Science.gov

Sample records for clinical oncology chemotherapy

  1. Principles and major agents in clinical oncology chemotherapy

    SciTech Connect

    Weller, R.E.

    1991-10-01

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

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

    PubMed

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

    2016-08-01

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

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

    PubMed

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

    2014-01-01

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

  4. 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.

  5. Cutaneous side effects of chemotherapy in pediatric oncology patients.

    PubMed

    Ceylan, Can; Kantar, Mehmet; Tuna, Arzu; Ertam, Ilgen; Aksoylar, Serap; Günaydın, Aslı; Çetingül, Nazan

    2015-01-01

    Pediatric oncology patients can present with various skin lesions related to both primary disease and immunosuppressive treatments. This study aimed to evaluate the cutaneous side effects of chemotherapy in pediatric oncology patients. Sixty-five pediatric oncology patients who were scheduled to undergo chemotherapy from May 2011 to May 2013 were included in the study. Three patients were excluded from the results, as 2 patients died during treatment and 1 patient withdrew from the study; therefore, a total of 62 patients were evaluated for mucocutaneous findings. Patients were grouped according to their oncological diagnoses and a statistical analysis was performed. There was no statistical significance in the incidence of cutaneous side effects of chemotherapy among the different diagnostic groups. Awareness among dermatologists of the possible cutaneous side effects of chemotherapy in pediatric patients and their causes can promote early diagnosis and treatment in this patient population.

  6. 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

  7. 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)

  8. Quality Oncology Practice Initiative Certification Program: measuring implementation of chemotherapy administration safety standards in the outpatient oncology setting.

    PubMed

    Gilmore, Terry R; Schulmeister, Lisa; Jacobson, Joseph O

    2013-03-01

    The Quality Oncology Practice Initiative (QOPI) Certification Program (QCP) evaluates individual outpatient oncology practice performance in areas that affect patient care and safety and builds on the American Society of Clinical Oncology (ASCO) QOPI by assessing the compliance of a practice with certification standards based on the ASCO/Oncology Nursing Society standards for safe chemotherapy administration. To become certified, a practice must attain a benchmark quality score on certification measures in QOPI and attest that it complies with 17 QCP standards. Structured on-site reviews, initially performed in randomly selected practices, became mandatory beginning in September 2011. Of 111 practices that have undergone on-site review, only two were fully concordant with all of the standards (median, 11; range, seven to 17). Most practices were subsequently able to modify practice to become QOPI certified. The QCP addresses the call from the Institute of Medicine to close the quality gap by aligning evidence-based guidelines and consensus-driven standards with requirements for oncology practices to develop and maintain structural safety components, such as policies and procedures that ensure practice performance. On-site practice evaluation is a high-impact component of the program.

  9. 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.

  10. 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.

  11. 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

  12. 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…

  13. 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

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

    PubMed

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

    2012-01-01

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

  15. [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.

  16. 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.

  17. [Haemostatic aspects in clinical oncology].

    PubMed

    Langer, F; Holstein, K; Eifrig, B; Bokemeyer, C

    2008-12-01

    The clinical link between cancer and thrombosis has been recognized by Armand Trousseau in 1865. It has now become clear that clotting activation in malignancy not only plays an important role in the evolution of venous thromboembolism (VTE) or systemic coagulation disorders such as disseminated intravascular coagulation, but that multiple components of the haemostatic and fibrinolytic systems are directly involved in tumour progression. In particular, tissue factor (TF) appears to be involved in several pathways relevant to cancer growth and metastasis. Increasing evidence emerges that haemostatic perturbances in cancer patients are, at least in part, controlled by defined genetic events in molecular tumourigenesis including activating and inactivating mutations of oncogenes and tumour suppressor genes, respectively. Long-term therapy with low-molecular-weight heparin (LMWH) is considered as standard treatment for cancer-associated VTE. However, several experimental studies and clinical trials suggest that LMWH may also be beneficial as an adjunct in the treatment of patients with malignant disease. This article provides an overview on the significance, pathogenesis and treatment of cancer-related clotting disorders as well as on the cellular and molecular mechanisms, by which haemostatic components such as TF, platelets and fibrin(ogen) drive tumour progression. PMID:19132177

  18. American Society of Clinical Oncology clinical expert statement on cancer survivorship care planning.

    PubMed

    Mayer, Deborah K; Nekhlyudov, Larissa; Snyder, Claire F; Merrill, Janette K; Wollins, Dana S; Shulman, Lawrence N

    2014-11-01

    The seminal report from the Institute of Medicine, "From Cancer Patient to Cancer Survivor: Lost in Transition," identified four essential components of survivorship care and recommended that a survivorship care plan (SCP), consisting of a treatment summary and follow-up care plan, be developed and used as a tool to deliver patient-centered care by enhancing communication between the oncology team and the patient as well as communication and coordination of care between the oncology team and the primary care provider (PCP). Nearly a decade ago, the American Society of Clinical Oncology (ASCO) initiated a series of activities to promote chemotherapy treatment plans and summaries and SCPs. Unfortunately, there has been limited success in implementing SCPs in oncology practice because of barriers including, but not limited to, the time-consuming process of completing an SCP, lack of role clarity, and lack of reimbursement for preparation time. ASCO developed this statement and revised template to provide a framework for completing and sharing SCPs and to set clear expectations for survivorship care planning in the oncology setting. This statement is intended to help clinicians recognize the importance of developing patient-centered SCPs and delivering the information to both the patient and PCP and to identify barriers that may exist in completing and delivering these documents effectively.

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

    PubMed

    Hatton, M Q; Reed, N S

    1997-01-01

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

  20. Future of clinical genomics in pediatric oncology.

    PubMed

    Janeway, Katherine A; Place, Andrew E; Kieran, Mark W; Harris, Marian H

    2013-05-20

    The somatic genomic alterations in pediatric cancers to some extent overlap with those seen in adult cancers, but the exact distribution throughout the genome and the types and frequency of alterations differ. The ultimate goal of genomic research in children, as with adults, is translation to the clinic to achieve more accurate diagnosis, more precise risk stratification, and more effective, less toxic therapy. The genomic features of pediatric malignancies and pediatric-specific issues in clinical investigation may make translating genomic discoveries to the clinic more difficult. However, through large-scale molecular profiling of pediatric tumors, continued coordinated efforts to evaluate novel therapies in the pediatric population, thoughtful phase II and III trial design, and continued drug development, genomically based therapies will become more common in the pediatric oncology clinic in the future.

  1. Critical Evaluation of Oncology Clinical Practice Guidelines

    PubMed Central

    Reames, Bradley N.; Krell, Robert W.; Ponto, Sarah N.; Wong, Sandra L.

    2013-01-01

    Purpose Significant concerns exist regarding the content and reliability of oncology clinical practice guidelines (CPGs). The Institute of Medicine (IOM) report “Clinical Practice Guidelines We Can Trust” established standards for developing trustworthy CPGs. By using these standards as a benchmark, we sought to evaluate recent oncology guidelines. Methods CPGs and consensus statements addressing the screening, evaluation, or management of the four leading causes of cancer-related mortality in the United States (lung, breast, prostate, and colorectal cancers) published between January 2005 and December 2010 were identified. A standardized scoring system based on the eight IOM standards was used to critically evaluate the methodology, content, and disclosure policies of CPGs. All CPGs were given two scores; points were awarded for eight standards and 20 subcriteria. Results No CPG fully met all the IOM standards. The average overall scores were 2.75 of 8 possible standards and 8.24 of 20 possible subcriteria. Less than half the CPGs were based on a systematic review. Only half the CPG panels addressed conflicts of interest. Most did not comply with standards for inclusion of patient and public involvement in the development or review process, nor did they specify their process for updating. CPGs were most consistent with IOM standards for transparency, articulation of recommendations, and use of external review. Conclusion The vast majority of oncology CPGs fail to meet the IOM standards for trustworthy guidelines. On the basis of these results, there is still much to be done to make guidelines as methodologically sound and evidence-based as possible. PMID:23752105

  2. 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

  3. A Clinical Prediction Model to Assess Risk for Chemotherapy-Related Hospitalization in Patients Initiating Palliative Chemotherapy

    PubMed Central

    Brooks, Gabriel A.; Kansagra, Ankit J.; Rao, Sowmya R.; Weitzman, James I.; Linden, Erica A.; Jacobson, Joseph O.

    2015-01-01

    IMPORTANCE Chemotherapy-related hospitalizations in patients with advanced cancer are common, distressing, and costly. Methods to identify patients at high risk of chemotherapy toxic effects will permit development of targeted strategies to prevent chemotherapy-related hospitalizations. OBJECTIVE To demonstrate the feasibility of using readily available clinical data to assess patient-specific risk of chemotherapy-related hospitalization. DESIGN, SETTING, AND PARTICIPANTS Nested case-control study conducted from January 2003 through December 2011 at the Mass General/North Shore Cancer Center, a community-based cancer center in north eastern Massachusetts. The parent cohort included 1579 consecutive patients with advanced solid-tumor cancer receiving palliative-intent chemotherapy. Case patients (n = 146) included all patients from the parent cohort who experienced a chemotherapy-related hospitalization. Controls (n = 292) were randomly selected from 1433 patients who did not experience a chemotherapy-related hospitalization. EXPOSURES Putative risk factors for chemotherapy-related hospitalization—including patient characteristics, treatment characteristics, and pretreatment laboratory values—were abstracted from medical records. Multivariable logistic regression was used to model the patient-specific risk of chemotherapy-related hospitalization. MAIN OUTCOMES AND MEASURES Chemotherapy-related hospitalization, as adjudicated by the oncology clinical care team within a systematic quality-assessment program. RESULTS A total of 146 (9.2%) of 1579 patients from the parent cohort experienced a chemotherapy-related hospitalization. In multivariate regression, 7 variables were significantly associated with chemotherapy-related hospitalization: age, Charlson comorbidity score, creatinine clearance, calcium level, below-normal white blood cell and/or platelet count, polychemotherapy (vs monotherapy), and receipt of camptothecin chemotherapy. The median predicted risk of

  4. Clinical oncology in Malaysia: 1914 to present.

    PubMed

    Lim, Gcc

    2006-01-01

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

  5. 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

  6. 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)

  7. Clinical benefits of metformin in gynecologic oncology

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  9. The cancer registry: a clinical repository of oncology data.

    PubMed

    Hoyler, S S

    1997-02-01

    Health care institutions need complete and accurate data to plan, monitor, and evaluate their oncology programs. Although financial and discharge data are available, clinical repositories generally are not. For oncology, the cancer registry database serves as a clinical repository. The data in the registry are complete, accurate, and readily available. They can be used to plan new services, evaluate existing programs, and monitor patient care. PMID:10165382

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

    PubMed

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

    2006-03-01

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

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

    PubMed

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

    1990-01-01

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

  12. 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

  13. Regulatory and clinical considerations for biosimilar oncology drugs

    PubMed Central

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

    2015-01-01

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

  14. 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.

  15. 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.

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

    PubMed Central

    Jacobs, Volker R.; Mallmann, Peter

    2011-01-01

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

  17. American Society of Clinical Oncology guidelines for the use of hematopoietic colony-stimulating factors.

    PubMed

    Ozer, H

    1996-01-01

    The hematopoietic colony-stimulating factors have been introduced into clinical practice as additional supportive measures that can reduce the likelihood of neutropenic complications due to chemotherapy. Clinical benefit has been shown, but the high cost of colony-stimulating factors has led to concern about their appropriate use. The American Society of Clinical Oncology has established evidence-based, clinical practice guidelines for the use of colony-stimulating factors in patients who are not enrolled in clinical trials. An expert multidisciplinary panel reviewed the clinical data documenting the activity of colony-stimulating factors. For each common clinical situation, the panel formulated a guideline to encourage reasonable use of colony-stimulating factors to preserve effectiveness but discourage excess use when little marginal benefit is anticipated. Outcomes considered in evaluating colony stimulating factor benefit included duration of neutropenia, incidence of febrile neutropenia, incidence and duration of antibiotic use, frequency and duration of hospitalization, infectious mortality, chemotherapy dose intensity, chemotherapy efficacy, quality of life, colony-stimulating factor toxicity, and economic impact. To the extent that these data were available, the panel placed greatest value on survival benefit, reduction in rates of febrile neutropenia, decreased hospitalization, and reduced costs. Lesser value was placed on alterations in absolute neutrophil counts.

  18. 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.

  19. 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.

  20. 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.

  1. Ambient noise levels in the chemotherapy clinic

    PubMed Central

    Gladd, Dana K.; Saunders, Gabrielle H.

    2016-01-01

    Many of the drugs used for chemotherapy treatments are known to be ototoxic, and can result in permanent hearing threshold shifts. The degree of ototoxic damage can be influenced by many factors including dosage, duration of exposure, genetics, and coadministration with other ototoxic agents. Cisplatin is known for its ototoxic effects on hearing thresholds, particularly in the high frequencies. Recent studies have indicated a synergistic relationship between Cisplatin administration and moderate to high noise level exposure starting between 70–85 dB SPL. This study measured the noise levels in the Portland Veteran’s Affairs Medical Center’s outpatient chemotherapy clinic. Average (LAeq) and peak (LCpeak) noise measures were recorded every minute from 7 am until 6 pm on the two busiest clinic days. Patients, visitors, and staff members filled out anonymous surveys regarding their reactions to noise levels. Cumulative noise levels were not at levels known to interact with Cisplatin for a significant period of time. Noise measurement analysis indicated that levels were at or above 70 dB SPL for less than ten minutes during the 11-hour recording window. The patient and visitor surveys indicated that both groups were unbothered by noise in the clinic. However, most staff members were bothered by or concerned about noise levels, and many felt that it caused stress and difficulty communicating on the phone. PMID:22122961

  2. Clinical oncology and palliative medicine as a combined specialty--a unique model in Hong Kong.

    PubMed

    Yeung, Rebecca; Wong, Kam-Hung; Yuen, Kwok-Keung; Wong, Ka-Yan; Yau, Yvonne; Lo, Sing-Hung; Liu, Rico

    2015-07-01

    The importance of early integration of palliative care (PC) into oncology treatment is increasingly being recognized. However, there is no consensus on what is the optimal way of integration. This article describes a unique model in Hong Kong where clinical oncology and palliative medicine (PM) is integrated through the development of PM as a subspecialty under clinical oncology.

  3. 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

  4. Oncological approach with antihelminthic chemotherapy and wide resection in the treatment of musculoskeletal hydatidosis. A review of 10 cases with mean follow-up of 64 months.

    PubMed

    Erol, Bülent; Onay, Tolga; Çalışkan, Emrah; Okay, Erhan

    2015-09-01

    The objective of this retrospective study was to evaluate clinical outcomes, local recurrence and complication rates of antihelminthic chemotherapy and wide resection in patients with muscle or bone hydatidosis. The authors treated 10 patients (6 females, 4 males) between 2004 and 2012: 8 with muscle and 2 with bone hydatidosis. The mean age at surgery was 42.5 years (range, 11-66 years). All patients were treated with wide resection and pre- and postoperative chemotherapy with albendazole. The mean follow-up was 64 months (range, 28-120 months). All patients achieved satisfactory clinical outcomes. There were no local recurrences. Surgical complications were seen in 3 patients (30%) : one superficial infection, one deep infection, and one hematoma. Two (20%) required additional surgery. An aggressive oncological approach, consisting of antihelminthic chemotherapy and wide resection, can provide favorable clinical outcomes and prevent local recurrence in patients with musculoskeletal hydatidosis. Potential complications of aggressive surgery should be preferred to potential morbidity of local and systemic dissemination.

  5. Challenges in launching multinational oncology clinical trials in India

    PubMed Central

    Saini, Kamal S.; Agarwal, Gaurav; Jagannathan, Ramesh; Metzger-Filho, Otto; Saini, Monika L.; Mistry, Khurshid; Ali, Raghib; Gupta, Sudeep

    2013-01-01

    In the recent past, there has been an impressive growth in the number of clinical trials launched worldwide, including India. Participation in well-designed oncology clinical trials is of advantage to Indian healthcare system in general, and cancer patients in particular. However, the number of clinical trials being run in India is not commensurate with the cancer burden prevailing in the country. In this article, the authors investigate the reasons for this discrepancy, highlight critical bottlenecks, and propose ways to ameliorate the situation. PMID:24455545

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

    PubMed

    Liang, Bohui; Turkcan, Ayten

    2016-09-01

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

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

    PubMed

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

    2013-01-01

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

  8. Prospective Clinical Study of Precision Oncology in Solid Tumors.

    PubMed

    Sohal, Davendra P S; Rini, Brian I; Khorana, Alok A; Dreicer, Robert; Abraham, Jame; Procop, Gary W; Saunthararajah, Yogen; Pennell, Nathan A; Stevenson, James P; Pelley, Robert; Estfan, Bassam; Shepard, Dale; Funchain, Pauline; Elson, Paul; Adelstein, David J; Bolwell, Brian J

    2015-11-09

    Systematic studies evaluating clinical benefit of tumor genomic profiling are lacking. We conducted a prospective study in 250 patients with select solid tumors at the Cleveland Clinic. Eligibility required histopathologic diagnosis, age of 18 years or older, Eastern Cooperative Oncology Group performance status 0-2, and written informed consent. Tumors were sequenced using FoundationOne (Cambridge, MA). Results were reviewed at the Cleveland Clinic Genomics Tumor Board. Outcomes included feasibility and clinical impact. Colorectal (25%), breast (18%), lung (13%), and pancreatobiliary (13%) cancers were the most common diagnoses. Median time from consent to result was 25 days (range = 3-140). Of 223 evaluable samples, 49% (n = 109) of patients were recommended a specific therapy, but only 11% (n = 24) received such therapy: 12 on clinical trials, nine off-label, three on-label. Lack of clinical trial access (n = 49) and clinical deterioration (n = 29) were the most common reasons for nonrecommendation/nonreceipt of genomics-driven therapy.

  9. Pyriform sinus squamous cell carcinoma: oncological outcomes in good responders of induction chemotherapy-based larynx preservation protocols.

    PubMed

    Vourexakis, Zacharias; Le Ridant, Anne-Marie; Dulguerov, Pavel; Janot, François

    2015-07-01

    Induction chemotherapy-based larynx preservation protocols use chemotherapy to select exclusively patients with 'chemosensitive' tumors for a nonsurgical treatment with radiation therapy. This study on pyriform sinus squamous cell carcinoma (SCC) is interested in the oncological outcome of treatment based on radiation therapy when offered to patients with tumors responding to induction chemotherapy. This was a retrospective cohort study. The cohort included good responders to induction chemotherapy, subsequently treated with definite radiation therapy (with or without concomitant chemotherapy) for pyriform sinus SCC, in a tertiary referral cancer center. The primary endpoints were overall, laryngectomy-free and disease-free survival and the secondary endpoints were analysis of treatment failures and possibilities of salvage treatment. Forty-two patients fulfilled the inclusion criteria and were retained for analysis; 7% were stage II (3/42), 48% stage III (20/42) and 45% stage IV (19/42). At 1, 3 and 5 years, the overall survival was 95% (40/42), 74% (31/42), and 60% (SE ≈ 0.08), respectively. For the same intervals, the laryngectomy-free survival was 90% (38/42), 69% (29/42) and 50% (SE ≈ 0.08), respectively. The estimated 5-year disease-free survival was also 50%. Disease-free survival was significantly better for N0 patients. There was a 28% recurrence rate, mainly in the primary tumor site (9/11), with or without simultaneous nodal recurrence. Interestingly, more than one-third of all oncologic failures occurred beyond the first 3 years of follow-up. Salvage treatment was not possible or definitely inefficient in at least 2/3 of all recurrences. In candidates for larynx preservation for a pyriform sinus SCC, good response to induction chemotherapy followed by definite radiation therapy seems to be associated with a more favorable prognosis. Nevertheless, in case of locoregional recurrence the possibilities for efficient salvage treatment are limited.

  10. Clinical PET/MR Imaging in Oncology: Future Perspectives.

    PubMed

    Kjær, Andreas; Torigian, Drew A

    2016-10-01

    In 2011, the first fully integrated commercially available clinical PET/MR imaging systems became available, and the imaging community thought that these scanners would replace PET/CT systems. However, today a disappointing number of less than 100 scanners have been installed worldwide. The question, therefore, arises regarding what the future clinical applications of PET/MR imaging will be. In this article, the authors discuss ways in which PET/MR imaging may be used in future applications that justify the added cost, predominantly focusing on oncologic applications. The authors suggest that such areas include combined molecular and functional imaging, multimodality radiomics, and hyperPET. PMID:27593252

  11. Found in translation: Integrating laboratory and clinical oncology research

    PubMed Central

    Wagner, H

    2008-01-01

    Translational research in medicine aims to inform the clinic and the laboratory with the results of each other’s work, and to bring promising and validated new therapies into clinical application. While laudable in intent, this is complicated in practice and the current state of translational research in cancer shows both striking success stories and examples of the numerous potential obstacles as well as opportunities for delays and errors in translation. This paper reviews the premises, promises, and problems of translational research with a focus on radiation oncology and suggests opportunities for improvements in future research design. PMID:21611010

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

    PubMed

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

    2015-09-01

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

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

    PubMed

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

    2015-09-01

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

  14. The circadian timing system in clinical oncology.

    PubMed

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

    2014-06-01

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

  15. Theory and practice of clinical pharmacodynamics in oncology drug development.

    PubMed

    Parchment, Ralph E; Doroshow, James H

    2016-08-01

    The clinical development of molecularly targeted cancer therapies is enhanced by proof of mechanism of action as well as proof of concept, which relate molecular pharmacodynamics to efficacy via changes in cancer cell biology and physiology resulting from drug action on its intended target. Here, we present an introduction to the field of clinical pharmacodynamics, its medical and laboratory aspects, and its practical incorporation into clinical trials. We also describe key success factors that are useful for judging the quality of clinical pharmacodynamic studies, including biopsy quality and suitability, specimen handling, assay fitness-for-purpose, and reagent quality control. This introduction provides not only context for the following articles in this issue, but also an appreciation of the role of well-conducted clinical pharmacodynamic studies in oncology drug development. PMID:27663474

  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. PMID:27610198

  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.

