

    PubMed

    Cho, William Chi-Shing

    2008-03-01

    The 10th Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) was held on 19-23 September 2007 in Harbin. The theme of this conference was "putting standard multidisciplinary cancer management into practice" and special reports of standard multidisciplinary management on various cancers were presented. Over 3 500 clinical oncologists and scientists participated in the 2007 CSCO Annual Meeting where more than ten international top experts were invited to exchange valuable experiences with the delegates. The programs consisted of Education Session, Satellite Symposium and Meet the Professor Session. The latest research results were presented as oral presentations and posters at the congress. Several hotspots were particularly highlighted in this report, including innovative radiotherapy and chemotherapy methods, researches on molecular targets and clinical trials of targeted therapy, such as endostatin, volociximab, cetuximab, bevacizumab and temozolomide. The remarkable research results of anti-cancer Chinese medicine, cancer screening and prognosis were also introduced. This article tries to call the attention to some hot topics in the program that are both new and noteworthy, and it may serve as a highlight of this important international cancer research meeting for clinical oncologists and scientists.

  15. 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

  16. 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

  17. [Clinical relevance of immunotyping of oncologic and hematologic diseases].

    PubMed

    Diehl, V; Pfreundschuh, M

    1987-06-01

    Progress in immunology and molecular biology have provided a better understanding of etiology, pathogenesis and biology of many oncological and hematological diseases. In clinical practice, certain new methods of immunotyping (IT) are of diagnostic importance in assigning undifferentiated tumors to lymphoid, epithelial or mesenchymal origin and in defining subgroups of leukemias and lymphomas. The demonstration of rearrangements of gene coding for immunoglobulins or T-cell receptors assigns hematological malignancies of early differentiation to the B- or T-cell lineage, discriminates between reactive lymphoid changes and clonal lymphoid expansion and detects persistent clonal growth after therapy. In certain clinical entities (e.g. ALL) the immunological subtypes are of importance for differential therapy. By means of IT new clinical entities have been defined (Ki-1-lymphoma, T gamma-lymphoproliferative, LFA-1-deficiency) and the pathomechanisms of others have been elucidated (Bernard-Soulier-disease Syndrome, Glanzmann-Nägeli thrombasthenia). Of immediate therapeutic importance is the identification by IT of receptors for specific hormones or biological response modifiers on malignant cells. In-vivo diagnosis by monoclonal antibodies opens a way to define more exactly the extent of malignant disease by scintigrams or NMR.

  18. Metronomic chemotherapy.

    PubMed

    Mutsaers, Anthony J

    2009-08-01

    Chemotherapy drugs are usually administered at doses that are high enough to result in an obligatory break period to allow for the observation of potential side effects and institution of supportive care, if required. In recent years, efforts to administer chemotherapy on a more continuous basis, with a much shorter break period, or none at all, have received increased interest, and the practice has come to be known as metronomic chemotherapy. The basis for success with this currently investigational approach may be rooted in continuous drug exposure to susceptible cancer cells, inhibition of tumor blood vessel growth-a process known as tumor angiogenesis, and/or alterations in tumor immunology. Increased benefit also appears to occur when metronomic chemotherapy is used in combination with newer, targeted antiangiogenic agents, and therefore represents a promising approach to combination therapy, particularly as targeted oncology drugs make their way into veterinary oncology applications. There is still much to be learned in this field, especially with regard to optimization of the proper drugs, dose, schedule, and tumor applications. However, the low cost, ease of administration, and acceptable toxicity profiles potentially associated with this therapeutic strategy make metronomic chemotherapy protocols attractive and suitable to veterinary applications. Preliminary clinical trial results have now been reported in both human and veterinary medicine, including adjuvant treatment of canine splenic hemangiosarcoma and incompletely resected soft tissue sarcoma, and, further, more powerful studies are currently ongoing.

  19. The role of the clinical research coordinator – data manager – in oncology clinical trials

    PubMed Central

    Rico-Villademoros, Fernando; Hernando, Teresa; Sanz, Juan-Luis; López-Alonso, Antonio; Salamanca, Oscar; Camps, Carlos; Rosell, Rafael

    2004-01-01

    Background The purpose of this study was to determine the standard tasks performed by clinical research coordinators (CRCs) in oncology clinical trials. Methods Forty-one CRCs were anonymously surveyed, using a four-page self-administered questionnaire focused on demographics, qualifications, and professional experience. The survey questions on responsibilities consisted of an ad-hoc 32-item questionnaire where respondents had to rate the frequency of involvement in the listed activities using a 3-point scale. We defined as "standard" a task that was rated as "in all or nearly all trials" by at least half of the respondents. Results A response rate of 90% (37 out of 41) was achieved after two mailings. Less than half of the respondents had received additional training in oncology, clinical research or Good Clinical Practices (GCP). Overall, all standard tasks performed by CRCs were in the category of "monitoring activities" (those usually performed by a Clinical Research Associate "CRA") and included patient registration/randomization, recruitment follow-up, case report form completion, collaboration with the CRA, serious adverse events reporting, handling of investigator files, and preparing the site for and/or attending audits. Conclusions CRCs play a key role in the implementation of oncology clinical trials, which goes far beyond mere data collection and/or administrative support, and directly contributes to the gathering of good quality data. PMID:15043760

  20. Phase 3 Oncology Clinical Trials in South Africa: Experimentation or Therapeutic Misconception?

    PubMed

    Malan, Tina; Moodley, Keymanthri

    2016-02-01

    Although clinical research in oncology is vital to improve current understanding of cancer and to validate new treatment options, voluntary informed consent is a critical component. Oncology research participants are a particularly vulnerable population; hence, therapeutic misconception often leads to ethical and legal challenges. We conducted a qualitative study administering semi-structured questionnaires on 29 adult, Phase 3, oncology clinical trial participants at three different private oncology clinical trial sites in South Africa. A descriptive content analysis was performed to identify perceptions of these participants regarding Phase 3 clinical trials. We found that most participants provided consent to be included in the trial for self-benefit. More than half of the participants had a poor understanding of Phase 3 clinical trials, and almost half the participants believed the clinical trial did not pose any significant risk to them. The word "hope" was used frequently by participants, displaying clear optimism with regard to the clinical trial and its outcome. This indicated that therapeutic misconception does occur in the South African oncology research setting and has the potential to lead to underestimation of the risks of a Phase 3 clinical trial. Emphasizing the experimental nature of a clinical trial during the consent process is critical to address therapeutic misconception in oncology research.

  1. Practical use of perioperative chemotherapy for muscle-invasive bladder cancer: summary of session at the Society of Urologic Oncology annual meeting.

    PubMed

    Apolo, Andrea B; Grossman, Herbert Barton; Bajorin, Dean; Steinberg, Gary; Kamat, Ashish M

    2012-01-01

    At the 11th annual meeting of the Society of Urologic Oncology, an expert panel was convened to discuss the practical use of perioperative chemotherapy for muscle-invasive bladder cancer. The discussion was structured as a case-based debate among the panelists. The topics included: neoadjuvant chemotherapy with a focus on T2 disease, pros and cons, survival data, tolerability of cisplatin-based therapy, can we avoid radical cystectomy in complete responders, limitations and alternatives to cisplatin-based therapy, management of 'suboptimal' chemotherapy, residual disease after neoadjuvant chemotherapy, adjuvant chemotherapy, and key aspects of radical cystectomy and lymph-node dissection in multimodal therapy. The presentations were derived from published literature. The panelists agreed that patients with muscle-invasive bladder cancer should be managed with a multidisciplinary team, including urologist and medical oncologist. Cisplatin-based neoadjuvant chemotherapy has demonstrated improved survival and should be incorporated into the management of all eligible patients with muscle-invasive bladder cancer. However, in some centers, neoadjuvant chemotherapy is reserved for patients with >T2 disease or high-risk features. There are no data for the administration of non-cisplatin-based neoadjuvant chemotherapy, such as carboplatin-combinations. Cisplatin-ineligible patients should proceed directly to surgical extirpation with adjuvant cisplatin-based chemotherapy considered based on pathologic findings. However, the data for adjuvant chemotherapy is less compelling. As our refinement of the selection process continues, we may be able to better identify subsets of patients who may be spared chemotherapy, but much work remains to be done in this arena. The current standard for muscle-invasive bladder cancer patients is cisplatin-based neoadjuvant chemotherapy followed by radical cystectomy and pelvic lymph-node dissection.

  2. Outbreak of Pantoea agglomerans Bloodstream Infections at an Oncology Clinic-Illinois, 2012-2013.

    PubMed

    Yablon, Brian R; Dantes, Raymund; Tsai, Victoria; Lim, Rachel; Moulton-Meissner, Heather; Arduino, Matthew; Jensen, Bette; Patel, Megan Toth; Vernon, Michael O; Grant-Greene, Yoran; Christiansen, Demian; Conover, Craig; Kallen, Alexander; Guh, Alice Y

    2017-03-01

    OBJECTIVE To determine the source of a healthcare-associated outbreak of Pantoea agglomerans bloodstream infections. DESIGN Epidemiologic investigation of the outbreak. SETTING Oncology clinic (clinic A). METHODS Cases were defined as Pantoea isolation from blood or catheter tip cultures of clinic A patients during July 2012-May 2013. Clinic A medical charts and laboratory records were reviewed; infection prevention practices and the facility's water system were evaluated. Environmental samples were collected for culture. Clinical and environmental P. agglomerans isolates were compared using pulsed-field gel electrophoresis. RESULTS Twelve cases were identified; median (range) age was 65 (41-78) years. All patients had malignant tumors and had received infusions at clinic A. Deficiencies in parenteral medication preparation and handling were identified (eg, placing infusates near sinks with potential for splash-back contamination). Facility inspection revealed substantial dead-end water piping and inadequate chlorine residual in tap water from multiple sinks, including the pharmacy clean room sink. P. agglomerans was isolated from composite surface swabs of 7 sinks and an ice machine; the pharmacy clean room sink isolate was indistinguishable by pulsed-field gel electrophoresis from 7 of 9 available patient isolates. CONCLUSIONS Exposure of locally prepared infusates to a contaminated pharmacy sink caused the outbreak. Improvements in parenteral medication preparation, including moving chemotherapy preparation offsite, along with terminal sink cleaning and water system remediation ended the outbreak. Greater awareness of recommended medication preparation and handling practices as well as further efforts to better define the contribution of contaminated sinks and plumbing deficiencies to healthcare-associated infections are needed. Infect Control Hosp Epidemiol 2017;38:314-319.

  3. Chemotherapy

    Cancer.gov

    Chemotherapy is a type of cancer treatment that uses drugs to kill cancer cells. Learn how chemotherapy works against cancer, why it causes side effects, and how it is used with other cancer treatments.

  4. 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.

  5. Porphyrin and nonporphyrin photosensitizers in oncology: preclinical and clinical advances in photodynamic therapy.

    PubMed

    O'Connor, Aisling E; Gallagher, William M; Byrne, Annette T

    2009-01-01

    Photodynamic therapy (PDT) is now a well-recognized modality for the treatment of cancer. While PDT has developed progressively over the last century, great advances have been observed in the field in recent years. The concept of dual selectivity of PDT agents is now widely accepted due to the relative specificity and selectivity of PDT along with the absence of harmful side effects often encountered with chemotherapy or radiotherapy. Traditionally, porphyrin-based photosensitizers have dominated the PDT field but these first generation photosensitizers have several disadvantages, with poor light absorption and cutaneous photosensitivity being the predominant side effects. As a result, the requirement for new photosensitizers, including second generation porphyrins and porphyrin derivatives as well as third generation photosensitizers has arisen, with the aim of alleviating the problems encountered with first generation porphyrins and improving the efficacy of PDT. The investigation of nonporphyrin photosensitizers for the development of novel PDT agents has been considerably less extensive than porphyrin-based compounds; however, structural modification of nonporphyrin photosensitizers has allowed for manipulation of the photochemotherapeutic properties. The aim of this review is to provide an insight into PDT photosensitizers clinically approved for application in oncology, as well as those which show significant potential in ongoing preclinical studies.

  6. Chemotherapy

    MedlinePlus

    ... to Know Central Venous Catheters Track Your Chemotherapy Side Effects [PDF] Common Concerns About Chemotherapy Get information about common concerns people have when getting chemotherapy, and learn more about related topics. Is It Safe to Keep My Pet While I’m Being Treated for ... Drug Use ...

  7. 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

  8. Chemotherapy Order Entry by a Clinical Support Pharmacy Technician in an Outpatient Medical Day Unit

    PubMed Central

    Neville, Heather; Broadfield, Larry; Harding, Claudia; Heukshorst, Shelley; Sweetapple, Jennifer; Rolle, Megan

    2016-01-01

    Background: Pharmacy technicians are expanding their scope of practice, often in partnership with pharmacists. In oncology, such a shift in responsibilities may lead to workflow efficiencies, but may also cause concerns about patient risk and medication errors. Objectives: The primary objective was to compare the time spent on order entry and order-entry checking before and after training of a clinical support pharmacy technician (CSPT) to perform chemotherapy order entry. The secondary objectives were to document workflow interruptions and to assess medication errors. Methods: This before-and-after observational study investigated chemotherapy order entry for ambulatory oncology patients. Order entry was performed by pharmacists before the process change (phase 1) and by 1 CSPT after the change (phase 2); order-entry checking was performed by a pharmacist during both phases. The tasks were timed by an independent observer using a personal digital assistant. A convenience sample of 125 orders was targeted for each phase. Data were exported to Microsoft Excel software, and timing differences for each task were tested with an unpaired t test. Results: Totals of 143 and 128 individual orders were timed for order entry during phase 1 (pharmacist) and phase 2 (CSPT), respectively. The mean total time to perform order entry was greater during phase 1 (1:37 min versus 1:20 min; p = 0.044). Totals of 144 and 122 individual orders were timed for order-entry checking (by a pharmacist) in phases 1 and 2, respectively, and there was no difference in mean total time for order-entry checking (1:21 min versus 1:20 min; p = 0.69). There were 33 interruptions not related to order entry (totalling 39:38 min) during phase 1 and 25 interruptions (totalling 30:08 min) during phase 2. Three errors were observed during order entry in phase 1 and one error during order-entry checking in phase 2; the errors were rated as having no effect on patient care. Conclusions: Chemotherapy order

  9. 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

  10. 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.

  11. 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

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

    PubMed

    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.

  13. The importance of clinical grading of heart failure and other cardiac toxicities during chemotherapy: updating the common terminology criteria for clinical trial reporting.

    PubMed

    Hossain, Akm; Chen, Alice; Ivy, Percy; Lenihan, Daniel J; Kaltman, Jonathan; Taddei-Peters, Wendy; Remick, Scot C

    2011-07-01

    Although the use of chemotherapy and targeted therapy has improved the clinical benefit, progression-free survival, and overall survival of various cancers in recent years, old and new toxicities have limited their use. To balance the risk with the benefit of treatment, Common Toxicity Criteria and now Common Terminology Criteria for Adverse Events (CTCAE) have been used by the oncology community for more than 20 years to assess toxicity from cancer treatment. This article details the description and grading of cardiac toxicities reported in association with cancer treatment and the use of CTCAE to assess them.

  14. 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.

  15. Adjuvant systemic chemotherapy for stages II and III colon cancer after complete resection: a clinical practice guideline

    PubMed Central

    Meyers, B.M.; Cosby, R.; Quereshy, F.; Jonker, D.

    2016-01-01

    Background Updated practice guidelines on adjuvant chemotherapy for completely resected colon cancer are lacking. In 2008, Cancer Care Ontario’s Program in Evidence-Based Care developed a guideline on adjuvant therapy for stages ii and iii colon cancer. With newer regimens being assessed in this patient population and older agents being either abandoned because of non-effectiveness or replaced by agents that are more efficacious, a full update of the original guideline was undertaken. Methods Literature searches (January 1987 to August 2015) of medline, embase, and the Cochrane Library were conducted; in addition, abstracts from the American Society of Clinical Oncology, the European Society for Medical Oncology, and the European Cancer Congress were reviewed (the latter for January 2007 to August 2015). A practice guideline was drafted that was then scrutinized by internal and external reviewers whose comments were incorporated into the final guideline. Results Twenty-six unique reports of eighteen randomized controlled trials and thirteen unique reports of twelve meta-analyses or pooled analyses were included in the evidence base. The 5 recommendations developed included 3 for stage ii colon cancer and 2 for stage iii colon cancer. Conclusions Patients with completely resected stage iii colon cancer should be offered adjuvant 5-fluorouracil (5fu)–based chemotherapy with or without oxaliplatin (based on definitive data for improvements in survival and disease-free survival). Patients with resected stage ii colon cancer without “high-risk” features should not receive adjuvant chemotherapy. For patients with “high-risk” features, 5fu-based chemotherapy with or without oxaliplatin should be offered, although no clinical trials have been conducted to conclusively demonstrate the same benefits seen in stage iii colon cancer. PMID:28050138

  16. Advances in brain metastases presented at the American Society of Clinical Oncology 2016 Annual Meeting: Part I.

    PubMed

    Chen, Lucy F; Patel, Jyoti D; Lukas, Rimas V

    2016-11-01

    American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, IL, USA, 3-7 June 2016 The American Society of Clinical Oncology Annual Meeting took place in Chicago, IL, USA from 3 to 7 June 2016. Over 30,000 oncologists, researchers, related professionals and advocates participated in the conference which covered all aspects of oncology. An overview of the key studies in brain metastases presented at the 2016 American Society of Clinical Oncology Annual Meeting is highlighted here. This report highlights biology, epidemiology, prognosis and treatment sequelae of brain metastases.

  17. Advances in brain metastases presented at the American Society of Clinical Oncology 2016 Annual Meeting: Part II.

    PubMed

    Chen, Lucy F; Patel, Jyoti D; Lukas, Rimas V

    2016-12-01

    American Society of Clinical Oncology Annual Meeting, Chicago, IL, USA, 3-7 June 2016 The American Society of Clinical Oncology Annual Meeting took place in Chicago, IL, USA, from 3 to 7 June 2016. Over 30,000 oncologists, researchers, related professionals and advocates participated in the conference, which covered all aspects of oncology. An overview of the key studies in brain metastases presented at the 2016 American Society of Clinical Oncology Annual Meeting is highlighted here. Key data presented on radiotherapy, and systemic therapy for brain metastases are reviewed.

  18. 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

  19. Chemotherapy

    MedlinePlus

    ... needs plenty of rest to recover from chemotherapy. Scale back on strenuous stuff, and make time to ... teeth very gently to avoid bleeding. Once you've finished chemo, it's still important to visit the ...

  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.

  1. The history and future of the Urologic Oncology Study Group (UOSG) of the Japan Clinical Oncology Group (JCOG).

    PubMed

    Tobisu, Kenichi

    2012-05-01

    The Urologic Oncology Study Group (UOSG) of the Japan Clinical Oncology Group was founded in 2001. At the beginning, 41 collaborative institutions participated, and the first group representative was Kenichi Tobisu, from the Shizuoka Cancer Center. In the last 10 years, three JCOG studies have been conducted. In two of them, patient registration has been closed and they are now in the follow-up period. The third study has just started registration in 2011. At present, we have not yet completed the final data analyses in any of the studies. In the meantime, however, we have performed a few retrospective analyses by collecting clinical data from each of the participating institutions, and the results were published as important Japanese data. All the activities of the investigation were supported by the Health and Labor Sciences Research Grants for Clinical Research in Japan. The UOSG encountered great difficulties in planning the prospective study, completing the sophisticated protocol and recruiting the expected number of patients. It usually took a longer time than expected to achieve the final goal. This was probably due to insufficient experience in conducting sophisticated protocol studies and immaturity in managing a study group. Now, the UOSG consists of 38 institutions and is gradually overcoming these problems. In 2011, the UOSG changed its group representative to Yoshiyuki Kakehi from Kagawa University and continues to strive to meet the challenge of becoming a more active group. In this review, we provide an overview of the history and achievements of the UOSG over the past 10 years, along with a list of participating institutions.

  2. Adjuvant intrahepatic chemotherapy with mitomycin and 5-FU combined with hepatic irradiation in high-risk patients with carcinoma of the colon: a Southwest Oncology Group phase II pilot study

    SciTech Connect

    McCracken, J.D.; Weatherall, T.J.; Oishi, N.; Janaki, L.; Boyer, C.

    1985-01-01

    The Southwest Oncology Group conducted a pilot study in patients who had had total clinical resection of cancer of the colon and had a high risk of recurrence (Duke's C); the purpose of the study was to determine the toxic effects of intra-arterial chemotherapy combined with hepatic radiotherapy, in anticipation of their potential use in an adjuvant groupwide protocol. The treatment plan included intra-arterial chemotherapy with mitomycin (3 mg/m2) on Days 1, 4, 35, and 38 by slow intra-arterial push and 5-FU (1000 mg/m2) on Days 1-4 and 35-38 by continuous 96-hour infusion. Radiation therapy was begun on Day 8 of therapy and consisted of 1950 rads in 13 fractions over 2 1/2 weeks. Nineteen patients have been studied. Of 13 fully evaluable patients, two have relapsed in the liver. Eleven patients have developed significant, persistent liver enzyme elevations, and one patient has died from therapy-related liver failure. Combined radiotherapy and intra-arterial chemotherapy may result in significant chronic liver damage, and caution should be exercised in future adjuvant trials.

  3. 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.

  4. 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…

  5. American Society of Clinical Oncology clinical practice guidelines: opportunities and challenges.

    PubMed

    Somerfield, Mark R; Einhaus, Kaitlin; Hagerty, Karen L; Brouwers, Melissa C; Seidenfeld, Jerome; Lyman, Gary H

    2008-08-20

    The American Society of Clinical Oncology (ASCO) published its first clinical practice guideline, which focused on the use of hematopoietic colony-stimulating factors, in 1994. Since then, ASCO has published 24 additional guidelines or technology assessments on a range of topics and is developing 11 additional guidelines. Guidelines are among ASCO's most valued products, according to membership surveys and data from the JCO.org Web site. However, the same data from ASCO members have highlighted a number of limitations to the guideline program. These relate to the timelines of guideline updates, difficulties locating guidelines and related products, and challenges to implementing ASCO guidelines in everyday clinical practice. This article outlines the concrete steps that the ASCO Health Services Committee (HSC) is taking to address these limitations, including the institution of a more aggressive guideline updating schedule, a transition from narrative to systematic literature reviews to support the practice recommendations, a new Board of Directors-approved policy to permit endorsement of other groups' guidelines, and a robust Clinical Tools and Resources program that offers a range of guideline dissemination and implementation aids. Additional work is underway to establish stronger and deeper collaborations with practicing oncologists to expand their role in the review, field testing, and implementation of guideline clinical tools and resources. Finally, the HSC is discussing evaluation of the guidelines program to maximize the impact of ASCO clinical practice guidelines on clinical decision making and, ultimately, the quality of cancer care.

  6. Media Reporting of Practice-Changing Clinical Trials in Oncology: A North American Perspective

    PubMed Central

    Vickers, Michael M.; O’Connor, Stephen; Valdes, Mario; Tang, Patricia A.

    2016-01-01

    Introduction. Media reporting of clinical trials impacts patient-oncologist interactions. We sought to characterize the accuracy of media and Internet reporting of practice-changing clinical trials in oncology. Materials and Methods. The first media articles referencing 17 practice-changing clinical trials were collected from 4 media outlets: newspapers, cable news, cancer websites, and industry websites. Measured outcomes were media reporting score, social media score, and academic citation score. The media reporting score was a measure of completeness of information detailed in media articles as scored by a 15-point scoring instrument. The social media score represented the ubiquity of social media presence referencing 17 practice-changing clinical trials in cancer as determined by the American Society of Clinical Oncology in its annual report, entitled Clinical Cancer Advances 2012; social media score was calculated from Twitter, Facebook, and Google searches. The academic citation score comprised total citations from Google Scholar plus the Scopus database, which represented the academic impact per clinical cancer advance. Results. From 170 media articles, 107 (63%) had sufficient data for analysis. Cohen’s κ coefficient demonstrated reliability of the media reporting score instrument with a coefficient of determination of 94%. Per the media reporting score, information was most complete from industry, followed by cancer websites, newspapers, and cable news. The most commonly omitted items, in descending order, were study limitations, exclusion criteria, conflict of interest, and other. The social media score was weakly correlated with academic citation score. Conclusion. Media outlets appear to have set a low bar for coverage of many practice-changing advances in oncology, with reports of scientific breakthroughs often omitting basic study facts and cautions, which may mislead the public. The media should be encouraged to use a standardized reporting

  7. 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…

  8. 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.

  9. Assessing the Value of an Optional Radiation Oncology Clinical Rotation During the Core Clerkships in Medical School

    SciTech Connect

    Zaorsky, Nicholas G.; Malatesta, Theresa M.; Den, Robert B.; Wuthrick, Evan; Ahn, Peter H.; Werner-Wasik, Maria; Shi, Wenyin; Dicker, Adam P.; Anne, P. Rani; Bar-Ad, Voichita; Showalter, Timothy N.

    2012-07-15

    Purpose: Few medical students are given proper clinical training in oncology, much less radiation oncology. We attempted to assess the value of adding a radiation oncology clinical rotation to the medical school curriculum. Methods and Materials: In July 2010, Jefferson Medical College began to offer a 3-week radiation oncology rotation as an elective course for third-year medical students during the core surgical clerkship. During 2010 to 2012, 52 medical students chose to enroll in this rotation. The rotation included outpatient clinics, inpatient consults, didactic sessions, and case-based presentations by the students. Tests of students' knowledge of radiation oncology were administered anonymously before and after the rotation to evaluate the educational effectiveness of the rotation. Students and radiation oncology faculty were given surveys to assess feedback about the rotation. Results: The students' prerotation test scores had an average of 64% (95% confidence interval [CI], 61-66%). The postrotation test scores improved to an average of 82% (95% CI, 80-83%; 18% absolute improvement). In examination question analysis, scores improved in clinical oncology from 63% to 79%, in radiobiology from 70% to 77%, and in medical physics from 62% to 88%. Improvements in all sections but radiobiology were statistically significant. Students rated the usefulness of the rotation as 8.1 (scale 1-9; 95% CI, 7.3-9.0), their understanding of radiation oncology as a result of the rotation as 8.8 (95% CI, 8.5-9.1), and their recommendation of the rotation to a classmate as 8.2 (95% CI, 7.6-9.0). Conclusions: Integrating a radiation oncology clinical rotation into the medical school curriculum improves student knowledge of radiation oncology, including aspects of clinical oncology, radiobiology, and medical physics. The rotation is appreciated by both students and faculty.

  10. 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.

  11. Innovations for phase I dose-finding designs in pediatric oncology clinical trials.

    PubMed

    Doussau, Adelaide; Geoerger, Birgit; Jiménez, Irene; Paoletti, Xavier

    2016-03-01

    Phase I oncology clinical trials are designed to identify the optimal dose that will be recommended for phase II trials. In pediatric oncology, the conduct of those trials raises specific challenges, as the disease is rare with limited therapeutic options. In addition, the tolerance profile is known from adult trials. This paper provides a review of the major recent developments in the design of these trials, inspired by the need to cope with the specific challenges of dose finding in cancer pediatric oncology. We reviewed simulation studies comparing designs dedicated to address these challenges. We also reviewed the design used in published dose-finding trials in pediatric oncology over the period 2009-2014. Three main fields of innovation were identified. First, designs that were developed in order to relax the rules for more flexible inclusions. Second, methods to incorporate data emerging from adult studies. Third, designs accounting for toxicity evaluation at repeated cycles in pediatric oncology. In addition to this overview, we propose some further directions for designing pediatric dose-finding trials.

  12. 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

  13. [Evaluation of oncology clinical practice guidelines: the contribution of certified centers].

    PubMed

    Wesselmann, Simone

    2015-01-01

    The German Guideline Program in Oncology defines quality indicators which provide the basis for the certification of oncology centers of the German Cancer Society. The results of the quality indicators are published annually in benchmarking reports which summarize the data of over 400,000 oncological patients in the course of time. The reports will be presented to the guideline groups during their guideline updating process. In addition, the explanation of the certified centers and the auditors for non-adherence to guideline recommendations is being recorded. In this way, the guideline group obtains important information about how and to which extent the guideline is implemented in clinical routine, and can derive conclusions for the further definition of recommendations and quality indicators.

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

    PubMed

    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.

  15. Chemotherapy

    MedlinePlus

    ... cell death (apoptosis). Types There are two main types of chemotherapy drugs: Cytostatic: These drugs prevent cells from reproducing. They include: Anti-angiogenesis agents/Angiogenesis inhibitors—These drugs prevent the development of blood vessels around the tumor that provide it with ...

  16. 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

  17. Innovations in American Society of Clinical Oncology Practice Guideline Development.

    PubMed

    Somerfield, Mark R; Bohlke, Kari; Browman, George P; Denduluri, Neelima; Einhaus, Kaitlin; Hayes, Daniel F; Khorana, Alok A; Miller, Robert S; Mohile, Supriya G; Oliver, Thomas K; Ortiz, Eduardo; Lyman, Gary H

    2016-09-10

    Since the beginning of its guidelines program in 1993, ASCO has continually sought ways to produce a greater number of guidelines while maintaining its commitment to using the rigorous development methods that minimize the biases that threaten the validity of practice recommendations. ASCO is implementing a range of guideline development and implementation innovations. In this article, we describe innovations that are designed to (1) integrate consideration of multiple chronic conditions into practice guidelines; (2) keep more of its guidelines current by applying evolving signals or (more) rapid, for-cause updating approaches; (3) increase the number of high-quality guidelines available to its membership through endorsement and adaptation of other groups' products; (4) improve coverage of its members' guideline needs through a new topic nomination process; and (5) enhance dissemination and promote implementation of ASCO guidelines in the oncology practice community through a network of volunteer ambassadors. We close with a summary of ASCO's plans to facilitate the integration of data from its rapid learning system, CancerLinQ, into ASCO guidelines and to develop tactics through which guideline recommendations can be embedded in clinicians' workflow in digital form. We highlight the challenges inherent in reconciling the need to provide clinicians with more interactive, point-of-care guidance with ASCO's abiding commitment to methodologic rigor in guideline development.

  18. A clinical research information system: an example of prospective observational study in oncology.

    PubMed

    Leskosek, Branimir L

    2008-11-06

    The paper presents a web-based clinical research information system (RIS) used by physicians and pharmacists at Institute of Oncology, Ljubljana and its geographically remote partners to collect research clinical data for observational study. The RIS development was focused mainly on: formal electronic data collection with on-line data validation, computer data preparation for uniform analyses, user friendliness, security issues, low establishment and maintenance costs.

  19. 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

  20. Inside the 2016 American Society of Clinical Oncology Genitourinary Cancers Symposium: part 1 - kidney 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.

  1. 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.

  2. The role of clinical trials in veterinary oncology.

    PubMed

    Burton, Jenna; Khanna, Chand

    2014-09-01

    Clinical trials for companion animals are becoming more common and more accessible to pet owners as veterinary oncologists seek to expand their knowledge of tumor biology in companion animal species and improve the way they diagnose and treat cancer for these animals. Many owners enroll their pets because they wish to participate in clinical cancer research that may ultimately benefit pets and people. Understanding the goals, benefits, and risks of clinical trials participation provides the knowledge needed by primary care veterinarians to counsel their clients as to whether clinical trial participation is a good choice for them and their pets.

  3. Differences in Demographic, Clinical, and Symptom Characteristics and Quality of Life Outcomes Among Oncology Patients with Different Types of Pain

    PubMed Central

    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

    2016-01-01

    The purposes of this study, in oncology outpatients receiving chemotherapy (CTX, n=926), were to: describe the occurrence of different types of pain (i.e., no pain, only non-cancer 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 four 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 three pain groups, worst pain scores were in the moderate to severe range. Compared to 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 three 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

  4. 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.

  5. Polymer-Drug Conjugates: Recent Development in Clinical Oncology

    PubMed Central

    Li, Chun; Wallace, Sidney

    2008-01-01

    Targeted drug delivery aims to increase the therapeutic index by making more drug molecules available at the diseased sites while reducing systemic drug exposure. In this update, we provide an overview of polymer-drug conjugates that have advanced into the clinical trials. These systems use synthetic water-soluble polymers as the drug carriers. The preclinical pharmacology and recent data in clinical trials with poly(L-glutamic acid)-paclitaxel (PG-TXL) are discussed first. This is followed by a summary of conjugates of a variety of polymeric conjugates with chemotherapeutic agents. Results from early clinical trials of these polymer-drug conjugates have demonstrated several advantages over the corresponding parent drugs, including fewer side effects, enhanced therapeutic efficacy, ease of drug administration, and improved patient compliance. Collectively, these data warrant further clinical development of polymer-drug conjugates as a new class of anticancer agents. PMID:18374448

  6. Clinically relevant drug–drug interactions in oncology

    PubMed Central

    McLeod, Howard L

    1998-01-01

    Although anticancer agents are one of the most toxic classes of medication prescribed today, there is relatively little information available about clinically relevant drug–drug interactions. Pharmacokinetic drug interactions have been described, including alterations in absorption, catabolism, and excretion. For example, an increased bioavailability of 6-mercaptopurine has been observed when combined with either allopurinol or methotrexate, leading to increased toxicity in some patients. Induction of etoposide or teniposide clearance by anticonvulsants has also been described, resulting in a lower systemic exposure and risk for lower anticancer activity. Alterations in elimination of methotrexate has been observed with probenecid, presumably through competition for renal secretion. There are also several examples of pharmacodynamic interactions. The combination of 5-fluorouracil plus folinic acid results in more efficient inhibition of thymidylate synthase, a finding which is now utilized routinely in the treatment of colorectal cancer. Improvements in the in vitro and early clinical testing now allow a relatively high degree of prediction of potential clinical drug interactions, prior to observations of untoward drug effects. In conclusion, drug interactions among commonly used anticancer agents have been identified. Their clinical significance can have more impact than many other classes of medications due to the narrow therapeutic index of antineoplastic agents and the potential for lethal side-effects. It is only through prospective, preclinical and early clinical evaluation that the presence of clinically significant drug interactions can be identified and the information used to provide better therapy for this significant health problem. PMID:9663808

  7. Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study

    PubMed Central

    Schumacher, Andrew; Sikov, William M.; Quesenberry, Matthew I.; Safran, Howard; Khurshid, Humera; Mitchell, Kristen M.

    2017-01-01

    Background Informed consent forms (ICFs) for oncology clinical trials have grown increasingly longer and more complex. We evaluated objective understanding of critical components of informed consent among patients enrolling in contemporary trials of conventional or novel biologic/targeted therapies. Methods We evaluated ICFs for cancer clinical trials for length and readability, and patients registered on those studies were asked to complete a validated 14-question survey assessing their understanding of key characteristics of the trial. Mean scores were compared in groups defined by trial and patient characteristics. Results Fifty patients, of whom half participated in trials of immunotherapy or biologic/targeted agents and half in trials of conventional therapy, completed the survey. On average, ICFs for industry-originated trials (N = 9 trials) were significantly longer (P < .0001) and had lower Flesch ease-of-reading scores (P = .003) than investigator-initiated trials (N = 11). At least 80% of patients incorrectly responded to three key questions which addressed the experimental nature of their trial therapy, its purported efficacy and potential risks relative to alternative treatments. The mean objective understanding score was 76.9±8.8, but it was statistically significantly lower for patients who had not completed high school (P = .011). The scores did not differ significantly by type of cancer therapy (P = .12) or trial sponsor (P = .38). Conclusions Many participants enrolled on cancer trials had poor understanding of essential elements of their trial. In order to ensure true informed consent, innovative approaches, such as expanded in-person counseling adapted to the patient’s education level or cultural characteristics should be evaluated across socio-demographic groups. Trial registration Clinicaltrials.gov NCT01772511 PMID:28235011

  8. Perspectives on the design of clinical trials for targeted therapies and immunotherapy in veterinary oncology.

    PubMed

    Marconato, Laura; Buracco, Paolo; Aresu, Luca

    2015-08-01

    The field of oncology research has undergone major changes in recent years. Progress in molecular and cellular biology has led to a greater understanding of the cellular pathways and mechanisms of cell proliferation and tissue invasion associated with cancer. New classes of cancer therapies are becoming available or are in development but these new agents require a paradigm shift in the design of oncology clinical trials. This review provides an overview of clinical trial designs for the development of tumour vaccines and targeted therapeutic agents. In addition, some of the successes, limitations and challenges of these trials are discussed, with a special emphasis on the difficulties and particularities that are encountered in veterinary medicine compared to similar work in human patients.

  9. Ki67 Proliferation Index as a Tool for Chemotherapy Decisions During and After Neoadjuvant Aromatase Inhibitor Treatment of Breast Cancer: Results From the American College of Surgeons Oncology Group Z1031 Trial (Alliance).

    PubMed

    Ellis, Matthew J; Suman, Vera J; Hoog, Jeremy; Goncalves, Rodrigo; Sanati, Souzan; Creighton, Chad J; DeSchryver, Katherine; Crouch, Erika; Brink, Amy; Watson, Mark; Luo, Jingqin; Tao, Yu; Barnes, Michael; Dowsett, Mitchell; Budd, G Thomas; Winer, Eric; Silverman, Paula; Esserman, Laura; Carey, Lisa; Ma, Cynthia X; Unzeitig, Gary; Pluard, Timothy; Whitworth, Pat; Babiera, Gildy; Guenther, J Michael; Dayao, Zoneddy; Ota, David; Leitch, Marilyn; Olson, John A; Allred, D Craig; Hunt, Kelly

    2017-04-01

    Purpose To determine the pathologic complete response (pCR) rate in estrogen receptor (ER) -positive primary breast cancer triaged to chemotherapy when the protein encoded by the MKI67 gene (Ki67) level was > 10% after 2 to 4 weeks of neoadjuvant aromatase inhibitor (AI) therapy. A second objective was to examine risk of relapse using the Ki67-based Preoperative Endocrine Prognostic Index (PEPI). Methods The American College of Surgeons Oncology Group (ACOSOG) Z1031A trial enrolled postmenopausal women with stage II or III ER-positive (Allred score, 6 to 8) breast cancer whose treatment was randomly assigned to neoadjuvant AI therapy with anastrozole, exemestane, or letrozole. For the trial ACOSOG Z1031B, the protocol was amended to include a tumor Ki67 determination after 2 to 4 weeks of AI. If the Ki67 was > 10%, patients were switched to neoadjuvant chemotherapy. A pCR rate of > 20% was the predefined efficacy threshold. In patients who completed neoadjuvant AI, stratified Cox modeling was used to assess whether time to recurrence differed by PEPI = 0 score (T1 or T2, N0, Ki67 < 2.7%, ER Allred > 2) versus PEPI > 0 disease. Results Only two of the 35 patients in ACOSOG Z1031B who were switched to neoadjuvant chemotherapy experienced a pCR (5.7%; 95% CI, 0.7% to 19.1%). After 5.5 years of median follow-up, four (3.7%) of the 109 patients with a PEPI = 0 score relapsed versus 49 (14.4%) of 341 of patients with PEPI > 0 (recurrence hazard ratio [PEPI = 0 v PEPI > 0], 0.27; P = .014; 95% CI, 0.092 to 0.764). Conclusion Chemotherapy efficacy was lower than expected in ER-positive tumors exhibiting AI-resistant proliferation. The optimal therapy for these patients should be further investigated. For patients with PEPI = 0 disease, the relapse risk over 5 years was only 3.6% without chemotherapy, supporting the study of adjuvant endocrine monotherapy in this group. These Ki67 and PEPI triage approaches are being definitively studied in the ALTERNATE trial (Alternate

  10. Enhancing value of clinical pharmacodynamics in oncology drug development: An alliance between quantitative pharmacology and translational science.

    PubMed

    Venkatakrishnan, K; Ecsedy, J A

    2017-01-01

    Clinical pharmacodynamic evaluation is a key component of the "pharmacologic audit trail" in oncology drug development. We posit that its value can and should be greatly enhanced via application of a robust quantitative pharmacology framework informed by biologically mechanistic considerations. Herein, we illustrate examples of intersectional blindspots across the disciplines of quantitative pharmacology and translational science and offer a roadmap aimed at enhancing the caliber of clinical pharmacodynamic research in the development of oncology therapeutics.

  11. 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.

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

    PubMed

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

    2016-07-01

    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.

  13. Clinically Meaningful Use of Blood Tumor Markers in Oncology

    PubMed Central

    Pagliaro, Lance

    2016-01-01

    Before the introduction of modern imaging techniques and the recent developments in molecular diagnosis, tumor markers (TMs) were among the few available diagnostic tools for the management of cancer patients. Easily obtained from serum or plasma samples, TMs are minimally invasive and convenient, and the associated costs are low. Single TMs were traditionally used but these have come under scrutiny due to their low sensitivity and specificity when used, for example, in a screening setting. However, recent research has shown superior performance using a combination of multiple TMs as a panel for assessment, or as part of validated algorithms that also incorporate other clinical factors. In addition, newer TMs have been discovered that have an increased sensitivity and specificity profile for defined malignancies. The aim of this review is to provide a concise overview of the appropriate uses of both traditional and newer TMs and their roles in diagnosis, prognosis, and the monitoring of patients in current clinical practice. We also look at the future direction of TMs and their integration with other diagnostic modalities and other emerging serum based biomarkers, such as circulating nucleic acids, to ultimately advance diagnostic performance and improve patient management. PMID:28042579

  14. Fertility Preservation for Patients With Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update

    PubMed Central

    Loren, Alison W.; Mangu, Pamela B.; Beck, Lindsay Nohr; Brennan, Lawrence; Magdalinski, Anthony J.; Partridge, Ann H.; Quinn, Gwendolyn; Wallace, W. Hamish; Oktay, Kutluk

    2013-01-01

    Purpose To update guidance for health care providers about fertility preservation for adults and children with cancer. Methods A systematic review of the literature published from March 2006 through January 2013 was completed using MEDLINE and the Cochrane Collaboration Library. An Update Panel reviewed the evidence and updated the recommendation language. Results There were 222 new publications that met inclusion criteria. A majority were observational studies, cohort studies, and case series or reports, with few randomized clinical trials. After review of the new evidence, the Update Panel concluded that no major, substantive revisions to the 2006 American Society of Clinical Oncology recommendations were warranted, but clarifications were added. Recommendations As part of education and informed consent before cancer therapy, health care providers (including medical oncologists, radiation oncologists, gynecologic oncologists, urologists, hematologists, pediatric oncologists, and surgeons) should address the possibility of infertility with patients treated during their reproductive years (or with parents or guardians of children) and be prepared to discuss fertility preservation options and/or to refer all potential patients to appropriate reproductive specialists. Although patients may be focused initially on their cancer diagnosis, the Update Panel encourages providers to advise patients regarding potential threats to fertility as early as possible in the treatment process so as to allow for the widest array of options for fertility preservation. The discussion should be documented. Sperm and embryo cryopreservation as well as oocyte cryopreservation are considered standard practice and are widely available. Other fertility preservation methods should be considered investigational and should be performed by providers with the necessary expertise. PMID:23715580

  15. Pharmacogenomics in Pediatric Oncology: Review of Gene—Drug Associations for Clinical Use †

    PubMed Central

    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

  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. The conceptual and clinical problems of paraneoplastic syndrome in oncology and internal medicine.

    PubMed

    Bilynsky, B T; Dzhus, M B; Litvinyak, R I

    2015-06-01

    Symptomatology of oncological diseases consists not only of local symptoms caused by the primary malignancy or its metastases, but also by general systemic signs that are not directly connected with the tumor. These symptoms are mostly associated with auto-immunity or endocrine influences. In many cases, the source of paraneoplastic syndromes (PNS) is unknown. Nearly 15% of oncological patients demonstrate these syndromes but it is diagnosed much more rarely. The survey of the numerous PNS is offered. The significance of the PNS differs for oncologists and other physicians who encounter it in their practice. The reason of those differences, as well as the connection between PNS and cancer toxicity is discussed. The experience of antitoxic therapy (hemosorption, lymphosorption, enterosorption) used in our clinic in the previous years is overviewed.

  18. Statins in oncological research: from experimental studies to clinical practice.

    PubMed

    Kubatka, Peter; Kruzliak, Peter; Rotrekl, Vladimir; Jelinkova, Sarka; Mladosievicova, Beata

    2014-12-01

    Statins, 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors are commonly used drugs in the treatment of dyslipidemias, primarily raised cholesterol. Recently, many epidemiological and preclinical studies pointed to anti-tumor properties of statins, including anti-proliferative activities, apoptosis, decreased angiogenesis and metastasis. These processes play an important role in carcinogenesis and, therefore, the role of statins in cancer disease is being seriously discussed among oncologists. Anti-neoplastic properties of statins combined with an acceptable toxicity profile in the majority of individuals support their further development as anti-tumor drugs. The mechanism of action, current preclinical studies and clinical efficacy of statins are reviewed in this paper. Moreover, promising results have been reported regarding the statins' efficacy in some cancer types, especially in esophageal and colorectal cancers, and hepatocellular carcinoma. Statins' hepatotoxicity has traditionally represented an obstacle to the prescription of this class of drugs and this issue is also discussed in this review.

  19. Clinical applications of liquid biopsies in gastrointestinal oncology

    PubMed Central

    Zhu, Jason

    2016-01-01

    “Liquid biopsies” are blood based assays used to detect and analyze circulating tumor products, including circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), circulating messenger RNA (mRNA), circulating microRNA (miRNA), circulating exosomes, and tumor educated platelets (TEP). For patients with gastrointestinal (GI) malignancies, blood based biopsies may offer several advantages. First, tumor tissue samples are often challenging to procure, and when obtainable, are often insufficient for genomic profiling. Second, blood based assays offer a real-time overview of the entire tumor burden, and allow anatomically unbiased genomic profiling. Third, given the convenience and relative safety of liquid biopsies, this technology may facilitate identification of genomic alterations that confer sensitivity and resistance to targeted therapeutics. This review will assess the clinical applications of circulating tumor products for patients with GI tumors. PMID:27747082

  20. [Chemotherapy-induced febrile neutropenia: about 200 episodes. Clinical, microbiological and therapeutic characteristics].

    PubMed

    Gharbi, O; Ben Hadj Hassen, S; Kaabia, N; Limam, S; Hadj Amor, M; Ben Fatma, L; Landolsi, A; Hochlef, M; Letaief, A; Boukadida, J; Ben Ahmed, S

    2008-05-01

    Cytotoxic chemotherapy suppresses the haematopoietic system, febrile neutropenia is the most serious haematological toxicity associated with the risk of life-threatening infections. We present a retrospective study of 200 episodes of febrile neutropenia in 128 patients treated in department of medical oncology. The aim of this study was to determinate the clinical, therapeutic and evolutive characteristics in patients treated essentially for solid tumors. Among these patients, 72% of them have at least two episodes, the median age was 34 years with extremes six and 75 years. It has been noticed that 26.3% of patients have diabetes, the dominate neoplasm was solid tumors in 79.7%, 65% of patients have received preventive colony-stimulating factors, 83% have received preventive buccal disinfection with antifungic. The median duration of hospitalisation was 12 days, the median delay of febrile neutropenia was 10 days with extremes two and 31 days, median duration of febrile neutropenia was 5.45 days with extremes one and 24 days. Among these cases, 9.45% of them have nadir zero, 68% of patients have clinical documented infections, ORL in 47% of cases. According to the study, 12% of cases have documented microbiological fever, the sites was urinary in 33% of cases, blood in 33% of cases, derm in 30% of cases. The microbe was staphylococcus negative coagulase in 37.5% essentially in blood and derm, the Escherichia coli in 20.8% essentially in urinary and blood. First line antibiotherapy was cefotaxim associated with amikacine in 93.5%, second line antibiotherapy was association of imipenam and amikacine in 82% of cases. Among these cases,7% of them have received anti-staphylococcus, and antifungic treatment in 50% of cases. The thermic defervescence was obtained in median delay of 2.8 days. We have noted nine deaths (22% of cases). Recent surveys indicate that neutropenia remains a prevalent problem associated with substantial morbidity, mortality and costs. The colony

  1. Republished: Importance of carcinoma-associated fibroblast-derived proteins in clinical oncology.

    PubMed

    Valcz, Gabor; Sipos, Ferenc; Tulassay, Zsolt; Molnar, Bela; Yagi, Yukako

    2015-05-01

    Carcinoma-associated fibroblast (CAF) as prominent cell type of the tumour microenvironment has complex interaction with both the cancer cells and other non-neoplastic surrounding cells. The CAF-derived regulators and extracellular matrix proteins can support cancer progression by providing a protective microenvironment for the cancer cells via reduction of chemotherapy sensitivity. On the other hand, these proteins may act as powerful prognostic markers as well as potential targets of anticancer therapy. In this review, we summarise the clinical importance of the major CAF-derived signals influencing tumour behaviour and determining the outcome of chemotherapy.

  2. Importance of carcinoma-associated fibroblast-derived proteins in clinical oncology.

    PubMed

    Valcz, Gabor; Sipos, Ferenc; Tulassay, Zsolt; Molnar, Bela; Yagi, Yukako

    2014-12-01

    Carcinoma-associated fibroblast (CAF) as prominent cell type of the tumour microenvironment has complex interaction with both the cancer cells and other non-neoplastic surrounding cells. The CAF-derived regulators and extracellular matrix proteins can support cancer progression by providing a protective microenvironment for the cancer cells via reduction of chemotherapy sensitivity. On the other hand, these proteins may act as powerful prognostic markers as well as potential targets of anticancer therapy. In this review, we summarise the clinical importance of the major CAF-derived signals influencing tumour behaviour and determining the outcome of chemotherapy.

  3. A Clinical Decision Support Tool To Predict Survival in Cancer Patients beyond 120 Days after Palliative Chemotherapy

    PubMed Central

    Ng, Terence

    2012-01-01

    Abstract Background Palliative chemotherapy is often administered to terminally ill cancer patients to relieve symptoms. Yet, unnecessary use of chemotherapy can worsen patients' quality of life due to treatment-related toxicities. Thus, accurate prediction of survival in terminally ill patients can help clinicians decide on the most appropriate palliative care for these patients. However, studies have shown that clinicians often make imprecise predictions of survival in cancer patients. Hence, the purpose of this study was to create a clinical decision support tool to predict survival in cancer patients beyond 120 days after palliative chemotherapy. Materials and Methods Data were obtained from a retrospective study of 400 randomly selected terminally ill cancer patients in the National Cancer Centre Singapore (NCCS) from 2008 to 2009. After removing patients with missing data, there were 325 patients remaining for model development. Three classification algorithms, naive Bayes (NB), neural network (NN), and support vector machine (SVM) were used to create the models. A final model with the best prediction performance was then selected to develop the tool. Results The NN model had the best prediction performance. The accuracy, specificity, sensitivity, and area under the curve (AUC) of this model were 78%, 82%, 74%, and 0.857, respectively. Five patient attributes (albumin level, alanine transaminase level (ATL), absolute neutrophil count, Eastern Cooperative Oncology Group (ECOG) status, and number of metastatic sites) were included in the model. Conclusions A decision support tool to predict survival in cancer patients beyond 120 days after palliative chemotherapy was created. With further validation, this tool coupled with the professional judgment of clinicians can help improve patient care. PMID:22690950

  4. 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).

  5. Children of parents with cancer: a collaborative project between a child psychiatry clinic and an adult oncology clinic.

    PubMed

    Schmitt, Florence; Manninen, Hanna; Santalahti, Päivi; Savonlahti, Elina; Pyrhönen, Seppo; Romer, Georg; Piha, Jorma

    2007-07-01

    This article describes the development of a collaborative relationship between a child psychiatry clinic and an adult oncology clinic within a university hospital. The interest of the child psychiatry clinic was to pay attention to children of parents with cancer, and to propose an intervention to support them. A child-centred family counselling model was designed for this purpose. The preparation, implementation, and results of this project are described. Positive results, as well as mistakes and failures are discussed, and recommendations are made regarding this kind of collaboration.

  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.

  7. 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

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

    PubMed Central

    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

  9. 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.

  10. 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.

  11. Implementation of Electronic Checklists in an Oncology Medical Record: Initial Clinical Experience

    PubMed Central

    Albuquerque, Kevin V.; Miller, Alexis A.; Roeske, John C.

    2011-01-01

    Purpose: The quality of any medical treatment depends on the accurate processing of multiple complex components of information, with proper delivery to the patient. This is true for radiation oncology, in which treatment delivery is as complex as a surgical procedure but more dependent on hardware and software technology. Uncorrected errors, even if small or infrequent, can result in catastrophic consequences for the patient. We developed electronic checklists (ECLs) within the oncology electronic medical record (EMR) and evaluated their use and report on our initial clinical experience. Methods: Using the Mosaiq EMR, we developed checklists within the clinical assessment section. These checklists are based on the process flow of information from one group to another within the clinic and enable the processing, confirmation, and documentation of relevant patient information before the delivery of radiation therapy. The clinical use of the ECL was documented by means of a customized report. Results: Use of ECL has reduced the number of times that physicians were called to the treatment unit. In particular, the ECL has ensured that therapists have a better understanding of the treatment plan before the initiation of treatment. An evaluation of ECL compliance showed that, with additional staff training, > 94% of the records were completed. Conclusion: The ECL can be used to ensure standardization of procedures and documentation that the pretreatment checks have been performed before patient treatment. We believe that the implementation of ECLs will improve patient safety and reduce the likelihood of treatment errors. PMID:22043184

  12. Clinical applications of continuous infusion chemotherapy ahd concomitant radiation therapy

    SciTech Connect

    Rosenthal, C.J.; Rotman, M.

    1986-01-01

    This book presents information on the following topics: theoretical basis and clinical applications of 5-FU as a radiosensitizer; treatment of hepatic metastases from gastro intestingal primaries with split course radiation therapy; combined modality therapy with 5-FU, Mitomycin-C and radiation therapy for sqamous cell cancers; treatment of bladder carcinoma with concomitant infusion chemotherapy and irradiation; a treatment of invasiv bladder cancer by the XRT/5FU protocol; concomitant radiation therapy and doxorubicin by continuous infusion in advanced malignancies; cis platin by continuous infusion with concurrent radiation therapy in malignant tumors; combination of radiation with concomitant continuous adriamycin infusion in a patient with partially excised pleomorphic soft tissue sarcoma of the lower extremeity; treatment of recurrent carcinoma of the paranasal sinuses using concomitant infusion cis-platinum and radiation therapy; hepatic artery infusion for hepatic metastases in combination with hepatic resection and hepatic radiation; study of simultaneous radiation therapy, continuous infusion, 5FU and bolus mitomycin-C; cancer of the esophagus; continuous infusion VP-16, bolus cis-platinum and simultaneous radiation therapy as salvage therapy in small cell bronchogenic carcinoma; and concomitant radiation, mitomycin-C and 5-FU infusion in gastro intestinal cancer.

  13. [Loco-regional chemotherapy at the outpatient clinic for gastric cancer patients with home enteral nutrition].

    PubMed

    Maruyama, Michio; Nagahama, Takeshi; Sugano, Norihide; Satoh, Eigo; Maruyama, Shouji; Tanami, Hideo; Chiba, Tetsuma; Murakata, Ayano; Mitsuhashi, Yosuke; Uehira, Daisuke; Akazawa, Naoya; Suzuki, Keiichirou

    2011-11-01

    In over the 10 years from 2000-2010, 21 gastric cancer patients received loco-regional chemotherapy with home enteral nutrition (HEN) at an outpatient clinic because of insufficient oral intake. These loco-regional chemotherapy regimens consisted of 5 intra-aortic chemotherapies, 4 hepato-arterial infusions and 12 intra-peritoneal chemotherapies. Five out of 8 cases that had measurable lesions showed PR, and 3 cases revealed PD. The patients received HEN with peptide central formula, 400-1,200 kcal/day in night time. The average duration of HEN was 12.9 months. The post-operative nutritional management was needed for continuation and securing of outpatient chemotherapy. The author reported an experience of the outpatient loco-regional chemotherapy with HEN for the gastric cancer patients who could not eat a sufficient volume of food.

  14. Relationships between authorship contributions and authors' industry financial ties among oncology clinical trials.

    PubMed

    Rose, Susannah L; Krzyzanowska, Monika K; Joffe, Steven

    2010-03-10

    PURPOSE To test the hypothesis that authors who play key scientific roles in oncology clinical trials, and who therefore have increased influence over the design, analysis, interpretation or reporting of trials, are more likely than those who do not play such roles to have financial ties to industry. METHODS Data were abstracted from all trials (n = 235) of drugs or biologic agents published in the Journal of Clinical Oncology between January 1, 2006 and June 30, 2007. Article-level data included sponsorship, age group (adult v pediatric), phase, single versus multicenter, country (United States v other), and number of authors. Author-level data (n = 2,927) included financial ties (eg, employment, consulting) and performance of key scientific roles (ie, conception/design, analysis/interpretation, or manuscript writing). Associations between performance of key roles and financial ties, adjusting for article-level covariates, were examined using generalized linear mixed models. Results One thousand eight hundred eighty-one authors (64%) reported performing at least one key role, and 842 authors (29%) reported at least one financial tie. Authors who reported performing a key role were more likely than other authors to report financial ties to industry (adjusted odds ratio [OR], 4.3; 99% CI, 3.0 to 6.0; P < .0001). The association was stronger among trials with, compared with those without, industry funding (OR, 5.0 [99% CI, 3.4 to 7.5] v OR, 2.5 [99% CI, 1.3 to 4.8]), but was present regardless of sponsorship. CONCLUSION Authors who perform key roles in the conception and design, analysis, and interpretation, or reporting of oncology clinical trials are more likely than authors who do not perform such roles to have financial ties to industry.

  15. Robotic surgery for rectal cancer: current immediate clinical and oncological outcomes.

    PubMed

    Araujo, Sergio Eduardo Alonso; Seid, Victor Edmond; Klajner, Sidney

    2014-10-21

    Laparoscopic rectal surgery continues to be a challenging operation associated to a steep learning curve. Robotic surgical systems have dramatically changed minimally invasive surgery. Three-dimensional, magnified and stable view, articulated instruments, and reduction of physiologic tremors leading to superior dexterity and ergonomics. Therefore, robotic platforms could potentially address limitations of laparoscopic rectal surgery. It was aimed at reviewing current literature on short-term clinical and oncological (pathological) outcomes after robotic rectal cancer surgery in comparison with laparoscopic surgery. A systematic review was performed for the period 2002 to 2014. A total of 1776 patients with rectal cancer underwent minimally invasive robotic treatment in 32 studies. After robotic and laparoscopic approach to oncologic rectal surgery, respectively, mean operating time varied from 192-385 min, and from 158-297 min; mean estimated blood loss was between 33 and 283 mL, and between 127 and 300 mL; mean length of stay varied from 4-10 d; and from 6-15 d. Conversion after robotic rectal surgery varied from 0% to 9.4%, and from 0 to 22% after laparoscopy. There was no difference between robotic (0%-41.3%) and laparoscopic (5.5%-29.3%) surgery regarding morbidity and anastomotic complications (respectively, 0%-13.5%, and 0%-11.1%). Regarding immediate oncologic outcomes, respectively among robotic and laparoscopic cases, positive circumferential margins varied from 0% to 7.5%, and from 0% to 8.8%; the mean number of retrieved lymph nodes was between 10 and 20, and between 11 and 21; and the mean distal resection margin was from 0.8 to 4.7 cm, and from 1.9 to 4.5 cm. Robotic rectal cancer surgery is being undertaken by experienced surgeons. However, the quality of the assembled evidence does not support definite conclusions about most studies variables. Robotic rectal cancer surgery is associated to increased costs and operating time. It also seems to be

  16. 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.

  17. The use of a clinical resource nurse for newly graduated nurses in a pediatric oncology setting.

    PubMed

    MacKay, Lyndsay Jerusha; Bellamy-Stack, Catherine

    2010-01-01

    The pediatric oncology nursing unit at the Alberta Children's Hospital experienced a large influx of new staff nurses between May 2008 and November 2008. There were 16 in total, and only a few had previous experience, whereas the majority was newly graduated nurses. As a solution to the high numbers of new staff nurses, the role of a Resource Nurse was developed as a temporary position to assist new staff nurses with their patient assignment, prioritize their day, and deal with complex patient procedures/treatments. Also, the Resource Nurse assisted all staff on the unit in dealing with increased patient acuity, chemotherapy administration, acuity issues, family teaching, and complicated family situations. A total of 55 prebooked shifts were scheduled from November 2008 to January 2009. A questionnaire was handed out to the staff nurses as a means to determine the effectiveness of having a Resource Nurse work on the unit. Twenty-three nurses responded by filling out the confidential questionnaire. Overall, respondents reported that the Resource Nurse was beneficial to their practice on the unit.

  18. 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

  19. Integrating next-generation sequencing into clinical oncology: strategies, promises and pitfalls

    PubMed Central

    Horak, Peter; Fröhling, Stefan; Glimm, Hanno

    2016-01-01

    We live in an era of genomic medicine. The past five years brought about many significant achievements in the field of cancer genetics, driven by rapidly evolving technologies and plummeting costs of next-generation sequencing (NGS). The official completion of the Cancer Genome Project in 2014 led many to envision the clinical implementation of cancer genomic data as the next logical step in cancer therapy. Stemming from this vision, the term ‘precision oncology’ was coined to illustrate the novelty of this individualised approach. The basic assumption of precision oncology is that molecular markers detected by NGS will predict response to targeted therapies independently from tumour histology. However, along with a ubiquitous availability of NGS, the complexity and heterogeneity at the individual patient level had to be acknowledged. Not only does the latter present challenges to clinical decision-making based on sequencing data, it is also an obstacle to the rational design of clinical trials. Novel tissue-agnostic trial designs were quickly developed to overcome these challenges. Results from some of these trials have recently demonstrated the feasibility and efficacy of this approach. On the other hand, there is an increasing amount of whole-exome and whole-genome NGS data which allows us to assess ever smaller differences between individual patients with cancer. In this review, we highlight different tumour sequencing strategies currently used for precision oncology, describe their individual strengths and weaknesses, and emphasise their feasibility in different clinical settings. Further, we evaluate the possibility of NGS implementation in current and future clinical trials, and point to the significance of NGS for translational research. PMID:27933214

  20. 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

  1. 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.

  2. A study of motivations and expectations of patients seen in phase 1 oncology clinics

    PubMed Central

    Dolly, Saoirse O.; Kalaitzaki, Eleftheria; Puglisi, Martina; Stimpson, Sarah; Hanwell, Janet; Fandos, Sonia Serrano; Stapleton, Sarah; Ansari, Thushara; Peckitt, Clare; Kaye, Stan; Lopez, Juanita; Yap, Timothy A.; van der Graaf, Winette; de Bono, Johann

    2016-01-01

    BACKGROUND To better inform clinical practice, this study was aimed at capturing patients' motivations for enrolling in phase 1 trials and at quantifying their expectations of the benefits, risks, and commitment associated with clinical trials and the impact of the initial consultation on their expectations. METHODS This was a single‐center, prospective, quantitative study of newly referred adult patients considering their first phase 1 oncology trial. Participants completed questionnaires before they were seen and an abbreviated follow‐up version after their consultation. RESULTS Questionnaires were completed by 396 (99%) and 301 (76%) before and after the clinic, respectively. Participants ranked the possibility of tumor shrinkage (84%) as the most important motivation for considering a phase 1 trial; this was followed by no alternative treatments (56%), their physician's recommendation (44%), and the fact that the research might benefit others (38%). When they were asked about the potential personal benefit, 43% predicted tumor shrinkage initially. After the consultation, this increased to 47%. Fourteen percent of patients expected a cure. When asked about risks, 71% of the participants expected moderate side effects. When asked about expectations of time commitments, a majority of patients did not anticipate weekly visits, although this was understood by 93% of patients after the consultation. Overall, patients were keen to consider trials and when asked before and after the consultation 72% and 84% were willing to enroll in studies, respectively. CONCLUSIONS This study reports that more than 80% of patients enroll in early‐phase clinical oncology trials motivated by the potential of a clinical benefit, with approximately half expecting tumor shrinkage and approximately a tenth anticipating a cure. The typical phase 1 response rate is 4% to 20%, and this discrepancy exemplifies the challenges faced by patients and healthcare professionals during their

  3. [Galen's oncology].

    PubMed

    Vigliani, R

    1995-10-01

    "Claudius Galenus" is the Author of "De tumoribus praeter naturam". The book was studied on the original Greek text with Latin version edited by K.G. Kühn ("Opera omnia Claudii Galeni": VII, 705-732). This Galen's clinical and pathological oncology was examined as far as categorization, classification, morphology, etiology, pathogenesis, morphogenesis, topography, behaviour (with related therapeutic and prognostic implications) and terminology are concerned. Problems, aspects and concepts, more or less clarified by Galen, were extensively discussed with special reference to the Galen's scientific knowledge and compared with the modern oncology.

  4. [ANMCO/AICO/AIOM Consensus document: Clinical and management pathways in cardio-oncology].

    PubMed

    Tarantini, Luigi; Gulizia, Michele Massimo; Di Lenarda, Andrea; Maurea, Nicola; Abrignani, Maurizio Giuseppe; Bisceglia, Irma; Bovelli, Daniella; De Gennaro, Luisa; Del Sindaco, Donatella; Macera, Francesca; Parrini, Iris; Radini, Donatella; Russo, Giulia; Scardovi, Angela Beatrice; Inno, Alessandro

    2017-01-01

    In Italy, cardiovascular diseases and cancer are the leading causes of death. Both diseases share the same risk factors and, having the highest incidence and prevalence in the elderly, they often coexist in the same individual. Furthermore, the enhanced survival of cancer patients registered in the last decades and linked to early diagnosis and improvement of care, not infrequently exposes them to the appearance of ominous cardiovascular complications due to the deleterious effects of cancer treatment on the heart and circulatory system. The above considerations have led to the development of a new branch of clinical cardiology based on the principles of multidisciplinary collaboration between cardiologists and oncologists: Cardio-oncology, which aims to find solutions to the prevention, monitoring, diagnosis and treatment of heart damage induced by cancer care in order to pursue, in the individual patient, the best possible care for cancer while minimizing the risk of cardiac toxicity. In this consensus document we provide practical recommendations on how to assess, monitor, treat and supervise the candidate or patient treated with potentially cardiotoxic cancer therapy in order to treat cancer and protect the heart at all stages of the oncological disease.

  5. Predicting the performance of a strategic alliance: an analysis of the Community Clinical Oncology Program.

    PubMed Central

    Kaluzny, A D; Lacey, L M; Warnecke, R; Hynes, D M; Morrissey, J; Ford, L; Sondik, E

    1993-01-01

    OBJECTIVE. This study is designed to examine the effects of environment and structure of the Community Clinical Oncology Program (CCOP) on performance as measured by patient accrual to National Cancer Institute (NCI)-approved treatment protocols. DATA SOURCES/STUDY SETTING. Data and analysis are part of a larger evaluation of the NCI Community Clinical Oncology Program during its second funding cycle, June 1987-May 1990. Data, taken from primary and secondary sources, included a survey of selected informants in CCOPs and research bases, CCOP grant applications, CCOP annual progress reports, and site visits to a subsample of CCOPs (N = 20) and research bases (N = 5). Accrual data were obtained from NCI records. STUDY DESIGN. Analysis involved three complementary sets of factors: the local health care resources environment available to the CCOP, the larger policy environment as reflected by the relationship of the CCOP to selected research bases and the NCI, and the operational structure of the CCOP itself. A hierarchical model examined the separate and cumulative effects of local and policy environment and structure on performance. PRINCIPAL FINDINGS. Other things equal, the primary predictors of treatment accrual were: (1) the larger policy environment, as measured by the attendance of nurses at research base meetings; and (2) operational structure, as measured by the number and character of components within participating CCOPs and the number of hours per week worked by data managers. These factors explained 73 percent of the total variance in accrual performance. CONCLUSIONS. Findings suggest criteria for selecting the types of organizations to participate in the alliance, as well as for establishing guidelines for managing such alliances. A future challenge is to determine the extent to which factors predicting accrual to cancer treatment clinical trials are equally important as predictors of accrual to cancer prevention and control trials. PMID:8514498

  6. American Society of Clinical Oncology policy for relationships with companies: background and rationale.

    PubMed

    2013-06-01

    The American Society of Clinical Oncology's (ASCO's) new conflict of interest policy reflects a commitment to transparency and independence in the development and presentation of scientific and educational content. ASCO supports thorough and accessible disclosure of financial relationships with companies at institutional and individual levels and calls for rigorous evaluation of content in light of the information disclosed. For abstracts and articles presenting original research, ASCO holds first, last, and corresponding authors to a clear standard of independence. In imposing restrictions, the new policy focuses on the role of these authors rather than of the principal investigator(s) as in the previous policy. ASCO remains actively engaged with the broader scientific community in seeking and implementing efficient, effective approaches to conflict of interest management.

  7. Chromogranin A as a valid marker in oncology: Clinical application or false hopes?

    PubMed Central

    Gkolfinopoulos, Stavros; Tsapakidis, Konstantinos; Papadimitriou, Konstantinos; Papamichael, Demetris; Kountourakis, Panteleimon

    2017-01-01

    Chromogranin A, due to its primary expression throughout the neuroendocrine system, is a widely accepted biomarker for the assessment of neuro-endocrine tumors. It has been traditionally used in the management of patients with tumors of gastro-enteropancreatic origin. Lately, it has also been implicated in various conditions and diseases, both benign and malignant. However, the paucity of data of adequate strength, as well as its relation with common physiologic conditions and its interaction with commonly prescribed medications, limit its clinical use in only a narrow spectrum. Herein, we present a thorough review to the most frequent conditions where its levels are affected, focusing specifically on its potential use as a prognostic and predictive biomarker in oncology.

  8. Development of Clinical Trials in a Cooperative Group Setting: The Eastern Cooperative Oncology Group

    PubMed Central

    Sandler, Alan; Cheng, Steven; Crites, Joshua; Ferranti, Lori; Wu, Amy; Gray, Robert; MacDonald, Jean; Marinucci, Donna; Comis, Robert

    2009-01-01

    PURPOSE We examine the processes and document the calendar time required to activate Phase II and III clinical trials by an oncology group: the Eastern Cooperative Oncology Group (ECOG). METHODS Setup steps were documented by: 1) interviewing ECOG headquarters and statistical center staff, and committee chairs, 2) reviewing standard operating procedure manuals, and 3) inspecting study records, documents, and emails to identify additional steps. Calendar time was collected for each major process for each study in this set. RESULTS Twenty-eight Phase III studies were activated by ECOG during the 01/2000–07/2006 study period. We examined in detail a sample of 16 of those studies. More than 481 distinct processes were required for study activation: 420 working steps, 61 major decision points, 26 processing loops, and 13 stopping points. Median calendar days to activate a trial in the Phase III subset was 783 days (median, 285 to 1542 days) from executive approval and 808 days (range, 435 to 1604 days) from initial conception of the study. Data were collected for all Phase II and Phase III trials activated and completed during this time period (n=52) for which development time represented 43.9% and 54.1% of the total trial time respectively. CONCLUSION The steps required to develop and activate a clinical trial may require as much or more time than the actual completion of a trial. The data demonstrates that to improve the activation process, research should to be directed toward streamlining both internal and external groups and processes. PMID:18519773

  9. Towards in silico oncology: adapting a four dimensional nephroblastoma treatment model to a clinical trial case based on multi-method sensitivity analysis.

    PubMed

    Georgiadi, Eleni Ch; Dionysiou, Dimitra D; Graf, Norbert; Stamatakos, Georgios S

    2012-11-01

    In the past decades a great progress in cancer research has been made although medical treatment is still widely based on empirically established protocols which have many limitations. Computational models address such limitations by providing insight into the complex biological mechanisms of tumor progression. A set of clinically-oriented, multiscale models of solid tumor dynamics has been developed by the In Silico Oncology Group (ISOG), Institute of Communication and Computer Systems (ICCS)-National Technical University of Athens (NTUA) to study cancer growth and response to treatment. Within this context using certain representative parameter values, tumor growth and response have been modeled under a cancer preoperative chemotherapy protocol in the framework of the SIOP 2001/GPOH clinical trial. A thorough cross-method sensitivity analysis of the model has been performed. Based on the sensitivity analysis results, a reasonable adaptation of the values of the model parameters to a real clinical case of bilateral nephroblastomatosis has been achieved. The analysis presented supports the potential of the model for the study and eventually the future design of personalized treatment schemes and/or schedules using the data obtained from in vitro experiments and clinical studies.

  10. The approaches in the care for terminal cancer patients in radiotherapy and oncology clinic, Rijeka University Hospital Center.

    PubMed

    Dobrila-Dintinjana, Renata; Redzović, Arnela; Perić, Jana; Petranović, Duska

    2013-04-01

    We sought to determine the proportion of our admitted patients in terminal phase of ilness who recieved some kind of active oncological therapy. We conducted a pilot study on the records of patients who died in the University Hospital. We assessed the percentage of mortality, a therapeutic approach in terms of treating the underlying disease, and access to palliative treatment. Of 2097 patients hospitalized in the UHC Rijeka Department of Radiation Therapy and Oncology during 2010 and 2011, 44 pts died which accounts for 2.1%. The most common primary sites of cancer in patients who died in our Department were the lungs and then the breast. Ten (22.7%) patients were admitted exclusively to receive palliative care, while others (34-77.3%) were admitted for planned active chemo- and/or radiotherapy administration. Within three months before death, 18 (40.9%) patients underwent chemotherapy treatment. The number of patients hospitalized due to providing palliative care is extremely low, which could indicate a good supply of out-patient treatment of cancer patients in the terminal stage of the disease. However, concerned about the high percentage of patients who tried to provide oncology treatments in the three months before his death. The percentages referred to in their daily work is still guided by the principles of healing "to the end" and thus we plunge into the realm disthanasia.

  11. 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

    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

    2015-07-01

    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.

  12. 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.

  13. 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.

  14. Integrating Chemotherapy into the Management of Oligometastatic Colorectal Cancer: Evidence based Approach Using Clinical Trial Findings

    PubMed Central

    Semrad, Thomas J.; Fahrni, Ana Rodriguez; Gong, I-Yeh; Khatri, Vijay P.

    2015-01-01

    Purpose With the use of case presentations, we present a review of the role of systemic chemotherapy in oligometastatic colorectal cancer and suggest ways to integrate clinical research findings into the interdisciplinary management of this potentially curable subset of patients. Methods This educational review discusses the role of chemotherapy in the management of oligometastatic metastatic colorectal cancer. Results In initially resectable oligometastatic colorectal cancer, the goal of chemotherapy is to eradicate micrometastatic disease. Perioperative 5-fluorouracil and oxaliplatin along with surgical resection can result in 5-year survival rates as high as 57%. With the development of increasingly successful chemotherapy regimens, attention is being paid to the use of chemotherapy to convert patients with initially unresectable metastasis into patients with a chance of surgical cure. The choice of chemotherapy regimen requires consideration of the goals of therapy and assessment of both tumor and patient-specific factors. Discussion Herein we discuss the choice and timing of chemotherapy in patients with initially resectable and borderline resectable metastatic colorectal cancer. Coordinated multidisciplinary care of such patients can optimize survival outcomes and result in the cure of patients with this otherwise lethal disease. PMID:26100816

  15. 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

  16. [Current status of adjuvant chemotherapy for resected lung cancer at our institute--focus on clinical trial enrollment].

    PubMed

    Sawada, Shigeki; Yamashita, Motohiro; Komori, Eisaku; Suehiro, Hiroshi; Ogino, Atsuko; Nogami, Hiroyuki; Segawa, Yoshihiko; Shinkai, Tetsu

    2010-03-01

    Adjuvant chemotherapy after complete resection in Stage I B-III A non-small cell lung cancer is recommended. Several clinical trials of adjuvant chemotherapy are now underway in Japan. Our institute also participates in adjuvant clinical trials, but slow patient recruitment is a problem. In this paper, we reported the current status of adjuvant chemotherapy and recruitment for clinical trials at our institute. Between August 2001 and December 2008, candidates for adjuvant chemotherapy were 315 patients. Among them 186 who received adjuvant chemotherapy were younger and had less co-morbidity than those who did not receive adjuvant chemotherapy. Twenty-five of the 186 patients participated in the clinical trials. The major reason of refusal of a clinical trial was that patients preferred to choose their own treatment and disliked randomized trials.

  17. Nanotechnology in radiation oncology.

    PubMed

    Wang, Andrew Z; Tepper, Joel E

    2014-09-10

    Nanotechnology, the manipulation of matter on atomic and molecular scales, is a relatively new branch of science. It has already made a significant impact on clinical medicine, especially in oncology. Nanomaterial has several characteristics that are ideal for oncology applications, including preferential accumulation in tumors, low distribution in normal tissues, biodistribution, pharmacokinetics, and clearance, that differ from those of small molecules. Because these properties are also well suited for applications in radiation oncology, nanomaterials have been used in many different areas of radiation oncology for imaging and treatment planning, as well as for radiosensitization to improve the therapeutic ratio. In this article, we review the unique properties of nanomaterials that are favorable for oncology applications and examine the various applications of nanotechnology in radiation oncology. We also discuss the future directions of nanotechnology within the context of radiation oncology.

  18. Nanotechnology in Radiation Oncology

    PubMed Central

    Wang, Andrew Z.; Tepper, Joel E.

    2014-01-01

    Nanotechnology, the manipulation of matter on atomic and molecular scales, is a relatively new branch of science. It has already made a significant impact on clinical medicine, especially in oncology. Nanomaterial has several characteristics that are ideal for oncology applications, including preferential accumulation in tumors, low distribution in normal tissues, biodistribution, pharmacokinetics, and clearance, that differ from those of small molecules. Because these properties are also well suited for applications in radiation oncology, nanomaterials have been used in many different areas of radiation oncology for imaging and treatment planning, as well as for radiosensitization to improve the therapeutic ratio. In this article, we review the unique properties of nanomaterials that are favorable for oncology applications and examine the various applications of nanotechnology in radiation oncology. We also discuss the future directions of nanotechnology within the context of radiation oncology. PMID:25113769

  19. Differential clinical pharmacology of rolapitant in delayed chemotherapy-induced nausea and vomiting (CINV)

    PubMed Central

    Rashad, Noha; Abdel-Rahman, Omar

    2017-01-01

    Rolapitant is a highly selective neurokinin-1 receptor antagonist, orally administered for a single dose of 180 mg before chemotherapy with granisetron D1, dexamethasone 8 mg BID on day 2–4. It has a unique pharmacological characteristic of a long plasma half-life (between 163 and 183 hours); this long half-life makes a single use sufficient to cover the delayed emesis risk period. No major drug–drug interactions between rolapitant and dexamethasone or other cytochrome P450 inducers or inhibitors were observed. The clinical efficacy of rolapitant was studied in two phase III trials in highly emetogenic chemotherapy and in one clinical trial in moderately emetogenic chemotherapy. The primary endpoint was the proportion of patients achieving a complete response (defined as no emesis or use of rescue medication) in the delayed phase (>24–120 hours after chemotherapy). In comparison to granisetron (10 μg/kg intravenously) and dexamethasone (20 mg orally) on day 1, and dexamethasone (8 mg orally) twice daily on days 2–4 and placebo, rolapitant showed superior efficacy in the control of delayed and overall emesis. This review aims at revising the pharmacological characteristics of rolapitant, offering an updated review of the available clinical efficacy and safety data of rolapitant in different clinical settings, highlighting the place of rolapitant in the management of chemotherapy-induced nausea and vomiting (CINV) among currently available guidelines, and exploring the future directions of CINV management.

  20. Analysis of Clinical and Molecular Factors Impacting Oncologic Outcomes in Undifferentiated Pleomorphic Sarcoma

    PubMed Central

    Roland, Christina L.; May, Caitlin D.; Watson, Kelsey L.; Al Sannaa, Ghadah A.; Dineen, Sean P.; Feig, Rachel; Landers, Sharon; Ingram, Davis R.; Wang, Wei-Lien; Guadagnolo, B. Ashleigh; Feig, Barry; Hunt, Kelly K.; Cormier, Janice N.; Lazar, Alexander; Torres, Keila E.

    2016-01-01

    Background Undifferentiated pleomorphic sarcomas (UPS) present a diagnostic and therapeutic challenge. Identification of prognostic molecular markers is required for the discovery of novel treatment approaches. The aim of this study was to correlate clinicopathologic variables, expression of tyrosine kinase receptors, and markers of cell cycle progression and survival with oncologic outcomes. Methods A tissue microarray containing 208 primary UPS samples was analyzed by immunohistochemistry for protein markers and in situ hybridization for microRNA. Staining results were correlated with clinicopathologic features and oncologic outcomes. Univariate and multivariate analyses were conducted to assess associations between expression of protein markers, mi-RNA and outcome. Results At a median follow-up of 3.9 years (9 years for survivors), 5-year disease-specific survival (DSS) was 63%. Clinical variables associated with improved DSS included age < 61 years, tumor size < 10 cm, margin-negative resection and sporadic-tumor status. At the protein level, loss of cyclin D1 (p=0.06), pEGFR (p=0.023), pIGF-1R (p=0.022), and PTEN (p<0.001) and overexpression of AXL (p=0.015) were associated with reduced DSS on univariate analysis. Ki67, PCNA and pEGFR were more highly expressed in sporadic UPS than radiation-associated (RA-UPS) while RA-UPS samples expressed higher levels of both phosphorylated and total IGF-1R. Discussion Cyclin D1, AXL and PTEN are associated with cancer-specific outcomes and warrant further investigation in UPS. The differences in protein expression in sporadic versus RA-UPS may indicate that the activated molecular signaling nodes may be different for each specific histology and could also explain the aggressive phenotype seen in RA-UPS when compared to the sporadic lesions. PMID:26847678

  1. The Landscape of Clinical Trials Evaluating the Theranostic Role of PET Imaging in Oncology: Insights from an Analysis of ClinicalTrials.gov Database.