  18. 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.

  19. 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

  20. Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update

    PubMed Central

    Masters, Gregory A.; Temin, Sarah; Azzoli, Christopher G.; Giaccone, Giuseppe; Baker, Sherman; Brahmer, Julie R.; Ellis, Peter M.; Gajra, Ajeet; Rackear, Nancy; Schiller, Joan H.; Smith, Thomas J.; Strawn, John R.; Trent, David; Johnson, David H.

    2015-01-01

    Purpose To provide evidence-based recommendations to update the American Society of Clinical Oncology guideline on systemic therapy for stage IV non–small-cell lung cancer (NSCLC). Methods An Update Committee of the American Society of Clinical Oncology NSCLC Expert Panel based recommendations on a systematic review of randomized controlled trials from January 2007 to February 2014. Results This guideline update reflects changes in evidence since the previous guideline. Recommendations There is no cure for patients with stage IV NSCLC. For patients with performance status (PS) 0 to 1 (and appropriate patient cases with PS 2) and without an EGFR-sensitizing mutation or ALK gene rearrangement, combination cytotoxic chemotherapy is recommended, guided by histology, with early concurrent palliative care. Recommendations for patients in the first-line setting include platinum-doublet therapy for those with PS 0 to 1 (bevacizumab may be added to carboplatin plus paclitaxel if no contraindications); combination or single-agent chemotherapy or palliative care alone for those with PS 2; afatinib, erlotinib, or gefitinib for those with sensitizing EGFR mutations; crizotinib for those with ALK or ROS1 gene rearrangement; and following first-line recommendations or using platinum plus etoposide for those with large-cell neuroendocrine carcinoma. Maintenance therapy includes pemetrexed continuation for patients with stable disease or response to first-line pemetrexed-containing regimens, alternative chemotherapy, or a chemotherapy break. In the second-line setting, recommendations include docetaxel, erlotinib, gefitinib, or pemetrexed for patients with nonsquamous cell carcinoma; docetaxel, erlotinib, or gefitinib for those with squamous cell carcinoma; and chemotherapy or ceritinib for those with ALK rearrangement who experience progression after crizotinib. In the third-line setting, for patients who have not received erlotinib or gefitinib, treatment with erlotinib is

  1. [Advances in cancer research. Cancer research and clinical oncology in the 21st century].

    PubMed

    Kanamaru, R

    1999-06-01

    It is my great pleasure to congradulate the Japanese Journal of Cancer and Chemotherapy on its 25 th anniversary. During this period, great progress has been made in cancer research, mainly owing to the advances in technology in molecular biology. Recently, not only researchers, but lay people as well have come to understand that cancer is mainly a genetic disease. Advances in the human genome project, DNA chip technology and gene technology; including gene targeting and cloning techniques, will enable us to accelerate progress forward the final goal of cancer research in the coming century. Major changes are coming in both cancer research and clinical oncology, which will completely transform the human social environment.

  2. Clinical Applications of Metabolomics in Oncology: A Review

    PubMed Central

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

    2009-01-01

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

  3. 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.

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

    PubMed

    Cassinelli, Giuseppe

    2016-06-01

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

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

    PubMed

    Cassinelli, Giuseppe

    2016-06-01

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

  6. 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.

  7. 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

  8. 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.

  9. Toward a science of tumor forecasting for clinical oncology

    DOE PAGES

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

    2015-03-15

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

  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 Central

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

    2016-01-01

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

  11. Chemotherapy at end-of-life: an integration of oncology and palliative team.

    PubMed

    Chan, Wing-lok; Lam, Ka-on; Siu, Wai-kwan; Yuen, Kwok-keung

    2016-03-01

    Palliative chemotherapy is increasingly used in cancer patients near end of life. With the development of newer anticancer agents which have less side effects and higher expected efficacy, the decision on palliative chemotherapy in patients near end of life is complex. This article illustrates how oncologist and palliative care physicians can work together effectively. This article also gives an overview about the risks of palliative chemotherapy near end of life, patients' and physicians' perspectives in choosing the aggressive treatment and describes what an oncologist should do when facing this challenging situation.

  12. Safe chemotherapy in the home environment.

    PubMed

    Chavis-Parker, Paula

    2015-05-01

    The Oncology Nursing Society and the American Society of Clinical Oncology have established guidelines for the safe and effective use of chemotherapeutic medications in the acute and outpatient care settings. A review of literature was performed to determine the safe and effective administration of chemotherapy in the home environment. The administration of oral and intravenous chemotherapy in the home has become a common intervention for patients being treated for cancer based on patient preference, cost-effectiveness of healthcare delivery, and increasing demand for oncology services. Home healthcare nurses can greatly impact the management of adverse effects of chemotherapy in the home, increasing the quality of life and improving patient outcomes.

  13. [Chemotherapy].

    PubMed

    Aiba, Keisuke

    2004-05-01

    Cancer chemotherapy in the treatment of colorectal cancer has been evolving so extensively than ever. 5-fluorouracil (5-FU) has been a pivotal and a single active agent in the treatment of colorectal cancer. Reproducing and consistent better response rate has been shown since the introduction of the concept of biochemical modulation of 5-FU by leucovorin, a reduced folate, to the clinic and a combination chemotherapy of 5-FU and leucovorin (FL) has enable us to obtain a response rate around 20-30% and a median survival time ranging from 10 to 12 months. IFL regimen combing CPT-11 with FL showed a better MST ranging from 14 to 15 months, but now serious toxicity precludes general use outside of clinical trials. In the Europe, de Gramont regimen, an unique dose and schedule of 5-FU using a combination of continuous intravenous infusion of 5-FU with leucovorin over two days and bolus infusion of 5-FU twice over the same period, has been developed and shown improved antitumor activity and toxic profiles. FOLFOX 4, a combination chemotherapy of de Gramont regimen and oxaliplatin which is a third generation of cisplatin and a uniqe toxic profile with neuropathy, has demonstrated improved MST over a year and acceptable toxic profiles. Now FOLFOX 4 is considered to be a standard chemotherapy for the patients with advanced colorectal cancer, since a large phase III randomized study has shown that FOLFOX 4 was the most active and less toxic treatment regimen among active regimens such as IFL and IROX (CPT-11 and oxaliplatin). More recently, a combination of IFL and bevacizumab which is one of the molecular target agents and a antibody agent against vascular endothelial growth factor (VEGF), has demonstrated better MST reaching 20 months. Future large scale trials will attempt to develop more active regimen incorporating so-called molecular target agents.

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

    PubMed Central

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

    2014-01-01

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

  15. 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

  16. Chemotherapy

    MedlinePlus

    ... getting chemotherapy. Chemotherapy is most often given in cycles. These cycles may last one day, several days, or a ... period when no chemotherapy is given between each cycle. A rest period may last for days, weeks, ...

  17. 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…

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

    PubMed Central

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

    2012-01-01

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

  19. 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. PMID:27106890

  20. Clinical overview of metronomic chemotherapy in breast cancer.

    PubMed

    Munzone, Elisabetta; Colleoni, Marco

    2015-11-01

    Over 15 years ago, low-dose metronomic chemotherapy was shown to induce disease control in patients with advanced-stage breast cancer with a lower incidence of adverse events compared with conventional maximum tolerated dose chemotherapy. Good response rates have been seen in heavily pre-treated patients for whom limited treatment options are available. Most patients prefer oral therapy and metronomic chemotherapy is a convenient alternative in patients with advanced-stage disease in which minimal toxicity and good tumour control are the overall aims of treatment. The addition of metronomic protocols to standard neoadjuvant chemotherapy regimens has produced promising pathological complete response rates. Ongoing trials including the SYSUCC-001 trial in patients with triple-negative breast cancer and the IBCSG 22-00 trial that is assessing a cyclophosphamide-methotrexate maintenance regimen after standard adjuvant therapy in hormone receptor-negative disease, will clarify the value of adding this approach to conventional therapies. The low cost associated with metronomic chemotherapy represents an opportunity for the utilization of this treatment option, especially in developing countries, and poses a challenge for the launch of large trials sponsored by industry. Using breast cancer as the principal example, we discuss the key clinical advances in this area, including new trial design, appropriate patient and end point selection, as well as the evolving rationale for metronomic chemotherapy combinations.

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

    PubMed Central

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

    2014-01-01

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

  2. Hepatitis B Virus Screening for Patients With Cancer Before Therapy: American Society of Clinical Oncology Provisional Clinical Opinion Update

    PubMed Central

    Hwang, Jessica P.; Somerfield, Mark R.; Alston-Johnson, Devena E.; Cryer, Donna R.; Feld, Jordan J.; Kramer, Barnett S.; Sabichi, Anita L.; Wong, Sandra L.; Artz, Andrew S.

    2015-01-01

    Purpose This updated provisional clinical opinion presents a revised opinion based on American Society of Clinical Oncology panel consensus in the context of an evolving database. Context Despite the 2010 provisional clinical opinion recommendation, there is still evidence of suboptimal hepatitis B virus (HBV) screening among patients at high risk for HBV infection or HBV reactivation after chemotherapy. This updated provisional clinical opinion introduces a risk-adaptive strategy to identify and treat patients with HBV infection to reduce their risk of HBV reactivation. Provisional Clinical Opinion Medical providers should screen by testing patients for HBV infection before starting anti-CD20 therapy or hematopoietic cell transplantation. Providers should also screen patients with risk factors for HBV infection. Screening should include both hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc), because reactivation can occur in patients who are HBsAg positive/anti-HBc positive or HBsAg negative/anti-HBc positive. Either total anti-HBc or anti-HBc immunoglobulin G (not immunoglobulin M) test should be used. Clinicians should start antiviral therapy for HBsAg-positive/anti-HBc–positive patients before or contemporaneously with cancer therapy and monitor HBsAg-negative/anti-HBc–positive patients for reactivation with HBV DNA and ALT levels, promptly starting antivirals if reactivation occurs. Clinicians can initiate antivirals for HBsAg-negative/anti-HBc–positive patients anticipating cancer therapies associated with a high risk of reactivation, or they can monitor HBV DNA and ALT levels and initiate on-demand antivirals. For patients who neither have HBV risk factors nor anticipate cancer therapy associated with a high risk of reactivation, current evidence does not support HBV screening before initiation of cancer therapy. Two panel members provided a minority viewpoint, involving a strategy of universal HBsAg and selective anti

  3. Implementing effective and sustainable multidisciplinary clinical thoracic oncology programs.

    PubMed

    Osarogiagbon, Raymond U; Freeman, Richard K; Krasna, Mark J

    2015-08-01

    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

  4. Implementing effective and sustainable multidisciplinary clinical thoracic oncology programs

    PubMed Central

    Freeman, Richard K.; Krasna, Mark J.

    2015-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  6. Pretreatment Mitochondrial Priming Correlates with Clinical Response to Cytotoxic Chemotherapy

    PubMed Central

    Chonghaile, Triona Ni; Sarosiek, Kristopher A.; Vo, Thanh-Trang; Ryan, Jeremy A.; Tammareddi, Anupama; Moore, Victoria Del Gaizo; Deng, Jing; Anderson, Ken; Richardson, Paul; Tai, Yu-Tzu; Mitsiades, Constantine S.; Matulonis, Ursula A.; Drapkin, Ronny; Stone, Richard; DeAngelo, Daniel J.; McConkey, David J.; Sallan, Stephen E.; Silverman, Lewis; Hirsch, Michelle S.; Carrasco, Daniel Ruben; Letai, Anthony

    2011-01-01

    Cytotoxic chemotherapy targets elements common to all nucleated human cells, such as DNA and microtubules, yet it selectively kills tumor cells. Here we show that clinical response to these drugs correlates with, and may be partially governed by, the pre-treatment proximity of tumor cell mitochondria to the apoptotic threshold, a property called mitochondrial priming. We used BH3 profiling to measure priming in tumor cells from patients with multiple myeloma, acute myelogenous and lymphoblastic leukemia, and ovarian cancer. This assay measures mitochondrial response to peptides derived from pro-apoptotic BH3 domains of proteins critical for death signaling to mitochondria. Patients with highly primed cancers exhibited superior clinical response to chemotherapy. In contrast, chemoresistant cancers and normal tissues were poorly primed. Manipulation of mitochondrial priming might enhance the efficacy of cytotoxic agents. PMID:22033517

  7. Adjuvant chemotherapy for resected non-small-cell lung cancer: future perspectives for clinical research

    PubMed Central

    2011-01-01

    Adjuvant chemotherapy for non-small-cell lung carcinoma (NSCLC) is a debated issue in clinical oncology. Although it is considered a standard for resected stage II-IIIA patients according to the available guidelines, many questions are still open. Among them, it should be acknowledged that the treatment for stage IB disease has shown so far a limited (if sizable) efficacy, the role of modern radiotherapies requires to be evaluated in large prospective randomized trials and the relative impact of age and comorbidities should be weighted to assess the reliability of the trials' evidences in the context of the everyday-practice. In addition, a conclusive evidence of the best partner for cisplatin is currently awaited as well as a deeper investigation of the fading effect of chemotherapy over time. The limited survival benefit since first studies were published and the lack of reliable prognostic and predictive factors beyond pathological stage, strongly call for the identification of bio-molecular markers and classifiers to identify which patients should be treated and which drugs should be used. Given the disappointing results of targeted therapy in this setting have obscured the initial promising perspectives, a biomarker-selection approach may represent the basis of future trials exploring adjuvant treatment for resected NSCLC. PMID:22206620

  8. 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.

  9. 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

  10. 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.

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

    PubMed

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

    2011-03-01

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

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

    PubMed

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

    2016-10-01

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

  13. 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.

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

    PubMed Central

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

    2014-01-01

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

  15. 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

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

    PubMed

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

    2015-01-01

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

  17. 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…

  18. 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.

  19. Impact of Clinical Oral Chemotherapy Program on Wastage and Hospitalizations

    PubMed Central

    Khandelwal, Nikhil; Duncan, Ian; Ahmed, Tamim; Rubinstein, Elan; Pegus, Cheryl

    2011-01-01

    Purpose: The oral chemotherapy cycle management program (CMP) provides clinical management support to patients receiving certain oral chemotherapies. The CMP includes a dose-monitoring (ie, split-fill) plan for early identification and management of adverse effects. If serious adverse effects are identified mid cycle, the remainder of the monthly supply is withheld, thus avoiding potential waste associated with early therapy discontinuation. This study investigated medication wastage and estimated potential cost savings for patients who were enrolled in the CMP, as compared with those who were not enrolled in the program. Study Design: Retrospective test-control study. Patients and Methods: Patients whose oral chemotherapy was initiated between June 2008 and February 2010 and who were enrolled in the CMP were included as the test group. Patient whose oral chemotherapy was initiated between June 2007 and May 2008 and who were not part of the CMP were included as the control group. Results: Medication wastage associated with early therapy discontinuation was found to be lower in the CMP group. Approximately 34% of patients in the CMP group could have avoided medication wastage if split-fill plans had been available, potentially realizing savings of approximately $934.20 per patient. Linear probability regression models showed that the CMP group had a 2.9% probability for reduction in hospital admissions (P < .05), resulting in additional savings of approximately $440.0 per patient. Combined savings resulting from reduced wastage and hospital admissions was approximately $1,374 per patient. Conclusion: Dose-monitoring programs such as the CMP effectively reduce wastage and serious adverse effects associated with oral chemotherapeutic agents, realizing potential cost savings for both payers and patients. PMID:21886508

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

    PubMed

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

    2007-09-01

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

  1. 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.

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

    PubMed Central

    2014-01-01

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

  3. 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…

  4. 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.

  5. 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.

  6. 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.

  7. 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.

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

    PubMed

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

    2016-05-20

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

  9. 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

  10. 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

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

    PubMed Central

    Strom, Samuel P.

    2016-01-01

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

  12. 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.

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

    PubMed

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

    2016-09-01

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

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

    PubMed

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

    2016-09-01

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

  15. 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

  16. 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

  17. A national study of the provision of oncology sperm banking services among Canadian fertility clinics.

    PubMed

    Yee, S; Buckett, W; Campbell, S; Yanofsky, R A; Barr, R D

    2013-07-01

    The purpose of this study was to survey the current state of oncology sperm banking services provided by fertility clinics across Canada. A total of 78 Canadian fertility facilities were invited to complete a questionnaire related to the availability, accessibility, affordability and utilisation of sperm banking services for cancer patients. The total response rate was 59%, with 20 (69%) in vitro fertilisation clinics and 26 (53%) other fertility centres returning the survey. A total of 24 responding facilities accepted oncology sperm banking referrals. The time frame to book the first banking appointment for 19 (79%) facilities was within 2 days. Inconsistent practice was found regarding the consent process for cancer patients who are of minority age. Eight (33%) facilities did not provide any subsidy and charged a standard banking fee regardless of patients' financial situations. Overall, the utilisation of oncology sperm banking services was low despite its availability and established efficacy, suggesting that Canadian cancer patients are notably underserved. The study has highlighted some important issues for further consideration in improving access to sperm banking services for cancer patients, especially for adolescents. Better collaboration between oncology and reproductive medicine to target healthcare providers would help to improve sperm banking rates.

  18. 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.

  19. Advances in management of malignant diseases with the combination of radiation therapy and chemotherapy. Highlights from the 45th Annual Meeting of the American Society for Therapeutic Radiology and Oncology.

    PubMed

    Corn, Benjamin W

    2004-01-01

    From October 19 through October 24, 2003, the American Society for Therapeutic Radiology and Oncology held its 45th Annual Meeting in Salt Lake City, Utah. The meeting was devoted to the presentation of advances in the management of malignant diseases with radiation modalities. The meeting brought together investigators, clinicians, policy makers and professionals interested in the science and impact of radiation on cancerous disease. This report examines the advances in combined modality approaches (i.e., the use of radiation therapy and chemotherapy) for the treatment of malignant disease. The American Society for Therapeutic Radiology and Oncology sponsors an annual meeting devoted to the presentation of radiation-related advances in malignant disorders. The educational elements of this program are targeted at oncologists of all disciplines (i.e., surgical oncologists, medical oncologists, radiation oncologists), physicists, biologists, nurses, and therapists as well as all health care workers who are involved in the treatment of patients with malignant diseases. The program includes presentations on standard, investigational and experimental therapeutics as well as intensity-modulated radiation therapy, treatment planning, alternative fractionation, and molecular and radiation biology. Specific clinical areas include breast, central nervous system, gastrointestinal, genitourinary, gynecological, head and neck, and lung cancers. In addition, the program addresses quality of life, supportive care and socioeconomic issues. These topics are addressed by a combination of educational sessions, panel discussions, proffered papers and posters. Since a diminishing number of tumors can be managed solely by radiation therapy, among the most noteworthy developments this year were the combined modality approaches (i.e. radiation therapy combined with chemotherapy) in the treatment of malignant disease. In particular, a cluster of seminal papers was presented pertaining to

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

    PubMed Central

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

    2012-01-01

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

  1. Clinical and outcome research in oncology. The need for integration.

    PubMed

    Apolone, Giovanni

    2003-01-01

    Cancer is one of the main healthcare problems in Europe. Although significant progress has recently been made, long-term survival is still disappointing for most common solid tumours. The explosion of information has strengthened the need to create and sustain coordinated interaction between technology, biology, clinical research, clinical practice and health policy. A simple process based on automatic and passive translation from bench to clinical research and eventually to the bed side is usually assumed but cannot be taken for granted. A critical role might be played by Outcome Research (OR), defined as the discipline that describes, interprets, and predicts the impact of various influences, especially interventions, on final endpoints (from survival to satisfaction with care) that matter to decision makers (from patients to society at large), with special emphasis on the use of patient-reported outcomes (PRO). Recently, under pressure from several parts of society, the FDA, recognizing the need for faster drug approval, has modified existing regulations and created new rules to allow anti-cancer drugs to be approved more quickly and, in certain but quite common circumstances, single arm trials and surrogate endpoints to be used as measures of clinical benefit. In this context, the faster approval process may lead to drugs being marketed without there being a complete picture of how effective or safe they are. The FDA move to speed up drug approval, together with the use of not fully validated surrogate endpoints, give OR the unique opportunity to help understand the value of drugs that have received accelerated approval. Despite this opportunity, OR has yet to demonstrate its role in this specific setting and provide proof of the validity, reliability and added value of its primary endpoint measures when evaluated in a broader context. The implementation of lines of OR in the development and evaluation of anti-cancer drugs hinges upon the availability of

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

    PubMed

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

    2014-06-01

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

  3. Clinical Practices and Outcomes on Chemotherapy-Induced Nausea and Vomiting Management in South Korea: Comparison with Asia-Pacific Data of the Pan Australasian Chemotherapy Induced Emesis Burden of Illness Study

    PubMed Central

    Lee, Myung Ah; Cho, Eun Kyung; Oh, Sung Yong; Ahn, Joong Bae; Lee, Ji Yun; Thomas, Burke; Jung, Hun; Kim, Jong Gwang

    2016-01-01

    Purpose This study reported patient outcomes of chemotherapy-induced nausea and vomiting (CINV) prophylaxis for highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC) regimens and evaluated its adherence to acute-phase CINV prophylaxis in the Korean population subset of the Pan Australasian Chemotherapy Induced Emesis burden of illness (PrACTICE) study. Materials and Methods This subgroup analysis evaluated 158 Korean patients receiving HEC or MEC and compared the data (wherever possible) with that of 648 patients from the Asia-Pacific (AP) region. Study endpoints included evaluation of primary CINV prophylaxis and adherence to acute-phase CINV prophylaxis in cycle 1 (American Society of Clinical Oncology [ASCO] Quality Oncology Practice Initiative [QOPI]). Results In South Korea and the AP, a 5-hydroxytryptamine-3 receptor antagonist (5HT3-RA) prophylaxis for the acute phase was administered to 79/80 patients (98.8%) for HEC and 70/71 patients (98.6%) for MEC regimens (QOPI-1). Triple regimen (corticosteroid–5HT3-RA–neurokinin 1-RA) was initiated in 46/80 patients (57.5%) for prophylaxis of acute CINV in cycle 1 of HEC (QOPI-3). Double regimen (corticosteroid–5HT3-RA, with or within NK1-RA) was initiated in 61/71 patients (83.1%) for control of acute CINV in cycle 1 of MEC a(QOPI-2). Conclusion Active management of CINV is necessary in cycle 1 of HEC in South Korea, despite higher rates than the AP region. Adherence to the international guidelines for CINV prophylaxis requires attention in the acute phase in cycle 1 of the HEC regimen. PMID:26875197

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

    PubMed

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

    2015-11-20

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

  5. Characteristics of drug combination therapy in oncology by analyzing clinical trial data on ClinicalTrials.gov.

    PubMed

    Wu, Menghua; Sirota, Marina; Butte, Atul J; Chen, Bin

    2015-01-01

    Within the past few decades, drug combination therapy has been intensively studied in oncology and other complex disease areas, especially during the early drug discovery stage, as drug combinations have the potential to improve treatment response, minimize development of resistance or minimize adverse events. In the present, designing combination trials relies mainly on clinical and empirical experience. While empirical experience has indeed crafted efficacious combination therapy clinical trials (combination trials), however, garnering experience with patients can take a lifetime. The preliminary step to eliminating this barrier of time, then, is to understand the current state of combination trials. Thus, we present the first large-scale study of clinical trials (2008-2013) from ClinicalTrials.gov to compare combination trials to non-combination trials, with a focus on oncology. In this work, we developed a classifier to identify combination trials and oncology trials through natural language processing techniques. After clustering trials, we categorized them based on selected characteristics and observed trends present. Among the characteristics studied were primary purpose, funding source, endpoint measurement, allocation, and trial phase. We observe a higher prevalence of combination therapy in oncology (25.6% use combination trials) in comparison to other disease trials (6.9%). However, surprisingly the prevalence of combinations does not increase over the years. In addition, the trials supported by the NIH are significantly more likely to use combinations of drugs than those supported by industry. Our preliminary study of current combination trials may facilitate future trial design and move more preclinical combination studies to the clinical trial stage.

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

    PubMed

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

    2016-09-01

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

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

    PubMed

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

    2016-01-01

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

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

    PubMed

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

    2016-01-01

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

  9. 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

  10. 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

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

    PubMed

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

    2014-02-01

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

  12. 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

  13. Personalized care in neuro-oncology coming of age: why we need MGMT and 1p/19q testing for malignant glioma patients in clinical practice.

    PubMed

    Weller, Michael; Stupp, Roger; Hegi, Monika E; van den Bent, Martin; Tonn, Joerg C; Sanson, Marc; Wick, Wolfgang; Reifenberger, Guido

    2012-09-01

    Histological subtyping and grading by malignancy are the cornerstones of the World Health Organization (WHO) classification of tumors of the central nervous system. They shall provide clinicians with guidance as to the course of disease to be expected and the choices of treatment to be made. Nonetheless, patients with histologically identical tumors may have very different outcomes, notably in patients with astrocytic and oligodendroglial gliomas of WHO grades II and III. In gliomas of adulthood, 3 molecular markers have undergone extensive studies in recent years: 1p/19q chromosomal codeletion, O(6)-methylguanine methyltransferase (MGMT) promoter methylation, and mutations of isocitrate dehydrogenase (IDH) 1 and 2. However, the assessment of these molecular markers has so far not been implemented in clinical routine because of the lack of therapeutic implications. In fact, these markers were considered to be prognostic irrespective of whether patients were receiving radiotherapy (RT), chemotherapy, or both (1p/19q, IDH1/2), or of limited value because testing is too complex and no chemotherapy alternative to temozolomide was available (MGMT). In 2012, this situation has changed: long-term follow-up of the Radiation Therapy Oncology Group 9402 and European Organisation for Research and Treatment of Cancer 26951 trials demonstrated an overall survival benefit from the addition to RT of chemotherapy with procarbazine/CCNU/vincristine confined to patients with anaplastic oligodendroglial tumors with (vs without) 1p/19q codeletion. Furthermore, in elderly glioblastoma patients, the NOA-08 and the Nordic trial of RT alone versus temozolomide alone demonstrated a profound impact of MGMT promoter methylation on outcome by therapy and thus established MGMT as a predictive biomarker in this patient population. These recent results call for the routine implementation of 1p/19q and MGMT testing at least in subpopulations of malignant glioma patients and represent an

  14. Attitudinal barriers to participation in oncology clinical trials: factor analysis and correlates of barriers

    PubMed Central

    MANNE, S.; KASHY, D.; ALBRECHT, T.; WONG, Y.-N.; FLAMM, A. LEDERMAN; BENSON, A. B.; MILLER, S.M.; FLEISHER, LINDA; BUZAGLO, J.; ROACH, N.; KATZ, M.; ROSS, E.; COLLINS, M.; POOLE, D.; RAIVITCH, S.; MILLER, D.M.; KINZY, T.G.; LIU, T.; MEROPOL, N.J.

    2015-01-01

    Patient participation in cancer clinical trials is low. Little is known about attitudinal barriers to participation, particularly among patients who may be offered a trial during an imminent initial oncology consult. The aims of the present study were to confirm the presence of proposed subscales of a recently developed cancer clinical trial attitudinal barriers measure, describe the most common cancer clinical trials attitudinal barriers, and evaluate socio-demographic, medical and financial factors associated with attitudinal barriers. A total of 1256 patients completed a survey assessing demographic factors, perceived financial burden, prior trial participation and attitudinal barriers to clinical trials participation. Results of a factor analysis did not confirm the presence of the proposed four attitudinal barriers subscale/factors. Rather, a single factor represented the best fit to the data. The most highly-rated barriers were fear of side-effects, worry about health insurance and efficacy concerns. Results suggested that less educated patients, patients with non-metastatic disease, patients with no previous oncology clinical trial participation, and patients reporting greater perceived financial burden from cancer care were associated with higher barriers. These patients may need extra attention in terms of decisional support. Overall, patients with fewer personal resources (education, financial issues) report more attitudinal barriers and should be targeted for additional decisional support. PMID:24467411

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

    PubMed

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

    2016-01-01

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

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

    PubMed

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

    2016-01-01

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

  17. [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.

  18. 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.

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

    PubMed

    Basu, Sandip; Alavi, Abass

    2016-07-01

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

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

    PubMed

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

    2016-01-01

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

  1. 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.

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

    PubMed Central

    Craike, Melinda; Slavin, Monica

    2012-01-01

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

  3. New evidence-based adaptive clinical trial methods for optimally integrating predictive biomarkers into oncology clinical development programs

    PubMed Central

    Beckman, Robert A.; Chen, Cong

    2013-01-01

    Predictive biomarkers are important to the future of oncology; they can be used to identify patient populations who will benefit from therapy, increase the value of cancer medicines, and decrease the size and cost of clinical trials while increasing their chance of success. But predictive biomarkers do not always work. When unsuccessful, they add cost, complexity, and time to drug development. This perspective describes phases 2 and 3 development methods that efficiently and adaptively check the ability of a biomarker to predict clinical outcomes. In the end, the biomarker is emphasized to the extent that it can actually predict. PMID:23489587

  4. Exploratory survey of patients' needs and perceptions of psychosocial oncology.

    PubMed

    Preyde, Michele; Macdonald, Janice; Seegmiller, Merle

    2014-03-01

    Cancer is a major disease that affects a significant proportion of the population worldwide. With a decrease in mortality due to advancements in oncology treatment, there is an expanding role for psychosocial oncology. A satellite clinic for medical treatment (only chemotherapy) of cancer is available at the Guelph General Hospital (GGH). Patients accessing the chemotherapy clinic at GGH have minimal access to psychosocial or supportive care and it is not known if the existing services are addressing the psychosocial symptoms of cancer patients. Participants were asked to complete an anonymous survey which included self-report measures of depression, symptom severity, quality of life, and social support while receiving treatment at this facility. There was a great deal of variability in the patients' emotional symptoms at this satellite clinic, though many patients reported emotional difficulties. Greater social work presence may lead to better identification of patients who would benefit from psychosocial oncology services. PMID:24193219

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

    PubMed

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

    2012-05-01

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

  6. 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

  7. 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

  8. 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.

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

    PubMed

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

    2016-09-01

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

  10. Clinical evolution of cystic teratoma during treatment with combination chemotherapy.

    PubMed

    Taylor, H G; Tell, D T; Skoog, S J; McLeod, D G

    1986-09-01

    Progressive, cystic tumor enlargement in the abdomen developed in a patient with teratocarcinoma during treatment with systemic chemotherapy. Tumor markers were elevated in the cyst fluid and negative in serum. Further, the patient underwent a successful surgical debulking of large amounts of cystic teratoma.

  11. 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.

  12. 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

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

    PubMed Central

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

    2012-01-01

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

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

    PubMed

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

    2015-11-01

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

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

    PubMed

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

    2016-05-01

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

  16. Testing of evaluation bias for progression free survival endpoint in oncology clinical trials.

    PubMed

    Sun, Yan; Wu, Wenting; Sargent, Daniel

    2016-09-30

    Progression-free survival is an increasingly popular end point in oncology clinical trials. A complete blinded independent central review (BICR) is often required by regulators in an attempt to reduce the bias in progression-free survival (PFS) assessment. In this paper, we propose a new methodology that uses a sample-based BICR as an audit tool to decide whether a complete BICR is needed. More specifically, we propose a new index, the differential risk, to measure the reading discordance pattern, and develop a corresponding hypothesis testing procedure to decide whether the bias in local evaluation is acceptable. Simulation results demonstrate that our new index is sensitive to the change of discordance pattern; type I error is well controlled in the hypothesis testing procedure, and the calculated sample size provides the desired power. Copyright © 2016 John Wiley & Sons, Ltd. PMID:27089832

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

    PubMed

    Seider, Michael I; Damato, Bertil E

    2015-05-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed

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

    2012-01-01

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

  20. 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.

  1. 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.

  2. [Up for Discussion: Using study registries for Oncology: StudyBox and the German Clinical Trials Register (DRKS)].

    PubMed

    Kowalski, Christoph; Jena, Susanne; Kliemann, Denise; Antes, Gerd

    2015-01-01

    Study registries serve various purposes. Primarily, they provide as complete an overview as possible on planned, ongoing and completed studies and are thus intended to contribute to transparency in research. As such, they are an instrument for identifying and reducing publication bias. Study registries can also help doctors and patients to identify suitable studies for them. The National Cancer Plan (NCP) calls for ensuring an efficient oncological treatment, which requires the knowledge derived from trials. Study registries can play an important role in their identification. This paper describes the purpose that study registries fulfil in oncology as well as their health policy rationale. It then discusses two registries relevant for oncology, i. e. StudyBox and the German Clinical Trials Register (DRKS), against the backdrop of the National Cancer Plan and introduces the cooperation of the two registries.

  3. 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

  4. After chemotherapy - discharge

    MedlinePlus

    ... the patient with cancer. In: Niederhuber JE, Armitage JO, Doroshow JH, et al, eds. Abeloff's Clinical Oncology . ... Loprinzi CL. Oral complications. In: Niederhuber JE, Armitage JO, Doroshow JH, et al, eds. Abeloff's Clinical Oncology . ...

  5. Nutrition modulation of gastrointestinal toxicity related to cancer chemotherapy: from preclinical findings to clinical strategy.

    PubMed

    Xue, Hongyu; Sawyer, Michael B; Wischmeyer, Paul E; Baracos, Vickie E

    2011-01-01

    Chemotherapy-induced gut toxicity is a major dose-limiting toxicity for many anticancer drugs. Gastrointestinal (GI) complications compromise the efficacy of chemotherapy, promote overall malnutrition, aggravate cancer cachexia, and may contribute to worsened prognosis. The GI tract is an attractive target for nutrition modulation, owing to its direct exposure to the diet, participation in uptake and metabolism of nutrients, high rate of cell turnover, and plasticity to nutrition stimuli. Glutamine, ω-3 polyunsaturated fatty acids, and probiotics/prebiotics are therapeutic factors that potentially modulate GI toxicity related to cancer treatments. Preclinical and clinical evidence are reviewed to critically define plausible benefits of these factors and their potential development into adjuncts to cancer chemotherapy. Mechanisms underlying the action of these nutrients are being unraveled in the laboratory. Optimal strategies to translate these findings into clinical care still remain to be elucidated. Key questions that remain to be answered include the following: which nutrient or combination of nutrients is selected for which patient and chemotherapy regimen? What mechanisms are responsible for modulation, and how are nutrient(s) administered in a clinically optimal manner? Research exploring interactions between different nutrients in GI protection is ongoing and demands further understanding. How nutrition preparations given to chemotherapy-treated patients are formulated in terms of component selection and dose optimization should be carefully studied and justified. PMID:21224434

  6. Tissue-Based Approaches to Study Pharmacodynamic Endpoints in Early Phase Oncology Clinical Trials

    PubMed Central

    Ang, Joo Ern; Kaye, Stan; Banerji, Udai

    2012-01-01

    Anti-cancer clinical drug development is currently costly and slow with a high attrition rate. There is thus an urgent and unmet need to integrate pharmacodynamic biomarkers into early phase clinical trials in the framework provided by the “pharmacologic audit trail” in order to overcome this challenge. This review discusses the rationale, advantages and disadvantages, as well as the practical considerations of various tissue-based approaches to perform pharmacodynamic studies in early phase oncology clinical trials using case histories of molecular targeting agents such as PI3K, m-TOR, HSP90, HDAC and PARP inhibitors. These approaches include the use of normal “surrogate” tissues such as peripheral blood mononuclear cells, platelet-rich plasma, plucked hair follicles, skin biopsies, plasma-based endocrine assays, proteomics, metabolomics and circulating endothelial cells. In addition, the review discusses the use of neoplastic tissues including tumor biopsies, circulating tumor DNA and tumor cells and metabolomic approaches. The utilization of these tissues and technology platforms to study biomarkers will help accelerate the development of molecularly targeted agents for the treatment of cancer. PMID:22974395

  7. Extracapsular dissection for clinically benign parotid lumps: reduced morbidity without oncological compromise.

    PubMed

    McGurk, M; Thomas, B L; Renehan, A G

    2003-11-01

    Previous studies have shown that extracapsular dissection (ECD) is an alternative approach to superficial parotidectomy (SP) for pleomorphic adenoma parotid tumours, associated with low recurrence rates equal to those following SP, but with significantly reduced morbidity. However, if a malignant tumour masquerades as a clinically benign lump, this approach may be inappropriate. This study addressed this question by analysing the outcome of 821 consecutive patients with parotid tumours treated at one centre over 40 years and with a median 12 (range 5-30) years follow-up. Tumours were classified as 'simple' (discrete, mobile, < 4 cm: n=662) and 'complex' (deep, fixed, facial nerve palsy, > or =4 cm: n=159). Among the 'simple' or clinically benign tumours, 503 patients underwent ECD; 159 patients underwent SP. In all, 32 (5%) clinically benign cases were subsequently revealed as malignant histologies (ECD, 12; SP, 20). For each group, 5- and 10-year cancer-specific survival rates were 100 and 98%, respectively. There were no differences in recurrence rates when subanalysed by surgical groups, but ECD was associated with significantly reduced morbidity (P < 0.001). This study demonstrates that ECD is a viable alternative to superficial parotidectomy for the majority of parotid tumours, associated with reduced morbidity without oncological compromise.

  8. 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

  9. 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

  10. 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.

  11. Neobladders: clinical management and considerations for patients receiving chemotherapy.

    PubMed

    Broderick, G A; Stone, A R; deVere White, R

    1990-10-01

    have a tendency toward dehydration because of increased loss of free water through bowel transit. 4. Absorption of chloride, ammonium, and hydrogen ions may cause hyperchloremic acidosis, especially in face of imparied renal function. 5. Because of the potential for drug absorption across reservoir mucosa, patients receiving chemotherapy may require Foley catheterization with irrigation in addition to intravenous hydration. 6. Creatinine clearance is unsuitable for studying the renal function of reservoir patients because urine passes through the intestinal segment where creatinine is absorbed; glomerular filtration is better estimated by nuclear scanning with the reservoir emptied. 7. Most reservoirs will remain colonized with bacteria. 8. Antibiotic prophylaxis for the patient with temporary impairment of immune function during chemotherapy may be necessary. 9. Mucus may entrap bacteria serving as a host defense; its production may diminish with time from construction. All patients should be capable of performing reservoir irrigations to manage mucus obstruction.(ABSTRACT TRUNCATED AT 400 WORDS) PMID:2218572

  12. 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

  13. 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.

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

    SciTech Connect

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

    1980-06-01

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

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

    PubMed

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

    2016-01-01

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

  16. Pitfalls in MR image interpretation prompting referrals to an orthopedic oncology clinic.

    PubMed

    Stacy, Gregory Scott; Dixon, Larry B

    2007-01-01

    Patients referred to the authors' hospital for evaluation on suspicion of a bone or soft-tissue malignancy frequently present to the Orthopaedic Oncology Clinic with magnetic resonance (MR) images that show typical features of nonmalignant or nonneoplastic entities. The purpose of this article is to review the benign entities that may be mistaken by the radiologist for a malignancy and thus lead to needless referral to an orthopedic oncologist. Normal hematopoietic marrow and marrow edema due to a stress reaction may mimic a neoplasm at MR imaging, but knowledge of the typical patterns and locations of these features allows an accurate radiologic interpretation. The MR imaging appearance of osteonecrosis, Paget disease, benign bone lesions, and rheumatologic conditions may be confusing; in such circumstances, radiographic findings may help formulate a correct diagnosis. Knowledge of the common locations and appearances of bursae and ganglia is necessary so that radiologists do not misinterpret these benign entities as soft-tissue sarcomas. Soft-tissue trauma and inflammation also may mimic tumors at MR imaging, but a familiarity with the imaging patterns of nonneoplastic change in muscle allows the avoidance of misinterpretation. The clinical history, as always, is an important component of proper diagnosis. The radiologist can be especially useful to both the clinician and the patient by recognizing entities that are highly unlikely to represent malignancy and by confidently reporting those entities as benign, thereby sparing the patient an unnecessary trip to the orthopedic oncologist.

  17. 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.

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

    PubMed

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

    2016-01-01

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

  19. Cancer stem cells in basic science and in translational oncology: can we translate into clinical application?

    PubMed

    Schulenburg, Axel; Blatt, Katharina; Cerny-Reiterer, Sabine; Sadovnik, Irina; Herrmann, Harald; Marian, Brigitte; Grunt, Thomas W; Zielinski, Christoph C; Valent, Peter

    2015-02-25

    Since their description and identification in leukemias and solid tumors, cancer stem cells (CSC) have been the subject of intensive research in translational oncology. Indeed, recent advances have led to the identification of CSC markers, CSC targets, and the preclinical and clinical evaluation of the CSC-eradicating (curative) potential of various drugs. However, although diverse CSC markers and targets have been identified, several questions remain, such as the origin and evolution of CSC, mechanisms underlying resistance of CSC against various targeted drugs, and the biochemical basis and function of stroma cell-CSC interactions in the so-called 'stem cell niche.' Additional aspects that have to be taken into account when considering CSC elimination as primary treatment-goal are the genomic plasticity and extensive subclone formation of CSC. Notably, various cell fractions with different combinations of molecular aberrations and varying proliferative potential may display CSC function in a given neoplasm, and the related molecular complexity of the genome in CSC subsets is considered to contribute essentially to disease evolution and acquired drug resistance. In the current article, we discuss new developments in the field of CSC research and whether these new concepts can be exploited in clinical practice in the future.

  20. 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.

  1. 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

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

    PubMed Central

    Matoušková, Ivanka; Holy, Ondřej

    2014-01-01

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

  3. 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.