    PubMed

    Chen, Yu-Pei; Lv, Jia-Wei; Liu, Xu; Zhang, Yuan; Guo, Ying; Lin, Ai-Hua; Sun, Ying; Mao, Yan-Ping; Ma, Jun

    2017-01-01

    In the war on cancer marked by personalized medicine, positron emission tomography (PET)-based theranostic strategy is playing an increasingly important role. Well-designed clinical trials are of great significance for validating the PET applications and ensuring evidence-based cancer care. This study aimed to provide a comprehensive landscape of the characteristics of PET clinical trials using the substantial resource of ClinicalTrials.gov database. We identified 25,599 oncology trials registered with ClinicalTrials.gov in the last ten-year period (October 2005-September 2015). They were systematically reviewed to validate classification into 519 PET trials and 25,080 other oncology trials used for comparison. We found that PET trials were predominantly phase 1-2 studies (86.2%) and were more likely to be single-arm (78.9% vs. 57.9%, P <0.001) using non-randomized assignment (90.1% vs. 66.7%, P <0.001) than other oncology trials. Furthermore, PET trials were small in scale, generally enrolling fewer than 100 participants (20.3% vs. 25.7% for other oncology trials, P = 0.014), which might be too small to detect a significant theranostic effect. The funding support from industry or National Institutes of Health shrunk over time (both decreased by about 5%), and PET trials were more likely to be conducted in only one region lacking international collaboration (97.0% vs. 89.3% for other oncology trials, P <0.001). These findings raise concerns that clinical trials evaluating PET imaging in oncology are not receiving the attention or efforts necessary to generate high-quality evidence. Advancing the clinical application of PET imaging will require a concerted effort to improve the quality of trials.

  2. The Landscape of Clinical Trials Evaluating the Theranostic Role of PET Imaging in Oncology: Insights from an Analysis of ClinicalTrials.gov Database

    PubMed Central

    Chen, Yu-Pei; Lv, Jia-Wei; Liu, Xu; Zhang, Yuan; Guo, Ying; Lin, Ai-Hua; Sun, Ying; Mao, Yan-Ping; Ma, Jun

    2017-01-01

    In the war on cancer marked by personalized medicine, positron emission tomography (PET)-based theranostic strategy is playing an increasingly important role. Well-designed clinical trials are of great significance for validating the PET applications and ensuring evidence-based cancer care. This study aimed to provide a comprehensive landscape of the characteristics of PET clinical trials using the substantial resource of ClinicalTrials.gov database. We identified 25,599 oncology trials registered with ClinicalTrials.gov in the last ten-year period (October 2005-September 2015). They were systematically reviewed to validate classification into 519 PET trials and 25,080 other oncology trials used for comparison. We found that PET trials were predominantly phase 1-2 studies (86.2%) and were more likely to be single-arm (78.9% vs. 57.9%, P <0.001) using non-randomized assignment (90.1% vs. 66.7%, P <0.001) than other oncology trials. Furthermore, PET trials were small in scale, generally enrolling fewer than 100 participants (20.3% vs. 25.7% for other oncology trials, P = 0.014), which might be too small to detect a significant theranostic effect. The funding support from industry or National Institutes of Health shrunk over time (both decreased by about 5%), and PET trials were more likely to be conducted in only one region lacking international collaboration (97.0% vs. 89.3% for other oncology trials, P <0.001). These findings raise concerns that clinical trials evaluating PET imaging in oncology are not receiving the attention or efforts necessary to generate high-quality evidence. Advancing the clinical application of PET imaging will require a concerted effort to improve the quality of trials. PMID:28042342

  3. 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

  4. New developments in clinical oncology: the interdependence of bench and bedside.

    PubMed

    Antman, K H

    1991-09-15

    Efforts to diminish the overall morbidity and mortality of malignancy have required a variety of strategies and a balanced national research agenda. The design of curative regimens against leukemia, lymphomas, testis cancer, and childhood malignancies is a tribute to the interactions between laboratory and clinical scientists. Laboratory models illustrated the importance of dose and the need for combinations to avoid the emergence of drug resistance in heterogeneous tumors. In addressing the incurability of common epithelial cancers in adults once disseminated, again laboratory models suggested that regimens which produced responses in advanced disease might be curative in patients with micro-metastases. Such proved to be the case in adjuvant therapy for breast cancer involving lymph nodes and for osteogenic sarcoma. Recent studies have extended this strategy to less advanced breast cancer and to locally advanced colon cancer. Lung cancer has required a different strategy. A coalition has developed to support the strongest possible public position against smoking. For the first time lung cancer incidence has leveled off in white males. Women and minorities continue to be a major target for smoking cessation programs. While large randomized trials are expensive (and to some scientists, unexciting), they are our most reliable means of detecting treatment differences of 10 to 15%. Because lung, breast, and colon cancer kill almost 250,000 Americans each year, such "small" differences represent thousands of Americans. There are also a number of interesting current studies that may impact in the longer term on the care of patients with cancer. Research of three different groups of investigators has recently converged. Over the past 3 decades several groups of basic laboratory investigators had been studying and cloning hematopoietic growth factors. Large randomized trials now confirm that myelosuppression after intensive chemotherapy can be substantially ameliorated

  5. Controversies on the management of clinical situations with low therapeutic effectiveness in oncology.

    PubMed

    Expósito, José; Bretón, Juan José; Domínguez, Carmen; Pons, Joana

    2010-07-01

    Clinical scenarios associated with low therapeutic effectiveness (LTE) are especially complex and highly relevant in oncology. The objective was to test a methodological framework for creating consensual clinical recommendations for routine practice. The study was in three phases from Mars 2006 to January 2008: 1) Definition of LTE situations; 2) Preparation by 10 experts of a panel of LTE situations in cancers of breast, lung, head and neck, colon and rectum and brain; and 3) Development of a consensus on each situation and its optimal treatment by gathering agreement and disagreements (two-round Delphi method) from 68 practicing oncologists in Andalusian Community. Three major and three minor criteria were established for an LTE situation, defined when at least one major or two minor criteria were met. The expert group proposed 48 possible LTE clinical scenarios for breast (n = 7), lung (10), brain (11), head and neck (11) and colorectal cancers (9). Sixty-eight oncologists agreed to participate in the study; the response rate was 79% (from 34 medical and 17 radiation oncologists) In the first round (definition), maximum agreement was obtained with the LTE definition of 10 of the 48 scenarios; in the second round (treatment options), maximum agreement was obtained on the treatment of 3 of these 10 scenarios. Oncologists reached low levels of agreement on the definition of an LTE situation and on its treatment recommendations. This study proposes an approach to the improvement of cancer management in situations of high uncertainty.

  6. Chemotherapy and novel therapeutics before radical prostatectomy for high-risk clinically localized prostate cancer.

    PubMed

    Cha, Eugene K; Eastham, James A

    2015-05-01

    Although both surgery and radiation are potential curative options for men with clinically localized prostate cancer, a significant proportion of men with high-risk and locally advanced disease will demonstrate biochemical and potentially clinical progression of their disease. Neoadjuvant systemic therapy before radical prostatectomy (RP) is a logical strategy to improve treatment outcomes for men with clinically localized high-risk prostate cancer. Furthermore, delivery of chemotherapy and other systemic agents before RP affords an opportunity to explore the efficacy of these agents with pathologic end points. Neoadjuvant chemotherapy, primarily with docetaxel (with or without androgen deprivation therapy), has demonstrated feasibility and safety in men undergoing RP, but no study to date has established the efficacy of neoadjuvant chemotherapy or neoadjuvant chemohormonal therapies. Other novel agents, such as those targeting the vascular endothelial growth factor receptor, epidermal growth factor receptor, platelet-derived growth factor receptor, clusterin, and immunomodulatory therapeutics, are currently under investigation.

  7. 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

  8. Clinical Cancer Advances 2005: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology.

    PubMed

    Herbst, Roy S; Bajorin, Dean F; Bleiberg, Harry; Blum, Diane; Hao, Desirée; Johnson, Bruce E; Ozols, Robert F; Demetri, George D; Ganz, Patricia A; Kris, Mark G; Levin, Bernard; Markman, Maurie; Raghavan, Derek; Reaman, Gregory H; Sawaya, Raymond; Schuchter, Lynn M; Sweetenham, John W; Vahdat, Linda T; Vokes, Everett E; Winn, Rodger J; Mayer, Robert J

    2006-01-01

    This year, for the first time, the American Society of Clinical Oncology (ASCO) is publishing Clinical Cancer Advances 2005: Major Research Advances in Cancer Treatment, Prevention, and Screening, an annual review of the most significant clinical research presented or published over the past year across all cancer types. ASCO embarked on this project to provide the public, patients, policymakers, and physicians with an accessible summary of the year's most important research advances. While not intended to serve as a comprehensive review, this report provides a year-end snapshot of research that will have the greatest impact on patient care. As you will read, there is much good news from the front lines of cancer research. These pages report on new chemotherapy regimens that sharply reduce the risk of recurrence for very common cancers; the "coming of age" of targeted cancer therapies; promising studies of drugs to prevent cancer; and improvements in quality of life for people living with the disease, among many other advances. Survival rates for cancer are on the rise, increasing from 50% to 64% over the last 30 years. Cancer still exacts an enormous toll, however. Nearly 1.4 million Americans will be diagnosed this year, and some 570,000 will die of the disease. Clearly, more research is needed to find effective therapies for the most stubborn cancer types and stages. We need to know more about the long-term effects of newer, more targeted cancer therapies, some of which need to be taken over long periods of time. And we need to devote far greater attention to tracking and improving the care of the nearly 10 million cancer survivors in the United States today. Despite these and other challenges, the message of this report is one of hope. Through the dedicated, persistent pursuit of clinical research and participation in clinical trials by people with cancer, we steadily uncover new and better ways of treating, diagnosing, and preventing a disease that touches the

  9. Immune contexture and histological response after neoadjuvant chemotherapy predict clinical outcome of lung cancer patients.

    PubMed

    Remark, Romain; Lupo, Audrey; Alifano, Marco; Biton, Jerome; Ouakrim, Hanane; Stefani, Alessandro; Cremer, Isabelle; Goc, Jeremy; Régnard, Jean-Francois; Dieu-Nosjean, Marie-Caroline; Damotte, Diane

    2016-01-01

    There is now growing evidence that the immune contexture influences cancer progression and clinical outcome of patients with non-small cell lung cancer (NSCLC). If chemotherapy is widely used to treat patients with advanced-stage NSCLC, it remains unclear how it could modify the immune contexture and impact its prognostic value. Here, we analyzed two retrospective cohorts, respectively composed of 122 stage III-N2 NSCLC patients treated with chemotherapy before surgery and 39 stage-matched patients treated by surgery only. In patients treated with neoadjuvant chemotherapy, the histological characteristics, the expression of PD-L1 protein, and the tumor immune microenvironment (CD8(+) T cells, DC-LAMP(+) mature dendritic cells, and CD68(+) macrophages) were evaluated and their prognostic value assessed together with standard clinical parameters. By analyzing pre- and post-treatment specimens, we did not find any changes in the PD-L1 expression. We also found that the tumor immune contexture in patients treated with neoadjuvant chemotherapy exhibited a similar pattern that the one found in chemotherapy-naive patients, with comparable densities of tumor-infiltrating CD8(+) and DC-LAMP(+) cells and a similar spatial organization. The percentage of residual viable tumor cells and the immune pattern (CD8(+) and DC-LAMP(+) cell densities) were significantly associated with the clinical outcome and allowed the identification of short- and long-term survivors, respectively. In multivariate analysis, the immune pattern was found to be the strongest independent prognostic factor. In conclusion, this study decrypts the complex interplay between cancer and immune cells in patients undergoing chemotherapy and supports potential beneficial synergistic effect of immunotherapy and chemotherapy.

  10. End points and trial design in geriatric oncology research: a joint European organisation for research and treatment of cancer--Alliance for Clinical Trials in Oncology--International Society Of Geriatric Oncology position article.

    PubMed

    Wildiers, Hans; Mauer, Murielle; Pallis, Athanasios; Hurria, Arti; Mohile, Supriya G; Luciani, Andrea; Curigliano, Giuseppe; Extermann, Martine; Lichtman, Stuart M; Ballman, Karla; Cohen, Harvey Jay; Muss, Hyman; Wedding, Ulrich

    2013-10-10

    Selecting the most appropriate end points for clinical trials is important to assess the value of new treatment strategies. Well-established end points for clinical research exist in oncology but may not be as relevant to the older cancer population because of competing risks of death and potentially increased impact of therapy on global functioning and quality of life. This article discusses specific clinical end points and their advantages and disadvantages for older individuals. Randomized or single-arm phase II trials can provide insight into the range of efficacy and toxicity in older populations but ideally need to be confirmed in phase III trials, which are unfortunately often hindered by the severe heterogeneity of the older cancer population, difficulties with selection bias depending on inclusion criteria, physician perception, and barriers in willingness to participate. All clinical trials in oncology should be without an upper age limit to allow entry of eligible older adults. In settings where so-called standard therapy is not feasible, specific trials for older patients with cancer might be required, integrating meaningful measures of outcome. Not all questions can be answered in randomized clinical trials, and large observational cohort studies or registries within the community setting should be established (preferably in parallel to randomized trials) so that treatment patterns across different settings can be compared with impact on outcome. Obligatory integration of a comparable form of geriatric assessment is recommended in future studies, and regulatory organizations such as the European Medicines Agency and US Food and Drug Administration should require adequate collection of data on efficacy and toxicity of new drugs in fit and frail elderly subpopulations.

  11. 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.

  12. Optimising translational oncology in clinical practice: strategies to accelerate progress in drug development.

    PubMed

    Stahel, R; Bogaerts, J; Ciardiello, F; de Ruysscher, D; Dubsky, P; Ducreux, M; Finn, S; Laurent-Puig, P; Peters, S; Piccart, M; Smit, E; Sotiriou, C; Tejpar, S; Van Cutsem, E; Tabernero, J

    2015-02-01

    Despite intense efforts, the socioeconomic burden of cancer remains unacceptably high and treatment advances for many common cancers have been limited, suggesting a need for a new approach to drug development. One issue central to this lack of progress is the heterogeneity and genetic complexity of many tumours. This results in considerable variability in therapeutic response and requires knowledge of the molecular profile of the tumour to guide appropriate treatment selection for individual patients. While recent advances in the molecular characterisation of different cancer types have the potential to transform cancer treatment through precision medicine, such an approach presents a major economic challenge for drug development, since novel targeted agents may only be suitable for a small cohort of patients. Identifying the patients who would benefit from individual therapies and recruiting sufficient numbers of patients with particular cancer subtypes into clinical trials is challenging, and will require collaborative efforts from research groups and industry in order to accelerate progress. A number of molecular screening platforms have already been initiated across Europe, and it is hoped that these networks, along with future collaborations, will benefit not only patients but also society through cost reductions as a result of more efficient use of resources. This review discusses how current developments in translational oncology may be applied in clinical practice in the future, assesses current programmes for the molecular characterisation of cancer and describes possible collaborative approaches designed to maximise the benefits of translational science for patients with cancer.

  13. [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

  14. 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

  15. A review of Raman spectroscopy advances with an emphasis on clinical translation challenges in oncology

    NASA Astrophysics Data System (ADS)

    Jermyn, Michael; Desroches, Joannie; Aubertin, Kelly; St-Arnaud, Karl; Madore, Wendy-Julie; De Montigny, Etienne; Guiot, Marie-Christine; Trudel, Dominique; Wilson, Brian C.; Petrecca, Kevin; Leblond, Frederic

    2016-12-01

    There is an urgent need for improved techniques for disease detection. Optical spectroscopy and imaging technologies have potential for non- or minimally-invasive use in a wide range of clinical applications. The focus here, in vivo Raman spectroscopy (RS), measures inelastic light scattering based on interaction with the vibrational and rotational modes of common molecular bonds in cells and tissue. The Raman ‘signature’ can be used to assess physiological status and can also be altered by disease. This information can supplement existing diagnostic (e.g. radiological imaging) techniques for disease screening and diagnosis, in interventional guidance for identifying disease margins, and in monitoring treatment responses. Using fiberoptic-based light delivery and collection, RS is most easily performed on accessible tissue surfaces, either on the skin, in hollow organs or intra-operatively. The strength of RS lies in the high biochemical information content of the spectra, that characteristically show an array of very narrow peaks associated with specific chemical bonds. This results in high sensitivity and specificity, for example to distinguish malignant or premalignant from normal tissues. A critical issue is that the Raman signal is often very weak, limiting clinical use to point-by-point measurements. However, non-linear techniques using pulsed-laser sources have been developed to enable in vivo Raman imaging. Changes in Raman spectra with disease are often subtle and spectrally distributed, requiring full spectral scanning, together with the use of tissue classification algorithms that must be trained on large numbers of independent measurements. Recent advances in instrumentation and spectral analysis have substantially improved the clinical feasibility of RS, so that it is now being investigated with increased success in a wide range of cancer types and locations, as well as for non-oncological conditions. This review covers recent advances and

  16. 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.

  17. Chemical shift and diffusion-weighted magnetic resonance imaging of the anterior mediastinum in oncology: Current clinical applications in qualitative and quantitative assessment.

    PubMed

    Priola, Adriano Massimiliano; Gned, Dario; Veltri, Andrea; Priola, Sandro Massimo

    2016-02-01

    Recently, the use of magnetic resonance (MR) in clinical practice for the evaluation of the anterior mediastinum has considerably increased due to technological improvements and standardization of thoracic protocols. Currently, MR imaging is increasingly seen as a useful problem-solving modality, especially in equivocal cases at computed tomography, with the advantage of a higher contrast resolution and no radiation exposure. Chemical shift and diffusion-weighted MR are helpful in tissue characterization and present advantages over conventional MR imaging, first in providing quantitative data, without the need for the administration of contrast medium. By detecting microscopic fat in tissue, chemical shift imaging is useful for differentiating normal thymus and rebound hyperplasia from cancer tissue at diagnosis and after chemotherapy in oncologic patients, and for distinguishing lymphoid hyperplasia from thymoma in autoimmune diseases such as myasthenia gravis. Diffusion-weighted MR reflects diffusivity of water molecules within tissue and is increasingly used as a cancer biomarker, even in the thorax, for the detection and characterization of tumors, for their differentiation from benign conditions, and for monitoring treatment response. In this review, based on the current literature, technical considerations about image acquisition and data analysis of chemical shift and diffusion-weighted MR are discussed along with clinical applications in the field of benign and malignant disease of the anterior mediastinum.

  18. Covariate pharmacokinetic model building in oncology and its potential clinical relevance.

    PubMed

    Joerger, Markus

    2012-03-01

    When modeling pharmacokinetic (PK) data, identifying covariates is important in explaining interindividual variability, and thus increasing the predictive value of the model. Nonlinear mixed-effects modeling with stepwise covariate modeling is frequently used to build structural covariate models, and the most commonly used software-NONMEM-provides estimations for the fixed-effect parameters (e.g., drug clearance), interindividual and residual unidentified random effects. The aim of covariate modeling is not only to find covariates that significantly influence the population PK parameters, but also to provide dosing recommendations for a certain drug under different conditions, e.g., organ dysfunction, combination chemotherapy. A true covariate is usually seen as one that carries unique information on a structural model parameter. Covariate models have improved our understanding of the pharmacology of many anticancer drugs, including busulfan or melphalan that are part of high-dose pretransplant treatments, the antifolate methotrexate whose elimination is strongly dependent on GFR and comedication, the taxanes and tyrosine kinase inhibitors, the latter being subject of cytochrome p450 3A4 (CYP3A4) associated metabolism. The purpose of this review article is to provide a tool to help understand population covariate analysis and their potential implications for the clinic. Accordingly, several population covariate models are listed, and their clinical relevance is discussed. The target audience of this article are clinical oncologists with a special interest in clinical and mathematical pharmacology.

  19. 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

  20. Use of liposomal doxorubicin for adjuvant chemotherapy of breast cancer in clinical practice*

    PubMed Central

    Zhao, Ming; Ding, Xian-feng; Shen, Jian-yu; Zhang, Xi-ping; Ding, Xiao-wen; Xu, Bin

    2017-01-01

    Breast cancer is one of the malignant tumors with the highest morbidity and mortality. It is helpful to reduce the rate of tumor recurrence and metastasis by treating breast cancer with adjuvant chemotherapy, so as to increase the cure rate or survival of patients. In recent years, liposomes have been regarded as a kind of new carrier for targeted drugs. Being effective for enhancing drug efficacy and reducing side effects, they have been widely used for developing anticancer drugs. As a kind of anthracycline with high anticancer activity, doxorubicin can treat or alleviate a variety of malignant tumors effectively when it is used on its own or in combination with other anticancer drugs. Although liposomal doxorubicin has been extensively used in the adjuvant chemotherapy of breast cancer, its exact therapeutic efficacy and side effects have not been definitely proven. Various clinical studies have adopted different combined regimes, dosages, and staging, so their findings differ to certain extent. This paper reviews the clinical application of liposomal doxorubicin in the adjuvant chemotherapy of breast cancer and illustrates therapeutic effects and side effects of pegylated liposomal doxorubicin (PLD) and non-PLD (NPLD) in clinical research, in order to discuss the strategies for applying these drugs in such adjuvant chemotherapy, looking forward to providing references for related research and clinical treatment in terms of dosage, staging, combined regimes, and analysis methods and so on. PMID:28070993

  1. Mass spectrometry strategies for clinical metabolomics and lipidomics in psychiatry, neurology, and neuro-oncology.

    PubMed

    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.

  2. American Society of Clinical Oncology guidance statement: the cost of cancer care.

    PubMed

    Meropol, Neal J; Schrag, Deborah; Smith, Thomas J; Mulvey, Therese M; Langdon, Robert M; Blum, Diane; Ubel, Peter A; Schnipper, Lowell E

    2009-08-10

    Advances in early detection, prevention, and treatment have resulted in consistently falling cancer death rates in the United States. In parallel with these advances have come significant increases in the cost of cancer care. It is well established that the cost of health care (including cancer care) in the United States is growing more rapidly than the overall economy. In part, this is a result of the prices and rapid uptake of new agents and other technologies, including advances in imaging and therapeutic radiology. Conventional understanding suggests that high prices may reflect the costs and risks associated with the development, production, and marketing of new drugs and technologies, many of which are valued highly by physicians, patients, and payers. The increasing cost of cancer care impacts many stakeholders who play a role in a complex health care system. Our patients are the most vulnerable because they often experience uneven insurance coverage, leading to financial strain or even ruin. Other key groups include pharmaceutical manufacturers that pass along research, development, and marketing costs to the consumer; providers of cancer care who dispense increasingly expensive drugs and technologies; and the insurance industry, which ultimately passes costs to consumers. Increasingly, the economic burden of health care in general, and high-quality cancer care in particular, will be less and less affordable for an increasing number of Americans unless steps are taken to curb current trends. The American Society of Clinical Oncology (ASCO) is committed to improving cancer prevention, diagnosis, and treatment and eliminating disparities in cancer care through support of evidence-based and cost-effective practices. To address this goal, ASCO established a Cost of Care Task Force, which has developed this Guidance Statement on the Cost of Cancer Care. This Guidance Statement provides a concise overview of the economic issues facing stakeholders in the cancer

  3. Low Enrollment of Adolescents and Young Adults Onto Cancer Trials: Insights From the Community Clinical Oncology Program

    PubMed Central

    Roth, Michael E.; O’Mara, Ann M.; Seibel, Nita L.; Dickens, David S.; Langevin, Anne-Marie; Pollock, Brad H.

    2016-01-01

    Purpose: Stagnant outcomes for adolescents and young adults (AYAs; 15 to 39 years old) with cancer are partly attributed to poor enrollment onto clinical trials. The National Cancer Institute (NCI) Community Clinical Oncology Program (CCOP) was developed to improve clinical trial participation in the community setting, where AYAs are most often treated. Further, many CCOP sites had pediatric and medical oncologists with collaborative potential for AYA recruitment and care. For these reasons, we hypothesized that CCOP sites enrolled proportionately more AYAs than non-CCOP sites onto Children’s Oncology Group (COG) trials. Methods: For the 10-year period 2004 through 2013, the NCI Division of Cancer Prevention database was queried to evaluate enrollments into relevant COG studies. The proportional enrollment of AYAs at CCOP and non-CCOP sites was compared and the change in AYA enrollment patterns assessed. All sites were COG member institutions. Results: Although CCOP sites enrolled a higher proportion of patients in cancer control studies than non-CCOP sites (3.5% v 1.8%; P < .001), they enrolled a lower proportion of AYAs (24.1% v 28.2%, respectively; P < .001). Proportional AYA enrollment at CCOP sites decreased during the intervals 2004 through 2008 and 2009 through 2013 (26.7% v 21.7%; P < .001). Conclusion: Despite oncology practice settings that might be expected to achieve otherwise, CCOP sites did not enroll a larger proportion of AYAs in clinical trials than traditional COG institutions. Our findings suggest that the CCOP (now the NCI Community Oncology Research Program) can be leveraged for developing targeted interventions for overcoming AYA enrollment barriers. PMID:27026648

  4. A golden anniversary: highlights of the 50th annual meeting of the American Society of Clinical Oncology

    PubMed Central

    McVie, Gordon; Nailor, Audrey

    2014-01-01

    The 50th Annual Meeting of the American Society of Clinical Oncology showed a shift in the culture of cancer research, moving towards multidisciplinary, integrated, and patient-centric work. Hormone-sensitive cancers were particularly highlighted at this meeting, and impressive strides were made in the previously underserved areas of the lung and thyroid cancer. Interestingly, immunotherapy was one of the strongest themes to emerge. PMID:25075218

  5. Clinical value of stool culture in paediatric oncology patients: hospital evaluation and UK survey of practice.

    PubMed

    O'Connor, O; Cooke, R P D; Cunliffe, N A; Pizer, B

    2017-01-01

    Diarrhoea is a frequently occurring symptom in paediatric oncology patients. The role of routine testing for enteric bacteria in hospitalized patients with diarrhoea is considered limited, but the diagnostic value of testing in children with oncological conditions has not been reported. Therefore, we conducted a five-year retrospective service evaluation in our tertiary paediatric oncology unit together with a national survey of 21 centres to estimate the utility of stool cultures in oncology patients with diarrhoea and the national approach to testing. Our local survey demonstrated very low diagnostic yield using routine enteric stool cultures with only one sample out of 842 (0.1%) testing positive. The national survey demonstrated considerable variation in practice. There is little evidence to support the use of conventional stool culture for enteric bacteria in children with cancer in our centre. These findings should inform national testing policies.

  6. A Review of Modeling Approaches to Predict Drug Response in Clinical Oncology

    PubMed Central

    2017-01-01

    Model-based approaches have emerged as important tools for quantitatively understanding temporal relationships between drug dose, concentration, and effect over the course of treatment, and have now become central to optimal drug development and tailored drug treatment. In oncology, the therapeutic index of a chemotherapeutic drug is typically narrow and a full dose–response relationship is not available, often because of treatment failure. Noting the benefits of model-based approaches and the low therapeutic index of oncology drugs, in recent years, modeling approaches have been increasingly used to streamline oncologic drug development through early identification and quantification of dose–response relationships. With this background, this report reviews publications that used model-based approaches to evaluate drug treatment outcome variables in oncology therapeutics, ranging from tumor size dynamics to tumor/biomarker time courses and survival response. PMID:27873489

  7. Turkish Ministry of Health, 2nd Turkish Medical General Assembly Clinical Oncology Study Group Report

    PubMed Central

    Özmen, Vahit; Dağoğlu, Nergiz; Dede, İsmet; Akçakaya, Adem; Kerem, Mustafa; Göksel, Fatih; Özgür, Enver; Başkan, Emel; Yaylacı, Mustafa; Ceydeli, Adil; Baykara, Meltem; Kızıltan, Huriye Şenay; Kömürcü, Şeref; Gümüş, Mahmut; Türk, H. Mehmet; Demirhan, Recep; Akgün, Ali; Kadoglou, Naim; Yatman, Emre; Elbi, Cem Cüneyt; Güleç, Seza; Soran, Atilla; Özet, Ahmet; Keleştimur, Fahrettin

    2016-01-01

    Objective There is an increase in the incidence of cancer, and consequently in mortality rates, both in the world and in Turkey. The increase in the incidence and mortality rate of cancer are more prominent in our country as well as in other developing countries. The aim of this workshop was to determine the current status on prevention, screening, early diagnosis and treatment of cancer in our country, to identify related shortcomings, specify solutions and to share these with health system operators, and to aid in implementation of these systems. Developments on palliative care were also evaluated. Materials and Methods The current situation in the practice of clinical oncology, related drawbacks, problems encountered during multidisciplinary approach and their solutions were discussed under several sub-headings during a 3-day meeting organized by the Turkish Ministry of Health (Türkiye Cumhuriyeti Sağlık Bakanlığı-TCSB) with participation of 16 scientists from Turkey and 6 from abroad, and the conclusions were reported. Results It is expected that the newly established Turkish Health Institutes Association (Türkiye Sağlık Enstitüleri Başkanlığı-TÜSEB) and the National Cancer Institute (Ulusal Kanser Enstitüsü) will provide a new framework in the field of oncology. The current positive findings include the increase in the number of scientists who carry out successful trials in oncology both in Turkey and abroad, the implementation of the national cancer registry program by the Cancer Control Department and the breast cancer registry program by the Turkish Federation of Breast Diseases Societies (Türkiye Meme Hastalıkları Dernekleri Federasyonu-TMHDF), and introduction of Cancer Early Diagnosis, Screening, and Training Centers (Kanser Erken Tanı, Tarama ve Eğitim Merkezi-KETEM) for the application of community-based cancer screening programs. In addition to these, obvious shortcomings related to education, implementation, management and

  8. 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

  9. Sickness certification at oncology clinics: perceived problems, support, need for education and reasons for certifying unnecessarily long sickness absences.

    PubMed

    Bränström, R; Arrelöv, B; Gustavsson, C; Kjeldgård, L; Ljungquist, T; Nilsson, G H; Alexanderson, K

    2014-01-01

    Physicians' work with sickness certifications is an understudied field. The aims of this study were to gain knowledge of experiences concerning the sickness certification process among physicians working at oncology clinics. In 2008, all physicians working in Sweden (n = 36 898) were sent a questionnaire concerning sick-listing practices. All respondents working at an oncology clinic (n = 428) were included in the current study. Most of the physicians had sickness certification consultations at least weekly (91.3%). More than one fifth (22.3%) reported that they worked at a clinic with a workplace policy regarding the handling of sickness certification and 61.1% reported receiving at least some support in such cases from their immediate manager. Issuing unnecessary long sickness certificates were related to experiencing delicate interactions with patients and to lack of time. To a moderate degree, further competence was requested regarding: different types of compensation in the social insurance system, responsibilities of the Social Insurance Agency and employers, and sickness insurance rules. The large majority of physicians working in oncology reported regularly having consultations involving sickness certification. Overall, they reported few problems, low level of need for more competence regarding sickness certification, and low frequency of issuing sickness absences for longer periods than necessary.

  10. 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.

  11. Differential pharmacology and clinical utility of rolapitant in chemotherapy-induced nausea and vomiting

    PubMed Central

    Rapoport, Bernardo Leon

    2017-01-01

    Chemotherapy-induced nausea and vomiting (CINV) is a debilitating side effect of many cytotoxic chemotherapy regimens. CINV typically manifests during two well-defined time periods (acute and delayed phases). The acute phase is the first 24 hours after chemotherapy and is largely managed with 5-hydroxytryptamine 3 receptor antagonists. The delayed phase, a 5-day at-risk period during which patients are not often in direct contact with their health care provider, remains a significant unmet medical need. Neurokinin-1 (NK-1) receptor antagonists have demonstrated protection against acute and delayed CINV in patients treated with highly emetogenic chemotherapy and moderately emetogenic chemotherapy when used in combination with a 5-hydroxytryptamine 3 receptor antagonist and dexamethasone. Furthermore, recent data indicate that this protection is maintained over multiple treatment cycles. Rolapitant, a selective and long-acting NK-1 receptor antagonist, is approved as oral formulation for the prevention of delayed CINV in adults. This review discusses the differential pharmacology and clinical utility of rolapitant in preventing CINV compared with other NK-1 receptor antagonists. PMID:28260945

  12. 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

  13. [Clinical trials: prerequisite of evidence-based oncology: reality, perspectives and a new tool recruited--the Internet].

    PubMed

    Mross, K; März, W

    2001-02-01

    Scientifically sound clinical research is an undispensable prerequisite to establish innovative therapeutic principles, to support applications for marketing authorization of proprietary new drugs, to advance therapeutic results in cancer therapy, and the only route towards an evidence-based clinical oncology at the advent of the 21st century. Treatment of cancer patients based on scientific evidence derived from clinical studies outperforms compassionate individual therapeutic decisions with a lack of evidence, whenever such evidence is available or whenever a clinical trial is addressing the clinical situation that must be addressed for an individual patient. A stable trend towards improved survival of cancer patients was first observed in 1999. The advent of new technologies of drug design, the integration of pharmacology, genomics and DNA microarray chip technologies will produce a myriad of new anticancer drugs with promising potential for cancer therapy that need to be tested in the clinical setting without delay. To match that challenge, clinical oncology must streamline the laborious process of conducting clinical trials. The process of planning, multicenter coordinating, recruiting, treatment, analyzing, and reporting of clinical trial results must be further optimized. The best possible quality control of all steps of that process is a prerequisite to motivate patients to participate in clinical trials of cancer therapy - always one of the most promising treatment options for patients seeking the best possible cancer care. At the same time as the internet goes mainstream and cancer care information is ubiquitously laymanized and dispersed via cancer cybermedicine, clinical researchers may employ the internet to exchange information, facilitate conduction of clinical trials, and facilitate recruitment to clinical studies via web-based trial registries. This will be more than an incremental step forward to deliver the best possible clinical care towards the

  14. [Challenges for clinical trials in oncology within the scope of early benefit assessment of drugs].

    PubMed

    Lange, Stefan

    2015-01-01

    Until May 31, 2015 the German Institute for Quality and Efficiency in Health Care (IQWiG) conducted 108 assessments for various diseases on the basis of 103 dossiers within the scope of the early benefit assessment of drugs pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG). 29 of these assessments (28 dossiers) referred to advanced stages of oncologic (including neoplastic-hematologic) diseases. In 21 of these 29 assessments (72%), IQWiG found an added benefit for at least one subpopulation or subgroup, compared to 33% with non-oncologic diseases. For oncologic diseases, the extent of benefit was classified as "major" in six assessments (21%), compared to 5% for non-oncologic disorders. In contrast, the conclusions of the oncologic studies were less certain: only one assessment provided proof (of an added benefit); for non-oncologic diseases, this was the case in eight assessments. A distinctive methodological feature of the available oncologic studies is that, as a rule, treatment switching was planned in the event of progression (normally on the basis of imaging or laboratory findings) and that shortly afterwards the follow-up of important endpoints (adverse events and patient-reported outcomes) was normally discontinued. In particular, the pre-specified option in the study protocol allowing the control group to switch treatment to the experimental intervention after progression ("protocol-permitted treatment switches") makes it extremely difficult to interpret the results beyond the outcome "progression" (or progression-free survival). This treatment switching is mostly justified by reference to ethical necessity. This, however, alleges that the experimental intervention (i. e., the new drug) is superior to the control intervention, which means that circular reasoning is unavoidable. But despite this, oncologic studies are better than their reputation. Hence, so far the results of the early benefit assessment of new drugs (regarding

  15. Cultural Competency Training to Increase Minority Enrollment into Radiation Therapy Clinical Trials-an NRG Oncology RTOG Study.

    PubMed

    Wells, Jessica S; Pugh, Stephanie; Boparai, Karan; Rearden, Jessica; Yeager, Katherine A; Bruner, Deborah W

    2016-05-21

    Despite initiatives to increase the enrollment of racial and ethnic minorities into cancer clinical trials in the National Cancer Institute National Cancer Clinical Trials Network (NCCTN), participation by Latino and African American populations remain low. The primary aims of this pilot study are (1) to develop a Cultural Competency and Recruitment Training Program (CCRTP) for physician investigators and clinical research associates (CRAs), (2) to determine if the CCRTP increases cultural competency scores among physician investigators and CRAs, and (3) to determine the impact of the CCRTP on minority patient recruitment into NRG Oncology Radiation Therapy Oncology Group (RTOG) clinical trials. Sixty-seven CRAs and physicians participated in an in-person or online 4-h CRRTP training. Five knowledge and attitude items showed significant improvements from pre- to post-training. A comparison between enrolling sites that did and did not participate in the CCRTP demonstrated a pre to 1-year post-incremental increase in minority accrual to clinical trials of 1.2 % among participating sites. While not statistically significant, this increase translated into an additional 300 minority patients accrued to NCCTN clinical trials in the year following the training from those sites who participated in the training.

  16. The American Society of Clinical Oncology Cancer Foundation Grants Program: a 25-year report and a look toward the future.

    PubMed

    King, Jennifer C; Lawrence, Theodore S; Murphy, Sharon B; Davidson, Nancy E; Mayer, Robert J

    2010-03-20

    The American Society of Clinical Oncology (ASCO) Grants Program began in 1984 with a single $16,000 grant to a young investigator for start-up research funding. In 2009, the Grants Program, now administered by The ASCO Cancer Foundation, awarded more than $6.5 million to 70 different investigators. This article, celebrating the 25th anniversary of this initiative, describes the history and evolution of the Grants Program, attempts to measure the impact of the program on clinical cancer research through an analysis of the career paths of past recipients, and addresses challenges that the program will face as it enters its second 25 years.

  17. Fast-Track Surgery in Gynaecology and Gynaecologic Oncology: A Review of a Rolling Clinical Audit

    PubMed Central

    Carter, Jonathan

    2012-01-01

    Clinical audit is the process by which clinicians are able to demonstrate to themselves, their patients, hospital administrators, and healthcare financial providers the outcome and safety of their clinical practice. It is a process by which the public can be assured of safety and outcomes. A fast-track surgery program was initiated in January 2008, and this paper represents a rolling clinical audit of the outcomes of that program until the end of June 2012. Three hundred and eighty-nine patients underwent fast track surgical management after having a laparotomy for suspected or confirmed gynaecological cancer. There were no exclusions and the data presented represents the practice and outcomes of all patients referred to a single gynaecological oncologist. The majority of patients were deemed to have complex surgical procedures performed usually through a vertical midline incision. One third of patients had a nonzero performance status, median weight was 68 kilograms, and median BMI was 26.5 with 31% being classified as obese. Median operating time was 2.25 hours, and the median estimated blood loss was 175 mL. Overall the median length of stay (LOS) was 3 days with 95% of patients tolerating early oral feeding. Four percent of patients required readmission, and 0.5% were required to return to the operating room. Whilst the wound infection rate was 2.6%, there were no ureteric, bowel or neurovascular injuries. Overall there were 2 bladder injuries (0.5%), and the incidence of venous thromboembolism was 1%. Subset analysis was also undertaken. Whilst a number of variables were associated with reduced LOS, on multivariate analysis, benign pathology, shorter operating time, and the ability to tolerate early oral feeding were found to be significant. The data and experience presented is the largest and most extensive reported in the literature relating to fast-track surgery in gynaecology and gynaecologic oncology. The public can be reassured of the safety and

  18. The role of Internet resources in clinical oncology: promises and challenges.

    PubMed

    Hesse, Bradford W; Greenberg, Alexandra J; Rutten, Lila J Finney

    2016-12-01

    The Internet is a valuable tool that continues to revolutionize many aspects of our lives; however, the ability to disseminate diverse data across populations and nations presents both opportunities and challenges. Online resources are increasingly used in health care, providing wider access to information for patients, researchers, and clinicians. At the turn of the millennium, the National Cancer Institute (NCI) predicted that Internet-based technologies would create a revolution in communication for oncology professionals and patients with cancer. Herein, findings from the NCI's Health Information National Trends Survey are reviewed to give insight into how Internet trends related to oncology patients are evolving. Future trends are discussed, including examples of 'connected health' in oncology; the spread of mobile and ubiquitous access points to Internet-hosted information; the diffusion of devices, sensors, and apps; the spread of personal data sharing; and an evolution in how networks can support person-centred and family-centred care.

  19. 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.

  20. Past and present achievements, and future direction of the Gastrointestinal Oncology Study Group (GIOSG), a Division of Japan Clinical Oncology Group (JCOG).

    PubMed

    Boku, Narikazu

    2011-12-01

    Initially, Gastrointestinal Study Group in Japan Clinical Oncology Group (GIOSG/JCOG) focused on gastric cancer. In 1980s, fluoropyrimidine, cisplatin and mitomycin C were key drugs. A randomized Phase II trial (JCOG8501) comparing futrafur plus mitomycin C and uracil plus futrafur and mitomycin C showed a higher response rate of uracil plus futrafur and mitomycin C than futrafur plus mitomycin C. From the results of two Phase II trials of etoposide, adriamycin and cisplatin, and cisplatin plus 5-fluorouracil, uracil plus futrafur and mitomycin C and cisplatin plus 5-fluorouracil were adopted for the test arms of the Phase III trial (JCOG9205) comparing with continuous infusion of 5-fluorouracil as a control arm. Neither cisplatin plus 5-fluorouracil nor uracil plus futrafur and mitomycin C showed a survival benefit over continuous infusion of 5-fluorouracil. In late 1990s, new agents, irinotecan and S-1, were developed for gastric cancer in Japan. GIOSG conducted a Phase III trial (JCOG9912) investigating superiority of irinotecan plus cisplatin and non-inferiority of monotherapy with S-1 compared with continuous infusion of 5-fluorouracil, and S-1 succeeded in showing non-inferiority. Then, SPIRITS trial showed a survival benefit of S-1 plus cisplatin over S-1, resulting in the establishment of a standard care for advanced gastric cancer in Japan. GIOSG have merged with Gastric Cancer Study Group as the Stomach Cancer Study Group (SCSG) from 2011. Recent progress in the development of new drugs has been remarkable. From the point of the roles shared with many other study groups for clinical trials, including registration trials of new drugs conducted by pharmaceutical companies, SCSG should recognize its role and conduct clinical trials with high quality for establishing new standard treatment.