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

    PubMed

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

    2016-06-23

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

  5. The impact of adjuvant chemotherapy in older breast cancer patients on clinical and biological aging parameters

    PubMed Central

    Brouwers, Barbara; Hatse, Sigrid; Lago, Lissandra Dal; Neven, Patrick; Vuylsteke, Peter; Dalmasso, Bruna; Debrock, Guy; Van Den Bulck, Heidi; Smeets, Ann; Bechter, Oliver; Bailur, Jithendra Kini; Kenis, Cindy; Laenen, Annouschka; Schöffski, Patrick; Pawelec, Graham; Journe, Fabrice; Ghanem, Ghanem-Elias; Wildiers, Hans

    2016-01-01

    Purpose This prospective observational study aimed to evaluate the impact of adjuvant chemotherapy on biological and clinical markers of aging and frailty. Methods Women ≥ 70 years old with early breast cancer were enrolled after surgery and assigned to a chemotherapy (Docetaxel and Cyclophosphamide) group (CTG, n=57) or control group (CG, n=52) depending on their planned adjuvant treatment. Full geriatric assessment (GA) and Quality of Life (QoL) were evaluated at inclusion (T0), after 3 months (T1) and at 1 year (T2). Blood samples were collected to measure leukocyte telomere length (LTL), levels of interleukin-6 (IL-6) and other circulating markers potentially informative for aging and frailty: Interleukin-10 (IL-10), Tumor Necrosis Factor Alpha (TNF-α), Insulin-like Growth Factor 1 (IGF-1), Monocyte Chemotactic Protein 1 (MCP-1) and Regulated on Activation, Normal T cell Expressed and Secreted (RANTES). Results LTL decreased significantly but comparably in both groups, whereas IL-6 was unchanged at T2. However, IL-10, TNF-α, IGF-1 and MCP-1 suggested a minor biological aging effect of chemotherapy. Clinical frailty and QoL decreased at T1 in the CTG, but recovered at T2, while remaining stable in the CG. Conclusion Chemotherapy (TC) is unlikely to amplify clinical aging or induce frailty at 1 year. Accordingly, there is no impact on the most established aging biomarkers (LTL, IL-6). PMID:27102154

  6. Metronomic chemotherapy from rationale to clinical studies: a dream or reality?

    PubMed

    Gnoni, Antonio; Silvestris, Nicola; Licchetta, Antonella; Santini, Daniele; Scartozzi, Mario; Ria, Roberto; Pisconti, Salvatore; Petrelli, Fausto; Vacca, Angelo; Lorusso, Vito

    2015-07-01

    Metronomic chemotherapy (MC) refers to the close administration of a chemotherapeutic drug for a long time with no extended drug-free breaks. It was developed to overcome drug resistance, partly by shifting the therapeutic target from tumor cells to the tumor vasculature, with less toxicity. Because of this peculiar way of administration, MC can be viewed as a form of long-term 'maintenance' treatment, and can be integrated with standard and conventional chemotherapy in a "chemo-switching" strategy. Additional mechanisms are involved in its antitumor activity, such as activation of immunity, induction of tumor dormancy, chemotherapy-driven dependency of cancer cells, and the '4D effect'. In this paper we report the most important studies that have analyzed these processes. In fact, a number of preclinical and clinical studies in solid tumors as well as in multiple myeloma, have been reported regarding several chemotherapy drugs which have been proposed with a metronomic schedule: vinorelbine, cyclophosphamide, capecitabine, methotrexate, bevacizumab, etoposide, gemcitabine, sorafenib, everolimus and temozolomide. The results of these studies have been sometimes conflicting, highlighting the need to develop reliable tools for patient selection and stratification. However, a more precise evaluation of MC strategies with the ongoing randomized phase II/III clinical is fundamental, because of the strict correlation of this approach with translational research and target therapy. Moreover, because of the low toxicity of MC, these studies will also help to better evaluate the clinical benefit of this treatment, with a special focus on elderly and low performance status patients.

  7. Oncotherapy: A System for Requesting Chemotherapy Protocols.

    PubMed

    Righi, Laura Vera

    2015-01-01

    A clinical decision support system is able to provide oncologists with suitable treatment options at the moment of decision making regarding which chemotherapy protocol is the best to apply to a particular oncological case. The National Cancer Institute has created a Guidelines Committee that establishes therapeutical options for each clinical case. The Health Informatics Department has developed Oncotherapy, a knowledge database that incorporates information provided by the Guidelines Committee. Oncotherapy includes a tailored information repository to provide oncologists in the public health system with the chemotherapy protocols available given three types of data: clinical diagnosis, clinical stage and therapy criteria. The protocol selected by the treating oncologist is sent back to Oncotherapy, which may create new knowledge that can be incorporated into the knowledge database. In this way, the system supports making the best decision according to the chemotherapy protocol options available. Furthermore, it can warn of errors that could result from mistakenly chosen therapies. PMID:26262420

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

    PubMed

    Mitchell, T

    2013-07-01

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

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

    PubMed

    Mitchell, T

    2013-07-01

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

  10. 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

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

    PubMed

    Imamura, Kiyonari

    2015-01-01

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

  12. New issues for copper-64: from precursor to innovative PET tracers in clinical oncology.

    PubMed

    Evangelista, Laura; Luigi, Mansi; Cascini, Giuseppe Lucio

    2013-09-01

    The role of copper in the metabolism of human cancer cells has been largely investigated in the last 20 years and a strong relationship between copper levels and cancer progression has been demonstrated. Moreover copper is involved in tumor angiogenesis as well as in non-neoplastic conditions like neurodegenerative diseases. The main mechanism of action is related to a cellular transporter (CTR1) that plays a pivotal role in preserving the intra-cellular homeostasis, allowing at the same time the anti- tumor activity of platinum based therapies. Copper-64, emitting positrons and β- radiations, is suitable for the labeling of a large number of molecules that could be used for radionuclide imaging, being also usable in radionuclide therapy. Nevertheless few data are at present available on radiotracers labeled with radiocopper and in particular on the use of (64)Cu-Cl2 in cancer patients. In this paper we analyze the potential applications for Copper-64 as PET agent in the clinical oncological scenario.

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

    PubMed Central

    Wood, Paul L

    2014-01-01

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

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

    PubMed

    2003-06-15

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

  15. Bridging the gap: the Virtual Chemotherapy Unit.

    PubMed

    Scavuzzo, Jennifer; Gamba, Nicole

    2004-01-01

    Due to the complexity of pediatric chemotherapy administration, systems promoting safety must be utilized. Computerized order entry has been proven to reduce errors in the ordering of chemotherapeutic agents. A task force (the Breakthrough Committee) at The Children's Hospital of Philadelphia (CHOP) evaluated systems and identified the need to streamline the chemotherapy admission process from the outpatient clinic to the inpatient unit. In the outpatient setting chemotherapy orders were handwritten, whereas inpatient orders were computerized. Patients due for chemotherapy admissions were unable to start chemotherapy until they were physically admitted to an inpatient bed. In many cases, patients would not start receiving chemotherapy until late in the evening or even overnight. The Breakthrough Committee created the Virtual Chemotherapy Unit (Virtual Unit), which standardizes the ordering and documentation for all chemotherapy admissions. As per its name, the Virtual Unit is not an actual hospital unit but merely a location in the computer system where the patient is admitted prior to having a bed on the inpatient unit. Patients are now able to start chemotherapy infusions in the outpatient setting early in the day, rather than waiting until arrival to the inpatient unit. The nurses in the outpatient clinic are able to document chemotherapy administration online, giving the inpatient staff the ability to view the medications that were given. The Virtual Unit bridges the gap in chemotherapy ordering and documentation by utilizing 1 online episode per patient admission. Oncology nurses at CHOP played a fundamental role in the creation of the Virtual Unit. Nurses identified situations with potential for error in the ordering and administration of chemotherapy. These scenarios were analyzed and used in creating a safer system.

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

    PubMed Central

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

    2012-01-01

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

  17. 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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-01-01

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

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

    PubMed

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

    1998-03-01

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

  1. Optimal and minimax three-stage designs for phase II oncology clinical trials.

    PubMed

    Chen, Kun; Shan, Michael

    2008-01-01

    The common objective of oncology phase II trials is to evaluate the anti-tumor activity of a new agent and to determine whether the new drug warrants further investigation. For cancer drugs that significantly shrink tumors, response (CR and PR) rate is usually the primary endpoint in cancer phase II trials for testing H(0): Por=P(1), where P(0) and P(1) are response rates which does not or does warrant further investigation given the rate of false positive (alpha) and false negative (beta). Multiple-stage designs including two-stage and three-stage have been developed by several authors. For example, Simon's optimal two-stage design [Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989;10:1-10], Ensign et al. optimal three-stage design with restriction at the first stage [Ensign LG, Gehan EA, Kamen DS, Thall PF. An optimal three-stage design for phase II clinical trials. Stat Med 1994;13:1727-1736], Chen's optimal three-stage design without any restriction [Chen TT. Optimal three-stage designs for phase II clinical trials. Stat Med 1997;16:2701-2711], etc. However, all the above designs only early terminate a trial due to lack of activity of the study drug. Fleming's multiple-stage design [Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics 1982;38:143-151] allows early stopping for either sufficient activity or lack of activity. But his design does not attempt to optimize its efficiency. We extend Chen's [Chen TT. Optimal three-stage designs for phase II clinical trials Stat Med 1997;16:2701-2711] design and propose an optimal and a minimax design for three-stage cancer phase II trials which allows early stopping under both hypotheses. The design is optimal in the sense that the average sample number (ASN) is minimized under P=P(0). The minimax design minimizes the maximal sample size (N) and then given this value of N minimizes the average sample number under P=P(0

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

    PubMed

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

    2016-09-01

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

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

    NASA Astrophysics Data System (ADS)

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

    2012-11-01

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

  4. 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.

  5. Fast-track surgery in gynaecology and gynaecologic oncology: a review of a rolling clinical audit.

    PubMed

    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

  6. 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.

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

    PubMed Central

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

    2014-01-01

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

  8. 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.

  9. 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)

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

    ClinicalTrials.gov

    2016-07-25

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

  11. 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

  12. Implementing and Integrating a Clinically Driven Electronic Medical Record for Radiation Oncology in a Large Medical Enterprise

    PubMed Central

    Kirkpatrick, John P.; Light, Kim L.; Walker, Robyn M.; Georgas, Debra L.; Antoine, Phillip A.; Clough, Robert W.; Cozart, Heidi B.; Yin, Fang-Fang; Yoo, Sua; Willett, Christopher G.

    2013-01-01

    , compared to paper charts, time required by clinicians to access/enter patient information has substantially increased. While productivity is improving with experience, substantial growth will require better integration of the system components, decreased access times, and improved user interfaces. $127K was spent on new hardware and software; elimination of paper yields projected savings of $21K/year. One year after conversion to an EMR, more than 90% of department staff favored the EMR over the previous paper charts. Conclusion: Successful implementation of a Radiation Oncology EMR required not only the effort and commitment of all functions of the department, but support from senior health system management, corporate IT, and vendors. Realization of the full benefits of an EMR will require experience, faster/better integrated software, and continual improvement in underlying clinical processes. PMID:23616946

  13. 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

  14. [Treatment of anaemia in medical oncology].

    PubMed

    Kullmann, Tamás; Culine, Stéphane

    2012-06-24

    Development of cytotoxic chemotherapy, which has several side effects, has resulted in the development in supportive care as well. Two families of novel drugs have spread in the care of chemotherapy induced anaemia: human recombinant erythropoietin and intravenous iron. They were praised for the decreased transfusion demand and the increased quality of life. However, if we read the literature critically, our enthusiasm should be decreased. New data show an unfavourable impact of erythropoietin on life expectancy. Furthermore, the health care policy has changed since the introduction of erythropoietin 25 years ago. Transfusion control has improved and cost awareness in health care has increased. Recommendations of the American Societies of Haematology and Clinical Oncology reflect on these considerations. Erythropoietin is not recommended in adjuvant settings. The choice between erythropoietin and transfusion is conferred to the clinician in case of the development of metastases. No sufficient scientific argument was found to support the use of intravenous iron supplementation.

  15. [Microbial analysis of clinical material taken from patients at the Oncology Center, Maria Skłodowkda-Curie Institute in Warsaw in 1997].

    PubMed

    Fuksiewicz, A; Połowniak-Pracka, H; Ochman, E; Podsiadło, B

    1999-01-01

    An analysis was carried out of the microbiological investigations of clinical material samples obtained from the patients of two oncology centres belonging to the Warsaw Oncology Centre. Microorganisms cultured from urine, blood, catheters, smears of wounds and other materials were analysed. From 4839 clinical material samples from the Ursynów centre 1755 bacterial strains were isolated. From 423 samples from the centre in Wawelska Street 171 strains were obtained. In infections of patients from the centres the number of Gram-positive cocci was twice that of Gram-negative rods. In the investigated clinical material S. aureus was the most frequently isolated Gram-positive coccus, while E. coli was the most frequent species among Gram-negative bacteria. In the infections of oncological patients a considerable frequency was noted of yeast-like fungi, especially C. albicans. Particularly disquieting was the increasing number of isolates of C. glabrata and C. krusei strains resistant to fluconazole.

  16. 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.

  17. 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 |

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

    PubMed

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

    2016-07-01

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

  19. 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. PMID:26433555

  20. 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

  1. Clinical Profile and Chemotherapy Response in Children with Hodgkin Lymphoma at a Tertiary Care Centre

    PubMed Central

    Das, Rashmi Ranjan; Puri, Kirti; Singh, Prashant

    2015-01-01

    Introduction Optimal treatment strategy in children with advance stage Hodgkin Lymphoma (HL) still remains controversial. Aim To evaluate the clinical profile and the efficacy of chemotherapy (CT) as a treatment modality in paediatric HL. Material and Methods Retrospective case record evaluation of paediatric HL cases over 5 years (October 2005 to October 2010) period. Results Thirty five cases (31 boys) with a median age of eight years were studied. 24 cases were <10-year-old, and 23 had late stage disease (stage III to IV). B-symptoms were present in 60%, bulky mediastinal disease in 25.7%, and spleen involvement in 60% cases. None had bone marrow involvement. Most common histological type was nodular sclerosis (28.6%). Most cases received ABVD/COPP or ABVD regimen. Two cases needed BEACOPP due to progressive disease, and 4 needed low-dose involved field radiotherapy (RT). At a mean (SD) extended event-free follow-up of 42.7(±17.1) months, four cases relapsed (one was lost to follow-up, and three were treated with chemotherapy and low-dose involved field RT). None died due to the disease. Conclusion Present study found systemic CT alone to be an effective therapy in childhood Hodgkin lymphoma. However, a small sample in present study limits the generalisability of these findings. The findings needs to be replicated in larger population, preferably randomized clinical trials, before any firm conclusion can be made. PMID:26674594

  2. Barriers to a Career Focus in Cancer Prevention: A Report and Initial Recommendations From the American Society of Clinical Oncology Cancer Prevention Workforce Pipeline Work Group

    PubMed Central

    Meyskens, Frank L.; Bajorin, Dean F.; George, Thomas J.; Jeter, Joanne M.; Khan, Shakila; Tyne, Courtney A.; William, William N.

    2016-01-01

    Purpose To assist in determining barriers to an oncology career incorporating cancer prevention, the American Society of Clinical Oncology (ASCO) Cancer Prevention Workforce Pipeline Work Group sponsored surveys of training program directors and oncology fellows. Methods Separate surveys with parallel questions were administered to training program directors at their fall 2013 retreat and to oncology fellows as part of their February 2014 in-training examination survey. Forty-seven (67%) of 70 training directors and 1,306 (80%) of 1,634 oncology fellows taking the in-training examination survey answered questions. Results Training directors estimated that ≤ 10% of fellows starting an academic career or entering private practice would have a career focus in cancer prevention. Only 15% of fellows indicated they would likely be interested in cancer prevention as a career focus, although only 12% thought prevention was unimportant relative to treatment. Top fellow-listed barriers to an academic career were difficulty in obtaining funding and lower compensation. Additional barriers to an academic career with a prevention focus included unclear career model, lack of clinical mentors, lack of clinical training opportunities, and concerns about reimbursement. Conclusion Reluctance to incorporate cancer prevention into an oncology career seems to stem from lack of mentors and exposure during training, unclear career path, and uncertainty regarding reimbursement. Suggested approaches to begin to remedy this problem include: 1) more ASCO-led and other prevention educational resources for fellows, training directors, and practicing oncologists; 2) an increase in funded training and clinical research opportunities, including reintroduction of the R25T award; 3) an increase in the prevention content of accrediting examinations for clinical oncologists; and 4) interaction with policymakers to broaden the scope and depth of reimbursement for prevention counseling and

  3. "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.

  4. Randomized phase III trial of platinum-doublet chemotherapy followed by gefitinib compared with continued platinum-doublet chemotherapy in Japanese patients with advanced non-small-cell lung cancer: results of a west Japan thoracic oncology group trial (WJTOG0203).

    PubMed

    Takeda, Koji; Hida, Toyoaki; Sato, Tosiya; Ando, Masahiko; Seto, Takashi; Satouchi, Miyako; Ichinose, Yukito; Katakami, Nobuyuki; Yamamoto, Nobuyuki; Kudoh, Shinzoh; Sasaki, Jiichiro; Matsui, Kaoru; Takayama, Koichi; Kashii, Tatsuhiko; Iwamoto, Yasuo; Sawa, Toshiyuki; Okamoto, Isamu; Kurata, Takayasu; Nakagawa, Kazuhiko; Fukuoka, Masahiro

    2010-02-10

    PURPOSE Gefitinib is a small molecule inhibitor of the epidermal growth factor receptor tyrosine kinase. We conducted a phase III trial to evaluate whether gefitinib improves survival as sequential therapy after platinum-doublet chemotherapy in patients with advanced non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS Chemotherapy-naïve patients with advanced stage (IIIB/IV) NSCLC, Eastern Cooperative Oncology Group performance status of 0 to 1, and adequate organ function were randomly assigned to either platinum-doublet chemotherapy up to six cycles (arm A) or platinum-doublet chemotherapy for three cycles followed by gefitinib 250 mg orally once daily, until disease progression (arm B). Patients were stratified by disease stage, sex, histology, and chemotherapy regimens. The primary end point was overall survival; secondary end points included progression-free survival, tumor response, safety, and quality of life. Results Between March 2003 and May 2005, 604 patients were randomly assigned. There was a statistically significant improvement in progression-free survival in arm B (hazard ratio [HR], 0.68; 95% CI, 0.57 to 0.80; P < .001); however, overall survival results did not reach statistical significance (HR, 0.86; 95% CI, 0.72 to 1.03; P = .11). In an exploratory subset analysis of overall survival by histologic group, patients in arm B with adenocarcinoma did significantly better than patients in arm A with adenocarcinoma (n = 467; HR, 0.79; 95% CI, 0.65 to 0.98; P = .03). CONCLUSION This trial failed to meet the primary end point of OS in patients with NSCLC. The exploratory subset analyses demonstrate a possible survival prolongation for sequential therapy of gefitinib, especially for patients with adenocarcinoma.

  5. Identifying oncological emergencies.

    PubMed

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

    2013-01-01

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

  6. To friend or not to friend: the use of social media in clinical oncology.

    PubMed

    Wiener, Lori; Crum, Caroline; Grady, Christine; Merchant, Melinda

    2012-03-01

    Online social networking has replaced more traditional methods of personal and professional communication in many segments of society today. The wide reach and immediacy of social media facilitate dissemination of knowledge in advocacy and cancer education, but the usefulness of social media in personal relationships between patients and providers is still unclear. Although professional guidelines regarding e-mail communication may be relevant to social media, the inherent openness in social networks creates potential boundary and privacy issues in the provider-patient context. This commentary seeks to increase provider awareness of unique issues and challenges raised by the integration of social networking into oncology communications.

  7. 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

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

    PubMed

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

    1986-08-01

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

  9. 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

  10. Patterns of Chemotherapy-Induced Toxicities in Younger Children and Adolescents with Rhabdomyosarcoma: A Report from the Children’s Oncology Group Soft Tissue Sarcoma Committee

    PubMed Central

    Gupta, Abha A.; Anderson, James R.; Pappo, Alberto S.; Spunt, Sheri L.; Dasgupta, Roshni; Indelicato, Daniel J.; Hawkins, Douglas S.

    2014-01-01

    Purpose Patients aged older than 10 years with rhabdomyosarcoma (RMS) have an inferior outcome compared to patients aged 1–9 years which might be explained by toxicities (adverse events, AE) resulting in chemotherapy dose reductions. Methods AEs observed during one of 3 randomized chemotherapy regimens (VAC, VAI or VIE) in Intergroup Rhabdomyosarcoma Study (IRS)-IV were recorded. The incidence of toxicities by age and treatment regimen was determined. The odds of developing an AE in a particular age group (5–9, 10–14, and 15–20 years) were compared to the control age group, 1–4 years. Results 657 patients were eligible for analysis. Estimated 5-year EFS were 78%, 83%, 67%, and 58% for age groups 1–4, 5–9, 10–14, and 15–20, respectively. Patients 15–20 years experienced less neutropenia (OR 0.43, p<0.0001), thrombocytopenia (OR 0.41, p<0.0001), anemia (OR 0.34, p<0.0001) and infection (OR 0.41, p<0.0001) compared to younger patients, despite receiving similar amounts of chemotherapy. In contrast, peripheral nervous system (PNS) toxicity was higher in adolescents older than 10 years (OR 4.18, p<0.0001). Females experienced more neutropenia (OR 1.28, p=0.05) and thrombocytopenia (OR 1.26, p=0.06) compared to males. Conclusions Adolescents receiving treatment for RMS experience significantly less hematologic and more PNS toxicity compared to younger children despite receiving similar amounts of chemotherapy. Although outcome is inferior in adolescents, it is unclear whether the differences in toxicity observed in our study impact on outcome. Future studies examining the age and gender-related differences in pharmacokinetics of chemotherapy are necessary. PMID:21761400

  11. Clinical response to chemotherapy in oesophageal adenocarcinoma patients is linked to defects in mitochondria.

    PubMed

    Aichler, Michaela; Elsner, Mareike; Ludyga, Natalie; Feuchtinger, Annette; Zangen, Verena; Maier, Stefan K; Balluff, Benjamin; Schöne, Cédrik; Hierber, Ludwig; Braselmann, Herbert; Meding, Stephan; Rauser, Sandra; Zischka, Hans; Aubele, Michaela; Schmitt, Manfred; Feith, Marcus; Hauck, Stefanie M; Ueffing, Marius; Langer, Rupert; Kuster, Bernhard; Zitzelsberger, Horst; Höfler, Heinz; Walch, Axel K

    2013-08-01

    Chemotherapeutic drugs kill cancer cells, but it is unclear why this happens in responding patients but not in non-responders. Proteomic profiles of patients with oesophageal adenocarcinoma may be helpful in predicting response and selecting more effective treatment strategies. In this study, pretherapeutic oesophageal adenocarcinoma biopsies were analysed for proteomic changes associated with response to chemotherapy by MALDI imaging mass spectrometry. Resulting candidate proteins were identified by liquid chromatography-tandem mass spectrometry (LC-MS/MS) and investigated for functional relevance in vitro. Clinical impact was validated in pretherapeutic biopsies from an independent patient cohort. Studies on the incidence of these defects in other solid tumours were included. We discovered that clinical response to cisplatin correlated with pre-existing defects in the mitochondrial respiratory chain complexes of cancer cells, caused by loss of specific cytochrome c oxidase (COX) subunits. Knockdown of a COX protein altered chemosensitivity in vitro, increasing the propensity of cancer cells to undergo cell death following cisplatin treatment. In an independent validation, patients with reduced COX protein expression prior to treatment exhibited favourable clinical outcomes to chemotherapy, whereas tumours with unchanged COX expression were chemoresistant. In conclusion, previously undiscovered pre-existing defects in mitochondrial respiratory complexes cause cancer cells to become chemosensitive: mitochondrial defects lower the cells' threshold for undergoing cell death in response to cisplatin. By contrast, cancer cells with intact mitochondrial respiratory complexes are chemoresistant and have a high threshold for cisplatin-induced cell death. This connection between mitochondrial respiration and chemosensitivity is relevant to anticancer therapeutics that target the mitochondrial electron transport chain.