  1. Pediatric Oncology Clinic Care Model: Achieving Better Continuity of Care for Patients in a Medium-sized Program.

    PubMed

    Johnston, Donna L; Halton, Jacqueline; Bassal, Mylène; Klaassen, Robert J; Mandel, Karen; Ramphal, Raveena; Simpson, Ewurabena; Peckan, Li

    2016-10-25

    Providing the best care in both the inpatient and outpatient settings to pediatric oncology patients is all programs goal. Using continuous improvement methodologies, we changed from a solely team-based physician care model to a hybrid model. All patients were assigned a dedicated oncologist. There would then be 2 types of weeks of outpatient clinical service. A "Doc of the Day" week where each oncologist would have a specific day in clinic when their assigned patients would be scheduled, and then a "Doc of the Week" week where one physician would cover clinic for the week. Patient satisfaction surveys done before and 14 months after changing the model of care showed that patients were very satisfied with the care they received in both models. A questionnaire to staff 14 months after changing showed that the biggest effect was increased continuity of care, followed by more efficient clinic workflow and increased consistency of care. Staff felt it provided better planning and delivery of care. A hybrid model of care with a primary physician for each patient and assigned clinic days, alternating with weeks of single physician coverage is a feasible model of care for a medium-sized pediatric oncology program.

  2. 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.

  3. 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.

  4. Outcome of early clinical trials of the combination of hydroxychloroquine with chemotherapy in cancer.

    PubMed

    Poklepovic, Andrew; Gewirtz, David A

    2014-08-01

    The premise of inhibiting autophagy to overcome resistance to chemotherapy has been investigated in 5 clinical phase I trials combining hydroxychloroquine with vorinostat, temsirolimus, temozolomide, or bortezomib. These studies have provided a number of insights relating to the tolerability of the combination treatments. In addition, these studies should provide guidance in the planning and design of future trials to directly determine whether the strategy of autophagy inhibition could prove useful in the treatment of various malignancies.

  5. 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.

  6. Vascular access in oncology patients.

    PubMed

    Gallieni, Maurizio; Pittiruti, Mauro; Biffi, Roberto

    2008-01-01

    Adequate vascular access is of paramount importance in oncology patients. It is important in the initial phase of surgical treatment or chemotherapy, as well as in the chronic management of advanced cancer and in the palliative care setting. We present an overview of the available vascular access devices and of the most relevant issues regarding insertion and management of vascular access. Particular emphasis is given to the use of ultrasound guidance as the preferred technique of insertion, which has dramatically decreased insertion-related complications. Vascular access management has considerably improved after the publication of effective guidelines for the appropriate nursing of the vascular device, which has reduced the risk of late complications, such as catheter-related bloodstream infection. However, many areas of clinical practice are still lacking an evidence-based background, such as the choice of the most appropriate vascular access device in each clinical situation, as well as prevention and treatment of thrombosis. We suggest an approach to the choice of the most appropriate vascular access device for the oncology patient, based on the literature available to date.

  7. Management of Small Renal Masses: American Society of Clinical Oncology Clinical Practice Guideline.

    PubMed

    Finelli, Antonio; Ismaila, Nofisat; Bro, Bill; Durack, Jeremy; Eggener, Scott; Evans, Andrew; Gill, Inderbir; Graham, David; Huang, William; Jewett, Michael A S; Latcha, Sheron; Lowrance, William; Rosner, Mitchell; Shayegan, Bobby; Thompson, R Houston; Uzzo, Robert; Russo, Paul

    2017-02-20

    Purpose To provide recommendations for the management options for patients with small renal masses (SRMs). Methods By using a literature search and prospectively defined study selection, we sought systematic reviews, meta-analyses, randomized clinical trials, prospective comparative observational studies, and retrospective studies published from 2000 through 2015. Outcomes included recurrence-free survival, disease-specific survival, and overall survival. Results Eighty-three studies, including 20 systematic reviews and 63 primary studies, met the eligibility criteria and form the evidentiary basis for the guideline recommendations. Recommendations On the basis of tumor-specific findings and competing risks of mortality, all patients with an SRM should be considered for a biopsy when the results may alter management. Active surveillance should be an initial management option for patients who have significant comorbidities and limited life expectancy. Partial nephrectomy (PN) for SRMs is the standard treatment that should be offered to all patients for whom an intervention is indicated and who possess a tumor that is amenable to this approach. Percutaneous thermal ablation should be considered an option if complete ablation can reliably be achieved. Radical nephrectomy for SRMs should only be reserved for patients who possess a tumor of significant complexity that is not amenable to PN or for whom PN may result in unacceptable morbidity even when performed at centers with expertise. Referral to a nephrologist should be considered if chronic kidney disease (estimated glomerular filtration rate < 45 mL/min/1.73 m(2)) or progressive chronic kidney disease occurs after treatment, especially if associated with proteinuria.

  8. 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)

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

    ClinicalTrials.gov

    2017-02-14

    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

  10. 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

  11. 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.

  12. Oral Chemotherapy Adherence: A Novel Nursing Intervention Using an Electronic Health Record Workflow
.

    PubMed

    Rodriguez, German; Utate, Minerva A; Joseph, George; St Victor, Thelma

    2017-04-01

    In the ambulatory care setting, chemotherapy regimens have become increasingly complex with the combination of induction treatments and oral medications. Nurses at one cancer center implemented an oral adherence tracking documentation system in the electronic health record (EHR). Oncology nurses assessed and monitored adherence to oral chemotherapy at each clinical encounter and during telephone calls and then documented findings in the EHR. After implementing this new standardized approach, adherence rates were captured as a metric for the organization.

  13. Optimizing resource allocation and patient flow: process analysis and reorganization in three chemotherapy outpatient clinics.

    PubMed

    Holmes, Morgan; Bodie, Kelly; Porter, Geoffrey; Sullivan, Victoria; Tarasuk, Joy; Trembley, Jodie; Trudeau, Maureen

    2010-01-01

    Optimizing human and physical resources is a major concern for cancer care decision-makers and practitioners. This issue is particularly acute in the context of ambulatory out patient chemotherapy clinics, especially when - as is the case almost everywhere in the industrialized world - the number of people requiring systemic therapy is increasing while budgets, staffing and physical space remain static. Recent initiatives at three hospital-based chemotherapy units - in Halifax, Toronto and Kingston - shed light on the value of process analysis and reorganization for using existing human and physical resources to their full potential, improving patient flow and enhancing patient satisfaction. The steps taken in these settings are broadly applicable to other healthcare settings and would likely result in similar benefits in those environments.

  14. 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

  15. 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.

  16. Psychiatric morbidity in outpatients of gynecological oncology clinic in a tertiary care hospital

    PubMed Central

    Mendonsa, Rohan Dilip; Appaya, Prakash

    2010-01-01

    Background: Psychiatric morbidity in gynecological oncology patients is relatively less studied. Aims: This cross-sectional observational study was undertaken to assess the common psychiatric disorders in women who consult the gynecological oncology outpatients’ department. Materials and methods: We assessed a total of 101 outpatients who were recruited by convenience method of sampling. The main outcome measures were PRIME-MD PHQ diagnoses, gynecological and sociodemographic profiles. Results: Psychiatric disorders as detected by PRIME –MD PHQ were diagnosed in 44% of the patients. Mood disorders were most common. Major depression was present in 25.7% of patients. Anxiety disorders were diagnosed in 16.8% of the patients. Among 44 patients with a psychiatric diagnosis only one patient was on psychiatric treatment. Major depression was much more common (34.4%) in cancer patients than in women with benign conditions (16.6%). Conclusion: The findings of our study reveal a high rate of psychiatric morbidity in the gynecological oncology outpatients. PMID:21267366

  17. 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

  18. Cancer Stem Cell Hypothesis for Therapeutic Innovation in Clinical Oncology? Taking the Root Out, Not Chopping the Leaf.

    PubMed

    Dzobo, Kevin; Senthebane, Dimakatso Alice; Rowe, Arielle; Thomford, Nicholas Ekow; Mwapagha, Lamech M; Al-Awwad, Nasir; Dandara, Collet; Parker, M Iqbal

    2016-12-01

    Clinical oncology is in need of therapeutic innovation. New hypotheses and concepts for translation of basic research to novel diagnostics and therapeutics are called for. In this context, the cancer stem cell (CSC) hypothesis rests on the premise that tumors comprise tumor cells and a subset of tumor-initiating cells, CSCs, in a quiescent state characterized by slow cell cycling and expression of specific stem cell surface markers with the capability to maintain a tumor in vivo. The CSCs have unlimited self-renewal abilities and propagate tumors through division into asymmetric daughter cells. This differentiation is induced by both genetic and environmental factors. Another characteristic of CSCs is their therapeutic resistance, which is due to their quiescent state and slow dividing. Notably, the CSC phenotype differs greatly between patients and different cancer types. The CSCs may differ genetically and phenotypically and may include primary CSCs and metastatic stem cells circulating within the blood system. Targeting CSCs will require the knowledge of distinct stem cells within the tumor. CSCs can differentiate into nontumorigenic cells and this has been touted as the source of heterogeneity observed in many solid tumors. The latter cannot be fully explained by epigenetic regulation or by the clonal evolution theory. This heterogeneity markedly influences how tumors respond to therapy and prognosis. The present expert review offers an analysis and synthesis of the latest research and concepts on CSCs, with a view to truly disruptive innovation for future diagnostics and therapeutics in clinical oncology.

  19. Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and the American Society of Clinical Oncology.

    PubMed

    Sepulveda, Antonia R; Hamilton, Stanley R; Allegra, Carmen J; Grody, Wayne; Cushman-Vokoun, Allison M; Funkhouser, William K; Kopetz, Scott E; Lieu, Christopher; Lindor, Noralane M; Minsky, Bruce D; Monzon, Federico A; Sargent, Daniel J; Singh, Veena M; Willis, Joseph; Clark, Jennifer; Colasacco, Carol; Rumble, R Bryan; Temple-Smolkin, Robyn; Ventura, Christina B; Nowak, Jan A

    2017-02-06

    Purpose Molecular testing of colorectal cancers (CRCs) to improve patient care and outcomes of targeted and conventional therapies has been the center of many recent studies, including clinical trials. Evidence-based recommendations for the molecular testing of CRC tissues to guide epidermal growth factor receptor (EGFR) -targeted therapies and conventional chemotherapy regimens are warranted in clinical practice. The purpose of this guideline is to develop evidence-based recommendations to help establish standard molecular biomarker testing for CRC through a systematic review of the literature. Methods The American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and the American Society of Clinical Oncology (ASCO) convened an Expert Panel to develop an evidence-based guideline to help establish standard molecular biomarker testing, guide targeted therapies, and advance personalized care for patients with CRC. A comprehensive literature search that included over 4,000 articles was conducted to gather data to inform this guideline. Results Twenty-one guideline statements (eight recommendations, 10 expert consensus opinions and three no recommendations) were established. Recommendations Evidence supports mutational testing for genes in the EGFR signaling pathway, since they provide clinically actionable information as negative predictors of benefit to anti-EGFR monoclonal antibody therapies for targeted therapy of CRC. Mutations in several of the biomarkers have clear prognostic value. Laboratory approaches to operationalize molecular testing for predictive and prognostic molecular biomarkers involve selection of assays, type of specimens to be tested, timing of ordering of tests and turnaround time for testing results. Additional information is available at: www.asco.org/CRC-markers-guideline and www.asco.org/guidelineswiki.

  20. Bacterial pneumonia following cytotoxic chemotherapy for lung cancer: clinical features, treatment outcome and prognostic factors.

    PubMed

    Yoo, Seung Soo; Cha, Seung-Ick; Shin, Kyung-Min; Lee, Shin-Yup; Kim, Chang-Ho; Park, Jae-Yong; Jung, Tae-Hoon

    2010-10-01

    Data regarding treatment outcomes and prognosis in pneumonia that occurs after lung cancer chemotherapy are lacking. We performed a retrospective study of 84 patients with clinically suspected bacterial pneumonia after cytotoxic chemotherapy for lung cancer. Small cell carcinoma was the most common histological type (36.9%, n = 31), followed by squamous cell carcinoma (35.7%, n = 30) and adenocarcinoma (21.4%, n = 18). The most frequent pathogen was Streptococcus pneumoniae (n = 14), followed by Klebsiella pneumoniae (n = 10), Staphylococcus aureus (n = 8), and Pseudomonas aeruginosa (n = 7). Of 84 patients, treatment outcome was determined for 80; the outcome was success in 52 (61.9%) and failure in 28 (33.3%); outcome remained undetermined for 4 patients (4.8%). Based on multivariate analysis, tachypnoea (respiratory rate ≥20/min) was the only significant predictor of treatment failure (odds ratio 4.79, 95% confidence interval 1.17-19.70; p = 0.030). In conclusion, bacterial pneumonia after cytotoxic chemotherapy for lung cancer was found to be caused more often by S. pneumoniae and K. pneumoniae than P. aeruginosa, and treatment failure leading to death was found to be high. Tachypnoea was independently associated with treatment failure in this population.

  1. 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.

  2. Clinical and microarray analysis of breast cancers of all subtypes from two prospective preoperative chemotherapy studies

    PubMed Central

    Okuma, H S; Koizumi, F; Hirakawa, A; Nakatochi, M; Komori, O; Hashimoto, J; Kodaira, M; Yunokawa, M; Yamamoto, H; Yonemori, K; Shimizu, C; Fujiwara, Y; Tamura, K

    2016-01-01

    Background: We aimed to analyse clinical and gene expression profiles to predict pathologic complete response and disease-free survival using two consecutive, prospective, preoperative chemotherapy trial cohorts. Methods: Clinicopathological and gene expression data were evaluated in a cohort from two consecutive phase II preoperative studies that included patients with stage IIA–IIIC breast cancer of all subtypes. Analysed specimens were obtained before preoperative chemotherapy, and cDNA microarray analyses were performed using the Affymetrix Gene Chip U133 plus 2.0. Results: Between December 2005 and December 2010, 122 patients were analysed. The pathologic complete response rate was significantly higher in HER2+ and HR−/HER2− cancers. Age, pathologic complete response, HR−/HER2− status, and lymph node positivity (⩾4) were significant poor prognostic factors for disease-free survival. For the cDNA microarray analyses, sufficient tumour samples were available from 78 of the 107 patients (73%). An 8-gene signature predictive of pathologic complete response and a 17-gene signature predictive of prognosis were identified. Patients were categorised into low-risk (n=45) and high-risk groups (n=33) (HR 70.0, P=0.004). Conclusions: This study yielded preliminary data on the expression of specific genes predicting pathologic complete response and disease-free survival in a cohort of chemonaïve breast cancer patients. Further validation may distinguish those who would benefit most from perioperative chemotherapy as well as those needing further intervention. PMID:27415010

  3. The Danish Neuro-Oncology Registry

    PubMed Central

    Hansen, Steinbjørn

    2016-01-01

    Aim of database The Danish Neuro-Oncology Registry (DNOR) was established by the Danish Neuro-Oncology Group as a national clinical database. It was established for the purpose of supporting research and development in adult patients with primary brain tumors in Denmark. Study population DNOR has registered clinical data on diagnostics and treatment of all adult patients diagnosed with glioma since January 1, 2009, which numbers approximately 400 patients each year. Main variables The database contains information about symptoms, presurgical magnetic resonance imaging (MRI) characteristics, performance status, surgical procedures, residual tumor on postsurgical MRI, postsurgical complications, diagnostic and histology codes, radiotherapy, and chemotherapy. Descriptive data DNOR publishes annual reports on descriptive data. During the period of registration, postoperative MRI is performed in a higher proportion of the patients (Indicator II), and a higher proportion of patients have no residual tumor after surgical resection of the primary tumor (Indicator IV). Further data are available in the annual reports. The indicators reflect only minor elements of handling brain tumor patients. Another advantage of reporting indicators is the related multidisciplinary discussions giving a better understanding of what actually is going on, thereby facilitating the work on adjusting the national guidelines in the Danish Neuro-Oncology Group. Conclusion The establishment of DNOR has optimized the quality in handling primary brain tumor patients in Denmark by reporting indicators and facilitating a better multidisciplinary collaboration at a national level. DNOR provides a valuable resource for research. PMID:27822109

  4. 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 |

  5. Rituximab with chemotherapy in children and adolescents with central nervous system and/or bone marrow-positive Burkitt lymphoma/leukaemia: a Children's Oncology Group Report.

    PubMed

    Goldman, Stanton; Smith, Lynette; Galardy, Paul; Perkins, Sherrie L; Frazer, John Kimble; Sanger, Warren; Anderson, James R; Gross, Thomas G; Weinstein, Howard; Harrison, Lauren; Shiramizu, Bruce; Barth, Matthew; Cairo, Mitchell S

    2014-11-01

    Children and adolescents with Burkitt Lymphoma (BL) and combined central nervous system (CNS) and bone marrow involvement still have a poor prognosis with chemotherapy alone. We therefore investigated in children and adolescents with bone marrow (≥25% blasts) and/or CNS-positive Burkitt lymphoma the chemoimmunotherapy combination of rituximab (375 mg/m(2) ) and the standard chemotherapy arm of our previously reported French-American-British (FAB) Lymphome Malins de Burkitt (LMB) 96 trial. Central pathological and cytogenetic characterization was also performed. There were 40 evaluable patients with Burkitt histology (25 with leukaemia and 15 with CNS disease ± leukaemia). The chemoimmunotherapy regimen was well tolerated. The incidence of grade III/IV mucositis during induction cycles with combined chemotherapy and rituximab was 31% and 26%, respectively. The 3-year event-free survival (EFS)/overall survival (OS) was 90% (95% confidence interval [CI], 76-96%) in the entire cohort and 93% (95% CI, 61-99%) in patients with CNS disease. Based on the results of this trial, an international randomized study of FAB/LMB 96 chemotherapy ± rituximab for high-risk patients is currently under investigation.

  6. Enhancing Adolescent and Young Adult Oncology Research Within the National Clinical Trials Network: Rationale, Progress, and Emerging Strategies.

    PubMed

    Weiss, Aaron R; Nichols, Craig R; Freyer, David R

    2015-10-01

    Adolescent and Young Adult Oncology (AYAO, including patients 15-39 years of age) is an emerging discipline in the field of cancer treatment and research. Poorer survival outcomes for this population and characteristic age-related challenges in care have called attention to the need for increased AYAO research. This chapter outlines pressing questions and reviews recent progress in AYAO research within the current organizational structure of the federal clinical trials enterprise, emphasizing how the United States National Cancer Institute's National Clinical Trials Network (NCTN) has created novel opportunities for collaborative AYAO research among the pediatric and adult NCTN groups. Potential strategies for expanding AYAO research, both within the NCTN and with other partners in the federal and advocacy domains are identified.

  7. Clinical response in patients with ovarian cancer treated with metronomic chemotherapy

    PubMed Central

    Perroud, Herman Andrés; Scharovsky, O Graciela; Rozados, Viviana Rosa; Alasino, Carlos María

    2017-01-01

    Ovarian cancer (OC) is the leading cause of death from gynaecological cancer. It is extremely hard to diagnose in the early stages and around 70% of patients present with advanced disease. Metronomic chemotherapy (MCT) is described as the chronic administration of, generally low, equally spaced, doses of chemotherapeutic drugs with therapeutic efficacy and low toxicity. This is an effective and low-cost way to treat several types of tumours, including ovarian cancer. Here, we present six cases of advanced ovarian cancer treated with MCT with low doses of cyclophosphamide, which showed clinical response and stable disease. PMID:28275392

  8. "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.

  9. Outcomes after HLA-matched sibling transplantation or chemotherapy in children with B-precursor acute lymphoblastic leukemia in a second remission: a collaborative study of the Children's Oncology Group and the Center for International Blood and Marrow Transplant Research

    PubMed Central

    Eapen, Mary; Raetz, Elizabeth; Zhang, Mei-Jie; Muehlenbein, Catherine; Devidas, Meenakshi; Abshire, Thomas; Billett, Amy; Homans, Alan; Camitta, Bruce; Carroll, William L.; Davies, Stella M.

    2006-01-01

    The best treatment approach for children with B-precursor acute lymphoblastic leukemia (ALL) in second clinical remission (CR) after a marrow relapse is controversial. To address this question, we compared outcomes in 188 patients enrolled in chemotherapy trials and 186 HLA-matched sibling transplants, treated between 1991 and 1997. Groups were similar except that chemotherapy recipients were younger (median age, 5 versus 8 years) and less likely to have combined marrow and extramedullary relapse (19% versus 30%). To adjust for time-to-transplant bias, treatment outcomes were compared using left-truncated Cox regression models. The relative efficacy of chemotherapy and transplantation depended on time from diagnosis to first relapse and the transplant conditioning regimen used. For children with early first relapse (< 36 months), risk of a second relapse was significantly lower after total body irradiation (TBI)–containing transplant regimens (relative risk [RR], 0.49; 95% confidence interval [CI] 0.33-0.71, P < .001) than chemotherapy regimens. In contrast, for children with a late first relapse (≥ 36 months), risks of second relapse were similar after TBI-containing regimens and chemotherapy (RR, 0.92; 95% CI, 0.49-1.70, P = .78). These data support HLA-matched sibling donor transplantation using a TBI-containing regimen in second CR for children with ALL and early relapse. PMID:16493003

  10. Organizational Designs for Achieving High Treatment Trial Enrollment: A Fuzzy-Set Analysis of the Community Clinical Oncology Program

    PubMed Central

    Weiner, Bryan J.; Jacobs, Sara R.; Minasian, Lori M.; Good, Marjorie J.

    2012-01-01

    Purpose: To examine the organizational design features that were consistently associated in 2010 with high levels of patient enrollment onto National Cancer Institute (NCI) cancer treatment trials among the oncology practices and hospitals participating in the NCI Community Clinical Oncology Program (CCOP). Methods: Fuzzy-set qualitative comparative analysis was used to identify the recipes (ie, combinations of organizational design features) that CCOPs used to achieve high levels of patient enrollment onto NCI treatment trials in 2010. Four organizational design features were examined: number of open treatment trials with at least one patient enrolled, number of newly diagnosed patients with cancer, number of CCOP-affiliated physicians, and number of CCOP-affiliated hospitals or practices where patient enrollment could occur. Data were obtained from NCI data systems and CCOP grant progress reports. Results: Two recipes were consistently associated with high levels of patient enrollment onto NCI treatment trials in 2010: having many open treatment trials and many new patients with cancer, and having many open treatment trials and many affiliated hospitals or practices. Together, these recipes accounted for nearly two thirds of CCOP membership in the high-performance set in 2010. Conclusion: No single organizational design feature, by itself, was consistently associated with high levels of patient enrollment onto NCI treatment trials in 2010. Having a large menu of active treatment trials may be necessary to achieve high–patient enrollment performance, but this is not sufficient unless combined with either large patient volume or many participating sites. PMID:23277765

  11. Nutrition in oncology: the case of micronutrients (review).

    PubMed

    Ströhle, Alexander; Zänker, Kurt; Hahn, Andreas

    2010-10-01

    In the course of cancer disease, many oncological patients develop tumor-associated malnutrition characterized by an insufficient supply of macro- and micronutrients. The inadequate nutritional status and the cancer anorexia-cachexia syndrome related to it are clinically relevant, as the response to antineoplastic measures, such as radiation and chemotherapy, is diminished, their side effects aggravated and the patient's quality of life and prognosis negatively affected. Therefore, the supportive nutrition care of oncological patients is of central importance. In this context, vitamins, minerals and long-chain omega -3 fatty acids are becoming more and more relevant in oncology although the benefit of such supplements is discussed controversially. Starting from a description of the etiopathogenesis and the pathophysiological consequences of cancer-associated malnutrition, the present study provides an overview of the importance of micronutrients for oncological patients. In the case of reduced food intake and/or inappropriate food choice the use of a multi-vitamin-multimineral supplement administered in physiological doses, i.e. nutrient quantities approximately corresponding to the recommended daily allowances, can be generally recommended. However, to enhance postoperative wound healing, it seems that cancer patients require higher amounts of micronutrients than healthy individuals. Because vitamin D deficiency is highly prevalent in oncological patients, improvement of vitamin D status is of special interest.

  12. Oocyte cryopreservation in oncological patients.

    PubMed

    Porcu, Eleonora; Fabbri, Raffaella; Damiano, Giuseppe; Fratto, Rosita; Giunchi, Susanna; Venturoli, Stefano

    2004-04-05

    The use of chemotherapy and radiotherapy in oncological patients may reduce their reproductive potential. Sperm cryopreservation has been already used in men affected by neoplastic disease. Oocyte cryopreservation might be an important solution for these patients at risk of losing ovarian function. A program of oocyte cryopreservation for oncological patients is also present in our center. From June 1996 to January 2000, 18 patients awaiting chemotherapy and radiotherapy for neoplastic disease were included in our oocyte cryopreservation program. Our experience documents that oocyte storage may be a concrete and pragmatic alternative for oncological patients. The duration of oocyte storage does not seem to interfere with oocyte survival as pregnancies occurred even after several years of gamete cryopreservation in liquid nitrogen.

  13. Advances in management of adjuvant chemotherapy in rectal cancer: Consequences for clinical practice.

    PubMed

    Netter, Jeanne; Douard, Richard; Durdux, Catherine; Landi, Bruno; Berger, Anne; Taieb, Julien

    2016-11-01

    More than half the patients with rectal cancer present with locally advanced rectal disease at diagnosis with a high risk of recurrence. Preoperative chemoradiotherapy and standardized radical surgery with total mesorectal excision have been established as the 'gold standard' for treating these patients. Pathological staging using the ypTNM classification system to decide on adjuvant chemotherapy (ACT) is widely used in clinical practice, but the delivery of ACT is still controversial, as many discrepancies persist in the conclusions of different trials, due to heterogeneity of the inclusion criteria between studies, lack of statistical power, and variations in preoperative and adjuvant regimens. In 2014, a meta-analysis of four randomized phase-III trials (EORTC 22921, I-CNR-RT, PROCTOR-SCRIPT, CHRONICLE) failed to demonstrate any statistical efficacy of fluorouracil (5FU)-based ACT. Three recent randomized trials aimed to compare 5FU with 5FU plus oxaliplatin-based chemotherapy. Two of them (ADORE, CAO/ARO/AIO-04) appeared to find a disease-free survival benefit for patients treated with the combination therapy. Thus, while awaiting new data, it can be said that, as of 2015, patients with yp stage I tumors or histological complete response derived no benefit from adjuvant therapy. On the other hand, the FOLFOX chemotherapy regimen should be proposed for yp stage III patients, and may be considered for yp stage II tumors in fit patients with high-risk factors. Nevertheless, well-designed and sufficiently powered clinical trials dedicated to adjuvant treatments for rectal cancer remain justified in future to achieve a high level of proof in keeping with evidence-based medical standards.

  14. The European Society for Medical Oncology Magnitude of Clinical Benefit Scale in daily practice: a single institution, real-life experience at the Medical University of Vienna

    PubMed Central

    Kiesewetter, Barbara; Raderer, Markus; Steger, Günther G; Bartsch, Rupert; Pirker, Robert; Zöchbauer-Müller, Sabine; Prager, Gerald; Krainer, Michael; Preusser, Matthias; Schmidinger, Manuela; Zielinski, Christoph C

    2016-01-01

    Background The European Society for Medical Oncology (ESMO) Magnitude of Clinical Benefit Scale (MCBS) has been designed to stratify the therapeutic benefit of a certain drug registered for the treatment of cancer. However, though internally validated, this tool has not yet been evaluated for its feasibility in the daily practice of a major center of medical oncology. Methods The practicability of the MCBS for advanced oncological diseases at the Clinical Division of Oncology, Medical University of Vienna, which constitutes one of the largest oncological centres in Europe, was analysed in a three-step approach. First, retrospectively collected data were analysed to gain an overview of treatments in regular use. Second, data were scored by using the MCBS. Third, the ensuing results were evaluated within corresponding programme directorships to assess feasibility in a real-life clinical context. Results In the majority of tumour entities, the MCBS results reported earlier are consistent with daily clinical practice. Thus, in metastatic breast cancer or advanced lung cancer, there was a high level of clinical benefit for first-line treatment standards, and these results reflected well real-life experience. However, analyses based on the first version of the MCBS are limited if it comes to salvage treatment in tumour entities in which optimal sequencing of potential treatment options is of major importance, as in metastatic colorectal or renal cell cancer. In contrast to this, it is remarkable that certain novel therapies such as nivolumab assessed for heavily pretreated advanced renal cancer reached the highest level of clinical benefit due to prolongation in survival and a favourable toxicity profile. The MCBS clearly underlines the potential benefit of these compounds. Conclusions The MCBS is an excellent tool for daily clinical practice of a tertiary referral centre. It supports treatment decisions based on the clinical benefit to be expected from a novel approach

  15. Comparing oncology clinical programs by use of innovative designs and expected net present value optimization: Which adaptive approach leads to the best result?

    PubMed

    Parke, Tom; Marchenko, Olga; Anisimov, Vladimir; Ivanova, Anastasia; Jennison, Christopher; Perevozskaya, Inna; Song, Guochen

    2017-01-01

    Designing an oncology clinical program is more challenging than designing a single study. The standard approaches have been proven to be not very successful during the last decade; the failure rate of Phase 2 and Phase 3 trials in oncology remains high. Improving a development strategy by applying innovative statistical methods is one of the major objectives of a drug development process. The oncology sub-team on Adaptive Program under the Drug Information Association Adaptive Design Scientific Working Group (DIA ADSWG) evaluated hypothetical oncology programs with two competing treatments and published the work in the Therapeutic Innovation and Regulatory Science journal in January 2014. Five oncology development programs based on different Phase 2 designs, including adaptive designs and a standard two parallel arm Phase 3 design were simulated and compared in terms of the probability of clinical program success and expected net present value (eNPV). In this article, we consider eight Phase2/Phase3 development programs based on selected combinations of five Phase 2 study designs and three Phase 3 study designs. We again used the probability of program success and eNPV to compare simulated programs. For the development strategies, we considered that the eNPV showed robust improvement for each successive strategy, with the highest being for a three-arm response adaptive randomization design in Phase 2 and a group sequential design with 5 analyses in Phase 3.

  16. 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

  17. A Systematic Review of Experimental and Clinical Acupuncture in Chemotherapy-Induced Peripheral Neuropathy

    PubMed Central

    Franconi, Giovanna; Schröder, Sven; Marchetti, Paolo; Robinson, Nicola

    2013-01-01

    Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect that can be very disabling and can limit or delay the dose of chemotherapy that can be administered. Acupuncture may be effective for treating peripheral neuropathy. The aim of this study was to review the available literature on the use of acupuncture for CIPN. The systematic literature search was performed using MEDLINE, Google Scholar, Cochrane Database, CINHAL, and ISI Proceedings. Hand searching was conducted, and consensus was reached on all extracted data. Only papers in the English language were included, irrespective of study design. From 3989 retrieved papers, 8 relevant papers were identified. One was an experimental study which showed that electroacupuncture suppressed CIPN pain in rats. In addition, there were 7 very heterogeneous clinical studies, 1 controlled randomised study using auricular acupuncture, 2 randomized controlled studies using somatic acupuncture, and 3 case series/case reports which suggested a positive effect of acupuncture in CIPN. Conclusions. Only one controlled randomised study demonstrated that acupuncture may be beneficial for CIPN. All the clinical studies reviewed had important methodological limitations. Further studies with robust methodology are needed to demonstrate the role of acupuncture for treating CIPN resulting from cancer treatment. PMID:23983788

  18. Shortened intensified multi-agent chemotherapy and non-cross resistant maintenance therapy for advanced lymphoblastic lymphoma in children and adolescents: report from the Children's Oncology Group.

    PubMed

    Abromowitch, Minnie; Sposto, Richard; Perkins, Sherrie; Zwick, David; Siegel, Stuart; Finlay, Jonathan; Cairo, Mitchell S

    2008-10-01

    Pediatric lymphoblastic lymphoma (LL) has utilized treatment strategies similar to childhood acute lymphoblastic leukaemia (ALL) with prolonged maintenance chemotherapy. We report the results of a pilot study to estimate the feasibility, toxicity and efficacy of a 12-month aggressive multi-agent chemotherapy regimen in children and adolescents with advanced LL. Between July 1994 and June 1997, 85 eligible children and adolescents with advanced LL (Stage III/IV) were enrolled on this pilot study. Patients achieving a complete response following induction and consolidation received six cycles of maintenance chemotherapy for a total duration of 12 months. Grade III/IV toxicities included: hematological (80%), infections (20%), stomatitis and elevated transaminases, (29%). There were a total of 19 events, 13 relapses, two secondary acute myeloid leukaemia and four toxic deaths (5%). The 5-year event-free survival (EFS) and overall survival (OS) was 78 +/- 4.5% and 85 +/- 3.9%, respectively. Relapsed patients had a 5-year OS of only 33 +/- 14%. Multivariate analysis failed to demonstrate age, gender, lactate dehydrogenase level, presence of marrow and/or central nervous system disease to have independent prognostic value. These results suggest that this experimental approach is safe and results in similar outcomes as more prolonged childhood ALL regimens.

  19. Chemotherapy-induced monoamine oxidase expression in prostate carcinoma functions as a cytoprotective resistance enzyme and associates with clinical outcomes.

    PubMed

    Gordon, Ryan R; Wu, Mengchu; 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.

  20. 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

  1. AFOMP POLICY STATEMENT No. 2: recommended clinical radiation oncology medical physicist staffing levels in AFOMP countries.

    PubMed

    Round, W H; Tay, Y K; Ng, K H; Cheung, K Y; Fukuda, S; Han, Y; Huang, Y X; Kim, H J; Krisanachinda, A; Liu, H L

    2010-03-01

    This document is the second of a series of policy statements being issued by the Asia-Oceania Federation of Organizations for Medical Physics (AFOMP). The document was developed by the AFOMP Professional Development Committee (PDC) and was released by the AFOMP Council in 2009. The main purpose of the document is to give guidance as to how many medical physicists are required to staff a radiation oncology department. Strict guidelines are difficult to define as work practices vary from country-to-country and from hospital-to-hospital. A calculation scheme is presented to aid in estimating medical physics staffing requirements that is primarily based on equipment levels and patient numbers but also with allowances for staff training, professional development and leave requirements.

  2. 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…

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. Chemotherapy in advanced ovarian cancer: an overview of randomised clinical trials. Advanced Ovarian Cancer Trialists Group.

    PubMed Central

    1991-01-01

    OBJECTIVES--To consider the role of platinum and the relative merits of single agent and combination chemotherapy in the treatment of advanced ovarian cancer. DESIGN--Formal quantitative overview using updated individual patient data from all available randomised trials (published and unpublished). SUBJECTS--8139 patients (6408 deaths) included in 45 different trials. RESULTS--No firm conclusions could be reached. Nevertheless, the results suggest that in terms of survival immediate platinum based treatment was better than non-platinum regimens (overall relative risk 0.93; 95% confidence interval 0.83 to 1.05); platinum in combination was better than single agent platinum when used in the same dose (overall relative risk 0.85; 0.72 to 1.00); and cisplatin and carboplatin were equally effective (overall relative risk 1.05; 0.94 to 1.18). CONCLUSIONS--In the past, randomised clinical trials of chemotherapy in advanced ovarian cancer have been much too small to detect the degree of benefit which this overview suggests is realistic for currently available chemotherapeutic regimens. Hence a new trial comparing cisplatin, doxorubicin, and cyclophosphamide (CAP) with carboplatin has been launched and plans to accrue 2000 patients. PMID:1834291

  8. Immediate radical trachelectomy versus neoadjuvant chemotherapy followed by conservative surgery for patients with stage IB1 cervical cancer with tumors 2cm or larger: A literature review and analysis of oncological and obstetrical outcomes.

    PubMed

    Pareja, Rene; Rendón, Gabriel J; Vasquez, Monica; Echeverri, Lina; Sanz-Lomana, Carlos Millán; Ramirez, Pedro T

    2015-06-01

    Radical trachelectomy is the treatment of choice in women with early-stage cervical cancer wishing to preserve fertility. Radical trachelectomy can be performed with a vaginal, abdominal, or laparoscopic/robotic approach. Vaginal radical trachelectomy (VRT) is generally not offered to patients with tumors 2cm or larger because of a high recurrence rate. There are no conclusive recommendations regarding the safety of abdominal radical trachelectomy (ART) or laparoscopic radical trachelectomy (LRT) in such patients. Several investigators have used neoadjuvant chemotherapy in patients with tumors 2 to 4cm to reduce tumor size so that fertility preservation may be offered. However, to our knowledge, no published study has compared outcomes between patients with cervical tumors 2cm or larger who underwent immediate radical trachelectomy and those who underwent neoadjuvant chemotherapy followed by radical trachelectomy. We conducted a literature review to compare outcomes with these 2 approaches. Our main endpoints for evaluation were oncological and obstetrical outcomes. The fertility preservation rate was 82.7%, 85.1%, 89%; and 91.1% for ART (tumors larger than >2cm), ART (all sizes), NACT followed by surgery and VRT (all sizes); respectively. The global pregnancy rate was 16.2%, 24% and 30.7% for ART, VRT, and NACT followed by surgery; respectively. The recurrence rate was 3.8%, 4.2%, 6%, 7.6% and 17% for ART (all sizes), VRT (all sizes), ART (tumors>2cm), NACT followed by surgery, and VRT (tumors>2cm). These outcomes must be considered when offering a fertility sparing technique to patients with a tumor larger than 2cm.

  9. 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

  10. Clinical effectiveness of posaconazole versus fluconazole as antifungal prophylaxis in hematology-oncology patients: a retrospective cohort study.

    PubMed

    Kung, Hsiang-Chi; Johnson, Melissa D; Drew, Richard H; Saha-Chaudhuri, Paramita; Perfect, John R

    2014-06-01

    In preventing invasive fungal disease (IFD) in patients with acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS), clinical trials demonstrated efficacy of posaconazole over fluconazole and itraconazole. However, effectiveness of posaconazole has not been investigated in the United States in real-world setting outside the environment of controlled clinical trial. We performed a single-center, retrospective cohort study of 130 evaluable patients ≥18 years of age admitted to Duke University Hospital between 2004 and 2010 who received either posaconazole or fluconazole as prophylaxis during first induction or first reinduction chemotherapy for AML or MDS. The primary endpoint was possible, probable, or definite breakthrough IFD. Baseline characteristics were well balanced between groups, except that posaconazole recipients received reinduction chemotherapy and cytarabine more frequently. IFD occurred in 17/65 (27.0%) in the fluconazole group and in 6/65 (9.2%) in the posaconazole group (P = 0.012). Definite/probable IFDs occurred in 7 (10.8%) and 0 patients (0%), respectively (P = 0.0013). In multivariate analysis, fluconazole prophylaxis and duration of neutropenia were predictors of IFD. Mortality was similar between groups. This study demonstrates superior effectiveness of posaconazole over fluconazole as prophylaxis of IFD in AML and MDS patients. Such superiority did not translate to reductions in 100-day all-cause mortality.

  11. 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

  12. 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.

  13. 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.

  14. Biosimilar Retacrit® (epoetin zeta) in the treatment of chemotherapy-induced symptomatic anemia in hematology and oncology in Germany (ORHEO) – non-interventional study

    PubMed Central

    Losem, Christoph; Koenigsmann, Michael; Rudolph, Christine

    2017-01-01

    Background Symptomatic anemia is a frequent and severe complication of chemotherapy that is commonly treated with erythropoiesis-stimulating agents. The primary objective of this study was to assess the change in hemoglobin levels in patients with chemotherapy-induced anemia (CIA) following treatment with biosimilar Retacrit® (epoetin zeta). Secondary objectives included changes in hematologic parameters and tolerability. Methods This was a non-interventional, multicenter, long-term observational study that is part of an ongoing surveillance program for epoetin zeta. Adult patients (N=291) with solid tumors, malignant lymphomas or multiple myeloma, and chemotherapy-induced symptomatic anemia, who were eligible for treatment with biosimilar epoetin zeta, were enrolled. Patients were evaluated at enrollment, 3 months, and 6 months. Results Evaluable patients had lymphoma or myeloma (n=30) or solid tumors (n=260). At 3 months, patients with lymphoma and myeloma showed the greatest increase in mean (SD) hemoglobin from 9.2 (0.9) to 11.0 (1.8) g/dL, whereas patients with breast cancer showed the smallest increase from 10.0 (1.0) to 11.1 (1.2) g/dL. At 6 months, the greatest mean increase occurred in patients with lymphoma or myeloma from 11.0 (1.8) to 11.7 (2.3) g/dL, and the smallest in patients with other solid tumors from 10.9 (1.4) to 11.1 (1.5) g/dL. Patient evaluation of epoetin zeta therapy was positive, as most patients expressed satisfaction with epoetin zeta treatment during the study, compliance with treatment was high, and most indicated their willingness to be retreated if necessary. Epoetin zeta was also well tolerated; overall, in 25 patients (8.6%), there were 31 adverse events. Conclusion Despite variability among different disease groups, epoetin zeta was effective and well tolerated in patients with different types of solid tumors and hematologic malignancies. PMID:28280364

  15. Intracavitary chemotherapy

    SciTech Connect

    Markman, M.

    1985-01-01

    Pharmacokinetic modeling has suggested, and clinical investigations have confirmed, that intracavitary drug administration can result in a much greater drug exposure for the cavity into which the agent is instilled compared to the plasma. Both the safety and the efficacy of several agents administered individually or in combination have now been demonstrated. Several malignancies, in particular ovarian carcinoma and malignant mesothelioma, which remain confined to body cavities for much of their natural history, might be most rationally treated by the intracavitary treatment approach. Early clinical trials have demonstrated significant activity of intracavitary chemotherapy in both of these malignancies. Optimal drugs and dosages as well as appropriate scheduling for the various tumors involving body cavities remain to be defined. Whether or not combination intracavitary chemotherapy will significantly improve survival of patients with malignant disease confined to body cavities must await carefully controlled clinical trials comparing this treatment approach to standard systemically administered chemotherapy. 144 references.

  16. Is second-line systemic chemotherapy beneficial in patients with non-small cell lung cancer (NSCLC)? A multicenter data evaluation by the Anatolian Society of Medical Oncology.

    PubMed

    Odabas, Hatice; Ulas, Arife; Aydin, Kubra; Inanc, Mevlude; Aksoy, Asude; Yazilitas, Dogan; Turkeli, Mehmet; Yuksel, Sinemis; Inal, Ali; Ekinci, Ahmet S; Sevinc, Alper; Demirci, Nebi S; Uysal, Mukremin; Alkis, Necati; Dane, Faysal; Aliustaoglu, Mehmet; Gumus, Mahmut

    2015-12-01

    Patients with advanced non-small cell lung cancer (NSCLC) generally require second-line treatment although their prognosis is poor. In this multicenter study, we aimed to detect the characteristics related to patients and disease that can predict the response to second-line treatments in advanced NSCLC. Data of 904 patients who have progressed after receiving first-line platinum-based chemotherapy in 11 centers with the diagnosis of stage IIIB and IV NSCLC and who were evaluated for second-line treatment were retrospectively analyzed. The role of different factors in determining the benefit of second-line treatment was analyzed. Median age of patients was 57 years (range 19-86). Docetaxel was the most commonly used (20.9 %, n = 189) single agent, while gemcitabine-platinum was the most commonly used (6.7 %, n = 61) combination chemotherapy regimen in second-line setting. According to survival analysis, median progression-free survival after first-line treatment (PFS2) was 3.5 months (standard error (SE) 0.2; 95 % confidence interval (CI), 3.2-3.9), median overall survival (OS) was 6.7 months (SE 0.3; 95 % CI, 6.0-7.3). In multivariate analysis, independent factors affecting PFS2 were found to be hemoglobin (Hb) level over 12 g/dl and treatment-free interval (TFI) longer than 3 months (p = 0.006 and 0.003, respectively). Similarly, in OS analysis, Hb level over 12 g/dl and time elapsed after the first-line treatment that is longer than 3 months were found to be independent prognostic factors (p = 0.0001 and 0.045, respectively). In light of these findings, determining and using the parameters for which the treatment will be beneficial prior to second-line treatment can increase success rate.

  17. 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

  18. American Society of Clinical Oncology Obesity Initiative: Rationale, Progress, and Future Directions.

    PubMed

    Ligibel, Jennifer A; Wollins, Dana

    2016-12-10

    Obesity is increasingly being linked to the risk of developing and dying from cancer. In recognition of the growing contribution of obesity to cancer risk and outcomes, ASCO made obesity and cancer one of its core initiatives in 2014. The goals of this initiative included raising awareness of the relationship between obesity and cancer, providing tools and resources to oncology providers and patients to help encourage conversations regarding weight management in cancer survivors, fostering a robust research agenda, and advocating for access to evidence-based weight management programs for cancer survivors. Efforts to date have included developing patient and provider toolkits focused on weight management and physical activity, publishing a policy statement outlining ASCO's initiatives in this area, and hosting a summit focused on obesity research in cancer populations. As ASCO has defined its priorities in the area of obesity and cancer, it has become increasingly clear that obesity is a problem that extends far beyond its impact on cancer risk and outcomes. Many groups, including those focused on heart disease, diabetes, and endocrinology, have been developing, testing, and implementing obesity prevention and treatment strategies for years. As ASCO moves forward with its obesity initiative, the next steps will focus on forging collaboration with groups working on obesity-related initiatives both within and outside of the field of cancer to learn from their efforts and to partner with them on efforts to increase the education of medical professionals; raising awareness in lay populations regarding the negative health consequences of obesity and effective strategies to foster weight loss; developing collaborative research initiatives; and working together to advocate for the societal changes that will be needed to combat the obesity epidemic in the United States and beyond.

  19. [Oncology medications prescription in a cancer service: appropriateness to clinical practice guidelines].

    PubMed

    Palchik, Valeria; Traverso, María Luz; Colautti, Marisel; Bianchi, Mariela; Dolza, Lucía; Catena, José María; Salamano, Mercedes

    2016-11-01

    Objetivo: Evaluar la prescripción de medicamentos oncológicos de la Red de Salud Pública Municipal de Rosario según su adecuación las guías de práctica clínica. Método: Estudio farmacoepidemiológico descriptivo en pacientes adultos en un Servicio Oncológico. Enero-junio 2012. Se evaluó la adecuación de las prescripciones a las guías de práctica clínica de referencia. Resultados: El 51,8 % de los diagnósticos tuvo al menos un medicamento prescripto que no coincidía con lo recomendado por al menos una de las guías consideradas. Las prescripciones de doxorrubicina e ifosfamida no coincidieron con lo recomendado por ninguna guía. El 5,4% de las prescripciones no estaban consideradas en las guías locales, el 7,7% no lo estaban en las nacionales y, respecto de las internacionales, el 4,2 % no estaban consideradas en la European Society for Medical Oncology, el 2,3% por el American Cancer Society y solo el 1,9% por la National Comprehensive Cancer Network. Conclusiones: La prescripción de oncológicos se adecúa más a las guías internacionales. Podría deberse a que no existe aún una definición estándar en el manejo de las patologías tumorales por parte del Estado Nacional.

  20. 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

  1. 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

  2. Prostate Cancer With Metastatic Lytic Bone Lesions: Positive Bone Scan Post Docetaxel Chemotherapy in the Setting of Clinically Successful Treatment

    PubMed Central

    Bird, Victoria Yvonne; Domino, Paula M.; Sutkowski, Raymond; Stillings, Stephanie A.; Trejo-Lopez, Jorge A.

    2016-01-01

    Current treatment of metastatic bone prostate cancer with Docetaxel chemotherapy per CHAARTED trial is standard of care. Timing of CT and bone scintigraphy for evaluation of successful treatment of lytic lesions is not available in the literature. We present a case of a 70 year old male with PSA of 586 and wide spread metastatic bone lytic lesions, who underwent androgen deprivation therapy and six cycles of Docetaxel chemotherapy. The patient had clinically successful treatment. Contrast enhanced CT scan demonstrated sclerotic bone lesions with PSA 2.5 at this point in treatment; however, 99mTc-MDP bone scintigraphy remained positive for metastatic lesions. PMID:27169018

  3. 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.

  4. 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

  5. Metronomic chemotherapy

    PubMed Central

    Maiti, Rituparna

    2014-01-01

    Toxic effects and chemoresistance are major hurdles in chemotherapy and to avoid these problems caused by traditional chemotherapeutic regimens, a new modality of drug administration called “metronomic chemotherapy” has emerged. Such regimen involves the frequent administration of conventional chemotherapeutic agents at very low doses to target activated endothelial cells in tumors, the advantages of which include minimal adverse effects and a rare chance of developing acquired drug resistance. Previously it was thought that they act by targeting angiogenesis, but recently additional mechanisms have been discovered which has established metronomic chemotherapy as a type of multi-targeted therapy. The knowledge gained from the preclinical studies of metronomic chemotherapy, along with clinical experience, will help to design better therapeutic protocols against cancer. Detailed pharmacogenomic and pharmacoproteomic studies on tumor endothelial cells and large multi-centered clinical trials, integrating bio-marker analyzes, are needed to investigate and validate the best treatment combinations for each tumor type and patient population. PMID:25210398

  6. [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.

  7. Safe Implementation of Computerized Provider Order Entry for Adult Oncology

    PubMed Central

    Kaemingk, D.; Frieze, D.; Hendrie, P.; Payne, T.H.

    2015-01-01

    Summary Background Oncology has lagged in CPOE adoption due to the narrow therapeutic index of chemotherapy drugs, individualized dosing based on weight and height, regimen complexity, and workflows that include hard stops where safety checks are performed and documented. Objectives We sought to establish CPOE for chemotherapy ordering and administration in an academic teaching institution using a commercially available CPOE system. Methods A commercially available CPOE system was implemented throughout the hospital. A multidisciplinary team identified key safety gaps that required the development of a customized complex order display and a verification documentation workflow. Staff reported safety events were monitored for two years and compared to the year prior to go live. Results A workflow was enabled to capture real-time provider verification status during the time from ordering to the administration of chemotherapy. A customized display system was embedded in the EMR to provide a single screen view of the relevant parameters of chemotherapy doses including current and previous patient measurements of height and weight, dose adjustments, provider verifications, prior chemotherapy regimens, and a synopsis of the standard regimen for reference. Our system went live with 127 chemotherapy plans and has been expanded to 189. Staff reported safety events decreased following implementation, particularly in the area of prescribing and transcribing by the second year of use. Conclusions We observed reduced staff reported safety events following implementation of CPOE for inpatient chemotherapy using an electronic verification workflow and an embedded custom clinical decision support page. This implementation demonstrates that CPOE can be safely used for inpatient chemotherapy, even in an extremely complex environment. PMID:26767061

  8. Prospective evaluation of the clinical implications of the tumor metabolism and chemotherapy-related changes in advanced biliary tract cancer.

    PubMed

    Jo, Jaemin; Kwon, Hyun Woo; Park, Seongyeol; Oh, Do-Youn; Cheon, Gi Jeong; Bang, Yung-Jue

    2017-03-02

    Purpose: Tumor metabolism measured by (18)F-fluorodeoxy-D-glucose ((18)F-FDG) positron emission tomography (PET) has a diagnostic and prognostic role in several cancers. The clinical implication of tumor metabolism in biliary tract cancer (BTC) has not been studied well. Therefore, we evaluated the prognostic value of tumor metabolism and chemotherapy-related changes in advanced BTC patients. Materials and Methods: We prospectively enrolled advanced BTC patients before the initiation of palliative chemotherapy. Using (18)F-FDG PET, we assessed the baseline maximum standardized uptake value (SUVmax) and monitored the changes of SUVmax during chemotherapy. We analyzed the associations between SUVmax, and clinicopathologic factors and clinical outcomes. Results: A total of 75 patients were enrolled. All patients received gemcitabine/cisplatin as first-line chemotherapy. Primary tumor site, histologic differentiation, molecular characteristics, laboratory findings, and disease extent were associated with the metabolic characteristics. The high metabolism group showed worse survival outcome [Hazard ratio (HR)=4.09, P = 0.001 for progression-free survival (PFS); HR=2.61, P = 0.019 for overall survival (OS)] than the low metabolism group. The lesser reduction of SUVmax was also associated with worse outcome (HR=3.35, P = 0.002 for PFS; HR=1.96, P = 0.082 for OS). Considering both baseline tumor metabolism and its chemotherapy-related changes, patients with a low metabolism and a more reduction in metabolism obtained the best OS (20.7 months versus 6.2 months, P = 0.013). Conclusion: Tumor metabolic activity and the chemotherapy-related changes in the metabolism are associated with prognosis in advanced BTC patients.

  9. 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

  10. Oncologic Photodynamic Therapy: Basic Principles, Current Clinical Status and Future Directions

    PubMed Central

    van Straten, Demian; Mashayekhi, Vida; de Bruijn, Henriette S.; Oliveira, Sabrina; Robinson, Dominic J.

    2017-01-01

    Photodynamic therapy (PDT) is a clinically approved cancer therapy, based on a photochemical reaction between a light activatable molecule or photosensitizer, light, and molecular oxygen. When these three harmless components are present together, reactive oxygen species are formed. These can directly damage cells and/or vasculature, and induce inflammatory and immune responses. PDT is a two-stage procedure, which starts with photosensitizer administration followed by a locally directed light exposure, with the aim of confined tumor destruction. Since its regulatory approval, over 30 years ago, PDT has been the subject of numerous studies and has proven to be an effective form of cancer therapy. This review provides an overview of the clinical trials conducted over the last 10 years, illustrating how PDT is applied in the clinic today. Furthermore, examples from ongoing clinical trials and the most recent preclinical studies are presented, to show the directions, in which PDT is headed, in the near and distant future. Despite the clinical success reported, PDT is still currently underutilized in the clinic. We also discuss the factors that hamper the exploration of this effective therapy and what should be changed to render it a more effective and more widely available option for patients. PMID:28218708

  11. Randomized study of two chemotherapy regimens for treatment of low-grade glioma in young children: a report from the Children's Oncology Group.

    PubMed

    Ater, Joann L; Zhou, Tianni; Holmes, Emiko; Mazewski, Claire M; Booth, Timothy N; Freyer, David R; Lazarus, Ken H; Packer, Roger J; Prados, Michael; Sposto, Richard; Vezina, Gilbert; Wisoff, Jeffrey H; Pollack, Ian F

    2012-07-20

    PURPOSE Surgery is curative therapy for pediatric low-grade gliomas (LGGs) in areas of the brain amenable to complete resection. However, LGGs located in areas where complete resection is not possible can threaten both function and life. The purpose of this study was to compare two chemotherapy regimens for LGGs in children younger than age 10 years for whom radiotherapy was felt by the practitioner to pose a high risk of neurodevelopmental injury. PATIENTS AND METHODS Previously untreated children younger than age 10 years with progressive or residual LGGs were eligible. Children were randomly assigned to receive carboplatin and vincristine (CV) or thioguanine, procarbazine, lomustine, and vincristine (TPCV). Children with neurofibromatosis are reported separately. Results Of 274 randomly assigned patients who met eligibility requirements, 137 received CV and 137 received TPCV. The 5-year event-free survival (EFS) and overall survival (OS) rates for all eligible patients were 45% ± 3.2% and 86% ± 2.2%, respectively. The 5-year EFS rates were 39% ± 4% for CV and 52% ± 5% for TPCV (stratified log-rank test P = .10; cure model analysis P = .007). On multivariate analysis, factors independently predictive of worse EFS and OS were younger age and tumor size greater than 3 cm(2). Tumor location in the thalamus was also associated with poor OS. CONCLUSION The difference in EFS between the regimens did not reach significance on the basis of the stratified log-rank test. The 5-year EFS was higher for TPCV on the basis of the cure model analysis. Differences in toxicity may influence physician choice of regimens.

  12. Survival and secondary tumors in children with medulloblastoma receiving radiotherapy and adjuvant chemotherapy: results of Children's Oncology Group trial A9961.

    PubMed

    Packer, Roger J; Zhou, Tianni; Holmes, Emi; Vezina, Gilbert; Gajjar, Amar

    2013-01-01

    The purpose of the trial was to determine the survival and incidence of secondary tumors in children with medulloblastoma receiving radiotherapy plus chemotherapy. Three hundred seventy-nine eligible patients with nondisseminated medulloblastoma between the ages of 3 and 21 years were treated with 2340 cGy of craniospinal and 5580 cGy of posterior fossa irradiation. Patients were randomized between postradiation cisplatin and vincristine plus either CCNU or cyclophosphamide. Survival, pattern of relapse, and occurrence of secondary tumors were assessed. Five- and 10-year event-free survivals were 81 ± 2% and 75.8 ± 2.3%; overall survivals were 87 ± 1.8% and 81.3 ± 2.1%. Event-free survival was not impacted by chemotherapeutic regimen, sex, race, age at diagnosis, or gender. Seven patients had disease relapse beyond 5 years after diagnosis; relapse was local in 4 patients, local plus supratentorial in 2, and supratentorial alone in 1. Fifteen patients experienced secondary tumors as a first event at a median time of 5.8 years after diagnosis (11 >5 y postdiagnosis). All non-CNS solid secondary tumors (4) occurred in regions that had received radiation. Of the 6 high-grade gliomas, 5 occurred >5 years postdiagnosis. The estimated cumulative 10-year incidence rate of secondary malignancies was 4.2% (1.9%-6.5%). Few patients with medulloblastoma will relapse ≥ 5 years postdiagnosis; relapse will occur predominantly at the primary tumor site. Patients are at risk for development of secondary tumors, many of which are malignant gliomas. This may become an increasing issue as more children survive.

  13. [PET/CT tomography. Usefulness in oncology].

    PubMed

    Martínez-Villaseñor, David; Gerson-Cwilich, Raquel

    2006-01-01

    In order to have optimum results in oncological patients, precise evaluation, diagnosis and staging of the patient is necessary. Positron emission tomography (PET) yields a high negative predictive value through exploration of the entire body. It diagnoses the benign or malignant state of a neoplasm that has been detected by other imaging methods and establishes an extensive diagnosis previous to therapeutic treatment of a known cancer. It identifies residual tumor and changes produced after surgery, chemotherapy or radiotherapy and locates suspicious residual tumor clinically or by elevation of the tumor markers. It allows for a new extension study or re-staging after diagnosis of recurrence and permits early evaluation of response to a therapeutic regime and permits the search for a primary tumor in patients with metastasis of unknown origin. PET leads to a molecular functional imaging of cancer in the entire body.

  14. Clinical integration of picture archiving and communication systems with pathology and hospital information system in oncology.

    PubMed

    Duncan, Lisa D; Gray, Keith; Lewis, James M; Bell, John L; Bigge, Jeremy; McKinney, J Mark

    2010-09-01

    The complexity of our current healthcare delivery system has become an impediment to communication among caregivers resulting in fragmentation of patient care. To address these issues, many hospitals are implementing processes to facilitate clinical integration in an effort to improve patient care and safety. Clinical informatics, including image storage in a Picture Archiving and Communication System (PACS), represents a tool whereby clinical integration can be accomplished. In this study, we obtained intraoperative photographs of 19 cases to document clinical stage, extent of disease, disease recurrence, reconstruction/grafting, intraoperative findings not identified by preoperative imaging, and site verification as part of the Universal Protocol. Photographs from all cases were stored and viewed in PACS. Images from many of the cases were presented at our interdepartmental cancer conferences. The stored images improved communication among caregivers and preserved pertinent intraoperative findings in the patients' electronic medical record. In the future, pathology, gastroenterology, pulmonology, dermatology, and cardiology are just a few other subspecialties which could accomplish image storage in PACS. Multidisciplinary image storage in a PACS epitomizes the concept of clinical integration and its goal of improving patient care.

  15. Knowledge bases, clinical decision support systems, and rapid learning in oncology.

    PubMed

    Yu, Peter Paul

    2015-03-01

    One of the most important benefits of health information technology is to assist the cognitive process of the human mind in the face of vast amounts of health data, limited time for decision making, and the complexity of the patient with cancer. Clinical decision support tools are frequently cited as a technologic solution to this problem, but to date useful clinical decision support systems (CDSS) have been limited in utility and implementation. This article describes three unique sources of health data that underlie fundamentally different types of knowledge bases which feed into CDSS. CDSS themselves comprise a variety of models which are discussed. The relationship of knowledge bases and CDSS to rapid learning health systems design is critical as CDSS are essential drivers of rapid learning in clinical care.

  16. Aurora Kinase Inhibitors in Oncology Clinical Trials: Current State of the Progress.

    PubMed

    Falchook, Gerald S; Bastida, Christel C; Kurzrock, Razelle

    2015-12-01

    The Aurora kinase family of kinases (Aurora A, B, and C) are involved in multiple mitotic events, and aberrant expression of these kinases is associated with tumorigenesis. Aurora A and Aurora B are validated anticancer targets, and the development of Aurora kinase inhibitors has progressed from preclinical to clinical studies. A variety of Aurora A, B and pan-Aurora kinase inhibitors have entered the clinic. The main side effects include febrile neutropenia, stomatitis, gastrointestinal toxicity, hypertension, and fatigue. Responses including complete remissions have been described in diverse, advanced malignancies, most notably ovarian cancer and acute myelogenous leukemia. This review highlights the biologic rationale for Aurora kinase as a target, and clinical trials involving Aurora kinase inhibitors, with particular emphasis on published early phase studies, and the observed anti-tumor activity of these agents.

  17. Clinical efficacy of CyberKnife combined with chemotherapy and hyperthermia for advanced non-small cell lung cancer.

    PubMed

    Wang, Yuan-Yuan; Lin, Si-Xiang; Yang, Gui-Qing; Liu, Han-Chen; Sun, Dong-Ning; Wang, Yi-Shan

    2013-05-01

    Non-small cell lung cancer (NSCLC) is responsible for at least 80% of all lung tumors and has a poor prognosis, since 75% of NSCLCs are first diagnosed at an advanced stage. This study was conducted to evaluate the therapeutic efficacy of CyberKnife in combination with chemotherapy and hyperthermia for selected patients with advanced non-small cell lung cancer (NSCLC). Clinical charts, imaging and pathology reports of patients with advanced NSCLC who underwent CyberKnife therapy in our Tumor Therapy Center were retrospectively reviewed. Clinical efficacy was evaluated for local control, Karnofsky performance status scale (KPS) and toxicity analysis. A total of 119 patients with 136 target areas were evaluated. A prescribed dose of 24-51 Gy to the gross tumor volume was delivered in 3-6 fractions. The median prescription dose was 35 Gy (mean, 34.73±4.80 Gy), with an average of five fractions. Patients, who voluntarily participated in the study, were assigned to one of three groups, which were as follows: CyberKnife therapy alone, CyberKnife combined with chemotherapy and CyberKnife combined with chemotherapy and hyperthermia. The median follow-up period was 6 months and curative efficiencies were 62.16, 71.79 and 90.70%, respectively, as determined by radiographic and clinical re-examinations. Patients treated by CyberKnife combined with chemotherapy and hyperthermia achieved optimal improvement in the aspect of KPS, which was statistically different compared to the other two groups (P<0.05). In conclusion, our results indicated that CyberKnife combined with chemotherapy and hyperthermia achieved favorable short-term outcomes and may be a more viable option for patients with advanced NSCLC. However, further investigations are required to evaluate long-term outcomes.

  18. 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

  19. 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

  20. 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

  1. 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

  2. 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.

  3. Cancer-related neuropathic pain in out-patient oncology clinics: a European survey

    PubMed Central

    2013-01-01

    Background Although pain is frequently experienced by patients with cancer, it remains under-treated. The primary aim of this study was to estimate the prevalence of cancer-related neuropathic pain (CRNP) in patients with chronic pain who attended an outpatient clinic for standard care in Europe (irrespective of the reason or stage of the cancer). The secondary aims of this study were to characterise pain and cancer in patients with CRNP (including treatment) and to evaluate the usefulness of the painDETECT (PD-Q) screening tool to help physicians identify a potential neuropathic component of cancer-related pain. Methods An observational, non-interventional, cross-sectional, multi-centre study of adult patients with cancer using patient and physician case report forms (CRFs). Patients with CRNP were identified by physicians’ clinical assessments after examining the completed PD-Q. Results A total of 951 patients visiting outpatient clinics across Europe were enrolled in this study between August 2010 and July 2011. Of these, 310 patients (32.60%; 95% confidence interval 29.62, 35.58) were identified as having CRNP. Twenty-nine of 39 (74.4%) physicians who completed the CRF relating to the PD-Q considered it a useful tool to help detect CRNP in daily practice and 28 of 39 (71.8%) indicated that they would use this tool in the future for most or some of their patients. Data from physicians before and after review of the completed PD-Qs showed a shift in clinical opinion (either to positive CRNP diagnosis [yes] or negative CRNP diagnosis [no]) in respect of 142 patients; about half of which (74) were categorised with an initial diagnosis of unknown. Opinions also shifted from a no to a yes diagnosis in 10 patients and from a yes to a no diagnosis in 51 patients. Conclusions Approximately one-third of adults with cancer experiencing chronic pain attending outpatient clinics as part of routine care were considered to have CRNP in the opinion of the physicians after

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

    PubMed

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

    2015-12-01

    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.

  5. What is the Asian Consensus Statement on NCCN clinical practice guidelines in oncology (NCCN-ACS)?

    PubMed

    Akaza, Hideyuki

    2016-04-01

    Cancer treatment guidelines are compiled on the basis of established evidence. Such evidence is obtained from epidemiological, pathological and pharmacological study and, most importantly of all, the information gained from clinical trials. However, very little of the kind of evidence that is required for the compilation of treatment guidelines is actually obtained from Asian countries. When one considers the ethnic differences and disparities in medical care, coupled with the tremendous cultural diversity that characterize the Asian region, it would be difficult to conclude that there is currently sufficient evidence that could form the basis for the formulation of guidelines that would be relevant and applicable to all Asian countries. An urgent issue that needs to be addressed in order to achieve a breakthrough in this difficult situation is to build up a body of evidence at an advanced level that is specific to the Asian region and Asian ethnicities. For the interim, however, it is also necessary to efficiently incorporate evidence that has been obtained in Western countries. Furthermore, an effective method of utilizing guidelines that have already been compiled in Western countries is considered to be not by simply translating them into local languages, but rather to engage in a process of adaptation, whereby the guidelines are adjusted or modified to match the circumstances of a particular country or region. The NCCN Clinical Practice Guidelines-Asian Consensus Statement (NCCN-ACS) documents have been compiled with this intention in mind, utilizing the NCCN guidelines that are widely used internationally.

  6. Effects of tumor type, degree of obesity, and chemotherapy regimen on chemotherapy dose intensity in obese cancer patients.

    PubMed

    Miyahara, T; Mochinaga, S; Kimura, S; Aragane, N; Yakabe, T; Morita, S; Okudaira, K; Fujito, H

    2013-01-01

    The American Society of Clinical Oncology recently published a Clinical Practice Guideline entitled "Appropriate Chemotherapy Dosing for Obesity Adult Patients with Cancer." The panel recommended that full weight (actual weight)-based cytotoxic chemotherapy doses are used to treat obese patients with cancer, particularly when the goal of treatment is cure. However, no study has examined dosage calculation methods used for obese cancer patients in Japan. Here, we retrospectively studied the relationships between chemotherapy dose intensity, the occurrence of adverse events, and treatment outcomes in obese patients undergoing chemotherapy. Patients were divided into two groups: the actual BW group (BWg) was composed of patients receiving dosage amounts calculated using their actual BW (n = 64), and the ideal BWg was composed of patients receiving dosage amounts calculated using their ideal BW (n = 41). There were significant differences in the incidence of Grade 3/4 hematological toxicity in the actual and ideal BWg in solid tumor patients, but not in patients with hematological malignancies. In solid tumor patients with ≥30 body mass index (BMI), the incidence of Grade 3/4 hematological toxicity was significantly lower in the ideal BWg than in the actual BWg. Particularly, in patients with complications, incidence of Grade 4 hematological toxicity was significantly higher in the actual BWg than in the ideal BWg. These results suggest that the tumor type, degree of obesity, complications, and choice of chemotherapy regimen should be considered when determining chemotherapy dosage for obese patients.

  7. Clinical Outcomes and Cost-effectiveness of Primary Prophylaxis of Febrile Neutropenia During Adjuvant Docetaxel and Cyclophosphamide Chemotherapy for Breast Cancer.

    PubMed

    Yu, Joanne L; Chan, Kelvin; Kurin, Michael; Pasetka, Mark; Kiss, Alex; Sridhar, Srikala S; Warner, Ellen

    2015-01-01

    Docetaxel and cyclophosphamide (TC) is a widely used breast cancer adjuvant regimen. We sought to compare the rates of febrile neutropenia (FN) between patients receiving no primary prophylaxis (PP) and those receiving PP with either granulocyte-colony stimulating factor (G-CSF) or antibiotics. We also analyzed cost-effectiveness of TC with and without either G-CSF or antibiotics. Charts were reviewed of all 340 patients who received adjuvant TC between January 2008 and December 2012 at two major cancer centers. Rates of FN in the three groups - no PP, PP with G-CSF and PP with antibiotics were compared. A Markov model was constructed comparing cost-effectiveness of PP with G-CSF, PP with antibiotics, and secondary prophylaxis (SP) with G-CSF after an episode of FN in a previous cycle. Costs were based on actual resource utilization and supplemented by the published literature, adjusted to 2012 Canadian dollars. Of the 73 (21%) patients who did not receive any PP, 23 (32%) of patients developed FN. Of the 192 (57%) patients receiving PP with G-CSF alone, only two (1%; p < 0.0001) developed FN; and of the 53 (16%) receiving PP with antibiotics alone, six (11%; p < 0.01) developed FN. From a cost-standpoint, PP with G-CSF was less cost-effective than PP with antibiotics. The rate of FN with TC chemotherapy exceeds 30%, and American Society of Clinical Oncology guidelines recommend PP with G-CSF in this situation. PP with antibiotics is more cost-effective, and is a reasonable option in resource-limited settings or for patients who decline or do not tolerate G-CSF.

  8. Defining Clinical Response Criteria and Early Response Criteria for Precision Oncology: Current State-of-the-Art and Future Perspectives

    PubMed Central

    Subbiah, Vivek; Chuang, Hubert H.; Gambhire, Dhiraj; Kairemo, Kalevi

    2017-01-01

    In this era of precision oncology, there has been an exponential growth in the armamentarium of genomically targeted therapies and immunotherapies. Evaluating early responses to precision therapy is essential for “go” versus “no go” decisions for these molecularly targeted drugs and agents that arm the immune system. Many different response assessment criteria exist for use in solid tumors and lymphomas. We reviewed the literature using the Medline/PubMed database for keywords “response assessment” and various known response assessment criteria published up to 2016. In this article we review the commonly used response assessment criteria. We present a decision tree to facilitate selection of appropriate criteria. We also suggest methods for standardization of various response assessment criteria. The relevant response assessment criteria were further studied for rational of development, key features, proposed use and acceptance by various entities. We also discuss early response evaluation and provide specific case studies of early response to targeted therapy. With high-throughput, advanced computing programs and digital data-mining it is now possible to acquire vast amount of high quality imaging data opening up a new field of “omics in radiology”—radiomics that complements genomics for personalized medicine. Radiomics is rapidly evolving and is still in the research arena. This cutting-edge technology is poised to move soon to the mainstream clinical arena. Novel agents with new mechanisms of action require advanced molecular imaging as imaging biomarkers. There is an urgent need for development of standardized early response assessment criteria for evaluation of response to precision therapy. PMID:28212290

  9. Defining Clinical Response Criteria and Early Response Criteria for Precision Oncology: Current State-of-the-Art and Future Perspectives.

    PubMed

    Subbiah, Vivek; Chuang, Hubert H; Gambhire, Dhiraj; Kairemo, Kalevi

    2017-02-15

    In this era of precision oncology, there has been an exponential growth in the armamentarium of genomically targeted therapies and immunotherapies. Evaluating early responses to precision therapy is essential for "go" versus "no go" decisions for these molecularly targeted drugs and agents that arm the immune system. Many different response assessment criteria exist for use in solid tumors and lymphomas. We reviewed the literature using the Medline/PubMed database for keywords "response assessment" and various known response assessment criteria published up to 2016. In this article we review the commonly used response assessment criteria. We present a decision tree to facilitate selection of appropriate criteria. We also suggest methods for standardization of various response assessment criteria. The relevant response assessment criteria were further studied for rational of development, key features, proposed use and acceptance by various entities. We also discuss early response evaluation and provide specific case studies of early response to targeted therapy. With high-throughput, advanced computing programs and digital data-mining it is now possible to acquire vast amount of high quality imaging data opening up a new field of "omics in radiology"-radiomics that complements genomics for personalized medicine. Radiomics is rapidly evolving and is still in the research arena. This cutting-edge technology is poised to move soon to the mainstream clinical arena. Novel agents with new mechanisms of action require advanced molecular imaging as imaging biomarkers. There is an urgent need for development of standardized early response assessment criteria for evaluation of response to precision therapy.

  10. 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.

  11. Genomics-based early-phase clinical trials in oncology: recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies.

    PubMed

    Liu, Stephen V; Miller, Vincent A; Lobbezoo, Marinus W; Giaccone, Giuseppe

    2014-11-01

    The Methodology for the Development of Innovative Cancer Therapies (MDICT) task force discussed incorporation of genomic profiling into early (Phase I and II) clinical trials in oncology. The task force reviewed the challenges of standardising genomics data in a manner conducive to conducting clinical trials. Current barriers to successful and efficient implementation were identified and discussed, as well as the methods of genomic analysis, the proper setting for study and strategies to facilitate timely completion of genomics-based studies. The importance of properly capturing and cataloguing outcomes was also discussed. Several recommendations regarding the use of genomics in these trials are provided.

  12. Clinical impact of chemotherapy to improve tumor microenvironment of pancreatic cancer

    PubMed Central

    Tsuchikawa, Takahiro; Takeuchi, Shintaro; Nakamura, Toru; Shichinohe, Toshiaki; Hirano, Satoshi

    2016-01-01

    A perioperative multimodal strategy including combination chemotherapy and radiotherapy, in addition to surgical resection, has been acknowledged to improve patient prognosis. However chemotherapy has not been actively applied as an immunomodulating modality because of concerns about various immunosuppressive effects. It has recently been shown that certain chemotherapeutic agents could modify tumor microenvironment and host immune responses through several underlying mechanisms such as immunogenic cell death, local T-cell infiltration and also the eradication of immune-suppressing regulatory cells such as regulatory T cells (Tregs) and myeloid-derived suppressor cells. With the better understanding of the cell components in the tumor microenvironment and the effect of chemotherapy to improve tumor microenvironment, it has been gradually clear that the chemotherapeutic agents is two-edged sword to have both immune promoting and suppressing effects. The cellular components of the tumor microenvironment include infiltrating T lymphocytes, dendritic cells, regulatory T cells, tumor associated macrophages, myeloid derived suppressor cells and cancer associated fibroblasts. Based on the better understanding of tumor microenvironment following chemotherapy, the treatment protocol could be modified as personalized medicine and the prognosis of pancreas cancer would be more improved utilizing multimodal chemotherapy. Here we review the recent advances of chemotherapy to improve tumor microenvironment of pancreatic cancer, introducing the unique feature of tumor microenvironment of pancreatic cancer, interaction between anti-cancer reagents and these constituting cells and future prospects. PMID:27895816

  13. 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

  14. Application of Bayesian hierarchical models for phase I/II clinical trials in oncology.

    PubMed

    Yada, Shinjo; Hamada, Chikuma

    2017-03-01

    Treatment during cancer clinical trials sometimes involves the combination of multiple drugs. In addition, in recent years there has been a trend toward phase I/II trials in which a phase I and a phase II trial are combined into a single trial to accelerate drug development. Methods for the seamless combination of phases I and II parts are currently under investigation. In the phase II part, adaptive randomization on the basis of patient efficacy outcomes allocates more patients to the dose combinations considered to have higher efficacy. Patient toxicity outcomes are used for determining admissibility to each dose combination and are not used for selection of the dose combination itself. In cases where the objective is not to find the optimum dose combination solely for efficacy but regarding both toxicity and efficacy, the need exists to allocate patients to dose combinations with consideration of the balance of existing trade-offs between toxicity and efficacy. We propose a Bayesian hierarchical model and an adaptive randomization with consideration for the relationship with toxicity and efficacy. Using the toxicity and efficacy outcomes of patients, the Bayesian hierarchical model is used to estimate the toxicity probability and efficacy probability in each of the dose combinations. Here, we use Bayesian moving-reference adaptive randomization on the basis of desirability computed from the obtained estimator. Computer simulations suggest that the proposed method will likely recommend a higher percentage of target dose combinations than a previously proposed method.

  15. Clinical Cancer Advances 2008: Major Research Advances in Cancer Treatment, Prevention, and Screening—A Report From the American Society of Clinical Oncology

    PubMed Central

    Winer, Eric; Gralow, Julie; Diller, Lisa; Karlan, Beth; Loehrer, Patrick; Pierce, Lori; Demetri, George; Ganz, Patricia; Kramer, Barnett; Kris, Mark; Markman, Maurie; Mayer, Robert; Pfister, David; Raghavan, Derek; Ramsey, Scott; Reaman, Gregory; Sandler, Howard; Sawaya, Raymond; Schuchter, Lynn; Sweetenham, John; Vahdat, Linda; Schilsky, Richard L.

    2009-01-01

    most significant clinical research is conducted increasingly overseas. In addition, talented young physicians in the United States, seeing less opportunity in the field of oncology, are choosing other specialties instead. Although greater investment in research is critical, the need for new therapies is only part of the challenge. Far too many people in the United States lack access to the treatments that already exist, leading to unnecessary suffering and death. Uninsured cancer patients are significantly more likely to die than those with insurance, racial disparities in cancer incidence and mortality remain stark, and even insured patients struggle to keep up with the rapidly rising cost of cancer therapies. As this annual American Society of Clinical Oncology report of the major cancer research advances during the last year demonstrates, we are making important progress against cancer. But sound public policies are essential to accelerate that progress. In 2009, we have an opportunity to reinvest in cancer research, and to support policies that will help ensure that every individual in the United States receives potentially life-saving cancer prevention, early detection, and treatment. Sincerely, Richard L. Schilsky, MD President American Society of Clinical Oncology PMID:19103723

  16. Clinical cancer advances 2008: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology.

    PubMed

    Winer, Eric; Gralow, Julie; Diller, Lisa; Karlan, Beth; Loehrer, Patrick; Pierce, Lori; Demetri, George; Ganz, Patricia; Kramer, Barnett; Kris, Mark; Markman, Maurie; Mayer, Robert; Pfister, David; Raghavan, Derek; Ramsey, Scott; Reaman, Gregory; Sandler, Howard; Sawaya, Raymond; Schuchter, Lynn; Sweetenham, John; Vahdat, Linda; Schilsky, Richard L

    2009-02-10

    significant clinical research is conducted increasingly overseas. In addition, talented young physicians in the United States, seeing less opportunity in the field of oncology, are choosing other specialties instead. Although greater investment in research is critical, the need for new therapies is only part of the challenge. Far too many people in the United States lack access to the treatments that already exist, leading to unnecessary suffering and death. Uninsured cancer patients are significantly more likely to die than those with insurance, racial disparities in cancer incidence and mortality remain stark, and even insured patients struggle to keep up with the rapidly rising cost of cancer therapies. As this annual American Society of Clinical Oncology report of the major cancer research advances during the last year demonstrates, we are making important progress against cancer. But sound public policies are essential to accelerate that progress. In 2009, we have an opportunity to reinvest in cancer research, and to support policies that will help ensure that every individual in the United States receives potentially life-saving cancer prevention, early detection, and treatment. Sincerely, Richard L. Schilsky, MD President American Society of Clinical Oncology.

  17. MRI-guided laser interstitial thermal therapy in neuro-oncology: a review of its current clinical applications.

    PubMed

    Rahmathulla, Gazanfar; Recinos, Pablo F; Kamian, Kambiz; Mohammadi, Alireza M; Ahluwalia, Manmeet S; Barnett, Gene H

    2014-01-01

    Magnetic resonance imaging-guided laser interstitial thermal therapy (LITT) is a minimally invasive treatment modality with recent increasing use to ablate brain tumors. When originally introduced in the late 1980s, the inability to precisely monitor and control the thermal ablation limited the adoption of LITT in neuro-oncology. Popularized as a means of destroying malignant hepatic and renal metastatic lesions percutaneously, its selective thermal tumor destruction and preservation of adjacent normal tissues have since been optimized for use in neuro-oncology. The progress made in real-time thermal imaging with MRI, laser probe design, and computer algorithms predictive of tissue kill has led to the resurgence of interest in LITT as a means to ablate brain tumors. Current LITT systems offer a surgical option for some inoperable brain tumors. We discuss the origins, principles, current indications, and future directions of MRI-guided LITT in neuro-oncology.

  18. Impact of Intensity-Modulated Radiation Therapy Technique for Locally Advanced Non-Small-Cell Lung Cancer: A Secondary Analysis of the NRG Oncology RTOG 0617 Randomized Clinical Trial.