  12. 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

  13. Indication of metronomic chemotherapy for metastatic breast cancer: Clinical outcomes and responsive subtypes

    PubMed Central

    KONTANI, KEIICHI; HASHIMOTO, SHIN-ICHIRO; MURAZAWA, CHISA; NORIMURA, SHOKO; TANAKA, HIROAKI; OHTANI, MASAHIRO; FUJIWARA-HONJO, NAOMI; DATE, MANABU; TERAMOTO, KOJI; HOUCHI, HITOSHI; YOKOMISE, HIROYASU

    2016-01-01

    The survival of patients with metastatic breast cancer (MBC) has not improved, despite recent advances in therapeutic strategies. This is mainly due to the fact that cytotoxic agents cannot be administered over a long period, even if they exhibit favorable activity, due to treatment-related side effects or acquisition of tumor resistance to the administered agents. Thus, the development of therapeutic strategies that may be used over a long time period is required to improve survival. We assessed the availability and clinical outcomes of metronomic chemotherapy, which is defined as continuous or frequent treatment with low doses of cytotoxic drugs. A total of 80 patients with MBC received chemotherapy in the metastatic setting, and the clinicopathological factors and clinical outcomes were retrospectively compared between 52 patients who received metronomic regimens and 28 patients who received other cytotoxic regimens. As regards clinical outcomes, the median time-to-treatment failure (TTF) and overall survival (OS) were significantly longer in the metronomic group compared with those in the non-metronomic group (TTF, 15 vs. 4 months, P=0.0001; and OS, 53 vs. 28 months P=0.0012, respectively). In the metronomic group, none of the 18 patients who responded to the regimen had triple-negative (TN) cancer (17 had luminal-type tumors and 1 had a human epidermal factor receptor 2-type tumor). Furthermore, TTF and OS were significantly longer in patients with non-TN cancer compared with those in patients with TN cancer in the metronomic group (TTF, 16 vs. 7 months, P=0.0014; and OS, 108 vs. 20 months, P=0.000007, respectively). The proportion of patients who experienced treatment-related adverse events was significantly lower in the metronomic group compared with that in the non-metronomic group (36.5 vs. 61.5%, respectively; P=0.038). In conclusion, metronomic chemotherapy is a viable option for luminal-type MBC in terms of effectiveness and minimal toxicity, regardless

  14. 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…

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

    PubMed

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

    2016-01-01

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

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

    PubMed

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

    2016-01-01

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

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

    PubMed

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  19. Species differences in tumour responses to cancer chemotherapy

    PubMed Central

    Lawrence, Jessica; Cameron, David; Argyle, David

    2015-01-01

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

  20. 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.

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

    PubMed Central

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

    2013-01-01

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

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

    PubMed Central

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

    2014-01-01

    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. PMID:24644249

  3. Anticancer chemotherapy

    SciTech Connect

    Weller, R.E.

    1988-10-01

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

  4. 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.

  5. 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.

  6. 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

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

    PubMed

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

    2012-01-01

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

  8. 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

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

    PubMed

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

    2016-01-01

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

  10. Barriers to suicide risk management in clinical practice: a national survey of oncology nurses.

    PubMed

    Valente, Sharon; Saunders, Judith M

    2004-09-01

    Standards of practice identify the nurse's pivotal role in risk detection, assessment, intervention, and management of suicidal patients, but scant research explores the barriers that hinder this role. This study describes the analysis of barriers to suicide risk management from a survey of a random sample of members of a national organization, the Oncology Nursing Society (n = 1200), who participated in a descriptive study exploring nurses' knowledge and attitudes about suicide. The 454 (37%) respondents included respondents from the United States, Canada, and Puerto Rico. Instruments included a demographic inventory, the Suicide Opinion Questionnaire (SOQ), a suicide attitude measure (SUIATT), and a vignette of a suicidal patient. Nurses knew an average of 4.8 out of 9 suicide risk factors and 49.4% miscalculated the risk of suicide. In contrast with their moderate to high ratings of suicide risk, they indicated minimal interventions. Barriers to management of suicidal patients included deficits in skill, knowledge, referrals, patient teaching, advocacy, or consultation as well as participants' and religious/other values, uncomfortable feelings, personal experiences, and the weight of professional responsibility. Strategies for intervention include: suicide prevention education, consultation, values clarification, ethical analysis, and conflict resolution and psychosocial support to reduce barriers. Nurses are not alone in their request for more education about suicide prevention; this study confirms earlier research of psychologists and psychiatrists who report they need more education in suicide risk management. PMID:15371147

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

    PubMed Central

    Cai, Chunyan; Yuan, Ying; Ji, Yuan

    2013-01-01

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

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

    PubMed

    Cai, Chunyan; Yuan, Ying; Ji, Yuan

    2014-01-01

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

  13. 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.

  14. 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.

  15. Evaluation of Chemotherapy-Induced Peripheral Neuropathy using Current Perception Threshold and Clinical Evaluations

    PubMed Central

    Griffith, Kathleen A.; Couture, Darren J.; Zhu, Shijun; Pandya, Naimish; Johantgen, Mary E.; Cavaletti, Guido; Davenport, Joan M.; Tanguay, Lori J.; Choflet, Amanda; Milliron, Todd; Glass, Erica; Gambill, Nancy; Renn, Cynthia L.; Dorsey, Susan G.

    2014-01-01

    Purpose Chemotherapy-induced peripheral neuropathy (CIPN) is increasing with introduction of new and combination cancer pharmacotherapies. This study evaluated associations between clinical and self-report measurements and current perception threshold (CPT), a neuroselective measure of sensory nerve function that may detect asymptomatic CIPN damage. Methods Data for this secondary analysis were from a prospective, observational study using CPT to evaluate CIPN. Bivariate mixed models, accounting for the intra-class correlation between repeated patient assessments, were used to assess the relationship between CPT at each frequency (5Hz, 250Hz and 2000 Hz) and each subjective measure (Neuropathic Pain Scale, FACT-GOGntx) and objective measurement (quantitative sensory testing, deep tendon reflexes, grip strength). Results A total of 29 chemotherapy-naïve subjects with various cancer types had a mean age of 56.7 (SD 10.4); 9 subjects developed CIPN grade > 1 using NCI CTC-AE criteria. Cold detection thresholds were inversely associated with CPT 5 [b(95% CI) =−2.5(−4.5, −0.5)] and CPT 2000 [−7.5(−11.8, −3.3)] frequencies. FACT GOG-ntx quality of life (QoL) scale and neurotoxicity and function subscales were inversely associated with CPT 2000 [−1.8 (−3.5, −0.05), −2.2 (−4.2, −0.2), and −5.4(−9.8, −0.9), respectively], indicating worsening QoL, impairment, and function as hypoesthesia increases. Conclusions CPT 2000 may identify impending worsening of patient-reported outcomes, such as QoL. PMID:24362842

  16. Patient Comprehension and Attitudes toward Maintenance Chemotherapy for Lung Cancer

    PubMed Central

    Gerber, David E.; Hamann, Heidi A.; Rasco, Drew W.; Woodruff, Sharon; Craddock Lee, Simon J.

    2012-01-01

    Objective Maintenance chemotherapy is a recently approved approach to the treatment of advanced non-small cell lung cancer (NSCLC). We sought to gain insight into patients’ perceptions of maintenance chemotherapy using qualitative methods. Methods We conducted thematic content analysis of focus groups at a freestanding cancer center and at an associated safety-net county hospital. Patients with advanced NSCLC who had started but not yet completed first-line platinum doublet chemotherapy were provided visual and written explanations of maintenance chemotherapy before being guided in group discussion. Results Key themes to emerge for consideration of maintenance chemotherapy included (1) survival benefits, disease control, and “buying time”; (2) the importance of “doing something”; (3) quality of life concerns; (4) the role of provider opinion/preference; and (5) the importance of logistics. Conclusions Patients undergoing first-line chemotherapy for advanced NSCLC were able to understand the concept of maintenance chemotherapy, distinguish it from traditional treatment paradigms, identify pros and cons of this approach, and convey reasons for considering it. Practice Implications Advances in oncology care that alter therapy modalities and delivery may significantly impact patient perceptions and treatment experiences. Clinical team members may wish to elicit treatment preferences of first-line patients through clinical discussions that anticipate these considerations. PMID:22632736

  17. 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

  18. Clinical experience with titanium mesh in reconstruction of massive chest wall defects following oncological resection

    PubMed Central

    Yang, Haitang; Tantai, Jicheng

    2015-01-01

    Objectives To present our experience of reconstructing wide defects with porously titanium mesh after radical resection of malignant chest wall tumors. Methods A retrospective review of surgical reconstruction for large chest wall resections with titanium mesh was conducted from January 2009 to August 2014 in Shanghai Chest Hospital. Results A total of 27 patients underwent major chest wall reconstructions with titanium mesh, following oncological resections. Chest wall sarcomas were the most frequent (63.0%). The mean tumor size was 72.4 (range, 36-140) cm2. The average size of the applied porously titanium mesh was 140.9 (range, 80-225) cm2. Mean postoperative length of stay was 7.1 (range, 4-14) days. There were no perioperative mortalities. Four (14.8%) patients experienced treatable complications. All had a resection of at least 3 ribs (median 3, mean 3.5 ribs). A total of 22 patients underwent ribs without sternal resections, and five patients underwent partial sternal resections with adjacent costal cartilage. Anterior chest wall resections were performed in 13 patients while lateral chest wall resections were performed in 9 patients. Three patients had extended resections beyond the chest wall in patients with primary chest wall malignancies, including two with wedge resections of lung and one with partial resection of pericardium. No patient was lost to follow-up. Mean follow-up was 30.7 months. Neither chest wall instability nor wound infection/necrosis was observed. Of these, 23 patients (85.2%) were alive at the last follow-up. Local recurrence was detected in three cases. The 5-year disease-free and overall survivals of primary chest tumors were 72.1% and 80.8%, respectively. Conclusions Our results showed that chest wall reconstruction utilizing synthetic titanium meshes following extensive resections of the chest wall malignant tumors allowed adequate resection size, with acceptable complications and survival benefits. PMID:26380739

  19. [Chemotherapy for prostate cancer].

    PubMed

    Rauchenwald, Michael; De Santis, Maria; Fink, Eleonore; Höltl, Wolfgang; Kramer, Gero; Marei, Isabella-Carolina; Neumann, Hans-Jörg; Reissigl, Andreas; Schmeller, Nikolaus; Stackl, Walter; Hobisch, Alfred; Krainer, Michael

    2008-01-01

    For many years the benefit of chemotherapy in patients with prostate cancer was thought to be limited to palliation of late-stage disease, and thus this treatment option only became involved in patient care towards the end of the disease process, if at all. However, two landmark phase-III trials with docetaxel-based therapy (TAX 327 and Southwest Oncology Group, SWOG, 9916) have shown a survival benefit for patients with hormone refractory prostate cancer (HRPC) thus prompting a change in patterns of care. With raising interest for chemotherapeutic options and clinical trials for new drugs and new indications (neoadjuvant therapy, adjuvant therapy, increasing PSA levels after local treatment, and hormone sensitive cancer) under way our goal was to review within the context of a multidisciplinary team the available evidence and explore the standard for the medical treatment of prostate cancer outside of clinical trials. We are carefully evaluating the current treatment recommendations based on the available evidence and highlight potential future treatment options but also discuss important clinical topics (treatment until progression versus the advantage of chemo holidays, definition of particular patient subgroups and potential second line options) for which there are no clear cut answers to date. The role and importance of radiotherapy, biphosphonate treatment and the medical management of pain and side effects is also discussed. The multitude of treatment options for patients with advanced prostate cancer clearly asks for a close collaboration between urologists, medical oncologists and radiation therapists. PMID:18726672

  20. Cardiovascular Risk and Level of Statin Use Among Women With Breast Cancer in a Cardio-Oncology Clinic

    PubMed Central

    Shum, Kelly; Solivan, Amber; Parto, Parham; Polin, Nichole; Jahangir, Eiman

    2016-01-01

    Background: Because of the improvements in survival rates, patients with breast cancer are now more likely to die from cardiovascular disease than from cancer. Thus, providing appropriate preventive cardiovascular care to patients with cancer is of the utmost importance. Methods: We retrospectively compared the cardiovascular risk and management of 146 women treated at the Cardio-Oncology (Cardio-Onc) and the Obstetrics and Gynecology (Ob-Gyn) clinics. We calculated cardiovascular risk using the American College of Cardiology (ACC)/American Heart Association (AHA) atherosclerotic cardiovascular disease (ASCVD) risk calculator and the Framingham Risk Score Calculator. We also determined the prevalence of appropriate statin use according to both the 2013 ACC/AHA and the 2002 Adult Treatment Panel (ATP) III lipid guidelines. Results: The 10-year ASCVD risk score was not significantly different between the 2 cohorts. More patients in the Ob-Gyn cohort with an ASCVD risk score >7.5% were already appropriately on statins compared to patients in the Cardio-Onc cohort (60.9% vs 31.0%, respectively, P=0.003), but after the first Cardio-Onc visit, 4 additional patients with breast cancer were prescribed statins (44.8% total). Fourteen (19.2%) Cardio-Onc patients had a high Framingham Risk Score compared to 6 (8.2%) Ob-Gyn patients. Conclusion: We demonstrated that the ASCVD risk is similar between women with breast cancer attending the Cardio-Onc clinic and the women without breast cancer attending the Ob-Gyn clinic, but the Cardio-Onc cohort had significantly more patients with a high Framingham Risk Score. Both clinics had similarly poor rates of appropriate statin prescribing rates according to the ATP III guidelines.

  1. Cardiovascular Risk and Level of Statin Use Among Women With Breast Cancer in a Cardio-Oncology Clinic

    PubMed Central

    Shum, Kelly; Solivan, Amber; Parto, Parham; Polin, Nichole; Jahangir, Eiman

    2016-01-01

    Background: Because of the improvements in survival rates, patients with breast cancer are now more likely to die from cardiovascular disease than from cancer. Thus, providing appropriate preventive cardiovascular care to patients with cancer is of the utmost importance. Methods: We retrospectively compared the cardiovascular risk and management of 146 women treated at the Cardio-Oncology (Cardio-Onc) and the Obstetrics and Gynecology (Ob-Gyn) clinics. We calculated cardiovascular risk using the American College of Cardiology (ACC)/American Heart Association (AHA) atherosclerotic cardiovascular disease (ASCVD) risk calculator and the Framingham Risk Score Calculator. We also determined the prevalence of appropriate statin use according to both the 2013 ACC/AHA and the 2002 Adult Treatment Panel (ATP) III lipid guidelines. Results: The 10-year ASCVD risk score was not significantly different between the 2 cohorts. More patients in the Ob-Gyn cohort with an ASCVD risk score >7.5% were already appropriately on statins compared to patients in the Cardio-Onc cohort (60.9% vs 31.0%, respectively, P=0.003), but after the first Cardio-Onc visit, 4 additional patients with breast cancer were prescribed statins (44.8% total). Fourteen (19.2%) Cardio-Onc patients had a high Framingham Risk Score compared to 6 (8.2%) Ob-Gyn patients. Conclusion: We demonstrated that the ASCVD risk is similar between women with breast cancer attending the Cardio-Onc clinic and the women without breast cancer attending the Ob-Gyn clinic, but the Cardio-Onc cohort had significantly more patients with a high Framingham Risk Score. Both clinics had similarly poor rates of appropriate statin prescribing rates according to the ATP III guidelines. PMID:27660568

  2. 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

  3. 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.

  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. [CLINICAL GUIDELINES FOR DIAGNOSIS, TREATMENT AND MONITORING OF PATIENTS WITH INVASIVE BREAST CANCER--CROATIAN ONCOLOGY SOCIETY].

    PubMed

    Šeparović, Robert; Ban, Marija; Silovska, Tajana; Oresković, Lidija Beketić; Soldić, Željko; Podolski, Paula; Pleština, Stjepko; Gugić, Damir; Petković, Marija; Jakić-Razumović, Jasminka; Vojnović, Zeljko; Miše, Branka Petrić; Tomić, Snježana; Stanec, Zdenko; Vrdoljak, Danko Velemir; Drinković, Ivan; Brkljačić, Boris; Mustać, Elvira; Utrobičić, Ivan; Vrdoljak, Eduard

    2015-01-01

    Breast cancer is the most common cancer in women. It can be diagnosed in early stage through screening, early detection and educational programs, and when diagnosed early it can be efficiently treated. Treatment modalities include surgery, chemotherapy, radiotherapy, hormonal therapy and targeted biologic therapy, according to the stage of the disease and patient condition. Treatment decisions should be made after multidisciplinary team discussion. Due to the significance of this disease it is important to define and implement standardized approach for diagnostic, treatment and monitoring algorithm as well. The following text presents the clinical guidelines in order to standardize the procedures and criteria for diagnosis, management, treatment and monitoring of patients with breast cancer in the Republic of Croatia. PMID:26380471

  6. 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

  7. Pharmacodynamic endpoints as clinical trial objectives to answer important questions in oncology drug development.

    PubMed

    Parchment, Ralph E; Doroshow, James H

    2016-08-01

    Analyzing the molecular interplay between malignancies and therapeutic agents is rarely a straightforward process, but we hope that this special issue of Seminars has highlighted the clinical value of such endeavors as well as the relevant theoretical and practical considerations. Here, we conclude with both an overview of the various high-value applications of clinical pharmacodynamics (PD) in developmental therapeutics and an outline of the framework for incorporating PD analyses into the design of clinical trials. Given the increasingly recognized importance of determining and administering the biologically effective dose (BED) and schedule of targeted agents, we explain how clinical PD biomarkers specific to the agent mechanism of action (MOA) can be used for the development of pharmacodynamics-guided biologically effective dosage regimens (PD-BEDR) to maximize the efficacy and minimize the toxicity of targeted therapies. In addition, we discuss how MOA-based PD biomarker analyses can be used both as patient selection diagnostic tools and for designing novel drug combinations targeting the specific mutational signature of a given malignancy. We also describe the role of PD analyses in clinical trials, including for MOA confirmation and dosage regimen optimization during phase 0 trials as well as for correlating molecular changes with clinical efficacy when establishing proof-of-concept in phase I/II trials. Finally, we outline the critical technological developments that are needed to enhance the quality and quantity of future clinical PD data collection, broaden the types of molecular questions that can be answered in the clinic, and, ultimately, improve patient outcomes. PMID:27663483

  8. Pharmacodynamic endpoints as clinical trial objectives to answer important questions in oncology drug development.

    PubMed

    Parchment, Ralph E; Doroshow, James H

    2016-08-01

    Analyzing the molecular interplay between malignancies and therapeutic agents is rarely a straightforward process, but we hope that this special issue of Seminars has highlighted the clinical value of such endeavors as well as the relevant theoretical and practical considerations. Here, we conclude with both an overview of the various high-value applications of clinical pharmacodynamics (PD) in developmental therapeutics and an outline of the framework for incorporating PD analyses into the design of clinical trials. Given the increasingly recognized importance of determining and administering the biologically effective dose (BED) and schedule of targeted agents, we explain how clinical PD biomarkers specific to the agent mechanism of action (MOA) can be used for the development of pharmacodynamics-guided biologically effective dosage regimens (PD-BEDR) to maximize the efficacy and minimize the toxicity of targeted therapies. In addition, we discuss how MOA-based PD biomarker analyses can be used both as patient selection diagnostic tools and for designing novel drug combinations targeting the specific mutational signature of a given malignancy. We also describe the role of PD analyses in clinical trials, including for MOA confirmation and dosage regimen optimization during phase 0 trials as well as for correlating molecular changes with clinical efficacy when establishing proof-of-concept in phase I/II trials. Finally, we outline the critical technological developments that are needed to enhance the quality and quantity of future clinical PD data collection, broaden the types of molecular questions that can be answered in the clinic, and, ultimately, improve patient outcomes.

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

    PubMed

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

    2015-02-01

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

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

    PubMed

    Ruof, Jörg; Flückiger, Olivier; Andre, Niko

    2015-09-01

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

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

    SciTech Connect

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

    2009-07-01

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

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

    PubMed Central

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

    2010-01-01

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

  13. Clinical and oncological outcomes after surgical excision of parotid gland tumours in patients aged over 80 years.

    PubMed

    Fakhry, N; Aldosari, B; Michel, J; Giorgi, R; Collet, C; Santini, L; Giovanni, A; Dessi, P

    2013-11-01

    The objective of this study was to evaluate the surgical and long-term outcomes of a series of patients aged over 80 years, operated on for parotid neoplasms. Among 614 parotidectomies for neoplasms performed between 1998 and 2008, 34 patients (5.5%) aged over 80 years were identified retrospectively. Pathological examination showed a malignant tumour in 24 and a benign tumour in 10 cases. Overall survival (OS) and disease-free survival (DFS) were determined by Kaplan-Meier analysis. A search for parameters that could influence the postoperative complication rate and long-term outcomes was carried out by univariate analysis. There was no postoperative death. Eight patients (24%) had postoperative complications. Malignant histopathology (P=0.05) and radical resection (P=0.033) were found to have a significant negative impact on the postoperative course. Focusing on malignant tumours, only histopathological type (metastasis vs primary tumour) was found to have a negative impact on OS. The 2- and 5-year OS rates were 86% and 86%, respectively, for primary tumours, and 67% and 29%, respectively, for metastasis (P=0.05). Malignant or benign histopathology had no impact on OS. Our results showed acceptable clinical and long-term oncological outcomes in very elderly patients operated on for parotid tumours, including malignant tumours.