    PubMed

    Chun, Stephen G; Hu, Chen; Choy, Hak; Komaki, Ritsuko U; Timmerman, Robert D; Schild, Steven E; Bogart, Jeffrey A; Dobelbower, Michael C; Bosch, Walter; Galvin, James M; Kavadi, Vivek S; Narayan, Samir; Iyengar, Puneeth; Robinson, Clifford G; Wynn, Raymond B; Raben, Adam; Augspurger, Mark E; MacRae, Robert M; Paulus, Rebecca; Bradley, Jeffrey D

    2017-01-01

    Purpose Although intensity-modulated radiation therapy (IMRT) is increasingly used to treat locally advanced non-small-cell lung cancer (NSCLC), IMRT and three-dimensional conformal external beam radiation therapy (3D-CRT) have not been compared prospectively. This study compares 3D-CRT and IMRT outcomes for locally advanced NSCLC in a large prospective clinical trial. Patients and Methods A secondary analysis was performed to compare IMRT with 3D-CRT in NRG Oncology clinical trial RTOG 0617, in which patients received concurrent chemotherapy of carboplatin and paclitaxel with or without cetuximab, and 60- versus 74-Gy radiation doses. Comparisons included 2-year overall survival (OS), progression-free survival, local failure, distant metastasis, and selected Common Terminology Criteria for Adverse Events (version 3) ≥ grade 3 toxicities. Results The median follow-up was 21.3 months. Of 482 patients, 53% were treated with 3D-CRT and 47% with IMRT. The IMRT group had larger planning treatment volumes (median, 427 v 486 mL; P = .005); a larger planning treatment volume/volume of lung ratio (median, 0.13 v 0.15; P = .013); and more stage IIIB disease (30.3% v 38.6%, P = .056). Two-year OS, progression-free survival, local failure, and distant metastasis-free survival were not different between IMRT and 3D-CRT. IMRT was associated with less ≥ grade 3 pneumonitis (7.9% v 3.5%, P = .039) and a reduced risk in adjusted analyses (odds ratio, 0.41; 95% CI, 0.171 to 0.986; P = .046). IMRT also produced lower heart doses ( P < .05), and the volume of heart receiving 40 Gy (V40) was significantly associated with OS on adjusted analysis ( P < .05). The lung V5 was not associated with any ≥ grade 3 toxicity, whereas the lung V20 was associated with increased ≥ grade 3 pneumonitis risk on multivariable analysis ( P = .026). Conclusion IMRT was associated with lower rates of severe pneumonitis and cardiac doses in NRG Oncology clinical trial RTOG 0617, which supports

  19. Outcome assessment for clinical trials: how many adjudicators do we need? Canadian Lung Oncology Group.

    PubMed

    Walter, S D; Cook, D J; Guyatt, G H; King, D; Troyan, S

    1997-02-01

    Considerable effort is often expended to adjudicate outcomes in clinical trials, but little has been written on the administration of the adjudication process and its possible impact on study results. As a case study, we describe the function and performance of an adjudication committee in a large randomized trial of two diagnostic approaches to potentially operable lung cancer. Up to five independent adjudicators independently determined two primary outcomes: tumor status at death or at final follow-up and the cause of death. Patients for whom there was any disagreement were discussed in committee until a consensus was achieved. We describe the pattern of agreement among the adjudicators and with the final consensus result. Additionally, we model the adjudication process and predict the results if a smaller committee had been used. We found that reducing the number of adjudicators from five to two or three would probably have changed the consensus outcome in less than 10% of cases. Correspondingly, the effect on the final study results (comparing primary outcomes in both randomized arms) would have been altered very little. Even using a single adjudicator would not have affected the results substantially. About 90 minutes of person-time per patient was required for activities directly related to the adjudication process, or approximately 6 months of full time work for the entire study. This level of effort could be substantially reduced by using fewer adjudicators with little impact on the results. Thus, we suggest that when high observer agreement is demonstrated or anticipated, adjudication committees should consist of no more than three members. Further work is needed to evaluate if smaller committees are adequate to detect small but important treatment effects or if they compromise validity when the level of adjudicator agreement is lower.

  20. Nanomedicine in veterinary oncology.

    PubMed

    Lin, Tzu-Yin; Rodriguez, Carlos O; Li, Yuanpei

    2015-08-01

    Nanomedicine is an interdisciplinary field that combines medicine, engineering, chemistry, biology and material sciences to improve disease management and can be especially valuable in oncology. Nanoparticle-based agents that possess functions such as tumor targeting, imaging and therapy are currently under intensive investigation. This review introduces the basic concept of nanomedicine and the classification of nanoparticles. Because of their favorable pharmacokinetics, tumor targeting properties, and resulting superior efficacy and toxicity profiles, nanoparticle-based agents can overcome several limitations associated with conventional diagnostic and therapeutic protocols in veterinary oncology. The two most important tumor targeting mechanisms (passive and active tumor targeting) and their dominating factors (i.e. shape, charge, size and nanoparticle surface display) are discussed. The review summarizes published clinical and preclinical studies that utilize different nanoformulations in veterinary oncology, as well as the application of nanoparticles for cancer diagnosis and imaging. The toxicology of various nanoformulations is also considered. Given the benefits of nanoformulations demonstrated in human medicine, nanoformulated drugs are likely to gain more traction in veterinary oncology.

  1. 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

    2015-03-08

    < 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.

  2. 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

  3. Validity of Eight Integrated Healthcare Delivery Organizations’ Administrative Clinical Data to Capture Breast Cancer Chemotherapy Exposure

    PubMed Central

    Delate, Thomas; Bowles, Erin J. Aiello; Pardee, Roy; Wellman, Robert D.; Habel, Laurel A.; Yood, Marianne Ulcickas; Nekhlyudov, Larissa; Goddard, Katrina A.; Davis, Robert L.; McCarty, Catherine A.; Onitilo, Adedayo A.; Feigelson, Heather Spencer; Freml, Jared; Wagner, Edward

    2012-01-01

    Background Cancer Research Network (CRN) sites use administrative data to populate their Virtual Data Warehouse (VDW). However, information on VDW chemotherapy data validity is limited. The purpose of this study was to assess the validity of VDW chemotherapy data. Methods This was a retrospective, cohort study of women ≥18 years with incident, invasive breast cancer diagnosed between January 1999 and December 2007. Pharmacy and procedure chemotherapy data were extracted from each site’s VDW. Random samples of 50 patients stratified on trastuzumab, anthracyclines, and no chemotherapy exposure were selected from each site for detailed chart abstraction. Weighted sensitivities and specificities of VDW compared to abstracted data were calculated. Cumulative doses calculated from VDW data were compared to doses obtained from the medical chart review. Results The cohort included 13497 patients with 6456 (48%) chart-review eligible. Patients in the sample (N=400) had a mean age of 65 years. Trastuzumab, anthracycline, and other chemotherapy weighted sensitivities were 95%, 97%, and 100%, respectively; specificities were 99%, 99%, and 93%, respectively; positive predictive values were 96%, 99%, and 55%, respectively; and negative predictive values were 99%, 96%, and 100%. Trastuzumab and anthracyclines VDW mean doses were 873 mgs and 386 mgs, respectively, while abstracted mean doses were 1734 mgs and 369 mgs, respectively (R2=0.14, p<0.01 and R2=0.05, p=0.03, respectively). Conclusions Sensitivities and specificities for CRN chemotherapy VDW data were high and dosages were correlated with chart information. Impact The findings support the use of CRN data in evaluating chemotherapy exposures and related outcomes. PMID:22337532

  4. 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.

  5. A comparison of calorie and protein intake in hospitalized pediatric oncology patients dining with a caregiver versus patients dining alone: a randomized, prospective clinical trial.

    PubMed

    Williams, Ruth; Hinds, Pamela S; Ke, Weiming; Hu, X Joan

    2004-01-01

    Hospitalization and cancer therapy can contribute to decreased food intake in children and adolescents with cancer, making it a challenge to meet their nutritional needs. The affect of hospitalization and the eating environment for pediatric oncology patients has not been studied very well, and the effect of altering the social aspect of mealtime for hospitalized pediatric oncology patients has not been studied at all. The authors conducted a randomized, prospective clinical trial to determine if hospitalized pediatric oncology patients consume more protein and calories when eating with a family member or when eating alone in their room at mealtime. All food and beverage intake was recorded for 3 consecutive days, and a food service satisfaction survey was completed on Day 3. Food records were analyzed for calorie and protein intake, and surveys were analyzed for patient/parent satisfaction. The study was completed by 200 hospitalized patients and their parent/caregiver. Overall, neither calorie nor protein intake differed significantly between the two groups, but patient/parent satisfaction was significantly higher in the group of patients who dined with their caregiver. By using analysis of variance, the authors found that ideal body weight and years of sickness were significantly associated with calorie and protein intake.

  6. Oncological and complication assessment of CO2 laser-assisted endoscopic surgery for T1-T2 glottic tumours: clinical experience.

    PubMed

    Galli, A; Giordano, L; Sarandria, D; Di Santo, D; Bussi, M

    2016-06-01

    Several therapeutic options are used for treatment of early stage glottic carcinoma (Tis/T1/T2): open partial laryngectomy (OPL), radiotherapy and CO2 laser-assisted endoscopic surgery. Laser surgery has gradually gained approval in the management of laryngeal cancer. We present our experience in endoscopic laser surgery for early stage glottic carcinomas. This was a retrospective analysis of 72 patients with T1-T2 glottic cancer treated with laser cordectomy between 2006 and 2012. All patients had at least a 36-month follow-up period. Percentages for disease-specific survival, disease-free survival (DFS) and laryngeal preservation rates were 98.6%, 84.7% and 97.2% respectively. Considering neoplastic features that could predict long-term oncological outcome, tumoural involvement of anterior commissure and pathological staging (pT) significantly correlate with local recurrence (p = 0.021 and p = 0.035) and with a lowered DFS (p = 0.017 and p = 0.023). Other variables such as clinical staging, type of cordectomy, involvement of other structures and surgical margin status showed no significant impact on oncological endpoints. CO2 laser surgery is a reliable technique for T1-T2 glottic cancer considering oncological outcomes. The recurrence rate seems to be affected by involvement of anterior commissure and pT stage.

  7. 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

  8. Metronomic Chemotherapy: Seems Prowess to Battle against Cancer in Current Scenario

    PubMed Central

    Muthusamy, Prema; Nalini, GK

    2016-01-01

    Introduction Metronomic chemotherapy is an emerging method of chemotherapy. Metronomic ‘lowdose’ chemotherapy regimen induces tumour dormancy and reduces cancer resistance against anticancer drugs. It tends to improve overall success rate of cancer chemotherapy than conventional cyclical regimen. Aim The aim of this systemic review was to provide comprehensive data of metronomic chemotherapy trials, regimens used and it’s outcome in cancer therapeutics. Materials and Methods Fifty chemotherapy trial data were searched sequentially from web. The main sources were official website of Clinical trial forum, USA and Clinical Trial Registry India (CTRI). Evidence on efficacy and safety of such metronomic chemotherapy trials was gathered from various data published in Medline, New England Journal of Medicine (NEJM), Lancet Oncology and other journals with high credentials. As a result of our search, out of 50 trials including breast -15(30%), colon-, 5(10%) ovarian -5(10%), prostate-5(10%) and others including haematologic, soft tissue and nervous system malignancies -20 (50%). Twenty seven trials showed favourable, 20 trials showed equivocal outcome and 3 trials reported unfavourable outcome. Overall comparison showed definitive statistical significance for using metronomic regimen (p-0.05). Conclusion It can be concluded that metronomic chemotherapy regimen seems convincing beneficial to induce tumour remission and survival at a higher than conventional regimen. More metanalyses are needed to frame common metronomic chemotherapeutic regimen. PMID:28050393

  9. Chemotherapy Use, Performance Status, and Quality of Life at the End of Life

    PubMed Central

    Prigerson, Holly G.; Bao, Yuhua; Shah, Manish A.; Paulk, M. Elizabeth; LeBlanc, Thomas W.; Schneider, Bryan J.; Garrido, Melissa M.; Reid, M. Carrington; Berlin, David A.; Adelson, Kerin B.; Neugut, Alfred I.; Maciejewski, Paul K.

    2016-01-01

    IMPORTANCE Although many patients with end-stage cancer are offered chemotherapy to improve quality of life (QOL), the association between chemotherapy and QOL amid progressive metastatic disease has not been well-studied. American Society for Clinical Oncology guidelines recommend palliative chemotherapy only for solid tumor patients with good performance status. OBJECTIVE To evaluate the association between chemotherapy use and QOL near death (QOD) as a function of patients’ performance status. DESIGN, SETTING, AND PARTICIPANTS A multi-institutional, longitudinal cohort study of patients with end-stage cancer recruited between September 2002 and February 2008. Chemotherapy use (n = 158 [50.6%]) and Eastern Cooperative Oncology Group (ECOG) performance status were assessed at baseline (median = 3.8 months before death) and patients with progressive metastatic cancer (N = 312) following at least 1 chemotherapy regimen were followed prospectively until death at 6 outpatient oncology clinics in the United States. MAIN OUTCOMES AND MEASURES Patient QOD was determined using validated caregiver ratings of patients’ physical and mental distress in their final week. RESULTS Chemotherapy use was not associated with patient survival controlling for clinical setting and patients’ performance status. Among patients with good (ECOG score = 1) baseline performance status, chemotherapy use compared with nonuse was associated with worse QOD (odds ratio [OR], 0.35; 95% CI, 0.17-0.75; P = .01). Baseline chemotherapy use was not associated with QOD among patients with moderate (ECOG score = 2) baseline performance status (OR, 1.06; 95% CI, 0.51-2.21; P = .87) or poor (ECOG score = 3) baseline performance status (OR, 1.34; 95% CI, 0.46-3.89; P = .59). CONCLUSIONS AND RELEVANCE Although palliative chemotherapy is used to improve QOL for patients with end-stage cancer, its use did not improve QOD for patients with moderate or poor performance status and worsened QOD for patients

  10. The feasibility, perceived satisfaction, and value of using synchronous webinars to educate clinical research professionals on reporting adverse events in clinical trials: a report from the Children's Oncology Group.

    PubMed

    Borgerson, Dawn; Dino, Jennifer

    2012-01-01

    Clinical research professionals are faced with decreased funding and increased workloads; innovative methods of professional development programs are necessary to accommodate these factors. This study evaluated the feasibility, perceived satisfaction, and value of using webinars to educate clinical research professionals on reporting adverse events commonly experienced in pediatric oncology clinical trials. The setting incorporated synchronous web-based educational technology. Constructivist learning provides the theoretical framework for this study. Participants evaluated the professional development program at 2 time points: (a) at the conclusion and (b) 4 to 6 weeks afterward, using survey method. Synchronous webinars were both economical and effective in educating clinical research professionals across institutional sites. Participants reported exceptionally high levels of satisfaction with the accessibility, scope, quality, and interactivity of the professional development program. The vast majority of participants reported that the education would assist with reporting adverse events in pediatric oncology clinical trials and this perception persisted into clinical practice. Although the results of this study were intended to guide future educational efforts of the Children's Oncology Group, they may also apply to other cooperative groups.

  11. [Clinical curative efficacy of inducing remission for the newly diagnosed aged AML patients by chemotherapy with IA and DA regimens].

    PubMed

    Tian, Dong-Hua; Gan, Si-Lin; Xing, Hai-Zhou; Liu, Yan-Fang; Xie, Xin-Sheng; Sun, Hui

    2014-10-01

    This study was aimed to explore the clinical efficacy and toxicity of idarubicin (IA regimen) and daunoru-bicin combined with cytarabine (DA regimen) for treating aged patients with AML as induction chemotherapy. The clinical data of 60 newly diagnosed AML aged patients treated with IA or DA regimen were analyzed retrospectively. IA regimen group included 22 patients (8 male and 14 females with median age of 66 yrs), while the DA regimen group included 38 patients (20 males and 18 females with median age of 64 yrs). The complete remission rate, total effective rate and adverse effects after one chemotherapy course were compared. The results showed that the CR rate in IA regimen group was 63.63%, which was significantly higer than that in DA regimen group (31.58%) (P < 0.05). The total effective rate was 63.63% and 36.84% respectively in IA and DA regimen groups, there was significant difference between the two groups (P < 0.05). Both the hematological and non-hematological adverse effects were observed and no difference was found in the two regimen groups, neither in myelosupression (P > 0.05), the major hematological adverse effects, nor in non-hematological adverse effects (P > 0.05). It is concluded that for aged AML patients, IA regimen can achieve a higher CR rate and higher total effective rate than that in DA regimen without increase of adverse effects after one induction chemotherapy course.

  12. Effect of class IV laser therapy on chemotherapy-induced oral mucositis: a clinical and experimental study.

    PubMed

    Ottaviani, Giulia; Gobbo, Margherita; Sturnega, Mauro; Martinelli, Valentina; Mano, Miguel; Zanconati, Fabrizio; Bussani, Rossana; Perinetti, Giuseppe; Long, Carlin S; Di Lenarda, Roberto; Giacca, Mauro; Biasotto, Matteo; Zacchigna, Serena

    2013-12-01

    Oral mucositis (OM) is a serious and acute side effect in patients with cancer who receive chemotherapy or radiotherapy, often leading to the suspension of therapy and a need for opioid analgesic and enteral/parenteral nutrition, with an effect on patient survival. Among the various interventions proposed in OM management, laser therapy is becoming a recommended treatment option but has limitations due to its heterogeneous laser parameters. Here, we report on our successful clinical experience on the use of class IV laser therapy to treat OM induced by different chemotherapy regimens. To shed light on the mechanisms of action of laser therapy in improving OM resolution, we have developed an animal model of chemotherapy-induced OM, in which we compare the efficacy of the standard low-power laser therapy protocol with an innovative protocol, defined as high-power laser therapy. We show that high-power laser therapy is more effective than low-power laser therapy in improving OM lesion healing, reducing the inflammatory burden, and preserving tissue integrity. In addition, high-power laser therapy has been particularly effective in promoting the formation of new arterioles within the granulation tissue. Our results provide important insights into the mechanism of action of biostimulating laser therapy on OM in vivo and pave a way for clinical experimentation with the use of high-power laser therapy.

  13. Clinical Role of Adjuvant Chemotherapy after Radical Hysterectomy for FIGO Stage IB-IIA Cervical Cancer: Comparison with Adjuvant RT/CCRT Using Inverse-Probability-of-Treatment Weighting

    PubMed Central

    Jung, Phill-Seung; Kim, Dae-Yeon; Lee, Shin-Wha; Park, Jeong-Yeol; Suh, Dae-Shik; Kim, Jong-Hyeok; Kim, Yong-Man; Kim, Young-Tak; Nam, Joo-Hyun

    2015-01-01

    Objective To evaluate the clinical role of adjuvant chemotherapy (AC) in FIGO stage IB-IIA cervical cancer patients. Study Design A cohort of 262 patients with cervical cancer who received radical hysterectomy (RH) and adjuvant therapy at Asan Medical Center between 1992 and 2012 was enrolled. In this cohort, 85 patients received adjuvant chemotherapy (AC), and 177 received adjuvant radiotherapy or concurrent chemoradiation therapy (AR). Oncologic outcomes and adverse events in both treatment arms were compared using weighted Cox proportional hazards regression models with inverse-probability-of-treatment weighting (IPTW) to reduce the impact of treatment selection bias and potential confounding factors. Results During a 46.8-month median follow-up duration, 39 patients (14.9%) had recurrences, and 18 patients (6.9%) died of disease. In multivariate analysis, the hazard ratio (HR) for recurrence and death was not significantly different in patients in either treatment arm (p=0.62 and 0.12, respectively). Also, after IPTW matching, the HR for recurrence did not significantly differ between the arms (HR 1.57, 95% CI 0.68-3.62, p=0.29). Similarly, disease-free survival and overall survival were not significantly different between the arms (p=0.47 and 0.13, respectively). In addition, patients with AC had a much lower prevalence of long-term complications (lymphedema: n=8 (9.4%) vs. 46 (26.0%), p=0.03; ureteral stricture: n=0 vs. 9 (6.2%), p=0.05). Conclusion Patients with FIGO stage IB-IIA cervical cancer can benefit from AC after RH with fewer long-term complications and non-inferior therapeutic effect to AR. Chemotherapy may therefore be an alternative adjuvant treatment option for cervical cancer, particularly in younger patients. PMID:26176626

  14. Pre-operative chemotherapy for colorectal cancer liver metastases: an update of recent clinical trials.

    PubMed

    Nasti, G; Ottaiano, A; Berretta, M; Delrio, P; Izzo, F; Cassata, A; Romano, C; Facchini, G; Scala, D; Mastro, A; Romano, G; Perri, F; Iaffaioli, R V

    2010-07-01

    The standard treatment of CRC patients with hepatic metastases is systemic chemotherapy; however, 5-year survival is disappointingly poor despite recent advances. On the other hand, in patients who undergo immediate radical surgical resection of hepatic metastases, 5-year survival reaches 30-40%. Unfortunately, only 15-20% of patients with hepatic metastases are initially eligible for a radical surgical approach. The majority of patients undergoing liver resection relapse after surgery. For this reason, new onco-surgery approaches have been investigated in recent years and the addition of biological agents to chemotherapy, such as bevacizumab and cetuximab, and the improvements of surgical techniques have opened a new scenario in the management of colorectal liver metastases. Recently, the EORTC trial has demonstrated that perioperative chemotherapy (Folfox regimen) is feasible and improves progression-free survival in patients with resectable liver metastases. Chemotherapy and surgery can finally collaborate. In the unresectable setting, the association of chemotherapy with bevacizumab and cetuximab is particularly promising in improving resectability rate. In particular, K-RAS is a molecular response predictive factor that could be particularly useful in selecting the best treatment option in patients with unresectable liver disease.

  15. [Blastic plasmacytoid dendritic cell neoplasm with complete clinical remission with chemotherapy and central nervous system relapse: Report of one case].

    PubMed

    Contreras, Loreto; Mercado, Loreto; Delgado, Carolina; Cabezas, Claudia; Starke, Laksmi; Romero, Mónica; Ibieta, Fernando; Henríquez, Mauricio; Chandia, Mauricio

    2017-01-01

    Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare, clinically aggressive hematologic malignancy that most commonly manifests as cutaneous lesions with or without bone marrow involvement and leukemic dissemination. The demonstration of tumor cells with the characteristic immunophenotype with expression of CD56, generally CD4 and dendritic cell antigens (CD123, cyTCL-1, HLA-DR), in the absence of myeloid or lymphoid lineage markers is required for the diagnosis. Responses to chemotherapy are initially satisfactory, with frequent systemic and central nervous system relapses. We report a 24 year-old male with BPDCN, initially diagnosed and treated as non-Hodgkin CD4+ T-cell lymphoma, with initial complete remission who evolved with early central nervous system relapse. A second attempt of chemotherapy failed and the patient died two months later.

  16. Oncology in Cambodia.

    PubMed

    Eav, S; Schraub, S; Dufour, P; Taisant, D; Ra, C; Bunda, P

    2012-01-01

    Cambodia, a country of 14 million inhabitants, was devastated during the Khmer Rouge period and thereafter. The resources of treatment are rare: only one radiotherapy department, renovated in 2003, with an old cobalt machine; few surgeons trained to operate on cancer patients; no hematology; no facilities to use intensive chemotherapy; no nuclear medicine department and no palliative care unit. Cervical cancer incidence is one of the highest in the world, while in men liver cancer ranks first (20% of all male cancers). Cancers are seen at stage 3 or 4 for 70% of patients. There is no prevention program - only a vaccination program against hepatitis B for newborns - and no screening program for cervical cancer or breast cancer. In 2010, oncology, recognized as a full specialty, was created to train the future oncologists on site at the University of Phnom Penh. A new National Cancer Center will be built in 2013 with modern facilities for radiotherapy, medical oncology, hematology and nuclear medicine. Cooperation with foreign countries, especially France, and international organizations has been established and is ongoing. Progress is occurring slowly due to the shortage of money for Cambodian institutions and the lay public.

  17. 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

  18. Clinical outcomes following neoadjuvant cisplatin-based chemotherapy for bladder cancer in elderly compared with younger patients.

    PubMed

    Chau, C; Wheater, M; Geldart, T; Crabb, S J

    2015-03-01

    Bladder cancer is a disease of the elderly. Older patients might potentially be undertreated due to assumptions about benefit versus risk. Our objective was to determine outcomes in older patients receiving neoadjuvant chemotherapy for muscle-invasive bladder cancer (MIBC). We hypothesised that appropriately selected elderly patients (≥70 years) with MIBC could have similar clinical outcomes, and be safely treated, with standard neoadjuvant chemotherapy prior to definitive cystectomy or radiotherapy. We utilised a single institution case series analysis of patients with T2-4a N0 M0 transitional cell carcinoma of the bladder treated with cisplatin-based neoadjuvant chemotherapy between 2005 and 2011. Eighty-three patients were eligible. Median age was 68 (range 48-80), 33 patients (40%) were ≥70 years. Overall survival at 3 years was 65.8% (≥70) and 63.2% (<70) (P = 0.653), relapse-free survival at 3 years was 61.6% and 54.8% respectively (P = 0.471). The rates going forward to definitive local therapy (87.9% ≥ 70 and 84.0% < 70) and the pathological complete response rate (31.3% ≥ 70 and 40% < 70) were similar. Disease relapse rate was also similar (63.6% ≥ 70 vs. 60% < 70, P = 0.906). Elderly patients with good functional status and limited comorbidities diagnosed with MIBC receiving standard neoadjuvant chemotherapy followed by cystectomy or radiotherapy can have similar clinical outcomes as their younger counterparts. Prospective studies evaluating the optimum curative management in this elderly population are warranted.

  19. Prevention and Monitoring of Cardiac Dysfunction in Survivors of Adult Cancers: American Society of Clinical Oncology Clinical Practice Guideline.

    PubMed

    Armenian, Saro H; Lacchetti, Christina; Barac, Ana; Carver, Joseph; Constine, Louis S; Denduluri, Neelima; Dent, Susan; Douglas, Pamela S; Durand, Jean-Bernard; Ewer, Michael; Fabian, Carol; Hudson, Melissa; Jessup, Mariell; Jones, Lee W; Ky, Bonnie; Mayer, Erica L; Moslehi, Javid; Oeffinger, Kevin; Ray, Katharine; Ruddy, Kathryn; Lenihan, Daniel

    2016-12-05

    Purpose Cardiac dysfunction is a serious adverse effect of certain cancer-directed therapies that can interfere with the efficacy of treatment, decrease quality of life, or impact the actual survival of the patient with cancer. The purpose of this effort was to develop recommendations for prevention and monitoring of cardiac dysfunction in survivors of adult-onset cancers. Methods Recommendations were developed by an expert panel with multidisciplinary representation using a systematic review (1996 to 2016) of meta-analyses, randomized clinical trials, observational studies, and clinical experience. Study quality was assessed using established methods, per study design. The guideline recommendations were crafted in part using the Guidelines Into Decision Support methodology. Results A total of 104 studies met eligibility criteria and compose the evidentiary basis for the recommendations. The strength of the recommendations in these guidelines is based on the quality, amount, and consistency of the evidence and the balance between benefits and harms. Recommendations It is important for health care providers to initiate the discussion regarding the potential for cardiac dysfunction in individuals in whom the risk is sufficiently high before beginning therapy. Certain higher risk populations of survivors of cancer may benefit from prevention and screening strategies implemented during cancer-directed therapies. Clinical suspicion for cardiac disease should be high and threshold for cardiac evaluation should be low in any survivor who has received potentially cardiotoxic therapy. For certain higher risk survivors of cancer, routine surveillance with cardiac imaging may be warranted after completion of cancer-directed therapy, so that appropriate interventions can be initiated to halt or even reverse the progression of cardiac dysfunction.

  20. 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

  1. 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

  2. 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.

  3. Clinical Cancer Advances 2017: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology.

    PubMed

    Burstein, Harold J; Krilov, Lada; Aragon-Ching, Jeanny B; Baxter, Nancy N; Chiorean, E Gabriela; Chow, Warren Allen; De Groot, John Frederick; Devine, Steven Michael; DuBois, Steven G; El-Deiry, Wafik S; Epstein, Andrew S; Heymach, John; Jones, Joshua Adam; Mayer, Deborah K; Miksad, Rebecca A; Pennell, Nathan A; Sabel, Michael S; Schilsky, Richard L; Schuchter, Lynn Mara; Tung, Nadine; Winkfield, Karen Marie; Wirth, Lori J; Dizon, Don S

    2017-02-01

    A MESSAGE FROM ASCO'S PRESIDENT I am pleased to present Clinical Cancer Advances 2017, which highlights the most promising advances in patient-oriented cancer research over the past year. The report gives us an opportunity to reflect on what an exciting time it is for cancer research and how swiftly our understanding of cancer has improved. One year ago, the White House announced the national Cancer Moonshot program to accelerate progress against cancer. This shared vision of progress has reinvigorated the research community, identified new areas of scientific collaboration, and raised our ambitions regarding what may be possible beyond the progress we have already made. When I entered the field 35 years ago, I could not have imagined where we would be today. We can now detect cancer earlier, target treatments more effectively, and manage adverse effects more effectively to enable patients to live better, more fulfilling lives. Today, two of three people with cancer live at least 5 years after diagnosis, up from roughly one of two in the 1970s. This progress has resulted from decades of incremental advances that have collectively expanded our understanding of the molecular underpinnings of cancer. There is no better current example of this than ASCO's 2017 Advance of the Year: Immunotherapy 2.0. Over the last year, there has been a wave of new successes with immunotherapy. Research has proven this approach can be effective against a wide range of hard-to-treat advanced cancers previously considered intractable. Researchers are now working to identify biologic markers that can help increase the effectiveness of treatment and determine who is most likely to benefit from immunotherapy. This knowledge will enable oncologists to make evidence-based decisions so as many patients as possible might benefit from this new type of treatment. Each successive advance builds on the previous hard work of generations of basic, translational, and clinical cancer researchers

  4. Ongoing Use of Data and Specimens from NCI Sponsored Cancer Prevention Clinical Trials in the Community Clinical Oncology Program

    PubMed Central

    Minasian, Lori; Tangen, Catherine M.; Wickerham, D. Lawrence

    2015-01-01

    Large cancer prevention trials provide opportunities to collect a wide array of data and biospecimens at study entry and longitudinally, for a healthy, aging population without cancer. This provides an opportunity to use pre-diagnostic data and specimens to evaluate hypotheses about the initial development of cancer. This paper reports on strides made by, and future possibilities for, the use of accessible biorepositories developed from precisely annotated samples obtained through large-scale National Cancer Institute (NCI)-sponsored cancer prevention clinical trials conducted by the NCI Cooperative Groups. These large cancer prevention studies, which have enrolled over 80,000 volunteers, continue to contribute to our understanding of cancer development more than 10 years after they were closed. PMID:26433556

  5. High-Dose Intravenous Vitamin C Combined with Cytotoxic Chemotherapy in Patients with Advanced Cancer: A Phase I-II Clinical Trial

    PubMed Central

    Hoffer, L. John; Robitaille, Line; Zakarian, Robert; Melnychuk, David; Kavan, Petr; Agulnik, Jason; Cohen, Victor; Small, David; Miller, Wilson H.

    2015-01-01

    Background Biological and some clinical evidence suggest that high-dose intravenous vitamin C (IVC) could increase the effectiveness of cancer chemotherapy. IVC is widely used by integrative and complementary cancer therapists, but rigorous data are lacking as to its safety and which cancers and chemotherapy regimens would be the most promising to investigate in detail. Methods and Findings We carried out a phase I-II safety, tolerability, pharmacokinetic and efficacy trial of IVC combined with chemotherapy in patients whose treating oncologist judged that standard-of-care or off-label chemotherapy offered less than a 33% likelihood of a meaningful response. We documented adverse events and toxicity associated with IVC infusions, determined pre- and post-chemotherapy vitamin C and oxalic acid pharmacokinetic profiles, and monitored objective clinical responses, mood and quality of life. Fourteen patients were enrolled. IVC was safe and generally well tolerated, although some patients experienced transient adverse events during or after IVC infusions. The pre- and post-chemotherapy pharmacokinetic profiles suggested that tissue uptake of vitamin C increases after chemotherapy, with no increase in urinary oxalic acid excretion. Three patients with different types of cancer experienced unexpected transient stable disease, increased energy and functional improvement. Conclusions Despite IVC’s biological and clinical plausibility, career cancer investigators currently ignore it while integrative cancer therapists use it widely but without reporting the kind of clinical data that is normally gathered in cancer drug development. The present study neither proves nor disproves IVC’s value in cancer therapy, but it provides practical information, and indicates a feasible way to evaluate this plausible but unproven therapy in an academic environment that is currently uninterested in it. If carried out in sufficient numbers, simple studies like this one could identify

  6. 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.

  7. Investigation of the effects of planned mouth care education on the degree of oral mucositis in pediatric oncology patients.

    PubMed

    Yavuz, Betül; Bal Yılmaz, Hatice

    2015-01-01

    This study was designed as a longitudinal study with the purpose of investigating the effects of providing mouth care education to pediatric oncology patients on the degree of oral mucositis. The study sample included 16 children aged 8 to 18 years who were hospitalized in the pediatric oncology and hematology clinics at a university hospital. The results revealed a statistically significant difference between the degree of mucositis before and after the education given to children undergoing chemotherapy (P < .05). The median pain values were significantly different before and after the education (P < .05) as well. It was also found that there was a strong positive statistically significant correlation between the degree of mucositis and mean pain score both before and after the education (P < .001). Consequently, it is reported that both the degree of mucositis and pain levels decreased when children were given planned mouth care education before chemotherapy and when they regularly performed mouth care.

  8. American Society of Clinical Oncology Clinical Practice Guideline Update on the Use of Pharmacologic Interventions Including Tamoxifen, Raloxifene, and Aromatase Inhibition for Breast Cancer Risk Reduction

    PubMed Central

    Visvanathan, Kala; Chlebowski, Rowan T.; Hurley, Patricia; Col, Nananda F.; Ropka, Mary; Collyar, Deborah; Morrow, Monica; Runowicz, Carolyn; Pritchard, Kathleen I.; Hagerty, Karen; Arun, Banu; Garber, Judy; Vogel, Victor G.; Wade, James L.; Brown, Powel; Cuzick, Jack; Kramer, Barnett S.; Lippman, Scott M.

    2009-01-01

    Purpose To update the 2002 American Society of Clinical Oncology guideline on pharmacologic interventions for breast cancer (BC) risk reduction. Methods A literature search identified relevant randomized trials published since 2002. Primary outcome of interest was BC incidence (invasive and noninvasive). Secondary outcomes included BC mortality, adverse events, and net health benefits. An expert panel reviewed the literature and developed updated consensus guidelines. Results Seventeen articles met inclusion criteria. In premenopausal women, tamoxifen for 5 years reduces the risk of BC for at least 10 years, particularly estrogen receptor (ER) –positive invasive tumors. Women ≤ 50 years of age experience fewer serious side effects. Vascular and vasomotor events do not persist post-treatment across all ages. In postmenopausal women, raloxifene and tamoxifen reduce the risk of ER-positive invasive BC with equal efficacy. Raloxifene is associated with a lower risk of thromboembolic disease, benign uterine conditions, and cataracts than tamoxifen in postmenopausal women. No evidence exists establishing whether a reduction in BC risk from either agent translates into reduced BC mortality. Recommendations In women at increased risk for BC, tamoxifen (20 mg/d for 5 years) may be offered to reduce the risk of invasive ER-positive BC, with benefits for at least 10 years. In postmenopausal women, raloxifene (60 mg/d for 5 years) may also be considered. Use of aromatase inhibitors, fenretinide, or other selective estrogen receptor modulators to lower BC risk is not recommended outside of a clinical trial. Discussion of risks and benefits of preventive agents by health providers is critical to patient decision making. PMID:19470930

  9. Use of 5-α-Reductase Inhibitors for Prostate Cancer Chemoprevention: American Society of Clinical Oncology/American Urological Association 2008 Clinical Practice Guideline

    PubMed Central

    Kramer, Barnett S.; Hagerty, Karen L.; Justman, Stewart; Somerfield, Mark R.; Albertsen, Peter C.; Blot, William J.; Ballentine Carter, H.; Costantino, Joseph P.; Epstein, Jonathan I.; Godley, Paul A.; Harris, Russell P.; Wilt, Timothy J.; Wittes, Janet; Zon, Robin; Schellhammer, Paul

    2009-01-01

    Purpose To develop an evidence-based guideline on the use of 5-α-reductase inhibitors (5-ARIs) for prostate cancer chemoprevention. Methods The American Society of Clinical Oncology (ASCO) Health Services Committee (HSC), ASCO Cancer Prevention Committee, and the American Urological Association Practice Guidelines Committee jointly convened a Panel of experts, who used the results from a systematic review of the literature to develop evidence-based recommendations on the use of 5-ARIs for prostate cancer chemoprevention. Results The systematic review completed for this guideline identified 15 randomized clinical trials that met the inclusion criteria, nine of which reported prostate cancer period prevalence. Conclusion Asymptomatic men with a prostate-specific antigen (PSA) ≤ 3.0 ng/mL who are regularly screened with PSA or are anticipating undergoing annual PSA screening for early detection of prostate cancer may benefit from a discussion of both the benefits of 5-ARIs for 7 years for the prevention of prostate cancer and the potential risks (including the possibility of high-grade prostate cancer). Men who are taking 5-ARIs for benign conditions such as lower urinary tract [obstructive] symptoms (LUTS) may benefit from a similar discussion, understanding that the improvement of LUTS relief should be weighed with the potential risks of high-grade prostate cancer from 5-ARIs (although the majority of the Panel members judged the latter risk to be unlikely). A reduction of approximately 50% in PSA by 12 months is expected in men taking a 5-ARI; however, because these changes in PSA may vary across men, and within individual men over time, the Panel cannot recommend a specific cut point to trigger a biopsy for men taking a 5-ARI. No specific cut point or change in PSA has been prospectively validated in men taking a 5-ARI. PMID:19252137

  10. 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

  11. Head and Neck Cancer Survivorship Care Guideline: American Society of Clinical Oncology Clinical Practice Guideline Endorsement of the American Cancer Society Guideline.

    PubMed

    Nekhlyudov, Larissa; Lacchetti, Christina; Davis, Nancy B; Garvey, Thomas Q; Goldstein, David P; Nunnink, J Chris; Ninfea, Jose I Ruades; Salner, Andrew L; Salz, Talya; Siu, Lillian L

    2017-02-27

    Purpose This guideline provides recommendations on the management of adults after head and neck cancer (HNC) treatment, focusing on surveillance and screening for recurrence or second primary cancers, assessment and management of long-term and late effects, health promotion, care coordination, and practice implications. Methods ASCO has a policy and set of procedures for endorsing clinical practice guidelines that have been developed by other professional organizations. The American Cancer Society (ACS) HNC Survivorship Care Guideline was reviewed for developmental rigor by methodologists. An ASCO Expert Panel reviewed the content and recommendations, offering modifications and/or qualifying statements when deemed necessary. Results The ASCO Expert Panel determined that the ACS HNC Survivorship Care Guideline, published in 2016, is clear, thorough, clinically practical, and helpful, despite the limited availability of high-quality evidence to support many of the recommendations. ASCO endorsed the ACS HNC Survivorship Care Guideline, adding qualifying statements aimed at promoting team-based, multispecialty, multidisciplinary, collaborative head and neck survivorship care. Recommendations The ASCO Expert Panel emphasized that caring for HNC survivors requires a team-based approach that includes primary care clinicians, oncology specialists, otolaryngologists, dentists, and other allied professionals. The HNC treatment team should educate the primary care clinicians and patients about the type(s) of treatment received, the likelihood of potential recurrence, and the potential late and long-term complications. Primary care clinicians should recognize symptoms of recurrence and coordinate a prompt evaluation. They should also be prepared to manage late effects either directly or by referral to appropriate specialists. Health promotion is critical, particularly regarding tobacco cessation and dental care. Additional information is available at www

  12. Susceptibility to levofloxacin of clinical isolates of bacteria from intensive care and haematology/oncology patients in Switzerland: a multicentre study.

    PubMed

    Siegrist, H H; Nepa, M C; Jacquet, A

    1999-06-01

    The objective of this study was to examine the susceptibility of clinical isolates to levofloxacin, a fluoroquinolone with extended activity against Gram-positive bacteria, and other antibiotics in 12 Swiss clinical microbiology laboratories using the NCCLS disc diffusion technique. Isolates were prospectively collected from intensive care units (ICUs (59%), oncology wards (7%) and other units with haematology/oncology patients (34%) from June 1995 to March 1996. The levofloxacin breakpoints used were as recommended by the manufacturer. A total of 310 Gram-positive and 580 Gram-negative isolates from the respiratory tract (36%), skin/wounds (12%), blood (16%), urine (17%) and other sources (19%) were tested. The percentage of isolates susceptible to levofloxacin was 100% for Enterococcus spp. (38 strains), Streptococcus agalactiae (13), Streptococcus pneumoniae (65), Acinetobacter spp. (11), Citrobacter diversus (6), Citrobacter freundii (17), Klebsiella oxytoca (39), Morganella morganii (16), Proteus mirabilis (20), Proteus vulgaris (23), Serratia spp. (19), Stenotrophomonas maltophilia (10) and Haemophilus influenzae (41). The percentage of isolates susceptible to levofloxacin for Staphylococcus aureus (95 strains, including 2% MRSA) was 94%, coagulase-negative staphylococci (85) 65%, Enterobacter spp. (75) 99%, Escherichia coli (111) 97%, Klebsiella pneumoniae (45) 98% and Pseudomonas aeruginosa (124) 87%. In conclusion, levofloxacin is a new fluoroquinolone to which the most common clinical isolates in Switzerland are susceptible. The susceptibility of Enterococcus spp. and S. pneumoniae to levofloxacin was particularly remarkable. This compound appears to be a promising therapeutic alternative for the treatment of Gram-positive infections.

  13. 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

  14. 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.

  15. The organization of clinical trials for oncology at IRCCS Istituto Nazionale Tumori "Fondazione G. Pascale" Napoli and the impact of the OECI accreditation process.

    PubMed

    De Feo, Gianfranco; D'Ambrosio, Francesca; Palmieri, Giada; Perrone, Francesco; Ciliberto, Gennaro

    2015-01-01

    The Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Istituto Nazionale Tumori "Fondazione G. Pascale" (INT-Pascale) is the largest Clinical Care and Research Cancer Center in Southern Italy. The mission is prevention, diagnosis, and care of cancer and innovative research in oncology. In 2013, INT-Pascale joined the Organisation of European Cancer Institutes (OECI) accreditation and classification project along with other Italian IRCCS cancer centers. One of the major OECI requirements that a cancer center must fulfill in order to achieve and maintain OECI certification is a strong emphasis in translational and clinical research: increasing the number of patients enrolled in clinical trials, establishing easily accessible databases for operators, and informing all possible stakeholders, including patients. A characterizing theme of INT-Pascale is a strong commitment to clinical experimental studies. In the 2007-2014 period, 440 clinical trials were activated at INT-Pascale; in this period, the number of clinical trials and observational studies has had an increment achieving in 2014, respectively, the share of 60 clinical trials and 35 observational studies activated. Optimization of clinical trials management and dissemination of the clinical research culture at INT-Pascale are main objectives to be achieved through several actions and procedures being implemented as a component of the OECI improvement plan. Participation in the OECI program has represented an important challenge to improve quality and processes related to promoting, prioritizing, and monitoring clinical trials at INT-Pascale.

  16. 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.

  17. Clinical cancer advances 2006: major research advances in cancer treatment, prevention, and screening--a report from the American Society of Clinical Oncology.

    PubMed

    Ozols, Robert F; Herbst, Roy S; Colson, Yolonda L; Gralow, Julie; Bonner, James; Curran, Walter J; Eisenberg, Burton L; Ganz, Patricia A; Kramer, Barnett S; Kris, Mark G; Markman, Maurie; Mayer, Robert J; Raghavan, Derek; Reaman, Gregory H; Sawaya, Raymond; Schilsky, Richard L; Schuchter, Lynn M; Sweetenham, John W; Vahdat, Linda T; Winn, Rodger J

    2007-01-01

    A MESSAGE FROM ASCO's PRESIDENT For the second consecutive 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 developed this report to demonstrate the enormous progress being made on the front lines of cancer research today. The report is intended to give all those with an interest in cancer care-the general public, cancer patients and physicians, policymakers, oncologists, and other medical professionals-an accessible summary of the year's most important cancer research advances. These pages report on new targeted therapies that are improving survival and response rates in hard-to-treat cancers such as kidney cancer, HER-2-positive breast cancer, head and neck cancer, and chronic myelogenous leukemia; the FDA's approval of the world's first preventive vaccine for human papillomavirus (HPV), which has the potential to dramatically reduce the global burden of cervical cancer; and advances in the fast-growing field of personalized medicine, including a new lung cancer test that could help physicians better target treatments and predict prognosis. These advances are only part of the landscape. Survival rates are on the rise, the number of cancer deaths in the United States began declining for the first time since 1930, and new research is showing that the rates of certain common cancers, such as those of the breast and colon, have stabilized, and may have even begun to decline. However, cancer research still faces a number of major obstacles. At a time of extraordinary scientific potential, declining federal funding of cancer research threatens to stall or even reverse recent progress. Such funding cuts have already led to fewer clinical trials, fewer talented young physicians entering the field, and a growing bottleneck of basic science discoveries

  18. 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).

  19. [Definition and outline on geriatric oncology].

    PubMed

    Terret, C; Droz, J-P

    2009-11-01

    Geriatric oncology is the concept for management of elderly cancer patients. It is an equal approach of the health status problems and of cancer in a patient considered as a whole. Therefore it is not a subspecialty but a practice which can be translated in the elderly cancer patient's care. The treatment of cancer is based on the same principles than this of younger patients; recommendations used are those of the scientific oncological societies. Health problems of elderly patients are screened by specific tools. Patients without major health problems are managed by the oncological team in the routine; those for whom screening have demonstrated problems are first evaluated in the geriatrics setting and then oncological decisions are adapted to the patient situation. Decisions are made in specific geriatric oncology conferences. Specific clinical trials are required to build an Evidence Based Medicine background. Geriatric oncology teaching programs are warranted.

  20. Clinical analysis and prognostic significance of L-asparaginase containing multidrug chemotherapy regimen in incipient peripheral T-cell lymphoma

    PubMed Central

    Yao, Guoli; Zhou, De; Zhou, Meng; Bao, Changqian; He, Donghua; Li, Li; Zhu, Jingjing; He, Jinsong; Shi, Jimin; Zheng, Weiyan; Cai, Zhen; Huang, He; Ye, Xiujin; Xie, Wanzhuo

    2015-01-01

    Objective: To observe the clinical effects and adverse reactions, and analyze the clinical significance of L-asparaginase (L-ASP) containing multidrug chemotherapy regimen in incipient peripheral T-cell lymphoma (PTCL). Methods: A retrospective analysis was conducted of 102 patients with incipient PTCL who received L-ASP containing multidrug chemotherapy regimens or not in our hospital from January 2010 to December 2013. Complete remission (CR) rate, partial remission (PR) rate, overall remission (OR) rate, progression free survival (PFS), overall survival (OS) and adverse reactions were compared. Results: Patients who received L-ASP containing multidrug chemotherapy (L-ASP group) had higher OR rate than those who received L-ASP-free ones (non L-ASP group) (83.3% vs 61.7%, P=0.016), particularly those at phase III/IV (82.4% vs 54.0%, P=0.007) and with an international prognostic index (IPI) score of ≥2 (82.1% vs 50.0%, P=0.006). The median survival time (OS) was 10.5 months (range, 1-47months) in L-ASP group, while 13 months (range, 0.3-68 months) in non L-ASP group, and they had no statistically significance (P=0.754). Similarly, the progression free survival time(PFS)was 10 months (range, 1-47 months) in L-ASP group,while 11 months (range, 0.3-68 months) in non L-ASP group, also had no statistically significance (P=0.414). The 3-year OS rate of L-ASP group and non L-ASP group were 48.9% and 65.0% , respectively (P=0.974) and the 3-year PFS rate of L-ASP group and non L-ASP group were 40.8% and 61.0%, respectively (P=0.479). They all had no statistically significance. The L-ASP group had more adverse reactions than the non L-ASP group, though most of them were mild and could be improved by symptomatic and supportive care. Conclusion: L-ASP containing multidrug chemotherapy regimen in incipient PTCL showed a better short-term effect and controllable adverse reactions. A large prospective clinical trial of use L-ASP in first-line treatment of PTCL is worthy of

  1. Study of the prediction system for clinical response to M-VAC neoadjuvant chemotherapy for bladder cancer.

    PubMed

    Takata, R; Obara, W; Fujioka, T

    2010-01-01

    Neoadjuvant chemotherapy for invasive bladder cancer, involving a regimen of M-VAC, can manage micrometastasis and improve the prognosis. However, some patients suffer from severe adverse drug reactions without any effect, and no method yet exists for predicting the response of an individual patient to chemotherapy. Our purpose in this study is to establish a method for predicting the response to the M-VAC therapy. We analyzed gene-expression profiles of biopsy materials from 40 invasive bladder cancers using a cDNA microarray consisting of 27 648 genes, after populations of cancer cells had been purified by laser-microbeam microdissection. We identified 14 predictive genes that were expressed differently between nine responder and nine non-responder tumors and devised a prediction-scoring system that clearly separated the responder group from the non-responder group. This system accurately predicted the clinical response for 19 of the 22 additional test cases. The group of patients with positive predictive scores had significantly longer survival times than that with negative scores. As real-time RT-PCR data were highly concordant with the cDNA microarray data for those 14 genes, we developed a quantitative RT-PCR-based prediction system that could be feasible for routine clinical use. Taken together, our results suggest that the sensitivity of an invasive bladder cancer to the M-VAC neoadjuvant chemotherapy can be predicted by expression patterns in this set of genes, a step toward achievement of "personalized therapy" for treatment of this disease.

  2. 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

  3. 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.

  4. 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

  5. External audit of clinical practice and medical decision making in a new Asian oncology center: Results and implications for both developing and developed nations

    SciTech Connect

    Shakespeare, Thomas P. . E-mail: ThomasShakespeare@gmail.com; Back, Michael F.; Lu, Jiade J.; Lee, Khai Mun; Mukherjee, Rahul K.

    2006-03-01

    Purpose: The external audit of oncologist clinical practice is increasingly important because of the incorporation of audits into national maintenance of certification (MOC) programs. However, there are few reports of external audits of oncology practice or decision making. Our institution (The Cancer Institute, Singapore) was asked to externally audit an oncology department in a developing Asian nation, providing a unique opportunity to explore the feasibility of such a process. Methods and Materials: We audited 100 randomly selected patients simulated for radiotherapy in 2003, using a previously reported audit instrument assessing clinical documentation/quality assurance and medical decision making. Results: Clinical documentation/quality assurance, decision making, and overall performance criteria were adequate 74.4%, 88.3%, and 80.2% of the time, respectively. Overall 52.0% of cases received suboptimal management. Multivariate analysis revealed palliative intent was associated with improved documentation/clinical quality assurance (p = 0.07), decision making (p 0.007), overall performance (p = 0.003), and optimal treatment rates (p 0.07); non-small-cell lung cancer or central nervous system primary sites were associated with better decision making (p = 0.001), overall performance (p = 0.03), and optimal treatment rates (p = 0.002). Conclusions: Despite the poor results, the external audit had several benefits. It identified learning needs for future targeting, and the auditor provided facilitating feedback to address systematic errors identified. Our experience was also helpful in refining our national revalidation audit instrument. The feasibility of the external audit supports the consideration of including audit in national MOC programs.

  6. Children's Oncology Group's 2013 blueprint for research: behavioral science.

    PubMed

    Noll, Robert B; Patel, Sunita K; Embry, Leanne; Hardy, Kristina K; Pelletier, Wendy; Annett, Robert D; Patenaude, Andrea; Lown, E Anne; Sands, Stephen A; Barakat, Lamia P

    2013-06-01

    Behavioral science has long played a central role in pediatric oncology clinical service and research. Early work focused on symptom relief related to side effects of chemotherapy and pain management related to invasive medical procedures. As survival rates improved, the focused has shifted to examination of the psychosocial impact, during and after treatment, of pediatric cancer and its treatment on children and their families. The success of the clinical trials networks related to survivorship highlights an even more critical role in numerous domains of psychosocial research and care. Within the cooperative group setting, the field of behavioral science includes psychologists, social workers, physicians, nurses, and parent advisors. The research agenda of this group of experts needs to focus on utilization of psychometrically robust measures to evaluate the impact of treatment on children with cancer and their families during and after treatment ends. Over the next 5 years, the field of behavioral science will need to develop and implement initiatives to expand use of standardized neurocognitive and behavior batteries; increase assessment of neurocognition using technology; early identification of at-risk children/families; establish standards for evidence-based psychosocial care; and leverage linkages with the broader behavioral health pediatric oncology community to translate empirically supported research clinical trials care to practice.

  7. A Non-inferiority Pilot Study Comparing the Clinical Efficacy and Safety of Generic Wide-spectrum Antibiotic Use in Septic Oncology Patients.

    PubMed

    Araya, I; Fasce, G; Núñez, E; Opazo, J L; Saez, E; Hurtado, V; Contreras, S; Quiñones, L A

    2015-12-01

    The present study is a non-inferiority study based on a descriptive and comparative case series for comparison of generic vs. original intravenous antimicrobials in septic oncology patients at an oncology private ICU. 1906 cancer patients admitted to Arturo Lopez Perez Foundation, Chile, were included in this study. After recruitment, a first retrospective group of 206 septic cancer patients recorded from 1st January, 2008 until July 14th, 2010, treated with original antibiotics (cefoperazone-sulbactam, imipenem-cilastatin, piperacillin-tazobactam) were included for analyses and a second prospective group of 143 septic cancer patients recorded from July 15th, 2010 until January 02, 2013, treated with the same but generic antibiotics were also included for comparisons. The trial protocol was developed in accordance with Helsinki and Good Clinical Practices recommendations. The results of this study showed no significant differences between the 2 groups in days of treatment, rate of success and lab test determinations (white cell count, PCR and procalcitonin), with lower, but not significant, total bed days and CPU bed days for generic antibiotics. Therefore, we conclude that the safety and efficacy of the generic antibiotics cefactam®, imipen® and Piperazam® are not inferior to original antibiotics for the treatment of severe sepsis in hospitalised patients at the Arturo Lopez Perez Foundation.

  8. A phase 1 trial of temsirolimus and intensive re-induction chemotherapy for 2nd or greater relapse of acute lymphoblastic leukaemia: a Children's Oncology Group study (ADVL1114).

    PubMed

    Rheingold, Susan R; Tasian, Sarah K; Whitlock, James A; Teachey, David T; Borowitz, Michael J; Liu, Xiaowei; Minard, Charles G; Fox, Elizabeth; Weigel, Brenda J; Blaney, Susan M

    2017-03-14

    The phosphatidylinositol 3-kinase (PI3K)/mammalian (or mechanistic) target of rapamycin (mTOR) signalling pathway is commonly dysregulated in acute lymphoblastic leukaemia (ALL). A phase 1 trial of the mTOR inhibitor temsirolimus in combination with UKALL R3 re-induction chemotherapy was conducted in children and adolescents with second or greater relapse of ALL. The initial temsirolimus dose level (DL1) was 10 mg/m(2) weekly × 3 doses. Subsequent patient cohorts received temsirolimus 7·5 mg/m(2) weekly × 3 doses (DL0) or, secondary to toxicity, 7·5 mg/m(2) weekly × 2 doses (DL-1). Sixteen patients were enrolled, 15 were evaluable for toxicity. Dose-limiting toxicity (DLT) occurred at all three dose levels and included hypertriglyceridaemia, mucositis, ulceration, hypertension with reversible posterior leucoencephalopathy, elevated gamma-glutamyltransferase or alkaline phosphatase and sepsis. The addition of temsirolimus to UKALL R3 re-induction therapy resulted in excessive toxicity and was not tolerable in children with relapsed ALL. However, this regimen induced remission in seven of fifteen patients. Three patients had minimal residual disease levels <0·01%. Inhibition of PI3K signalling was detected in patients treated at all dose levels of temsirolimus, but inhibition at an early time point did not appear to correlate with clinical responses at the end of re-induction therapy.

  9. Transcranial electro-hyperthermia combined with alkylating chemotherapy in patients with relapsed high-grade gliomas: phase I clinical results.

    PubMed

    Wismeth, Caecilia; Dudel, Christine; Pascher, Christina; Ramm, Paul; Pietsch, Torsten; Hirschmann, Birgit; Reinert, Christiane; Proescholdt, Martin; Rümmele, Petra; Schuierer, Gerhard; Bogdahn, Ulrich; Hau, Peter

    2010-07-01

    Non-invasive loco-regional electro-hyperthermia (EHT) plus alkylating chemotherapy is occasionally used as salvage treatment in the relapse of patients with high-grade gliomas. Experimental data and retrospective studies suggest potential effects. However, no prospective clinical results are available. We performed a single-center prospective non-controlled single-arm Phase I trial. Main inclusion criteria were recurrent high-grade glioma WHO Grade III or IV, age 18-70, and Karnofsky performance score > or = 70. Primary endpoints were dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) with the combined regimen. Groups of 3 or 4 patients were treated 2-5 times a week in a dose-escalation scheme with EHT. Alkylating chemotherapy (ACNU, nimustin) was administered at a dose of 90 mg/m(2) on day 1 of 42 days for up to six cycles or until tumor progression (PD) or DLT occurred. Fifteen patients with high-grade gliomas were included. Relevant toxicities were local pain and increased focal neurological signs or intracranial pressure. No DLT occurred. In some patients, the administration of mannitol during EHT or long-term use of corticosteroids was necessary to resolve symptoms. Although some patients showed responses in their primarily treated sites, the pattern of response was not well defined. EHT plus alkylating chemotherapy is tolerable in patients with relapse of high-grade gliomas. Episodes of intracranial pressure were, at least, possibly attributed to EHT but did not cause DLTs. A Phase II trial targeting treatment effects is warranted on the basis of the results raised in this trial.

  10. 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

  11. 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; Rowe, R Grant

    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.

  12. Antibacterial honey (Medihoney®) for wound care of immunocompromised pediatric oncology patients

    PubMed Central

    Simon, Arne; Sofka, Kai; Wieszniewsky, Gertrud; Blaser, Gisela

    2006-01-01

    The physiologic process of wound healing is impaired and prolonged in paediatic patients receiving chemotherapy. Due to profound immunosuppression, wound infection can easily spread and act as the source of sepsis. Referring to in vitro studies, which confirmed the antibacterial potency of special honey preparations against typical isolates of nosocomially acquired wound infections (including MRSA and VRE) and considering the encouraging reports from other groups, Medihoney™ has now been used in wound care at the Department of Pediatric Oncology, Children's Hospital, University of Bonn for three years. Supplemented with exemplary clinical data from pediatric oncology patients, this presentation reviews the scientific background and our promising experience with Medihoney™ in wound care issues at our institution. PMID:20204081

  13. Antibacterial honey (Medihoney) for wound care of immunocompromised pediatric oncology patients.

    PubMed

    Simon, Arne; Sofka, Kai; Wieszniewsky, Gertrud; Blaser, Gisela

    2006-08-30

    The physiologic process of wound healing is impaired and prolonged in paediatic patients receiving chemotherapy. Due to profound immunosuppression, wound infection can easily spread and act as the source of sepsis. Referring to in vitro studies, which confirmed the antibacterial potency of special honey preparations against typical isolates of nosocomially acquired wound infections (including MRSA and VRE) and considering the encouraging reports from other groups, Medihoney has now been used in wound care at the Department of Pediatric Oncology, Children's Hospital, University of Bonn for three years. Supplemented with exemplary clinical data from pediatric oncology patients, this presentation reviews the scientific background and our promising experience with Medihoney in wound care issues at our institution.

  14. Wound care with antibacterial honey (Medihoney) in pediatric hematology-oncology.

    PubMed

    Simon, Arne; Sofka, Kai; Wiszniewsky, Gertrud; Blaser, Gisela; Bode, Udo; Fleischhack, Gudrun

    2006-01-01

    The physiologic process of wound healing is impaired and prolonged in pediatric patients receiving chemotherapy. Due to profound immunosuppression, wound infection can easily spread and act as the source of sepsis. Referring to in vitro studies, which confirmed the antibacterial potency of special honey preparations against typical isolates of nosocomially acquired wound infections (including Methicillin-resistant Staphylococcus aureus and Vancomycin-resistant enterococci) and considering the encouraging reports from other groups, Medihoney has now been used in wound care at the Department of Pediatric Oncology, Children's Hospital, University of Bonn for 3 years. Supplemented with clinical data from pediatric oncology patients, this article reviews the scientific background and our promising experience with Medihoney in wound care issues at our institution. To collect and analyze the available experience, we prepare an internet-based data documentation module for pediatric wound care with Medihoney.

  15. 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

  16. 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

  17. 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

  18. Orthodontic treatment in oncological patients.

    PubMed

    Mituś-Kenig, Maria; Łoboda, Magdalena; Marcinkowska-Mituś, Agata; Durka-Zajac, Magdalena; Pawłowska, Elzbieta

    2015-01-01

    The progress in oncological treatment has led to the current increase of childhood cancer survival rate to 80%. That is why orthodontists more and more frequently consult patients who had completed a successful anti-cancer therapy in childhood. Oncological treatments such as chemotherapy, radiotherapy or supportive immunosuppressive therapy cause numerous side effects in growing patients, connected i.a. with growth, the development of teeth or the viscerocranium. This is a special group of patients that needs an optimised plan of orthodontic treatment and often has to accept a compromise result. The purpose of the current work is to discuss the results of orthodontic treatment in patients after an anti-cancer therapy. Time of treatment was 12,5 months. In 6 patients (from 40 undergoing orthodontic therapy) we haven't reached a normocclusion, in 9 patients we should have stopped the therapy because of the recurrence. In 11 patients we found mucosa inflammation and in 1 patient the therapy stopped before the end because of very low oral hygiene level. Bearing in mind the limited number of original works on the above topic in Polish medical literature, the study has been carried out in order to make Polish orthodontists more acquainted with the topic and the standards of dealing with an oncological patient.

  19. Neuro-oncology: a selected review of ASCO 2016 abstracts.

    PubMed

    Chamberlain, Marc C

    2016-10-01

    ASCO 2016, 29 May-2 June 2016, Chicago, IL, USA The largest annual clinical oncology conference the American Society of Clinical Oncology is held in the USA and gives researchers and other key opinion leaders the opportunity to present new cancer clinical trials and research data. The CNS tumors section of the American Society of Clinical Oncology 2016 covered various aspects of neuro-oncology including metastatic CNS diseases and primary brain tumors, presented via posters, oral talks and over 100 abstracts. This brief review selectively highlights presentations from this meeting in an organizational manner that reflects clinically relevant aspects of a large and multifaceted meeting.

  20. Integrative Oncology Physician Consultations at a Comprehensive Cancer Center: Analysis of Demographic, Clinical and Patient Reported Outcomes.

    PubMed

    Lopez, Gabriel; McQuade, Jennifer; Cohen, Lorenzo; Williams, Jane T; Spelman, Amy R; Fellman, Bryan; Li, Yisheng; Bruera, Eduardo; Lee, Richard T

    2017-01-01

    Background: Integrative oncology (IO) is a relatively new field that seeks to bring evidence-based, non-conventional approaches into conventional oncology care in a coordinated and safe manner. Though complementary and alternative medicine (CAM) are highly utilized by cancer patients, little is known about the characteristics of patients seeking IO consultation. Methods: Patients presenting for an outpatient IO consultation completed a CAM use questionnaire, Measure Yourself Concerns and Wellbeing (MYCaW), Edmonton Symptom Assessment Scale (ESAS), Quality of Life Short Form 12 (SF-12), and post-consultation satisfaction item. Results: 2,474 new patient IO consultations were conducted from 9/2009 to 12/2013 and 2367 (96%) completed at least one measure. Most were female (69%); the most frequent cancer type was breast (29%); 38% had distant/advanced disease; 75% had used a CAM approach in prior 12 months. The most common concerns were seeking an integrative/holistic approach (34%), herbs/supplements (34%), and diet/nutrition (21%). Overall symptom burden was low, with baseline symptom scores (ESAS) highest (worst) for sleep (4.2; SD 2.8), fatigue (4.0; SD 2.8), and well-being (3.8; SD 2.6). On the SF-12, the physical health scores (35.3; SD 7.5) were significantly lower than that of a healthy population (50), but mental health scores were not (46.8; SD 10.2). Satisfaction was high (9.4; SD 1.3) with the consultation. Conclusions: Patients presenting for IO consultation tended to have early stage disease, had previously used a CAM approach, had a relatively low symptom burden, and were most interested in developing an integrative approach to their care or discussing herbs/supplement use.

  1. Integrative Oncology Physician Consultations at a Comprehensive Cancer Center: Analysis of Demographic, Clinical and Patient Reported Outcomes

    PubMed Central

    Lopez, Gabriel; McQuade, Jennifer; Cohen, Lorenzo; Williams, Jane T; Spelman, Amy R; Fellman, Bryan; Li, Yisheng; Bruera, Eduardo; Lee, Richard T

    2017-01-01

    Background: Integrative oncology (IO) is a relatively new field that seeks to bring evidence-based, non-conventional approaches into conventional oncology care in a coordinated and safe manner. Though complementary and alternative medicine (CAM) are highly utilized by cancer patients, little is known about the characteristics of patients seeking IO consultation. Methods: Patients presenting for an outpatient IO consultation completed a CAM use questionnaire, Measure Yourself Concerns and Wellbeing (MYCaW), Edmonton Symptom Assessment Scale (ESAS), Quality of Life Short Form 12 (SF-12), and post-consultation satisfaction item. Results: 2,474 new patient IO consultations were conducted from 9/2009 to 12/2013 and 2367 (96%) completed at least one measure. Most were female (69%); the most frequent cancer type was breast (29%); 38% had distant/advanced disease; 75% had used a CAM approach in prior 12 months. The most common concerns were seeking an integrative/holistic approach (34%), herbs/supplements (34%), and diet/nutrition (21%). Overall symptom burden was low, with baseline symptom scores (ESAS) highest (worst) for sleep (4.2; SD 2.8), fatigue (4.0; SD 2.8), and well-being (3.8; SD 2.6). On the SF-12, the physical health scores (35.3; SD 7.5) were significantly lower than that of a healthy population (50), but mental health scores were not (46.8; SD 10.2). Satisfaction was high (9.4; SD 1.3) with the consultation. Conclusions: Patients presenting for IO consultation tended to have early stage disease, had previously used a CAM approach, had a relatively low symptom burden, and were most interested in developing an integrative approach to their care or discussing herbs/supplement use. PMID:28261340

  2. 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.

  3. 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.

  4. Vesicant chemotherapy extravasation antidotes and treatments.

    PubMed

    Schulmeister, Lisa

    2009-08-01

    Oncology nurses and pharmacists often are given the responsibility of developing or updating institutional policies to manage vesicant chemotherapy extravasations. Antidote and treatment recommendations of vesicant chemotherapy manufacturers, antidotes and treatments approved by the U.S. Food and Drug Administration (FDA), and guidelines and recommendations made by professional oncology organizations are useful resources in this process. This article describes manufacturers' recommendations, lists antidotes and treatments approved by the FDA, and reviews published guidelines and recommendations. Available antidote and treatment formulations and their preparation and administration also are discussed.

  5. 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

  6. Micronutrients in Oncological Intervention.

    PubMed

    Gröber, Uwe; Holzhauer, Peter; Kisters, Klaus; Holick, Michael F; Adamietz, Irenäus A

    2016-03-12

    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.

  7. Clinical validation of chemotherapy predictors developed on global microRNA expression in the NCI60 cell line panel tested in ovarian cancer

    PubMed Central

    Prahm, Kira Philipsen; Høgdall, Claus; Karlsen, Mona Aarenstrup; Christensen, Ib Jarle; Novotny, Guy Wayne; Knudsen, Steen; Hansen, Anker; Jensen, Peter Buhl; Jensen, Thomas; Mirza, Mansoor Raza; Ekmann-Gade, Anne Weng; Nedergaard, Lotte; Høgdall, Estrid

    2017-01-01

    Objective Ovarian cancer is the leading cause of death among gynecologic malignancies. This is partly due to a non-durable response to chemotherapy. Prediction of resistance to chemotherapy could be a key role in more personalized treatment. In the current study we aimed to examine if microRNA based predictors could predict resistance to chemotherapy in ovarian cancer, and to investigate if the predictors could be prognostic factors for progression free and overall survival. Methods Predictors of chemotherapy-resistance were developed based on correlation between miRNA expression and differences in measured growth inhibition in a variety of human cancer cell lines in the presence of Carboplatin, Paclitaxel and Docetaxel. These predictors were then, retrospectively, blindly validated in a cohort of 170 epithelial ovarian cancer patients treated with Carboplatin and Paclitaxel or Docetaxel as first line treatment. Results In a multivariate cox proportional analysis the predictors of chemotherapy-resistance were not able to predict time to progression after end of chemotherapy (hazard ratio: 0.64, 95% CI: 0.36–1.12, P = 0.117). However, in a multivariate logistic analysis, where time to progression was considered as either more or less than 6 months, the predictors match clinical observed chemotherapy-resistance (odds ratio: 0.19, 95% CI: 0.05–0.73, P = 0.015). Neither univariate nor multivariate, time-dependent, cox analysis for progression free survival (PFS) or overall survival (OS) in all 170 patients showed to match predicted resistance to chemotherapy (PFS: hazard ratio: 0.69, 95% CI: 0.40–1.19, P = 0.183, OS: hazard ratio: 0.76, 95% CI: 0.42–1.40, P = 0.386). Conclusion In the current study, microRNA based predictors of chemotherapy-resistance did not demonstrate any convincing correlation to clinical observed chemotherapy-resistance, progression free survival, or overall survival, in patients with epithelial ovarian cancer. However the predictors did

  8. Phase II Trial Assessing the Ability of Neoadjuvant Chemotherapy With or Without Second-Look Surgery to Eliminate Measurable Disease for Nongerminomatous Germ Cell Tumors: A Children's Oncology Group Study

    PubMed Central

    Goldman, Stewart; Bouffet, Eric; Fisher, Paul G.; Allen, Jeffrey C.; Robertson, Patricia L.; Chuba, Paul J.; Donahue, Bernadine; Kretschmar, Cynthia S.; Zhou, Tianni; Buxton, Allen B.; Pollack, Ian F.

    2015-01-01

    Purpose This phase II trial evaluated the effect of neoadjuvant chemotherapy with or without second-look surgery before craniospinal irradiation on response rates and survival outcomes in children with newly diagnosed nongerminomatous germ cell tumors. Patients and Methods Induction chemotherapy consisted of six cycles of carboplatin/etoposide alternating with ifosfamide/etoposide. Patients demonstrating less than complete response after induction chemotherapy were encouraged to undergo second-look surgery. Patients who did not achieve complete response or partial response after chemotherapy with or without second-look surgery proceeded to high-dose chemotherapy with thiotepa and etoposide and autologous peripheral blood stem-cell rescue before craniospinal irradiation. Results The study included 102 patients treated between January 2004 and July 2008. Median age was 12 years, and 76% were male; 53.9% had pineal region masses, and 23.5% had suprasellar lesions. Sixty-nine percent of patients achieved complete response or partial response with neoadjuvant chemotherapy. At 5 years, event-free survival was 84% ± 4% (SE) and overall survival was 93% ± 3%. During the median follow-up of 5.1 years, 16 patients recurred or progressed, with seven deaths after relapse. No deaths were attributed to therapy-related toxicity. Relapse occurred at the site of primary disease in 10 patients, at a distant site in three patients, or both in one patient. In two patients, progression was detected by marker increase alone. Increased serum α-fetoprotein was a negative prognostic variable. Histologic subtype and increase of beta-human chorionic gonadotropin were not significantly correlated with worse outcomes. Conclusion Neoadjuvant chemotherapy with or without second-look surgery achieved high response rates contributing to excellent survival outcomes in children with newly diagnosed nongerminomatous germ cell tumors. This regimen should be included as a backbone for further

  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. [Clinical usefulness of ondansetron hydrochloride for nausea and vomiting during repeated courses of chemotherapy for malignant lymphoma--impact of prognosis announcement on anti-emetic effect and evaluation of patient perception of chemotherapy-associated adverse events].

    PubMed

    Kodama, Fumio; Mohri, Hiroshi; Motomura, Shigeki; Fukawa, Hitoshi; Tanabe, Juichi; Koharasawa, Hideyuki; Kanamori, Heiwa; Hashimoto, Yoshimi; Harano, Hiroshi; Sakai, Rika; Tomita, Naoto; Fujimaki, Katsumichi; Takemura, Sachiya; Hattori, Michiko

    2002-02-01

    We evaluated the efficacy and safety of ondansetron hydrochloride (OND) on nausea and vomiting during repeated courses of CHOP or ACOMP-B therapy in patients with malignant lymphoma. The impact of the prognosis announcement on the anti-emetic effect and chemotherapy-associated adverse events was also investigated. Forty-two subjects with malignant lymphoma who underwent CHOP or ACOMP-B therapy including cyclophosphamide 600 mg/m2 and adriamycin 40 mg/m2 were investigated for a maximum of 6 courses. For acute nausea and vomiting, ondansetron was injected intravenously before the start of chemotherapy on the first day of each course of chemotherapy. For delayed emesis, ondansetron was administered orally for 4 days from the following day. The efficacy on acute nausea and vomiting was found to be 95.0% (1st course), 95.0% (2nd course), 90.9% (3rd course), 88.2% (4th course), 92.3% (5th course) and 91.7% (6th course), respectively. A high efficacy of > or = 85% was also obtained for delayed nausea and vomiting on each day. Though the adverse event of elevated GPT value developed in one subject. It was mild and resolved. No difference in efficacy was seen with or without announcement of prognosis to patients. Following the investigation on antiemetic effect, patient perception of chemotherapy-induced adverse events was evaluated. The most common event was hair loss, followed by taste abnormality and numbness and hyposthesia of the tips of the fingers. The incidence of nausea and vomiting was the 4th and 5th most common, which are less frequent than in the report of Coates in 1983. In conclusion, ondansetron is considered clinically useful with stable anti-emetic effect on both acute and delayed nausea and vomiting over repeated courses of chemotherapy, without any significant safety problem.

  11. 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 ...

  12. 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.

  13. 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

  14. Photodynamic therapy: a promising alternative in oncology

    NASA Astrophysics Data System (ADS)

    Nelius, Thomas; de Riese, Werner T. W.; Filleur, Stephanie

    2004-07-01

    Photodynamic Therapy (PDT) is a treatment modality that is based on the administration of a photosensitizer and the following application of light in a wavelength range matching the absorption spectrum of the photosensitizer. Ideally the photosensitizer retains in the tumor tissue more than in normal tissue and thus allows targeted destruction of cancerous tissue. The use of PDT is slowly being accepted as a standard treatment for certain types of cancer. This includes mainly treatment strategies with only palliative intentions (obstructive esophageal cancer and advanced lung cancer) while for certain malignant conditions new applications exists that are already intended for cure (e.g. early stage of lung cancer). The main advantage of PDT is that the treatment can be repeated multiple times safely without major side effects. PDT can be safely combined with already established treatment options like surgery, chemotherapy or radiotherapy. A disadvantage of PDT is the only localized effect of the therapy, which usually cannot significantly alter the outcome of a systemic disease. In this paper we review the history of PDT as well as current clinical applications in oncology and future directions.

  15. Combined gemcitabine and S-1 chemotherapy for treating unresectable hilar cholangiocarcinoma: a randomized open-label clinical trial

    PubMed Central

    Zhou, Zun-Qiang; Guan, Jiao; Tong, Da-Nian; Zhou, Guang-Wen

    2016-01-01

    Although the combination of cisplatin and gemcitabine (GEM) is considered the standard first-line chemotherapy against unresectable hilar cholangiocarcinoma (HC), its efficacy is discouraging. The present randomized open-label clinical trial aimed to evaluate the efficacy and safety of the GEM plus S-1 (GEM-S-1) combination against unresectable HC. Twenty-five patients per group were randomly assigned to receive GEM, S-1 or GEM-S-1. Neutropenia (56%) and leukopenia (40%) were the most common chemotherapy-related toxicities in the GEM-S-1 group. Median overall survival (OS) in the GEM-S-1, GEM and S-1 groups was 11, 10 and 6 months, respectively. GEM plus S-1 significantly improved OS compared to S-1 monotherapy (OR=0.68; 95%CI, 0.50–0.90; P=0.008). Median progression-free survival (PFS) times in the GEM-S-1, GEM and S-1 groups were 4.90, 3.70 and 1.60 months, respectively. GEM plus S-1 significantly improved PFS compared to S-1 monotherapy (OR=0.50; 95%CI, 0.27–0.91; P=0.024). Response rates were 36%, 24% and 8% in the GEM-S-1, GEM and S-1 groups, respectively. A statistically significant difference was found in response rates between the gemcitabine-S-1 and S-1 groups (36% vs 8%, P=0.017). Patients with CA19-9<466 U/ml were more responsive to chemotherapeutic agents than those with CA19-9≥571 U/ml (88.9% vs 0%, P<0.001). We conclude that the combination of GEM plus S-1 provides a better OS, PFS and response rate than S-1 monotherapy, but it did not significantly differ from GEM monotherapy. (ChiCTR-TRC-14004733). PMID:27058753

  16. [Tropisetron for the prevention of nausea and vomiting during chemotherapy: multicenter clinical study].

    PubMed

    Gutiérrez, J; Bronfman, L; Cao, C; Vásquez, A; Derio, L; Rosas, J; del Castillo, C; Yáñez, M; Fodor, M; Gallardo, J; Cerda, B; Torres, R; Orlandi, L; Orlandi, F; Kleinman, S; Vogel, C

    1996-08-01

    The antiemetic effect of tropisetron was studied in 97 cancer patients (67 men, 30 women) receiving cisplatin in doses of 75 mg/m2 or higher. On 279 chemotherapy cycles studied (max 6 per patient) 5 mg of tropisetron was administered once a day i.v on day 1 and p.o. on days 2 to 6. Efficacy preventing vomiting and nausea was measured in 24 hour period as: complete control O episodes, major control 1 to 2 episodes, minor control 3 to 4 episodes and no control 5 or more episodes. Satisfactory vomiting control (complete and major) was 69%, 63%, 82%, 88%, 96% and 96% in days 1 to 6 of cycle 1. Satisfactory nausea control (complete and major) for the same days was 70%, 66%, 72%, 85%, 92% and 97%. Similar data was obtained for the subsequent cycles. Complete vomiting control was obtained in 47%, 35%, 56%, 72%, 81% and 84% and for nausea in 42%, 39%, 48%, 64%, 81% and 87%. 19 patients presented adverse effects (19.6%). Only 2 headache episodes had a definite relation with the antiemetic drug. 12 patients discontinued the medication; 6 due to drug inefficacy, 2 to illness unrelated to the drug, 1 to lack of collaboration, and 3 due to other reasons. We conclude that tropisetron allows satisfactory control of acute and delayed vomiting in a high percentage of patients treated with high doses of cisplatin. The drug does not have significant secondary effects. Tropisetron administration in only one daily dose implies an evident advantage and a treatment cost reduction.

  17. Serum protein profiling reveals baseline and pharmacodynamic biomarker signatures associated with clinical outcome in mCRC patients treated with chemotherapy ± cediranib

    PubMed Central

    Pommier, A J C; Shaw, R; Spencer, S K M; Morgan, S R; Hoff, P M; Robertson, J D; Barry, S T; Jürgensmeier, J M

    2014-01-01

    Background: This study evaluated soluble serum proteins as biomarkers to subset patients with metastatic colorectal cancer (mCRC) treated with chemotherapy±cediranib, a vascular endothelial growth factor (VEGF) signalling inhibitor (VEGFi). Exploring biomarkers at pre- and on-treatment may identify patient subgroups showing clinical benefit on cediranib combination. Methods: Two hundred and seven serum proteins were analysed in 588 mCRC patients at pre- and on-treatment with chemotherapy (FOLFOX/CAPOX)±cediranib 20 mg. Patients were enrolled in the phase III trial HORIZON II. We correlated baseline biomarker signatures and pharmacodynamic (PD) biomarkers with PFS and OS. Results: We identified a baseline signature (BS) of 47 biomarkers that included VEGFA, VEGFD, VEGFR2, VEGFR3 and TIE-2, which defined two distinct subgroups of patients. Patients treated with chemotherapy plus cediranib who had ‘high' BS had shorter PFS (HR=1.82, P=0.003) than patients with ‘low' BS. This BS did not correlate with PFS of the patients treated with chemotherapy plus placebo. In addition, we identified a profile of 16 PD proteins on treatment associated with PFS (HR=0.58, P<0.001) and OS (HR=0.52, P<0.001) in patients treated with chemotherapy plus cediranib. This PD profile did not correlate with PFS and OS in patients treated with chemotherapy plus placebo. Conclusions: Serum proteins may represent relevant biomarkers to predict the outcome of patients treated with VEGFi-based therapies. We report a BS and PD biomarkers that may identify mCRC patients showing increased benefit of combining cediranib with chemotherapy. These exploratory findings need to be validated in future prospective studies. PMID:25121956

  18. Radiotherapy and chemotherapy in locally advanced non-small cell lung cancer: preclinical and early clinical data.

    PubMed

    Reboul, François L

    2004-02-01

    Over the past 20 years, combined treatment with radiotherapy and second-generation chemotherapy drugs was extensively studied in patients with locally advanced NSCLC and became the standard over radiotherapy alone in patients with good performance status. Radiosensitizing properties of cisplatin have been identified in the laboratory. Close temporal administration of cisplatin and radiation is mandatory for enhanced antitumor efficacy, but results in significant toxicity to normal tissues. Early clinical studies demonstrated that the concurrent administration of cisplatin during STD-RT was feasible, with acceptable esophageal toxicity, and had the potential of significantly improving locoregional control. Carboplatin administered concurrently with accelerated HFX-RT was responsible for a higher rate of esophageal toxicity. Further improvement in survival also requires an effective treatment of micro-metastatic disease through full-dose delivery of cytotoxic drugs and the addition of at least one more active drug in conjunction with cisplatin and radiotherapy to further improve locoregional control of the disease. In most clinical studies, etoposide was the second drug of choice because of its own radiosensitizing properties and possible synergy with cisplatin. In numerous phase II studies, concurrent radiotherapy and PE resulted in reproducible results in terms of local control (30%-40%), median survival (15-18 months), survival at 2 years (35%-40%), and survival at 5 years (25%-30%). In phase III studies, these results were shown to be superior to radiotherapy alone and to induction chemotherapy followed by STD-RT. The question of the potential benefit of HFX-RT combined with PE has been addressed in phase II and III studies. At this time, there is no firm evidence that concurrent chemotherapy with HFX-RT is superior to concurrent chemotherapy with STD-RT in terms of local control and survival. Only a significant benefit in terms of local control or survival would

  19. 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

    Nakayama, Takahiro; 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.