  14. 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

  15. Chemotherapy-radiotherapy association in Hodgkin's disease, clinical stages IA, II/sub 2/A: results of a prospective clinical trial with 166 patients. [/sup 60/Co

    SciTech Connect

    Andrieu, J.M.; Montagnon, B.; Asselain, B.; Bayle-Weisgerber, C.; Chastang, C.; Teillet, F.; Bernard, J.

    1980-11-15

    One hundred sixty-six patients with clinical stages IA, II/sub 2/A Hodgkin's disease were treated between April 1972 and December 1976 with three courses of multiagent chemotherapy (methylchlorethamine, vincristine, procarbazine, prednisone) followed by mantle irradiation - excluding mediastinum for those with initial upper cervical presentation and absence of mediastinal involvement - or inverted Y radiotherapy. With a follow-up of 12 to 84 months, the overall survival is 93.5% and the overall relapse-free survival 89.9%. With chemotherapy-radiotherapy sequence, staging laparotomy is not indicated. Results and side effects of this treatment strategy are compared with those of other treatment policies.

  16. 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.

  17. 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.

  18. [Clinical Response of Metastatic Colon Cancer to Chemotherapy with S-1 and Oxaliplatin - A Case Report].

    PubMed

    Morimoto, Tomonori; Yata, Yoshihiro; Yonenaga, Yoshikuni; Hanaki, Kouji; Mise, Masahiro; Higaside, Shunichi; Kanda, Yuuji; Noda, Hideki

    2015-06-01

    Chemotherapy with S-1 and oxaliplatin is a new treatment for metastatic colorectal cancer. We present the first case of S-1, oxaliplatin, and bevacizumab therapy in our hospital. The patient was a 69-year-old woman with ascending colon cancer and multiple lung and liver metastases. She tended to suffer from constipation; stenoses at the cecum and colon cancer were detected by colon fiberscopy. Following surgical resection of the primary tumor, the patient received systemic chemotherapy with S-1, oxaliplatin, and bevacizumab. Following chemotherapy, CT showed no cancer in the lung and cancer reduction in the liver or dissemination. The patient had diarrhea and no appetite at first, so we reduced the oxaliplatin dose by 80%. After reduction of the oxaliplatin dose, we could treat the patient with S-1 and oxaliplatin continuously with no toxicity. S-1 and oxaliplatin chemotherapy is cost-effective, and has less toxicity than other chemotherapies, if proper measures are taken. It seemed to have a non-inferior response rate and disease control compared to other chemotherapies, such as FOLFOX. Thus, this chemotherapy is a valid choice for metastatic colorectal cancer.

  19. Evidence-based medicine and clinical fluorodeoxyglucose PET/MRI in oncology.

    PubMed

    Miles, Kenneth; McQueen, Liam; Ngai, Stanley; Law, Phillip

    2015-11-17

    Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI) is a hybrid of two technologies each with its own evidence for clinical effectiveness. This article amalgamates evidence for clinical effectiveness of fluorodeoxyglucose (FDG) PET/CT and MRI as separate modalities with current evidence for hybrid PET/MRI and considers whether such an approach might provide a stronger case for the clinical use of PET/MRI at an earlier stage.Because links between diagnostic accuracy and health outcomes have already been established for FDG-PET/CT in the investigation of suspected residual or recurrent malignancies, evidence showing improved diagnostic performance and therapeutic impact from the use of PET/MRI as an alternative would imply clinical effectiveness of this modality for this application. A meta-analysis of studies comparing FDG-PET/CT to MRI in patients with suspected residual disease or recurrence of tumours indicates complementary roles for these modalities. PET demonstrates greater sensitivity for recurrence within lymph nodes whereas MRI is more effective that PET/CT in the detection of skeletal and hepatic recurrence. A review of studies assessing therapeutic impact of PET/MRI suggests a greater likelihood for change in clinical management when PET/MRI is used for assessment of suspected residual or recurrent disease rather than tumour staging.Supplementing the evidence-base for FDG-PET/MRI with studies that compare the components of this hybrid technology deployed separately indicates that FDG-PET/MRI is likely to be clinical effective for the investigation of patients with a range of suspected residual or recurrent cancers. This indication should therefore be prioritised for further health technology assessment.

  20. Oncology legislative update.

    PubMed

    Holmes, H

    2000-11-01

    This article reviews current legislative and regulatory issues of importance to the oncology community. Topics include patient protection, Medicare support of clinical trials, research data protection, the Medical Innovation Tax Credit, National Cancer Institute appropriations, and medical record privacy issues. Other topics discussed included funding for stem-cell research, genetic therapy oversight, and coverage for uninsured patients.

  1. A contemporary case study illustrating the integration of health information technologies into the organisation and clinical practice of radiation oncology.

    PubMed

    Miller, Alexis Andrew; Phillips, Aaron K

    2006-01-01

    The development of software in radiation oncology departments has seen the increase in capability from the Record and Verify software focused on patient safety to a fully-fledged Oncology Information System (OIS). This paper reports on the medical aspects of the implementation of a modern Oncology Information System (IMPAC MultiAccess, also known as the Siemens LANTIS) in a New Zealand hospital oncology department. The department was successful in translating paper procedures into electronic procedures, and the report focuses on the changes in approach to organisation and data use that occurred. The difficulties that were faced, which included procedural re-design, management of change, removal of paper, implementation cost, integration with the HIS, quality assurance and datasets, are highlighted along with the local solutions developed to overcome these problems.

  2. 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

  3. 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

  4. [Factitious diseases in oncology].

    PubMed

    Reich, Michel; Clermont, Amélie; Amela, Éric; Kotecki, Nuria

    2015-12-01

    Factitious diseases and pathomimias and particularly Munchausen's syndrome, due to their rarity, are poorly diagnosed by medical teams working in oncology. Consequences can be serious and result in unadapted surgery or non justified implementation of chemotherapy and radiotherapy regimens. These patients simulate diseases in order to attract medical attention. They might become belligerent and are likely to promptly discharge themselves from hospital if they do not get the desired attention or are unmasked. With two following case reports and literature review, we would like to alert clinicians about difficulties encountered in diagnosis and management of factitious disorders. When faced with this diagnosis, the patient will tend to deny reality and break contact with the medical team who exposed him. Medical peregrinating behavior surrounded by conflicts with medical team, past psychiatric illness, history of working in the medical and paramedical field and social isolation can guide the diagnosis. Somaticians and especially surgeons working in the oncologic field must remain vigilant about this diagnosis and collaborate with either the psycho-oncologic team or the consultation-liaison psychiatric team. Some recommendations for medical professionals how to cope with these patients will be suggested. PMID:26597474

  5. 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

  6. 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

  7. American Society of Clinical Oncology Policy Statement: The Role of the Oncologist in Cancer Prevention and Risk Assessment

    PubMed Central

    Zon, Robin T.; Goss, Elizabeth; Vogel, Victor G.; Chlebowski, Rowan T.; Jatoi, Ismail; Robson, Mark E.; Wollins, Dana S.; Garber, Judy E.; Brown, Powel; Kramer, Barnett S.

    2009-01-01

    Oncologists have a critical opportunity to utilize risk assessment and cancer prevention strategies to interrupt the initiation or progression of cancer in cancer survivors and individuals at high risk of developing cancer. Expanding knowledge about the natural history and prognosis of cancers positions oncologists to advise patients regarding the risk of second malignancies and treatment-related cancers. In addition, as recognized experts in the full spectrum of cancer care, oncologists are afforded opportunities for involvement in community-based cancer prevention activities. Although oncologists are currently providing many cancer prevention and risk assessment services to their patients, economic barriers exist, including inadequate or lack of insurance, that may compromise uniform patient access to these services. Additionally, insufficient reimbursement for existing and developing interventions may discourage patient access to these services. The American Society of Clinical Oncology (ASCO), the medical society representing cancer specialists involved in patient care and clinical research, is committed to supporting oncologists in their wide-ranging involvement in cancer prevention. This statement on risk assessment and prevention counseling, although not intended to be a comprehensive overview of cancer prevention describes the current role of oncologists in risk assessment and prevention; provides examples of risk assessment and prevention activities that should be offered by oncologists; identifies potential opportunities for coordination between oncologists and primary care physicians in prevention education and coordination of care for cancer survivors; describes ASCO's involvement in education and training of oncologists regarding prevention; and proposes improvement in the payment environment to encourage patient access to these services. PMID:19075281

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-01-01

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

  11. 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

  12. 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.

  13. Pathology is a necessary and informative tool in oncology clinical trials.

    PubMed

    Nagtegaal, Iris D; West, Nicholas P; van Krieken, J Han J M; Quirke, Phil

    2014-01-01

    Clinical trials are essential for the improvement of cancer care. The complexity of modern cancer care and research require careful design, for which input from all disciplines is necessary. Pathologists should play a key role in the design and execution of modern cancer trials, with special attention to the eligibility, stratification and evaluation of response to therapy. In the current review all these aspects are discussed, with examples from colorectal cancer trials. We describe critical issues in biomarker evaluation and development and emphasize the importance of the role of the pathologist in quality control of cancer treatment.

  14. Pharmacological foundations of cardio-oncology.

    PubMed

    Minotti, Giorgio; Salvatorelli, Emanuela; Menna, Pierantonio

    2010-07-01

    Anthracyclines and many other antitumor drugs induce cardiotoxicity that occurs "on treatment" or long after completing chemotherapy. Dose reductions limit the incidence of early cardiac events but not that of delayed sequelae, possibly indicating that any dose level of antitumor drugs would prime the heart to damage from sequential stressors. Drugs targeted at tumor-specific moieties raised hope for improving the cardiovascular safety of antitumor therapies; unfortunately, however, many such drugs proved unable to spare the heart, aggravated cardiotoxicity induced by anthracyclines, or were safe in selected patients of clinical trials but not in the general population. Cardio-oncology is the discipline aimed at monitoring the cardiovascular safety of antitumor therapies. Although popularly perceived as a clinical discipline that brings oncologists and cardiologists working together, cardio-oncology is in fact a pharmacology-oriented translational discipline. The cardiovascular performance of survivors of cancer will only improve if clinicians joined pharmacologists in the search for new predictive models of cardiotoxicity or mechanistic approaches to explain how a given drug might switch from causing systolic failure to inducing ischemia. The lifetime risk of cardiotoxicity from antitumor drugs needs to be reconciled with the identification of long-lasting pharmacological signatures that overlap with comorbidities. Research on targeted drugs should be reshaped to appreciate that the terminal ballistics of new "magic bullets" might involve cardiomyocytes as innocent bystanders. Finally, the concepts of prevention and treatment need to be tailored to the notion that late-onset cardiotoxicity builds on early asymptomatic cardiotoxicity. The heart of cardio-oncology rests with such pharmacological foundations.

  15. Heterochromatin protein 1α: a hallmark of cell proliferation relevant to clinical oncology

    PubMed Central

    De Koning, Leanne; Savignoni, Alexia; Boumendil, Charlène; Rehman, Haniya; Asselain, Bernard; Sastre-Garau, Xavier; Almouzni, Geneviève

    2009-01-01

    Mammalian cells contain three closely related heterochromatin protein 1 (HP1) isoforms, HP1α, β and γ, which, by analogy to their unique counterpart in Schizosaccharomyces pombe, have been implicated in gene silencing, genome stability and chromosome segregation. However, the individual importance of each isoform during normal cell cycle and disease has remained an unresolved issue. Here, we reveal that HP1α shows a proliferation-dependent regulation, which neither HP1β nor γ display. During transient cell cycle exit, the HP1α mRNA and protein levels diminish. Transient depletion of HP1α, but not HP1β or γ, in tumoural and primary human cells leads to defects in chromosome segregation. Notably, analysis of an annotated collection of samples derived from carcinomas reveals an overexpression of HP1α mRNA and protein, which correlates with clinical data and disease outcome. Our results unveil a specific expression pattern for the HP1α isoform, suggesting a unique function related to cell division and tumour growth. The overexpression of HP1α constitutes a new example of a potential epigenetic contribution to tumourigenesis that is of clinical interest for cancer prognosis. PMID:20049717

  16. 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.

  17. The role of Tc-99m sestamibi imaging in predicting clinical response to chemotherapy in lung cancer.

    PubMed

    Dirlik, Aysegul; Burak, Zeynep; Goksel, Tuncay; Erinc, Ruya; Karakus, Haydar; Ozcan, Zehra; Veral, Ali; Ozhan, Mustafa

    2002-04-01

    Multidrug resistance (MDR) is a major problem in lung cancer. Tc-99m methoxyisobutyl isonitrile (MIBI) has been demonstrated to be a non-invasive marker to diagnose MDRI related P-glycoprotein (Pgp) and multidrug resistance-associated protein (MRP) expression in various solid tumors. The aim of this study was to evaluate the relationship between the degree of Tc-99m MIBI uptake and its retention on delayed images and the response to chemotherapy in lung cancer. Twenty-three patients (1 woman and 22 men, age range 40-67 years) with lung cancer (9 small cell and 14 non-small cell) were examined with Tc-99m MIBI imaging before chemotherapy. After i.v. administration of 740 MBq Tc-99m MIBI, planar and SPECT imaging at 30 minutes and 2 hours was performed. Tumor to normal lung uptake ratio (T/N) and percent retention were measured. Response to chemotherapy was evaluated according to follow-up CT and grouped as complete responders (CR), partial responders (PR) and non-responders (NR). Clinical follow-up and CT evaluation revealed that 12 patients had partial remission, 4 patients had complete remission and 7 patients had no-remission after chemotherapy. Statistically, there was no significant correlation between early (30 min), delayed (2 hr) T/N ratios and percent retention of Tc-99m MIBI with chemotherapeutic response of the lung cancer among the three groups (p > 0.05). Results of the current study imply that Tc-99m MIBI uptake and the retention index may not correlate with chemotherapy response in lung cancer, so that the accuracy of this method needs to be verified in a larger series with additional investigation at the molecular level.

  18. 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

  19. 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

  20. 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.

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

    PubMed

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

    2016-10-01

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

  2. [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.

  3. 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.

  4. Design and implementation of an electronic point-of-contact oncology clinical record.

    PubMed

    Laukkanen, E; Maier, M

    1995-01-01

    An electronic point-of-contact narrative clinical record was developed and implemented in a multidisciplinary regional cancer center with an annual new caseload of 1,200. Design principles included (1) natural clinician-intuitive interface with pen, touch, and sound input options; (2) structure and processes enabling direct input of both clinician-reported and patient-reported data; (3) embedding of decision support and practice guidelines directly into the interface; (4) incorporation of automated cancer staging algorithms; (5) automatic production of consultation and progress notes, limiting transcription requirements to sound fields; (6) outcomes--focused report formats; and (7) integrated billing and activity reporting. The system was implemented in Windows, both on a local area network and on mobile devices. Evaluation parameters included feasibility, acceptance, performance, cost of hardware and software development and/or customization, cost of system maintenance, and comparison of net clinician time for encounter documentation relative to a paper-based standard. Feasibility, acceptance, and cost-effectiveness were established.

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

    PubMed

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

    2008-01-10

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

  6. Results of the 2005-2008 Association of Residents in Radiation Oncology Survey of Chief Residents in the United States: Clinical Training and Resident Working Conditions

    SciTech Connect

    Gondi, Vinai; Bernard, Johnny Ray; Jabbari, Siavash; Keam, Jennifer; Amorim Bernstein, Karen L. de; Dad, Luqman K.; Li, Linna; Poppe, Matthew M.; Strauss, Jonathan B.; Chollet, Casey T.

    2011-11-15

    Purpose: To document clinical training and resident working conditions reported by chief residents during their residency. Methods and Materials: During the academic years 2005 to 2006, 2006 to 2007, and 2007 to 2008, the Association of Residents in Radiation Oncology conducted a nationwide survey of all radiation oncology chief residents in the United States. Chi-square statistics were used to assess changes in clinical training and resident working conditions over time. Results: Surveys were completed by representatives from 55 programs (response rate, 71.4%) in 2005 to 2006, 60 programs (75.9%) in 2006 to 2007, and 74 programs (93.7%) in 2007 to 2008. Nearly all chief residents reported receiving adequate clinical experience in commonly treated disease sites, such as breast and genitourinary malignancies; and commonly performed procedures, such as three-dimensional conformal radiotherapy and intensity-modulated radiotherapy. Clinical experience in extracranial stereotactic radiotherapy increased over time (p < 0.001), whereas clinical experience in endovascular brachytherapy (p <0.001) decreased over time. The distribution of gynecologic and prostate brachytherapy cases remained stable, while clinical case load in breast brachytherapy increased (p = 0.006). A small but significant percentage of residents reported receiving inadequate clinical experience in pediatrics, seeing 10 or fewer pediatric cases during the course of residency. Procedures involving higher capital costs, such as particle beam therapy and intraoperative radiotherapy, and infrequent clinical use, such as head and neck brachytherapy, were limited to a minority of institutions. Most residency programs associated with at least one satellite facility have incorporated resident rotations into their clinical training, and the majority of residents at these programs find them valuable experiences. The majority of residents reported working 60 or fewer hours per week on required clinical duties

  7. Shared Risk Factors for Cardiovascular Disease and Cancer: Implications for Preventive Health and Clinical Care in Oncology Patients.

    PubMed

    Johnson, Christopher B; Davis, Margot K; Law, Angeline; Sulpher, Jeffrey

    2016-07-01

    The cardiovascular toxicity of cancer therapy has raised awareness of the importance of heart disease in cancer care among oncologists and cardiologists, leading to the new interdisciplinary field of cardio-oncology. Evidence is accumulating to suggest that risk factors associated with cardiovascular disease are also related to an increased incidence of cancer and excess cancer mortality. We review the epidemiologic evidence that smoking, obesity, poor diet, and inactivity can cause both heart disease and cancer. The importance of cardiovascular disease and cardiovascular risk factors in adversely affecting oncological outcomes and leading to increased cancer mortality is discussed. Cardiotoxicity prediction tools that incorporate cardiac disease and risk factors are described. Raising awareness about shared risk factors for cancer and heart disease may result in more effective advocacy to promote healthy lifestyle changes through the combined efforts of the historically separate specialties of cardiology and oncology. PMID:27343745

  8. 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.

  9. Clinical benefits of combined chemotherapy with S-1, oxaliplatin, and docetaxel in advanced gastric cancer patients with palliative surgery

    PubMed Central

    Liu, Yan; Feng, Ye; Gao, Yongjian; Hou, Ruizhi

    2016-01-01

    Background and aim Advanced gastric cancer accounts for a substantial portion of cancer-related mortality worldwide. Surgical intervention is the curative therapeutic approach, but patients with advanced gastric cancer are not eligible for the radical resection. The present work aimed to investigate the efficacy and safety of palliative surgery combined with S-1, oxaliplatin, and docetaxel chemotherapy in the treatment of patients with advanced gastric cancer. Method A total of 20 patients who underwent palliative resection of gastric cancer in China–Japan Union Hospital of Jilin University from 2010 to 2011 were evaluated. Days 20–30 postoperative, these patients started to receive chemotherapy of S-1 (40 mg/m2, oral intake twice a day) and intravenous infusion of oxaliplatin (135 mg/m2) and docetaxel (75 mg/m2). After three cycles of chemotherapy (21 days/cycle), patients were evaluated, and only those who responded toward the treatment continued to receive six to eight cycles of the treatment and were included in end point evaluation. Patients’ survival time and adverse reactions observed along the treatment were compared with those treated with FOLFOX. Results Out of 20 patients evaluated, there was one case of complete response, nine cases of partial response, six cases of stable disease, and four cases of progressive disease. The total efficacy (complete response + partial response) and clinical benefit rates were 50% and 80%, respectively. Of importance, the treatment achieved a significantly longer survival time compared to FOLFOX, despite the fact that both regimens shared common adverse reactions. The adverse reactions were gastrointestinal reaction, reduction in white blood cells, and peripheral neurotoxicity. All of them were mild, having no impact on the treatment. Conclusion Combination therapy of S-1, oxaliplatin, and docetaxel improves the survival of gastric cancer patients treated with palliative resection, with adverse reactions being

  10. Multicriteria decision analysis in oncology

    PubMed Central

    Adunlin, Georges; Diaby, Vakaramoko; Montero, Alberto J.; Xiao, Hong

    2015-01-01

    Background There has been a growing interest in the development and application of alternative decision-making frameworks within health care, including multicriteria decision analysis (MCDA). Even though the literature includes several reviews on MCDA methods, applications of MCDA in oncology are lacking. Aim The aim of this paper is to discuss a rationale for the use of MCDA in oncology. In this context, the following research question emerged: How can MCDA be used to develop a clinical decision support tool in oncology? Methods In this paper, a brief background on decision making is presented, followed by an overview of MCDA methods and process. The paper discusses some applications of MCDA, proposes research opportunities in the context of oncology and presents an illustrative example of how MCDA can be applied to oncology. Findings Decisions in oncology involve trade-offs between possible benefits and harms. MCDA can help analyse trade-off preferences. A wide range of MCDA methods exist. Each method has its strengths and weaknesses. Choosing the appropriate method varies depending on the source and nature of information used to inform decision making. The literature review identified eight studies. The analytical hierarchy process (AHP) was the most often used method in the identified studies. Conclusion Overall, MCDA appears to be a promising tool that can be used to assist clinical decision making in oncology. Nonetheless, field testing is desirable before MCDA becomes an established decision-making tool in this field. PMID:24635949

  11. 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

  12. 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

  13. 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.

  14. Response Assessment in Neuro-Oncology working group and European Association for Neuro-Oncology recommendations for the clinical use of PET imaging in gliomas.

    PubMed

    Albert, Nathalie L; Weller, Michael; Suchorska, Bogdana; Galldiks, Norbert; Soffietti, Riccardo; Kim, Michelle M; la Fougère, Christian; Pope, Whitney; Law, Ian; Arbizu, Javier; Chamberlain, Marc C; Vogelbaum, Michael; Ellingson, Ben M; Tonn, Joerg C

    2016-09-01

    This guideline provides recommendations for the use of PET imaging in gliomas. The review examines established clinical benefit in glioma patients of PET using glucose ((18)F-FDG) and amino acid tracers ((11)C-MET, (18)F-FET, and (18)F-FDOPA). An increasing number of studies have been published on PET imaging in the setting of diagnosis, biopsy, and resection as well radiotherapy planning, treatment monitoring, and response assessment. Recommendations are based on evidence generated from studies which validated PET findings by histology or clinical course. This guideline emphasizes the clinical value of PET imaging with superiority of amino acid PET over glucose PET and provides a framework for the use of PET to assist in the management of patients with gliomas. PMID:27106405

  15. Locally Advanced Rectal Cancer Patients Receiving Radio-Chemotherapy: A Novel Clinical-Pathologic Score Correlates With Global Outcome

    SciTech Connect

    Berardi, Rossana; Mantello, Giovanna; Scartozzi, Mario; Del Prete, Stefano; Luppi, Gabriele; Martinelli, Roberto; Fumagalli, Marco; Grillo-Ruggieri, Filippo; Bearzi, Italo; Mandolesi, Alessandra; Marmorale, Cristina; Cascinu, Stefano

    2009-12-01

    Purpose: To determine the importance of downstaging of locally advanced rectal cancer after neoadjuvant treatment. Methods and Materials: The study included all consecutive patients with locally advanced rectal cancer who underwent neoadjuvant treatment (chemotherapy and/or radiotherapy) in different Italian centers from June 1996 to December 2003. A novel score was used, calculated as the sum of numbers obtained by giving a negative or positive point, respectively, to each degree of increase or decrease in clinical to pathologic T and N status. Results: A total of 317 patients were eligible for analysis. Neoadjuvant treatments performed were as follows: radiotherapy alone in 75 of 317 patients (23.7%), radiotherapy plus chemotherapy in 242 of 317 patients (76.3%). Worse disease-free survival was observed in patients with a lower score (Score 1 = -3 to +3 vs. Score 2 = +4 to +7; p = 0.04). Conclusions: Our results suggest that a novel score, calculated from preoperative and pathologic tumor and lymph node status, could represent an important parameter to predict outcome in patients receiving neoadjuvant treatment for rectal cancer. The score could be useful to select patients for adjuvant chemotherapy after neoadjuvant treatment and surgery.

  16. Clinical effects of immunotherapy of DC-CIK combined with chemotherapy in treating patients with metastatic breast cancer.

    PubMed

    Mao, Qixin; Li, Lianfang; Zhang, Chongjian; Sun, Yadong; Liu, Shanqing; Cui, Shude

    2015-05-01

    This study aimed to analyze the clinical effects of dendritic cell (DC) and cytokine-induced killer (CIK) immunotherapy combined with chemotherapy on patients with metastatic breast cancer. Twenty patients were included into this study who were diagnosed as metastatic breast cancer (MBC). DC and CIK were augmented by in vitro culture and then rein fused into body through vein.The pain relief rate (RR), toxic and side effects of chemotherapy, immunity functions and living quality of patients were observed. DC and CIK cells were induced by the autologous peripheral blood mononuclear cells (PBMC). Meanwhile, flow cytometry was used to measure T cell subsets and natural killer T (NKT) cells in patients in the two groups before and after the biological treatment. After DC and CIK were rein fused into the patients body, no severe side-effect was found. It was also found that cellular immunotherapy combined with chemotherapy the immunotherapy of cells improved the immunity, the living quality of patients and the disease control rate (DCR). In conclusion, cellular immunotherapy produces small side effects; it combined with chemotherapyis able to improve the DCR and living quality of patients and prolong their lives.

  17. PD-L1 polymorphism can predict clinical outcomes of non-small cell lung cancer patients treated with first-line paclitaxel-cisplatin chemotherapy

    PubMed Central

    Lee, Shin Yup; Jung, Deuk Kju; Choi, Jin Eun; Jin, Cheng Cheng; Hong, Mi Jeong; Do, Sook Kyung; Kang, Hyo-Gyoung; Lee, Won Kee; Seok, Yangki; Lee, Eung Bae; Jeong, Ji Yun; Shin, Kyung Min; Yoo, Seung Soo; Lee, Jaehee; Cha, Seung Ick; Kim, Chang Ho; Park, Jae Yong

    2016-01-01

    This study was conducted to investigate whether polymorphisms of genes involved in immune checkpoints can predict the clinical outcomes of patients with advanced stage non-small cell lung cancer (NSCLC) after 1st line paclitaxel-cisplatin chemotherapy. A total of 379 NSCLC patients were enrolled. Twelve single nucleotide polymorphisms (SNPs) of PD-1, PD-L1, and CTLA-4 genes were selected and genotyped. The associations of SNPs with chemotherapy response and overall survival (OS) were analyzed. Among the 12 SNPs investigated, PD-L1 rs2297136T > C and rs4143815C > G were significantly associated with clinical outcomes after chemotherapy. The rs2297136T > C was significantly associated with both better chemotherapy response and better OS, and the rs4143815C > G had a significantly better response to chemotherapy. Consistent with the individual genotype analyses, rs2297136C-rs4143815G haplotype (ht4) carrying variant alleles at both loci was significantly associated with better chemotherapy response and OS compared with combined other haplotypes. Patients with at least one ht4 had significantly better chemotherapy response and OS compared to those without ht4. PD-L1 rs2297136T > C and rs4143815C > G polymorphisms may be useful for the prediction of clinical outcome of 1st line paclitaxel-cisplatin chemotherapy in NSCLC. Further studies are needed to confirm our findings and to understand the role of PD-L1 in the chemotherapy outcome of NSCLC patients. PMID:27181838

  18. 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.

  19. 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

  20. American Society of Clinical Oncology policy statement update: tobacco control--reducing cancer incidence and saving lives. 2003.

    PubMed

    2003-07-15

    As an international medical society dedicated to cancer prevention, the American Society of Clinical Oncology (ASCO) advocates a fundamental reform of United States and international policy toward addictive tobacco products. ASCO's goal is the immediate reduction of tobacco use and ultimate achievement of a tobacco-free world. The centerpiece of ASCO's policy is the recommendation for an independent commission to study the tobacco problem in all of its dimensions: social, medical, legal, and economic (both domestically and globally). The commission membership should include broad-based representation and expertise on tobacco issues. In ASCO's view, tobacco control efforts to date have been less than successful because they are too fragmented and incremental, leaving many important issues unaddressed. A more comprehensive solution could flow from this study, including input from a variety of government agencies involved with public health, agriculture, First Amendment and other legal considerations, and international trade. The study, within defined time limits, should culminate in a report that outlines a strategy for achieving immediate reduction of tobacco use and ultimate achievement of a tobacco-free world, including explicit plans and a timetable for implementation. Although this comprehensive approach to tobacco control will take many years to implement even under the best of circumstances, there are certain measures that could be undertaken immediately with meaningful impact on tobacco usage. These include: Increasing efforts to discourage tobacco use, particularly among the young Raising federal excise taxes by at least $2 per pack and encouraging states to consider tobacco taxes as a first resort in revenue enhancement Ensuring that tobacco settlement funds be devoted only to health-related projects, including medical treatment, biomedical research, and tobacco prevention efforts Requiring disclosure of all ingredients in tobacco products Comprehensively

  1. Eva Between Anxiety and Hope: Integrating Anthroposophic Music Therapy in Supportive Oncology Care.

    PubMed

    Ben-Arye, Eran; Ben-Arye, Yotam; Barak, Yael

    2015-11-30

    Music therapy is a significant modality in the treatment of patients with cancer, who suffer emotional and spiritual distress as well as chemotherapy side effects that impair their quality of life. In this article, we present a case study of a patient challenged with recurrent ovarian cancer who received, concomitant with chemotherapy, a special form of music therapy based on anthroposophic medicine (AM) aimed at alleviating anxiety and improving her general well-being. AM-centered music therapy goals are discussed in regard to two modes of treatment: receptive listening and clinical composition. Next, these two treatment modes are discussed in a broader context by reviewing conventional music therapy interventions during chemotherapy on two axes: a. standardized vs. individualized treatment; b. patient's involvement on a passive to active continuum. In conclusion, psycho-oncology care can be enriched by adding anthroposophic medicine-oriented music therapy integrated within patients' supportive care. PMID:26973967

  2. 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

  3. 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.

  4. Cytotoxic chemotherapy: Still the mainstay of clinical practice for all subtypes metastatic breast cancer.

    PubMed

    Twelves, Chris; Jove, Maria; Gombos, Andrea; Awada, Ahmad

    2016-04-01

    Cytotoxic chemotherapy remains central to the treatment of all subtypes of metastatic breast cancer (MBC). We review evidence-based chemotherapy options for women with MBC after an anthracycline and a taxane including re-challenge with anthracycline or taxane, capecitabine, eribulin and ixabepilone as a single agent or combination with capecitabine (not approved in the EU); and the vinca alkaloid vinflunine as single agent or combined with either capecitabine/gemcitabine (also not approved EU or USA). Etirinotecan pegol, comprising irinotecan bound to polyethylene glycol by a biodegradable linker, is a new cytotoxic agent for patients with MBC that has achieved encouraging response rates in phase II studies; it has been further evaluated in the phase III BEACON trial. New cytotoxics should address novel targets or modes of delivery, achieve meaningful improvements in outcomes and seek to identify predictive biomarker(s). PMID:26857987

  5. 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).

  6. Chemotherapy-induced peripheral neurotoxicity in cancer survivors: an underdiagnosed clinical entity?

    PubMed

    Cavaletti, Guido; Alberti, Paola; Marmiroli, Paola

    2015-01-01

    Systemic chemotherapy is a cornerstone of the modern medical management of cancer, although its use is limited by toxicity on normal tissues and organs, including the nervous system. Long-surviving or cured people strongly require a high level of wellness in addition to prolongation of life (the concept of the quality of survival), but neurologic dysfunction can severely affect daily life activities. Chemotherapy-related peripheral neurotoxicity is becoming one of the most worrisome long-term side effects in patients affected by a neoplasm. The central nervous system has a limited capacity to recover from injuries, and it is not surprising that severe damage can determine long-term or permanent neurologic dysfunction. However, the peripheral nervous system also can be permanently damaged by anticancer treatments despite its better regeneration capacities, and the effect on patients' daily life activities might be extremely severe. However, only recently, the paradigms of peripheral neurotoxicity reversibility have been scientifically challenged, and studies have been performed to capture the patients' perspectives on this issue and to measure the effect of peripheral neurotoxicity on their daily life activities. Despite these efforts, knowledge about this problem is still largely incomplete, and further studies are necessary to clarify the several still-unsettled aspects of long-term peripheral neurotoxicity of conventional and targeted anticancer chemotherapy.

  7. 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.

  8. 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

  9. Improved efficiency in clinical workflow of reporting measured oncology lesions via PACS-integrated lesion tracking tool.

    PubMed

    Sevenster, Merlijn; Travis, Adam R; Ganesh, Rajiv K; Liu, Peng; Kose, Ursula; Peters, Joost; Chang, Paul J

    2015-03-01

    OBJECTIVE. Imaging provides evidence for the response to oncology treatment by the serial measurement of reference lesions. Unfortunately, the identification, comparison, measurement, and documentation of several reference lesions can be an inefficient process. We tested the hypothesis that optimized workflow orchestration and tight integration of a lesion tracking tool into the PACS and speech recognition system can result in improvements in oncologic lesion measurement efficiency. SUBJECTS AND METHODS. A lesion management tool tightly integrated into the PACS workflow was developed. We evaluated the effect of the use of the tool on measurement reporting time by means of a prospective time-motion study on 86 body CT examinations with 241 measureable oncologic lesions with four radiologists. RESULTS. Aggregated measurement reporting time per lesion was 11.64 seconds in standard workflow, 16.67 seconds if readers had to register measurements de novo, and 6.36 seconds for each subsequent follow-up study. Differences were statistically significant (p < 0.05) for each reader, except for one difference for one reader. CONCLUSION. Measurement reporting time can be reduced by using a PACS workflow-integrated lesion management tool, especially for patients with multiple follow-up examinations, reversing the onetime efficiency penalty at baseline registration.

  10. Clinical Benefits of Systemic Chemotherapy for Patients with Metastatic Pheochromocytomas or Sympathetic Extra-Adrenal Paragangliomas: Insights from the Largest Single Institutional Experience

    PubMed Central

    Ayala-Ramirez, Montserrat; Feng, Lei; Habra, Mouhammed A.; Rich, Thereasa; Dickson, Paxton V.; Perrier, Nancy; Phan, Alexandria; Waguespack, Steven; Patel, Shreyaskumar; Jimenez, Camilo

    2013-01-01

    Background The purpose of this study was to evaluate the clinical benefits of systemic chemotherapy for patients with metastatic pheochromocytomas or sympathetic paragangliomas by assessing reduction in tumor size, blood pressure, and improvement in overall survival. Methods We retrospectively reviewed the medical records of patients with metastatic pheochromocytomas-sympathetic paragangliomas who had received chemotherapy at The University of Texas MD Anderson Cancer Center Results Clinical benefit and overall survival (OS) were assessed. Of fifty-four patients treated with chemotherapy, fifty-two were evaluable for response. Seventeen (33%) experienced a response, defined as decreased or normalized blood pressure/decreased number and dosage of antihypertensive medications and/or reduced tumor size after the first chemotherapy regimen. The median OS time was 6.4 years (95 confidence interval (CI): 5.2–16.4) for responders and 3.7 (95% CI: 3.0–7.5) years for non-responders. Of patients who had synchronous metastatic disease, a positive response at 1 year after the start of chemotherapy was associated with a trend toward a longer overall survival (log-rank test, P-value =0.095). In a multivariate Cox proportional hazards model, the effect of response to chemotherapy on overall survival was significant (hazard ratio=0.22, 95% confidence interval: 0.05–1.0; P-value = 0.05). All responders had been treated with dacarbazine and cyclophosphamide. Vincristine was included for 14 responders and doxorubicin was included for 12 responders. We could not identify clinical factors that predicted response to chemotherapy. Conclusion Chemotherapy may decrease tumor size and facilitate blood pressure control in about 33% of patients with metastatic pheochromocytoma-sympathetic paraganglioma. These patients exhibit a longer survival. PMID:22006217

  11. Hyperthermia in oncology.

    PubMed

    Falk, M H; Issels, R D

    2001-01-01

    The purpose of this article is to provide an overview on the current clinical application of hyperthermia combined with conventional treatment modalities (e.g. ionizing radiation, chemotherapy) in the treatment of malignant disease. The clinical application of hyperthermia with increase of tissue temperatures (range 40-44 degrees C) has been integrated in multimodal anti-cancer strategies. This review describes selected phase I or II (n = 17) and phase III trials (n = 16) investigating the effect of hyperthermia combined with radiotherapy (n = 10 trials), chemotherapy (n = 15 trials), or both (n = 8 trials) in a total of more than 2200 patients. The trials were performed in a variety of solid tumours (e.g. melanoma, head and neck cancer, breast cancer, cancer of the gastrointestinal or urogenital tract, glioblastoma, sarcoma) in paediatric or adult patients. Profound research has produced a scientific basis for the simultaneous application of hyperthermia in combination with ionizing radiation and/or systemic chemotherapy. Hyperthermia is becoming more accepted clinically, due to the substantial technical improvements made in achieving selected increase of temperatures in superficial and deep-seated tumours. At present, the combination of hyperthermia and chemotherapy or radiochemotherapy is further tested within clinical protocols (phase II/III) in order to improve local tumour control and relapse-free survival in patients with high-risk or advanced tumours of different entities.

  12. [Biosimilars in oncology].

    PubMed

    Barroso, Sérgio; Coutinho, Jorge; Damasceno, Margarida; Dinis, José; Forjaz de Lacerda, João; Gervásio, Helena; Leal da Costa, Fernando; Marques Pereira, Ana; Parreira, António; Principe, Fernando; Rodrigues, Helena; Sá, Anabela; Teixeira, Adriana

    2009-01-01

    The development of biotechnology drugs represents one of the great advances in medical therapy and it was observed an exponential growth in its use. The resource to these drugs in Oncology and Hematology is no exception and it soon became an essential element of an integrated and directed therapy strategy. The expiry of the first biotechnology drugs patents has opened the door for the development and marketing of biosimilars, which entry in the Portuguese market was recently approved. This article was built on the analysis of the available state-of-the-art information on biotechnology drugs, biosimilars and current legislation and it expresses the opinion of Oncology and Hematology experts about the substituition of biological drugs by biosimilars in clinical practice.

  13. [Therapeutic advances of nuclear medicine in oncology].

    PubMed

    Valdés Olmos, R A; Hoefnagel, C A; Bais, E; Boot, H; Taal, B; de Kraker, J; Vote, P A

    2001-12-01

    III studies as well as the planning of multicenter trials following the guidelines and criteria of clinical oncology will determine the future advances in this field.

  14. [Clinical evaluation of M-VAC (methotrexate, vinblastine, adriamycin and cisplatin) chemotherapy for advanced urothelial cancer].

    PubMed

    Mikami, K; Nakagawa, S; Takada, H; Ebisui, K; Sugimoto, K; Watanabe, H; Maegawa, M; Nakao, M

    1994-04-01

    M-VAC (methotrexate, vinblastine, adriamycin and cisplatin) chemotherapy was performed on 27 patients with advanced urothelial cancer. The patients included 20 with bladder cancer, 4 with upper urinary tract cancer and 3 with both lesions. Complete response (CR) was observed in 2 (7.4 +/- 9.9%) patients and partial response (PR) in 10 (37.0 +/- 18.2%) patients after the treatment, i.e., the overall objective response rate was 44.4 +/- 18.7%. The rate of relapse or recurrence in the patients with CR and PR was 100% and 90.0%, respectively. The mean duration of the response was 18.5 +/- 13.4 months and 10.7 +/- 10.9 months for CR and PR, respectively. The overall survival rate after one year was 30.2%. Bone marrow suppression was the most serious side effect. The white blood cell count became below 1,000/microliters in 10 patients (36.7%). Among them, 4 patients suffered from sepsis. In conclusion, M-VAC chemotherapy was effective for induction therapy against advanced urothelial cancer, although the effective duration was short. Further maintenance therapy should be established.

  15. 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

  16. 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

  17. Ethical issues at the interface of clinical care and research practice in pediatric oncology: a narrative review of parents' and physicians' experiences

    PubMed Central

    2011-01-01

    Background Pediatric oncology has a strong research culture. Most pediatric oncologists are investigators, involved in clinical care as well as research. As a result, a remarkable proportion of children with cancer enrolls in a trial during treatment. This paper discusses the ethical consequences of the unprecedented integration of research and care in pediatric oncology from the perspective of parents and physicians. Methodology An empirical ethical approach, combining (1) a narrative review of (primarily) qualitative studies on parents' and physicians' experiences of the pediatric oncology research practice, and (2) comparison of these experiences with existing theoretical ethical concepts about (pediatric) research. The use of empirical evidence enriches these concepts by taking into account the peculiarities that ethical challenges pose in practice. Results Analysis of the 22 studies reviewed revealed that the integration of research and care has consequences for the informed consent process, the promotion of the child's best interests, and the role of the physician (doctor vs. scientist). True consent to research is difficult to achieve due to the complexity of research protocols, emotional stress and parents' dependency on their child's physician. Parents' role is to promote their child's best interests, also when they are asked to consider enrolling their child in a trial. Parents are almost never in equipoise on trial participation, which leaves them with the agonizing situation of wanting to do what is best for their child, while being fearful of making the wrong decision. Furthermore, a therapeutic misconception endangers correct assessment of participation, making parents inaccurately attribute therapeutic intent to research procedures. Physicians prefer the perspective of a therapist over a researcher. Consequently they may truly believe that in the research setting they promote the child's best interests, which maintains the existence of a therapeutic

  18. 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. PMID:25811220

  19. 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.

  20. 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. PMID:26713672

  1. The impact of extracellular matrix on the chemoresistance of solid tumors--experimental and clinical results of hyaluronidase as additive to cytostatic chemotherapy.

    PubMed

    Baumgartner, G; Gomar-Höss, C; Sakr, L; Ulsperger, E; Wogritsch, C

    1998-09-11

    Chemoresistance is of outstanding importance for the limited results of chemotherapy in solid tumors. Chemoresistance of multicellular tumor tissues is more pronounced than that of single cells in vivo and in vitro. The enzyme hyaluronidase is able to loosen the cell-cell contact and the interstitial connective tissue and as such, in a number of preclinical and clinical trials, was shown to enhance the efficacy of cytostatic agents. Although proven to be very effective as additive to local chemotherapy, the systemic efficacy is not documented as well. We present a randomized trial done in high-grade astrocytomas with combined chemotherapy and radiation therapy with and without hyaluronidase. After very promising pilot results with systemic hyaluronidase in various tumor entities and also astrocytomas, this randomized study failed to show synergy to chemotherapy and radiation therapy in high-grade astrocytomas concerning survival. The promising preclinical data and the rather well documented activity in therapeutic use as additive to local chemotherapy seem to be an adequate motive to further elucidate the complex manner in which hyaluronidase is active in the interstitial tumor matrix and to obtain more information concerning the optimal route of application, the optimal dosage and the spectrum of tumor entities where it is synergistic with cytostatic chemotherapy and perhaps even radiation therapy.