  20. 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.

  1. Efficacy of Hypozalix spray and propolis mouthwash for prevention of chemotherapy-induced oral mucositis in leukemic patients: A double-blind randomized clinical trial

    PubMed Central

    Eslami, Hosein; Pouralibaba, Firouz; Falsafi, Parisa; Bohluli, Sepideh; Najati, Babak; Negahdari, Ramin; Ghanizadeh, Milad

    2016-01-01

    Background. Oral mucositis is the chief complication of head and neck chemotherapy. This study was conducted to evaluate Hypozalix artificial saliva and propolis mouthwash efficacy for the prevention of chemotherapy-induced oral mucositis in leukemic patients. Methods. The present double-blind clinical trial was carried out on 72 patients undergoing chemotherapy. The patients were assigned to 3 groups. In the control group, CHX mouthwash and fluconazole were used by the subjects. In groups 1 and 2, Hypozalix and propolis mouthwashes were added to the combination therapy used in the control group. The results were compared between the three groups after 14 days. Results. Mean score A was significantly higher than mean score B in children (P = 0.001). In contrast, mean score A was significantly lower than mean score B in young adults (P = 0.003). Conclusion. Use of Hypozalix spray or propolis mouthwash in association with CHX mouthwash and fluconazole simultaneously at the start of chemotherapy resulted in a decrease in chemotherapy complications after 14 days. In many cases the use of propolis mouthwash yielded better results and the patients exhibited a greater tendency to continue to use it. PMID:28096948

  2. [Clinical evaluation of new drugs against orphan diseases in oncology - the current situation in Europe and in our country].

    PubMed

    Stěrba, Jaroslav; Stěrbová, Sylva; Kodytková, Daniela; Valík, Dalibor; Demlová, Regina

    2014-01-01

    Cancer represents one of the main causes of death among diseases across the age spectrum. Tumors in children, however, represent less than 1% of the total number of cancers in the population and in terms of the definition of orphan diseases in Europe are all children's cancers considered as orphan diseases. This is the reason why the research and development of new agents against cancer in childhood stands outside of the main interest. Every year around 30,000 new cases of cancer in children and adolescents are diagnosed in the European Unioun (EU) and approximately 80% of them achieve long-term remission using mainly conventional methods of treatment. However, almost 6,000 children and adolescents die every year of malignant tumors therefore cancer remains a major cause of morbidity and mortality. Consequently, there is a demand for new and safe drugs for children suffering from cancer which would lead to improved survival and to risk reduction of late adverse effects of cancer treatment. In the past 10 years in the EU, more in the EU-15 than in our country, 20 performed oncology trials in phase I involving adults account for only one trial in pediatric patients. The issue of new drugs clinical testing in rare cancers is very complex, complicated and for current unsatisfactory situation might be responsible various aspects. These aspects contain the legislative field, the problem of determining the correct dose of testing drug as a single agent or in combination therapy, the use of testing drug in advanced disease or already in de novo diagnosed patients, as well as equity (equal) access to new drugs being tested, the goal set for each molecule/drug in clinical trials, the conflict of interest balanced with sufficient professionalism and last but not least, the need for new methodologies and statistical approaches. The aim of this article is to describe the issue complexity of incorporation of new, modern drug for cancer patients with orphan diseases, including

  3. [Management of the cardiovascular complications of treatment in thoracic oncology].

    PubMed

    Ederhy, S; Hollebecque, A; Haddour, N; Massard, C; Fleury, G; Ferte, C; Adavane, S; Besse, B; Boccara, F; Soria, J-C; Cohen, A

    2014-02-01

    The management of patients suffering from bronchial and lung tumors depends on conventional chemotherapy and/or targeted molecular therapies. The prescription of these chemotherapies may be accompanied by cardiovascular complications, principally congestive heart failure, arterial hypertension and arterial or venous thrombo-embolism, the frequency of which varies with the molecule administered. The management of these complications is currently poorly standardized and should take account of the patient's oncological prognosis.

  4. The Role of Cancer Boards in the Treatment Decisions Regarding Chemotherapy

    PubMed Central

    Nakamura, Sho; Fukui, Tadahisa; (Ito) Sasahara, Yuriko; Suzuki, Shuhei; Takeda, Hiroyuki; Miwa, Misako; Ichikawa, Mayumi; Nemoto, Kenji; Yamakawa, Mayumi; Yoshioka, Takashi

    2016-01-01

    Objective The influence of cancer boards with respect to the treatment decisions regarding chemotherapy remains to be elucidated. In the present study, we investigated the cases that presented at our institutional cancer boards, to assess the effect of cancer boards on the treatment decisions regarding chemotherapy. Methods Data from the cancer boards at Yamagata University Hospital, Yamagata, Japan, were collected. Along with data from the clinical records, the details of the discussions and the chosen plan of treatment of the cancer boards were analyzed. Results From February 2010 to February 2014, 1,541 cases were discussed at our cancer boards. Of these, 811 cases (52.6%) involved discussions about chemotherapy. Of those 811 cases, recommendations were made to alter the treatment plans for 189 cases (23.3%). The reasons for discouraging chemotherapy varied; however, 29/45 (64.4%) cases involved discouragement for the following reasons: old age, a comorbid condition, the physical (performance) status, or insufficient evidence to administer chemotherapy. Eighty-six patients were referred to the medical oncology department through the cancer boards. Conclusion Our results showed that cancer boards have a great influence on the treatment decisions regarding chemotherapy and the prompt referral of cases to medical oncologists as necessary. In terms of future research, we will evaluate the effect of cancer boards on the prognosis and outcomes of cases using the institutional cancer registry. PMID:27803404

  5. Pediatric oncology in Morocco: achievements and challenges.

    PubMed

    Hessissen, Laila; Madani, Abdellah

    2012-03-01

    Cancer in children is quickly becoming one of the leading causes of non traumatic death among children. In pediatric oncology, palliative care is a primary component of the cancer control plan. In low income countries also known as emerging nations or developing countries access to adequate care remains a challenge for most pediatric oncology patients. In Morocco the situation has dramatically improved in the last few years as both the government and NGOs have become more aware of the importance and urgency of the issue. The incidence of cancer in patients under 15 years of age in Morocco is estimated to be 1000 new cases per year and the incidence of leukemia to be 100 new cases diagnosed per year. Pediatric cancer patients are mostly managed by public hospitals. Thus they are highly influenced by the Moroccan public health system, which is now considering cancer management a priority. Since health cover is very limited, most chemotherapy drugs were purchased by local parent associations. Recently, a new large Moroccan NGO (ALSC) provides anti-cancer drugs to all government-run oncology units. Despite all the progress, Morocco has witnessed in the pediatric oncology field, the palliative aspect of the care is not yet organized. Pediatric oncology is supported by the work of the National Society of Pediatric Oncolgy. The opioide therapy is available. However its use is strongly limited by the current restrictive and obsolete legislation which represents a major barrier to care. Despite the latest progress, pediatric oncology in Morocco still needs to improve in order to achieve performances comparable to those of the developed world. These improvements include better survival rates, less treatment abandonment, developing new techniques, improving quality of life and creating data collection teams. In order for this action to succeed all the stakeholders (government, NGOs, medical societies, oncology teams) must work together and coordinate their efforts.

  6. The Integrated Oncology Program of the Italian Ministry of Health. Analytical and clinical validation of new biomarkers for early diagnosis: network, resources, methodology, quality control, and data analysis.

    PubMed

    Paradiso, Angelo; Mangia, Anita; Orlando, Claudio; Verderio, Paolo; Belfiglio, Maurizio; Marchetti, Antonio; Bertario, Lucio; Chiappetta, Gennaro; Gion, Massimo; Tonini, Gian Paolo; Podo, Franca; Vocaturo, Amina; Silvestrini, Rosella; Romani, Massimo; Belloni, Elena; Cavallo, Delia; Ulivi, Paola; Tommasi, Stefania; Steffan, Agostino; Russo, Antonio; Alessio, Massimo; Calistri, Daniele; Zancan, Matelda; Parrela, Paola; Broggini, Massimo; Giuseppe, Antonio; Buttitta, Fiamma; Finocchiaro, Gaetano; Mazzocco, Katia; Veronesi, Giulia; Landuzzi, Lorena; Benevolo, Maria; Mariani, Luciano; De Marco, Federico; Venuti, Aldo; Giannelli, Gianluigi; Quaranta, Michele; Trojano, Vito

    2009-01-01

    In 2007, an Italian cancer research group proposed a specific concerted action aimed at the "analytical and clinica validation of new biomarkers for early diagnosis: Network, resources, methodology, quality control, and data analysis." The proposal united 37 national operative units involved in different biomarker studies and it created a strong coordinative body with the necessary expertise in methodologies, statistical analysis, quality control, and biological resources to perform ad hoc validation studies for new biomarkers of early cancer diagnosis. The action, financed by the Italian Ministry of Health within the Integrated Oncology Program (PIO) coordinated by NCI-Istituto Tumori Bari, started in 2007 and activated 7 projects, each of which focused on disease-specific biomarker studies. Overall, the 37 participating units proposed studies on 50 biomarkers, including analytical and clinical validation procedures. Clusters of units were specifically involved in research of early-detection biomarkers for cancers of the lung, digestive tract, prostate/bladder, and nervous system, as well as female cancers. Furthermore, a cluster involved in biomarkers for bioimaging and infection-related cancers was created. The first investigators' meeting, "Analytical and clinical validation of new biomarkers for early diagnosis," was held on 9 September 2008 in Bari. During this meeting, methodological aspects, scientific programs and preliminary results were presented and discussed.

  7. Japan Clinical Oncology Group (JCOG) prognostic index and characterization of long-term survivors of aggressive adult T-cell leukaemia-lymphoma (JCOG0902A).

    PubMed

    Fukushima, Takuya; Nomura, Shogo; Shimoyama, Masanori; Shibata, Taro; Imaizumi, Yoshitaka; Moriuchi, Yoshiyuki; Tomoyose, Takeaki; Uozumi, Kimiharu; Kobayashi, Yukio; Fukushima, Noriyasu; Utsunomiya, Atae; Tara, Mitsutoshi; Nosaka, Kisato; Hidaka, Michihiro; Uike, Naokuni; Yoshida, Shinichiro; Tamura, Kazuo; Ishitsuka, Kenji; Kurosawa, Mitsutoshi; Nakata, Masanobu; Fukuda, Haruhiko; Hotta, Tomomitsu; Tobinai, Kensei; Tsukasaki, Kunihiro

    2014-09-01

    This study evaluated the clinical features of 276 patients with aggressive adult T-cell leukaemia-lymphoma (ATL) in 3 Japan Clinical Oncology Group (JCOG) trials. We assessed the long-term survivors who survived >5 years and constructed a prognostic index (PI), named the JCOG-PI, based on covariates obtained by Cox regression analysis. The median survival time (MST) of the entire cohort was 11 months. In 37 patients who survived >5 years, no disease-related deaths in 10 patients with lymphoma-type were observed in contrast to the 10 ATL-related deaths in other types. In multivariate analysis of 193 patients, the JCOG-PI based on corrected calcium levels and performance status identified moderate and high risk groups with an MST of 14 and 8 months respectively (hazard ratio, 1·926). The JCOG-PI was reproducible in an external validation. Patients with lymphoma-type who survived >5 years might have been cured. The JCOG-PI is valuable for identifying patients with extremely poor prognosis and will be useful for the design of future trials combining new drugs or investigational treatment strategies.

  8. 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.

    2010-01-01

    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:20404251

  9. 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

  10. Dosimetric verification in participating institutions in a stereotactic body radiotherapy trial for stage I non-small cell lung cancer: Japan clinical oncology group trial (JCOG0403)

    NASA Astrophysics Data System (ADS)

    Nishio, Teiji; Kunieda, Etsuo; Shirato, Hiroki; Ishikura, Satoshi; Onishi, Hiroshi; Tateoka, Kunihiko; Hiraoka, Masahiro; Narita, Yuichirou; Ikeda, Masataka; Goka, Tomonori

    2006-11-01

    A multicentre phase II trial of stereotactic body radiotherapy for T1N0M0 non-small cell lung cancer was initiated in Japan as the Japan Clinical Oncology Group trial (JCOG0403). Before starting the trial, a decision was made to evaluate the treatment machine and treatment planning in participating institutions to minimize the variations of the prescription dose between the institutions. We visited the 16 participating institutions and examined the absolute dose at the centre of a simulated spherical tumour of 3.0 cm diameter in the lung using the radiation treatment planning systems in each institution. A lung phantom for stereotactic body radiotherapy (SBRT) was developed and used for the treatment planning and film dosimetry. In the JCOG radiotherapy study group, the no model-based calculation algorithm or the model-based calculation algorithm with a dose kernel unscaled for heterogeneities were selected for use in the initial SBRT trials started in 2004, and the model-based calculation algorithm with a dose kernel scaled for heterogeneities was selected for the coming trial. The findings of this study suggest that the clinical results of lung SBRT trials should be carefully evaluated in comparison with the actual dose given to patients.

  11. Assessing Tumor Oxygenation for Predicting Outcome in Radiation Oncology: A Review of Studies Correlating Tumor Hypoxic Status and Outcome in the Preclinical and Clinical Settings

    PubMed Central

    Colliez, Florence; Gallez, Bernard; Jordan, Bénédicte F.

    2017-01-01

    Tumor hypoxia is recognized as a limiting factor for the efficacy of radiotherapy, because it enhances tumor radioresistance. It is strongly suggested that assessing tumor oxygenation could help to predict the outcome of cancer patients undergoing radiation therapy. Strategies have also been developed to alleviate tumor hypoxia in order to radiosensitize tumors. In addition, oxygen mapping is critically needed for intensity modulated radiation therapy (IMRT), in which the most hypoxic regions require higher radiation doses and the most oxygenated regions require lower radiation doses. However, the assessment of tumor oxygenation is not yet included in day-to-day clinical practice. This is due to the lack of a method for the quantitative and non-invasive mapping of tumor oxygenation. To fully integrate tumor hypoxia parameters into effective improvements of the individually tailored radiation therapy protocols in cancer patients, methods allowing non-invasively repeated, safe, and robust mapping of changes in tissue oxygenation are required. In this review, non-invasive methods dedicated to assessing tumor oxygenation with the ultimate goal of predicting outcome in radiation oncology are presented, including positron emission tomography used with nitroimidazole tracers, magnetic resonance methods using endogenous contrasts (R1 and R2*-based methods), and electron paramagnetic resonance oximetry; the goal is to highlight results of studies establishing correlations between tumor hypoxic status and patients’ outcome in the preclinical and clinical settings. PMID:28180110

  12. The impact of genomics on oncology nursing.

    PubMed

    Beamer, Laura Curr; Linder, Lauri; Wu, Bohua; Eggert, Julia

    2013-12-01

    Since 2003, genetics and genomics information has led to exciting new diagnostics, prognostics, and treatment options in oncology practice. Profiling of cancers offers providers insight into treatment and prognostic factors. Germline testing provides an individual with information for surveillance or therapy that may help them prevent cancer in their lifetime and options for family members as yet untouched by malignancy. This offers a challenge for oncology nurses and other oncology health care providers to become comfortable with incorporating education about genetics/genomics into their clinical practice and patient education.

  13. [A case of multiple lung and liver metastases from colon cancer treated with clinical benefit by hepatic arterial infusion chemotherapy plus cetuximab mono-therapy after standard chemotherapy failure].

    PubMed

    Osawa, Gakuji; Yoshimatsu, Kazuhiko; Yokomizo, Hajime; Otani, Taisuke; Yano, Yuki; Itagaki, Hiroko; Matsumoto, Atsuo; Fujimoto, Takashi; Umehara, Arihiro; Ogawa, Kenji

    2010-11-01

    We report a case of multiple lung and liver metastases from colon cancer treated with clinical benefit by hepatic arterial infusion chemotherapy plus cetuximab mono-therapy after a standard chemotherapy was failed. A 61-year-old female who had sigmoid colon cancer with unresectable multiple lung and liver metastases underwent sigmoidectomy. Bevacizumab plus mFOLFOX6 was performed as first-line therapy. Partial response was obtained temporarily. After the first-line therapy failed, bevacizumab plus FOLFIRI as second-line, and cetuximab plus CPT-11 as third-line therapy were performed. Since these regimens did not work, her performance status got worse by cholangitis due to progressive liver metastases and anemia. Hepatic arterial infusion chemotherapy for liver metastases and cetuximab for lung metastases as fourth therapy were chosen because we thought her liver metastases should be critical for the maintenance of her QOL and diagnosis. After that, serum CEA was reduced from 14,715 to 6,940 ng/mL during the 3 month period. And her performance status got better as cholongitis and anemia were improved. Additionally, lung metastases were controlled by cetuximab.

  14. 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

  15. Validation of a Prediction Tool for Chemotherapy Toxicity in Older Adults With Cancer

    PubMed Central

    Mohile, Supriya; Gajra, Ajeet; Klepin, Heidi; Muss, Hyman; Chapman, Andrew; Feng, Tao; Smith, David; Sun, Can-Lan; De Glas, Nienke; Cohen, Harvey Jay; Katheria, Vani; Doan, Caroline; Zavala, Laura; Levi, Abrahm; Akiba, Chie; Tew, William P.

    2016-01-01

    Purpose Older adults are at increased risk for chemotherapy toxicity, and standard oncology assessment measures cannot identify those at risk. A predictive model for chemotherapy toxicity was developed (N = 500) that consisted of geriatric assessment questions and other clinical variables. This study aims to externally validate this model in an independent cohort (N = 250). Patients and Methods Patients age ≥ 65 years with a solid tumor, fluent in English, and who were scheduled to receive a new chemotherapy regimen were recruited from eight institutions. Risk of chemotherapy toxicity was calculated (low, medium, or high risk) on the basis of the prediction model before the start of chemotherapy. Chemotherapy-related toxicity was captured (grade 3 [hospitalization indicated], grade 4 [life threatening], and grade 5 [treatment-related death]). Validation of the prediction model was performed by calculating the area under the receiver-operating characteristic curve. Results The study sample (N = 250) had a mean age of 73 years (range, 65 to 94 [standard deviation, 5.8]). More than one half of patients (58%) experienced grade ≥ 3 toxicity. Risk of toxicity increased with increasing risk score (36.7% low, 62.4% medium, 70.2% high risk; P < .001). The area under the curve of the receiver-operating characteristic curve was 0.65 (95% CI, 0.58 to 0.71), which was not statistically different from the development cohort (0.72; 95% CI, 0.68 to 0.77; P = .09). There was no association between Karnofsky Performance Status and chemotherapy toxicity (P = .25). Conclusion This study externally validated a chemotherapy toxicity predictive model for older adults with cancer. This predictive model should be considered when discussing the risks and benefits of chemotherapy with older adults. PMID:27185838

  16. Cerebral Perfusion and Gray Matter Changes Associated With Chemotherapy-Induced Peripheral Neuropathy

    PubMed Central

    Nudelman, Kelly N.H.; McDonald, Brenna C.; Wang, Yang; Smith, Dori J.; West, John D.; O'Neill, Darren P.; Zanville, Noah R.; Champion, Victoria L.; Schneider, Bryan P.

    2016-01-01

    Purpose To investigate the longitudinal relationship between chemotherapy-induced peripheral neuropathy (CIPN) symptoms (sx) and brain perfusion changes in patients with breast cancer. Interaction of CIPN-sx perfusion effects with known chemotherapy-associated gray matter density decrease was also assessed to elucidate the relationship between CIPN and previously reported cancer treatment–related brain structural changes. Methods Patients with breast cancer treated with (n = 24) or without (n = 23) chemotherapy underwent clinical examination and brain magnetic resonance imaging at the following three time points: before treatment (baseline), 1 month after treatment completion, and 1 year after the 1-month assessment. CIPN-sx were evaluated with the self-reported Functional Assessment of Cancer Therapy/Gynecologic Oncology Group–Neurotoxicity four-item sensory-specific scale. Perfusion and gray matter density were assessed using voxel-based pulsed arterial spin labeling and morphometric analyses and tested for association with CIPN-sx in the patients who received chemotherapy. Results Patients who received chemotherapy reported significantly increased CIPN-sx from baseline to 1 month, with partial recovery by 1 year (P < .001). CIPN-sx increase from baseline to 1 month was significantly greater for patients who received chemotherapy compared with those who did not (P = .001). At 1 month, neuroimaging showed that for the group that received chemotherapy, CIPN-sx were positively associated with cerebral perfusion in the right superior frontal gyrus and cingulate gyrus, regions associated with pain processing (P < .001). Longitudinal magnetic resonance imaging analysis in the group receiving chemotherapy indicated that CIPN-sx and associated perfusion changes from baseline to 1 month were also positively correlated with gray matter density change (P < .005). Conclusion Peripheral neuropathy symptoms after systemic chemotherapy for breast cancer are associated with

  17. 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

  18. [Dermato-oncological rehabilitation].

    PubMed

    Buhles, N; Sander, C

    2005-07-01

    National insurance companies in Germany support health cures for patients with malignant tumors (malignant melanoma, squamous cell carcinoma, Merkel cell tumor, malignant cutaneous lymphoma). The clinical requirements are an invasively growing tumor, problems of self-assurance, and dis-integration of the patient regarding his social and/or professional environment. The decision for a health cure is made by the treating dermatologist in the hospital. In this context, the following sociomedical criteria should be applied: impairment, disability, and handicap. Usually, rehabilitation starts after the patient is discharged from the hospital. The inpatient rehabilitation program should be performed at an institution capable of providing dermatological and psychological treatment. The dermatologist acts as a manager for the members of the rehabilitation team (psychologists, physiotherapists, social workers, and ergo-therapists). In conclusion, dermato-oncologic rehabilitation plays an important role in re-integrating the patient into his professional life to avoid retirement.

  19. Outpatient therapeutic nuclear oncology.

    PubMed

    Turner, J Harvey

    2012-05-01

    In the beginning, nuclear medicine was radionuclide therapy, which has evolved into molecular tumour-targeted control of metastatic cancer. Safe, efficacious, clinical practice of therapeutic nuclear oncology may now be based upon accurate personalised dosimetry by quantitative gamma SPECT/CT imaging to prescribe tumoricidal activities without critical organ toxicity. Preferred therapy radionuclides possess gamma emission of modest energy and abundance to enable quantitative SPECT/CT imaging for calculation of the beta therapy dosimetry, without radiation exposure risk to hospital personnel, carers, family or members of the public. The safety of outpatient radiopharmaceutical therapy of cancer with Iodine-131, Samarium-153, Holmium-166, Rhenium-186, Rhenium-188, Lutetium-177 and Indium-111 is reviewed. Measured activity release rates and radiation exposure to carers and the public are all within recommendations and guidelines of international regulatory agencies and, when permitted by local regulatory authorities allow cost-effective, safe, outpatient radionuclide therapy of cancer without isolation in hospital.

  20. Efficacy of adjuvant chemotherapy using oral fluorinated pyrimidines for curatively resected gastric cancer: a meta-analysis of centrally randomized controlled clinical trials in Japan.

    PubMed

    Oba, K; Morita, S; Tsuburaya, A; Kodera, Y; Kobayashi, M; Sakamoto, J

    2006-06-01

    Adjuvant chemotherapy for gastric cancer has been extensively explored in Japan since the 1950s, and a combination of oral fluorinated pyrimidines (o-FP) and mitomycin C (MMC) has been mainly utilized for adjuvant chemotherapy. However, there is no sufficient evidence for the efficacy of adjuvant therapy. Therefore, we assessed the efficacy of o-FPs over surgery alone (control) by means of a meta-analysis of Japanese centrally randomized controlled clinical trials conducted between 1980 and 2005. For inclusion in this study, studies had to compare adjuvant chemotherapy for curatively resected gastric cancer with surgery alone, mainly targeting o-FP, and central randomization designed to comply with contemporary standards for clinical trials in Japan. For the 4 trials that met the eligibility criteria, the estimated hazard ratio was 0.73 (95%CI=0.60-0.89). Our findings show that in Japan adjuvant chemotherapy using o-FP for long-term maintenance therapy appears to be effective for gastric cancer patients after curative resection.

  1. Combination of chemotherapy and cancer stem cell targeting agents: Preclinical and clinical studies.

    PubMed

    Li, Yanyan; Atkinson, Katharine; Zhang, Tao

    2017-03-12

    The cancer stem cell model claims that the initiation, maintenance, and growth of a tumor are driven by a small population of cancer cells termed cancer stem cells. Cancer stem cells possess a variety of phenotypes associated with therapeutic resistance and often cause recurrence of the diseases. Several strategies have been investigated to target cancer stem cells in a variety of cancers, such as blocking one or more self-renewal signaling pathways, reducing the expression of drug efflux and ATP-binding cassette efflux transporters, modulating epigenetic aberrations, and promoting cancer stem cell differentiation. A number of cell and animal studies strongly support the potential benefits of combining chemotherapeutic drugs with cancer stem cell targeting agents. Clinical trials are still underway to address the pharmacokinetics, safety, and efficacy of combination treatment. This mini-review provides an updated discussion of these preclinical and clinical studies.

  2. [Information technology in gynecological oncology today].

    PubMed

    Kupka, M S; Richter, O; Tutschek, B

    2003-11-01

    Information technology has been integrated in gynecological oncology treatment. Therefore, new software has been established in hospitals and out-patient clinics. A German law concerning data collection in oncology has attempted to unify different strategies. All intentions to establish new documentation systems for tumor diseases need a standardized basic data set. Nevertheless, local governmental health organizations are not yet prepared to implement a global information system such as prenatal and perinatal care databases. Financial support and political work is therefore needed.

  3. Factors associated with restricted mouth opening and its relationship to health-related quality of life in patients attending a Maxillofacial Oncology clinic.

    PubMed

    Scott, B; Butterworth, C; Lowe, D; Rogers, S N

    2008-05-01

    Trismus can be a problematic consequence of treatment for oral and oropharyngeal cancer. The aim of this study was to investigate the relationship between trismus, subjective function and health-related quality of life, in order to postulate a clinically relevant cut-off that might be useful as an indicator of patients who might benefit from intervention. One hundred consecutive patients attending the Maxillofacial Oncology clinic at the University Hospital Aintree were assessed during a period of four months. Mouth opening was recorded in millimetres. Subjective outcomes were evaluated using UW-QOL questionnaire for chewing, saliva, mood, anxiety and overall quality of life. The median age of patients was 63 (IQR 56-69) years. The median time since treatment was 16 (IQR 6-34) months. The median mouth opening (32 mm; range 6-53, IQR 24-40) was associated strongly with clinical T stage (Tis/T1-2 35 mm, T3-4 24 mm), radiotherapy (no 38 mm, yes 27 mm) and type of primary surgery (primary closure 38 mm, soft-tissue flaps 30 mm, composite flaps 24 mm). The amount of mouth opening and of the single question (about how much less mouth opening since treatment) was significantly associated with patients perception of chewing deficit, less than full diet and less than good overall quality of life. This study supports a 35 mm cut-off for trismus. There is merit including the two elements together (opening in mm and the single item question on mouth opening since treatment) as outcome parameters.

  4. 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.

  5. 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

  6. 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.

  7. 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

  8. Clinical effectiveness of itraconazole as antifungal prophylaxis in AML patients undergoing intensive chemotherapy in the modern era.

    PubMed

    Keighley, C L; Manii, P; Larsen, S R; van Hal, S

    2017-02-01

    Antifungal prophylaxis regimens vary between centres, informed by local epidemiology and antifungal stewardship practices. The advantages of itraconazole over posaconazole prophylaxis include maintaining the utility of azole therapy for suspected breakthrough invasive fungal infection (bIFI). We examined the effectiveness and tolerability of itraconazole as prophylaxis in acute myeloid leukaemia (AML) patients. We sought to determine the rate of probable and proven bIFI in the context of itraconazole prophylaxis in a real-life setting. Eighty-four patients corresponded to 175 episodes of primary antifungal prophylaxis with itraconazole solution (200 mg twice daily) as prophylaxis supported by a dedicated clinical pharmacist during induction, re-induction and consolidation chemotherapy for AML between January 2010 and January 2014. Assessment of clinical course included blinded review of all radiology scans. Episodes of bIFI were categorised according to consensus criteria. A low rate of bIFI (6/175, 3.4 %) occurred with the use of itraconazole. Tolerance was excellent with adverse events consisting predominantly of deranged liver function tests reported in 7/175 (4 %). Therapeutic drug monitoring performed at clinicians' discretion demonstrated appropriate levels in 12/14 (86 %). Persisting fever and suspicion of invasive fungal infection (IFI) led to empiric antifungal therapy with voriconazole or caspofungin in 33/175 episodes (19 %), ceased after a median of 5 days following investigation in 16/175 (9 %). In this setting, itraconazole is effective and well-tolerated as prophylaxis. An additional benefit was seen in empiric therapy of suspected bIFI with amphotericin formulations kept in reserve. Local epidemiology is vital in guiding prophylaxis strategy.

  9. 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.

  10. 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 cell drug resistance, and severe systemic side effects. Nanoparticles (NPs) achieve preferential accumulation in the tumor site by virtue of their passive and ligand-based targeting mechanisms. Polymer-based nanomedicine, an arena that entails the use of polymeric NPs, polymer micelles, dendrimers, polymersomes, polyplexes, polymer–lipid hybrid systems, and polymer–drug/protein conjugates for improvement in efficacy of cancer therapeutics, has been widely explored. The broad scope for chemically modifying the polymer into desired construct makes it a versatile delivery system. Several polymer-based therapeutic NPs have been approved for clinical use. This review provides an insight into the advances in polymer-based targeted nanocarriers with focus on therapeutic aspects in the field of oncology. PMID:25678788

  11. 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

  12. 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.

  13. Chemotherapy for cholangiocarcinoma: An update.

    PubMed

    Ramírez-Merino, Natalia; Aix, Santiago Ponce; Cortés-Funes, Hernán

    2013-07-15

    Cholangiocarcinomas (bile duct cancers) are a heterogeneous group of malignancies arising from the epithelial cells of the intrahepatic, perihilar and extrahepatic bile ducts. Patients diagnosed with cholangiocarcinoma must be evaluated by a multidisciplinary team and be treated with individualized management. First of all, it is very important to define the potential resectability of the tumor because surgery is the main therapeutic option for these patients. Overall, cholangiocarcinomas have a very poor prognosis. The 5-year survival rate is 5%-10%. In cases with a potentially curative surgery, 5-year survival rates of 25%-30% are reported. Therefore, it is necessary to increase the cure rate from surgery, exploring the survival benefit of any adjuvant strategy. It is difficult to clarify the role of adjuvant treatment in localized and locally advanced cholangiocarcinomas. There are limited data and the role of adjuvant chemotherapy/chemoradiation in patients with resected biliary tract cancer is poorly defined. The most relevant studies in the adjuvant setting are one from Japan, the well known ESPAC-3 and BILCAP from the United Kingdom and a meta-analysis. We show the results of these trials. According to medical oncology guidelines, postoperative adjuvant therapy is widely recommended for all patients with intrahepatic or extrahepatic cholangiocarcinoma who have microscopically positive resection margins, as well as for those with a complete resection but node-positive disease. Clinical trials are ongoing. The locally advanced cholangiocarcinoma setting includes a heterogeneous mix of patients: (1) patients who have had surgery but with macroscopic residual disease; (2) patients with locally recurrent disease after potentially curative treatment; and (3) patients with locally unresectable disease at presentation. In these patients, surgery is not an option and chemoradiation therapy can prolong overall survival and provide control of symptoms due to local

  14. Chemotherapy for cholangiocarcinoma: An update

    PubMed Central

    Ramírez-Merino, Natalia; Aix, Santiago Ponce; Cortés-Funes, Hernán

    2013-01-01

    Cholangiocarcinomas (bile duct cancers) are a heterogeneous group of malignancies arising from the epithelial cells of the intrahepatic, perihilar and extrahepatic bile ducts. Patients diagnosed with cholangiocarcinoma must be evaluated by a multidisciplinary team and be treated with individualized management. First of all, it is very important to define the potential resectability of the tumor because surgery is the main therapeutic option for these patients. Overall, cholangiocarcinomas have a very poor prognosis. The 5-year survival rate is 5%-10%. In cases with a potentially curative surgery, 5-year survival rates of 25%-30% are reported. Therefore, it is necessary to increase the cure rate from surgery, exploring the survival benefit of any adjuvant strategy. It is difficult to clarify the role of adjuvant treatment in localized and locally advanced cholangiocarcinomas. There are limited data and the role of adjuvant chemotherapy/chemoradiation in patients with resected biliary tract cancer is poorly defined. The most relevant studies in the adjuvant setting are one from Japan, the well known ESPAC-3 and BILCAP from the United Kingdom and a meta-analysis. We show the results of these trials. According to medical oncology guidelines, postoperative adjuvant therapy is widely recommended for all patients with intrahepatic or extrahepatic cholangiocarcinoma who have microscopically positive resection margins, as well as for those with a complete resection but node-positive disease. Clinical trials are ongoing. The locally advanced cholangiocarcinoma setting includes a heterogeneous mix of patients: (1) patients who have had surgery but with macroscopic residual disease; (2) patients with locally recurrent disease after potentially curative treatment; and (3) patients with locally unresectable disease at presentation. In these patients, surgery is not an option and chemoradiation therapy can prolong overall survival and provide control of symptoms due to local

  15. A Research Agenda for Radiation Oncology: Results of the Radiation Oncology Institute's Comprehensive Research Needs Assessment

    SciTech Connect

    Jagsi, Reshma; Bekelman, Justin E.; Brawley, Otis W.; Deasy, Joseph O.; Le, Quynh-Thu; Michalski, Jeff M.; Movsas, Benjamin; Thomas, Charles R.; Lawton, Colleen A.; Lawrence, Theodore S.; Hahn, Stephen M.

    2012-10-01

    Purpose: To promote the rational use of scarce research funding, scholars have developed methods for the systematic identification and prioritization of health research needs. The Radiation Oncology Institute commissioned an independent, comprehensive assessment of research needs for the advancement of radiation oncology care. Methods and Materials: The research needs assessment used a mixed-method, qualitative and quantitative social scientific approach, including structured interviews with diverse stakeholders, focus groups, surveys of American Society for Radiation Oncology (ASTRO) members, and a prioritization exercise using a modified Delphi technique. Results: Six co-equal priorities were identified: (1) Identify and develop communication strategies to help patients and others better understand radiation therapy; (2) Establish a set of quality indicators for major radiation oncology procedures and evaluate their use in radiation oncology delivery; (3) Identify best practices for the management of radiation toxicity and issues in cancer survivorship; (4) Conduct comparative effectiveness studies related to radiation therapy that consider clinical benefit, toxicity (including quality of life), and other outcomes; (5) Assess the value of radiation therapy; and (6) Develop a radiation oncology registry. Conclusions: To our knowledge, this prioritization exercise is the only comprehensive and methodologically rigorous assessment of research needs in the field of radiation oncology. Broad dissemination of these findings is critical to maximally leverage the impact of this work, particularly because grant funding decisions are often made by committees on which highly specialized disciplines such as radiation oncology are not well represented.

  16. Updates from the 2013 Society for Neuro-Oncology annual and World Federation for Neuro-Oncology quadrennial meeting.

    PubMed

    Lukas, Rimas V; Amidei, Christina

    2014-01-01

    We present an overview of a number of key clinical studies in infiltrating gliomas presented at the 2013 Society for Neuro-Oncology and World Federation of Neuro-Oncology joint meeting. This review focuses on efficacy results, including quality of life studies, from larger clinical trials in both high- and low-grade infiltrating gliomas.

  17. Predictive Factors and Value of ypN+ after Neoadjuvant Chemotherapy in Clinically Lymph Node-Negative Breast Cancer

    PubMed Central

    Fukada, Ippei; Araki, Kazuhiro; Kobayashi, Kokoro; Shibayama, Tomoko; Takahashi, Shunji; Horii, Rie; Akiyama, Futoshi; Iwase, Takuji; Ohno, Shinji; Hatake, Kiyohiko; Hozumi, Yasuo; Sata, Naohiro; Ito, Yoshinori

    2016-01-01

    Background Pathological complete response (pCR) with neoadjuvant chemotherapy (NAC) has been regarded as a surrogate endpoint for disease-free survival (DFS) and overall survival (OS) of patients with breast cancer. No consensus regarding the definition of pCR has been established; there are several definitions according to a variety of classifications. Eradication of cancer cells in both breast and lymph nodes has been better associated with improved prognosis than in the breast alone. Even in patients diagnosed as having clinically node-negative cancer before NAC, postoperative pathological examination often shows axillary lymph node metastases. Patients and Methods Of the 771 patients with breast cancer who underwent NAC in the Cancer Institute Hospital between January 2000 and May 2009, 146 patients preoperatively diagnosed as having node-negative breast cancer were retrospectively evaluated. We have made the definition of clinically lymph node-negative (N0) as follows: first, ultrasonography before NAC did not show any lymphadenopathy. Second, a cytological procedure confirmed negative study for each patient when ultrasonography suggested lymphadenopathy. Results The median observation period was 79.7 months, and the median age of the subjects was 51 years. Pathological examination at the time of the surgery showed lymph node metastases (ypN+) in 46 patients (31.5%). Histological therapeutic effects revealed ypT0/is in 9 patients (6.2%) and ypTinv in 137 (93.8%). Multivariate analysis demonstrated that younger age (49>), large tumor size, NG3, and ypN+ were significant poor prognostic factors for DFS (p = 0.020, p = 0.008, P = 0.022 and p = 0.010, respectively). Moreover, ypN+ was the only significant poor prognostic factor for OS (p = 0.022). The predictive factors of ypN+ in clinically lymph node–negative breast cancer were ypTinv (p = 0.036) and the luminal type (HR+ and HER2-) (p = 0.029). Conclusion The prognosis of clinically lymph node negative breast

  18. Chemotherapy of East Coast fever: parvaquone treatment of clinical disease induced by isolates of Theileria parva.

    PubMed

    Dolan, T T; Young, A S; Leitch, B L; Stagg, D A

    1984-08-01

    Two experiments were carried out in which parvaquone was used to treat experimentally-induced acute clinical East Coast fever infections. In the first experiment, infections with Theileria parva parva (Kiambu 5) were induced by applying infected Rhipicephalus appendiculatus ticks or by inoculation of triturated infected-tick stabilate. The character of the disease was similar with both methods of infection and following a single treatment with parvaquone at 20 mg kg-1, 5 of 7 cattle in each group recovered. All untreated control cattle died. In the second experiment, 5 stabilate isolates from different locations within East Africa, and representative of the challenge likely to be met in the field, were used. Treatment was administered in 2 X 10 mg kg-1 doses 48 h apart. The isolates used were T. p. parva (Mbita), T. p. parva (Pugu), T. p. parva (Entebbe), T. p. lawrencei (Mara) and T. p. lawrencei/(Manyara); following treatment 3/7, 6/6, 6/7, 5/7 and 6/7 animals recovered, respectively. All untreated control cattle died. There was evidence of a difference in susceptibility of isolates to treatment, and some animals showed prolonged disease episodes. The nature of the response to treatment and the problems in treating a lympho-destructive disease are discussed.

  19. 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

  20. 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

  1. Interpreting the economic literature in oncology.

    PubMed

    Grusenmeyer, Patrick A; Wong, Yu-Ning

    2007-01-10

    New treatment options provide hope for patients with localized and advanced cancer. However, these advances are associated with cost, both in terms of treatment-related expenditures and effects on quality of life. It is important that patients, physicians, insurers, and policymakers understand the relationship between costs and outcomes of new cancer treatments. Various methods of cost analysis can provide a structured manner to assess cost. Cost-effectiveness analysis (CEA) compares the cost of the intervention with the effect, resulting in a cost per effect (eg, cost per year of life gained) that can be compared across interventions. In this article, we review three recent CEAs in the oncology literature, including chemoprevention in breast cancer, adjuvant endocrine therapy in early-stage breast cancer, and salvage chemotherapy in advanced ovarian cancer. The important elements of CEA, including the recommendations of the US Public Health Service Panel on Cost Effectiveness in Health and Medicine as they relate to cancer treatments, are discussed. Many well-done CEAs in cancer treatment have been performed during the last decade. As with clinical trials, the rigor and methods of the analysis are critical to the reliability of the results. Therapies with high cost and small incremental improvement in survival and/or quality of life may find it difficult to meet the societal thresholds for what is considered cost effective. CEA is a method to assess the cost and effect of cancer treatments, providing important insights into the best use (ie, obtaining the most value for) of health care expenditures. As the literature indicates, one must be cognizant of the fact that there can be extraordinary costs associated with some newer cancer therapies that provide small incremental clinical benefit. Better understanding of the cancer economic literature can help lead to an inf