  2. 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.

  3. Induction cytotoxic chemotherapy: the significance of apparent complete clinical regression after using the Price Hill Schedule A protocol for squamous carcinoma of the head and neck.

    PubMed

    Shaw, H J

    1988-12-01

    A small group of 46 previously untreated patients out of about 260 in all who have received Price Hill Schedule A cytotoxic chemotherapy, achieved apparent complete clinical regression (ACCR) of their disease before local treatment. Forty patients were classified T3 or T4, over half having clinically positive nodes at the start of treatment. A determinate survival rate of 70 per cent disease free at three years was obtained and 74 per cent achieved quality relief of all symptoms. Two patients declined local treatment and survived three years disease free after chemotherapy alone. No recurrence has occurred to date in seven patients achieving apparent complete histological regression (ACHR) in their surgical specimens. Although ACCR does not automatically improve prognosis it is likely that it does enhance the complete remission rate, especially for those also achieving ACHR. Benefits to patients obtaining ACCR with this minimally toxic chemotherapy schedule are listed. PMID:2465362

  4. 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.

  5. The correlation between LDH serum levels and clinical outcome in advanced biliary tract cancer patients treated with first line chemotherapy

    PubMed Central

    Faloppi, Luca; Del Prete, Michela; Gardini, Andrea Casadei; Santini, Daniele; Silvestris, Nicola; Bianconi, Maristella; Giampieri, Riccardo; Valgiusti, Martina; Brunetti, Oronzo; Bittoni, Alessandro; Andrikou, Kalliopi; Lai, Eleonora; Dessì, Alessandra; Cascinu, Stefano; Scartozzi, Mario

    2016-01-01

    LDH may represent an indirect marker of neo-angiogenesis and worse prognosis in many tumour types. We assessed the correlation between LDH and clinical outcome for biliary tract cancer (BTC) patients treated with first-line chemotherapy. Overall, 114 advanced BTC patients treated with first-line gemcitabine and cisplatin were included. Patients were divided into two groups (low vs. high LDH), according to pre-treatment LDH values. Patients were also classified according to pre- and post-treatment variation in LDH serum levels (increased vs. decreased). Median progression free survival (PFS) was 5.0 and 2.6 months respectively in patients with low and high pre-treatment LDH levels (p = 0.0042, HR = 0.56, 95% CI: 0.37–0.87). Median overall survival (OS) was 7.7 and 5.6 months (low vs. high LDH) (p = 0.324, HR = 0.81, 95% CI: 0.54–1.24). DCR was 71% vs. 43% (low vs. high LDH) (p = 0.002). In 38 patients with decreased LDH values after treatment, PFS and OS were respectively 6.2 and 12.1 months, whereas in 76 patients with post-treatment increased LDH levels, PFS and OS were respectively 3.0 and 5.1 months (PFS: p = 0.0009; HR = 0.49; 95% IC: 0.33–0.74; OS: p < 0.0001; HR = 0.42; 95% IC: 0.27–0.63). Our data seem to suggest that LDH serum level may predict clinical outcome in BTC patients receiving first-line chemotherapy. PMID:27063994

  6. 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

  7. Chemotherapy-Related Neurotoxicity.

    PubMed

    Taillibert, Sophie; Le Rhun, Emilie; Chamberlain, Marc C

    2016-09-01

    Chemotherapy may have detrimental effects on either the central or peripheral nervous system. Central nervous system neurotoxicity resulting from chemotherapy manifests as a wide range of clinical syndromes including acute, subacute, and chronic encephalopathies, posterior reversible encephalopathy, acute cerebellar dysfunction, chronic cognitive impairment, myelopathy, meningitis, and neurovascular syndromes. These clinical entities vary by causative agent, degree of severity, evolution, and timing of occurrence. In the peripheral nervous system, chemotherapy-induced peripheral neuropathy (CIPN) and myopathy are the two main complications of chemotherapy. CIPN is the most common complication, and the majority manifest as a dose-dependent length-dependent sensory axonopathy. In severe cases of CIPN, the dose of chemotherapy is reduced, the administration delayed, or the treatment discontinued. Few treatments are available for CIPN and based on meta-analysis, duloxetine is the preferred symptomatic treatment. Myopathy due to corticosteroid use is the most frequent cause of muscle disorders in patients with cancer. PMID:27443648

  8. [Assessment and treatment of intractable pain: six months' experience in the relief of pain at the ludwig Boltzmann Institute of Clinical Oncology (author's transl)].

    PubMed

    Jenkner, F L

    1976-07-16

    A preliminary report is presented on the results achieved in the assessment and treatment of patients with intractable pain during the first six months experience gained following the appointment of a pain consultant at the Ludwig Boltzmann Institute of Clinical Oncology. Nerve blockade was carried out 106 times in 45 patients suffering from primary or secondary malignant disease and 71 times in 18 patients with other conditions; intrathecal instillation of 96% alcohol was performed once and 2 chordotomies were also performed. One patient needed antidepressive therapy. Major questions relating to this problem are discussed. Gratifyingly satisfactory results were observed in more than two thirds of the patients. These objective findings and the subjective impressions obtained from patients, their relatives and our personnel prompted us to continue with this type of treatment for pain and to increase our efforts in this direction.

  9. Adult medulloblastoma: multiagent chemotherapy.

    PubMed Central

    Greenberg, H. S.; Chamberlain, M. C.; Glantz, M. J.; Wang, S.

    2001-01-01

    In this study, the records of 17 adult patients with medulloblastoma treated with craniospinal radiation and 1 of 2 multiagent chemotherapy protocols were reviewed for progression-free survival, overall survival, and toxicity, and the patients were compared with each other and with similarly treated children and adults. Records of patients treated at 3 institutions were reviewed. Seventeen medulloblastoma patients (11 female, 6 male) with a median age of 23 years (range, 18-47 years) were treated with surgery, craniospinal radiation (CSRT) plus local boost, and 1 of 2 adjuvant chemotherapy regimens. All tumors were infratentorial (10 in 4th ventricle and 7 in left or right hemisphere). Ten patients presented with hydrocephalus, and 7 of them were shunted. Eight patients had gross total resection, 7 had subtotal resection (>50% removed), and 2 had partial resection (<50% removed). Postoperatively, 3 patients had positive cytology and 3 had positive spinal MRI. Five patients were classified as good risk and 12 were classified as poor risk (Chang staging system). Ten patients were treated with the "Packer protocol," consisting of CSRT plus weekly vincristine followed by 8 cycles of cisplatin, lomustine, and vincristine. Seven patients were treated with the Pediatric Oncology Group (POG) protocol, consisting of alternating courses of cisplatin/etoposide and cyclophosphamide/vincristine, followed by CSRT. Eight of 17 patients relapsed, with all 8 relapsing at the primary site. Other relapse sites included the leptomeninges (5), bone (1), and brain (1). The estimated median relapse-free survival (Kaplan-Meier) for all patients was 48 months (95% confidence interval, >26 months to infinity). Median relapse-free survival for patients on the Packer protocol was 26 months, and for those on the POG regimen was 48 months (P = 0.410). Five of 10 on the Packer protocol were relapse-free, while 4 of 7 were relapse-free on the POG regimen. Two patients relapsed during chemotherapy

  10. 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

  11. Saudi Oncology Society and Saudi Urology Association combined clinical management guidelines for urothelial cell carcinoma of the urinary bladder.

    PubMed

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

    2016-01-01

    This is an update to the previously published Saudi guidelines for the evaluation, medical, and surgical management of patients diagnosed with urothelial cell carcinoma of the urinary bladder. It is categorized according to the stage of the disease using the tumor node metastasis staging system 7(th) edition. The guidelines are presented with supporting evidence level, they are based on comprehensive literature review, several internationally recognized guidelines, and the collective expertise of the guidelines committee members (authors) who were selected by the Saudi Oncology Society and Saudi Urological Association. Considerations to the local availability of drugs, technology, and expertise have been regarded. These guidelines should serve as a roadmap for the urologists, oncologists, general physicians, support groups, and health care policy makers in the management of patients diagnosed with urothelial cell carcinoma of the urinary bladder. PMID:27141179

  12. [CROATIAN SOCIETY FOR MEDICAL ONCOLOGY CLINICAL GUIDELINES FOR DIAGNOSIS, TREATMENT AND FOLLOW-UP OF PATIENTS WITH MELANOMA].

    PubMed

    Herceg, Davorin; Buzina, Daska Stulhofer; Ceović, Romana; Dotlić, Snjezana; Ilić, Ivana; Orehovec, Sanda Smuđ; Herceg, Gordana Horvatić; Mijatović, Davor; Separović, Robert; Silovski, Tajana; Vrbanec, Damir

    2016-01-01

    Melanoma in the Western world has an increasing incidence. One of the most important factor for the increase in incidence is sporadic, uncontrolled exposure to the sun. The basis for the treatment of primary melanoma is surgical treatment. Treatment of metastatic disease of melanoma in recent years experienced significant changes. BRAF and MEK inhibitors, immunotherapy with programmed cell-death immune checkpoint inhibitors (anti-PD-1-antibodies) are new options for the treatment of metastatic disease. A mulitidisiplinary team of Croatian Society for Medical Oncology provides recommendations for diagnosis, treatment and follow-up of melanoma primarily driven to the discovery of new drugs and therapeutic options, that change the prognosis of patients with metastatic melanoma. PMID:27290810

  13. 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.

  14. Impact of Biochemical Failure Classification on Clinical Outcome: A Secondary Analysis of Radiation Therapy Oncology Group 9202 and 9413

    PubMed Central

    Hamstra, Daniel A.; Bae, Kyounghwa; Hanks, Gerald; Hu, Chen; Shipley, William U.; Pan, Charlie C.; Roach, Mack; Lawton, Colleen A.; Sandler, Howard M.

    2015-01-01

    BACKGROUND Biochemical failure (BF) after radiation therapy is defined on the basis of a rising prostate-specific antigen (PSA) level (A1 failure) or any event that prompts the initiation of salvage androgen-deprivation therapy without PSA failure (A2). It was hypothesized that A2 failure may have a different prognosis. METHODS Data for 2799 eligible patients from Radiation Therapy Oncology Group (RTOG) 9202 and RTOG 9413 were analyzed. BF was defined according to the 1997 American Society for Therapeutic Radiology and Oncology consensus definition as A1 for PSA failure or as A2 for the start of salvage hormone therapy before 3 consecutive PSA rises. RESULTS Rates of all-cause mortality (hazard ratio [HR], 1.7; 95% confidence interval [CI], 1.5-2.0; P <.0001) and distant metastasis (DM; HR, 1.6; 95% CI, 1.3-2.0; P <.0001) were greater with A2 failure. The 5-year overall survival (OS) rates were 88.2% and 74.6% for A1 and A2, respectively (P <.0001), and the DM rates were 15.7% and 29.0%, respectively (P <.0001). The DM rate was greater at 5 years for A2 patients with DM as the first sign of failure versus patients with other A2 failures (87.3% vs 11.7%, P <.001), and this also correlated with worse OS at 5 years: 81.1% for A2 failure without DM and 52.8% with DM (P <.001). After the removal of patients with DM, the difference between A1 and A2 BF persisted for OS (P =.002) but not for DM (P =.16) CONCLUSIONS These results suggest that patients with rising PSA levels alone have less risk than those with A2 failures; although DM was the largest contributor of adverse risk to A2 failure, it did not account for all excess risk in A2 failure. PMID:25410885

  15. 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

  16. 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.

  17. The Oncology Care Model: A Critique.

    PubMed

    Thomas, Christian A; Ward, Jeffrey C

    2016-01-01

    Rapidly increasing national health care expenditures are a major area of concern as threats to the integrity of the health care system. Significant increases in the cost of care for patients with cancer are driven by numerous factors, most importantly the cost of hospital care and escalating pharmaceutical costs. The current fee-for-service system (FFS) has been identified as a potential driver of the increasing cost of care, and multiple stakeholders are interested in replacing FFS with a system that improves the quality of care while at the same time reducing cost. Several models have been piloted, including a Center for Medicare & Medicaid Innovation (CMMI)-sponsored medical home model (COME HOME) for patients with solid tumors that was able to generate savings by integrating a phone triage system, pathways, and seamless patient care 7 days a week to reduce overall cost of care, mostly by decreasing patient admissions to hospitals and referrals to emergency departments. CMMI is now launching a new pilot model, the Oncology Care Model (OCM), which differs from COME HOME in several important ways. It does not abolish FFS but provides an additional payment in 6-month increments for each patient on active cancer treatment. It also allows practices to participate in savings if they can decrease the overall cost of care, to include all chemotherapy and supportive care drugs, and fulfill certain quality metrics. A critical discussion of the proposed model, which is scheduled to start in 2016, will be provided at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting with practicing oncologists and a Centers for Medicare & Medicaid Services (CMS) representative. PMID:27249711

  18. [THE TOXIC EFFECTS OF CHEMOTHERAPY ON THE GASTROINTESTINAL TRACT].

    PubMed

    Sivak, L A; Maidanevich, N N; Lyalkin, S A; Aleksik, E M; Askolskiy, A V; Klimanov, M Y; Kasap, N V

    2015-01-01

    Chemotherapy in modern oncology is one of the main methods of treatment, along with surgery and radiotherapy techniques. More than 60% of patients receiving chemotherapy at different stages of treatment. Recently, modern chemotherapy has become more urgent personal approach to the choice of drugs and their doses, aimed at reducing the toxicity of chemotherapy. Complications of chemotherapy significantly degrade the effectiveness of the treatment of patients with malignant tumors, because they require lower doses of anticancer drug, or lengthening the intervals between cycles of chemotherapy, which affects treatment outcomes and quality of life. PMID:26118038

  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. PMID:27616612

  20. 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.

  1. 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

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

    PubMed

    Li, Hao; Zhang, Zheng-Yun; Zhou, Zun-Qiang; Guan, Jiao; Tong, Da-Nian; Zhou, Guang-Wen

    2016-05-01

    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).

  3. First Clinical Experience with a High-Capacity Implantable Infusion Pump for Continuous Intravenous Chemotherapy

    SciTech Connect

    Damascelli, Bruno; Patelli, Gianluigi; Frigerio, Laura F.; Lanocita, Rodolfo; Di Tolla, Giuseppe; Marchiano, Alfonso; Spreafico, Carlo; Garbagnati, Francesco; Bonalumi, Maria G.; Monfardini, Lorenzo; Ticha, Vladimira; Prino, Aurelio

    1999-01-15

    Purpose: To evaluate the efficiency of a new high-capacity pump for systemic venous chemotherapy and to verify the quality of implantation by interventional radiology staff. Methods: A total of 47 infusion pumps with a 60-ml reservoir and variable flow rates (2, 6, 8, or 12 ml/24 hr) were implanted by radiologists in 46 patients with solid tumor metastases requiring treatment with a single, continuously infused cytostatic agent. The reservoir was refilled transcutaneously, usually once weekly. The flow accuracy of the pump was assessed from actual drug delivery recorded on 34 patients over a minimum observation period of 180 days. Results: No early complications occurred in any of the 47 implants in 46 patients. A total of 12 (25.53%) complications occurred between 3 and 24 months after implantation. Seven (14.90%) of these were due to the external design of the pump, while five (10.63%) were related to the central venous catheter. In the 34 patients available for pump evaluation (follow-up of at least 180 days), the system was used for a total of 14,191 days (range 180-911 days, mean 417.38 days), giving an overall complication rate of 0.84 per 1000 days of operation. The mean flow rate accuracy was 90.26%. Conclusion: The new implantable pump showed good flow rate accuracy and reliable operation. The pump-related complications were related to its external design and have now been corrected by appropriate modifications. From a radiologic and surgical viewpoint, the venous implantation procedure is identical to that of conventional vascular access devices and can be performed by radiologists familiar with these techniques. The current limitations lie in the high cost of the pump and, for certain drugs, the short time between refills.

  4. Rasch-Transformed Total Neuropathy Score clinical version (RT-TNSc(©) ) in patients with chemotherapy-induced peripheral neuropathy.

    PubMed

    Binda, Davide; Cavaletti, Guido; Cornblath, David R; Merkies, Ingemar S J

    2015-09-01

    Composite scales such as the Total Neuropathy Score clinical version (TNSc(©) ) have been widely used to measure neurological impairment in a standardized manner but they have been criticized due to their ordinal setting having no fixed unit. This study aims to improve impairment assessment in patients with chemotherapy-induced peripheral neuropathy (CIPN) by subjecting TNSc(©) records to Rasch analyses. In particular, we wanted to investigate the influence of factors affecting the use of the TNSc(©) in clinical practice. TNSc(©) has 7 domains (sensory, motor, autonomic, pin-prick, vibration, strength, and deep tendon reflexes [DTR]) each being scored 0-4. Data obtained in 281 patients with stable CIPN were subjected to Rasch analyses to determine the fit to the model. The TNSc(©) did not meet Rasch model's expectations primarily because of misfit statistics in autonomic and DTR domains. Removing these two, acceptable model fit and uni-dimensionality were obtained. However, disordered thresholds (vibration and strength) and item bias (mainly cultural) were still seen, but these findings were kept to balance the assessment range of the Rasch-Transformed TNSc(©) (RT-TNSc(©) ). Acceptable reliability findings were also obtained. A 5-domains RT-TNSc(©) may be a more proper assessment tool in patients with CIPN. Future studies are needed to examine its responsive properties.

  5. 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

  6. 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

  7. Different Clinical Utility of Oropharyngeal Bacterial Screening prior to Percutaneous Endoscopic Gastrostomy in Oncological and Neurological Patients

    PubMed Central

    Dastych, Milan; Senkyrik, Michal; Pavlik, Tomas; Prokesova, Jitka; Jecmenova, Marketa; Dolina, Jiri; Hep, Ales

    2014-01-01

    Background. The aim of this study was to monitor oropharyngeal bacterial colonization in patients indicated for percutaneous endoscopic gastronomy (PEG). Methods. Oropharyngeal swabs were obtained from patients prior to PEG placement. A development of peristomal infection was evaluated. The analysis of oropharyngeal and peristomal site pathogens was done. Results. Consecutive 274 patients referred for PEG due to neurological disorder or cancer completed the study. Oropharyngeal colonization with pathogens was observed in 69% (190/274), dominantly in the neurologic subgroup of patients (P < 0.001). Peristomal infection occurred in 30 (10.9%) of patients and in 57% of them the correlation between oropharyngeal and peristomal agents was present. The presence of oropharyngeal pathogens was assessed as an important risk factor for the development of peristomal infection only in oncological patients (OR = 8.33, 95% CI: 1.66–41.76). Despite a high prevalence of pathogens in neurological patients, it did not influence the risk of peristomal infection with the exception for methicillin resistant Staphylococcus aureus (MRSA) carriers (OR 4.5, 95% CI: 1.08–18.76). Conclusion. During oropharyngeal microbial screening prior to the PEG insertion, the detection of pathogens may be a marker of the increased risk of peristomal infection in cancer patients only. In neurological patients the benefit of the screening is limited to the detection of MRSA carriers. PMID:25243153

  8. Micronutrients in Oncological Intervention.

    PubMed

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

    2016-03-01

    Nutritional supplements are widely used among patients with cancer who perceive them to be anticancer and antitoxicity agents. Depending on the type of malignancy and the gender 30%-90% of the cancer patients supplement their diets with antioxidant and immuno-stabilizing micronutrients, such as selenium, vitamin C, and vitamin D, often without the knowledge of the treating physician. From the oncological viewpoint, there are justifiable concerns that dietary supplements decrease the effectiveness of chemotherapy and radiotherapy. Recent studies, however, have provided increasing evidence that treatment is tolerated better-with an increase in patient compliance and a lower rate of treatment discontinuations-when micronutrients, such as selenium, are added as appropriate to the patient's medication. Nutritional supplementation tailored to an individual's background diet, genetics, tumor histology, and treatments may yield benefits in subsets of patients. Clinicians should have an open dialogue with patients about nutritional supplements. Supplement advice needs to be individualized and come from a credible source, and it is best communicated by the physician. PMID:26985904

  9. 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

  10. Subcutaneous Administration of Bortezomib: A Pilot Survey of Oncology Nurses.

    PubMed

    Martin, Jasmine R; Beegle, Nancy L; Zhu, Yanyan; Hanisch, Ellen M

    2015-01-01

    Subcutaneous (SC) administration of the proteasome inhibitor bortezomib was approved in the United States and European Union in 2012. There is limited guidance regarding how to administer SC bortezomib and a general lack of clear direction on optimal techniques for administering SC chemotherapy injections. Nurses may be utilizing different techniques, and inconsistent techniques may result in injection-site reactions, causing patient discomfort and treatment cessatioin. This observational survey of oncology nurses in community oncology clinics aimed to identify techniques being used and explore nurses' opinions about SC bortezomib administration. A 44-question electronic survey was developed, based on the current literature regarding appropriate techniques for administering SC injections. A total of 43 nurses from 17 clinics in 12 states responded. The majority (74%) had been practicing oncology nursing for at more than 5 years. Respondents predominantly used and preferred the abdomen for injections (88%); 81% used a skin lift to ensure injection into adipose tissue. There was no relationship between the angle of insertion and the needle length; 51% used an air-bubble technique. Nurses took 3-5 (49%), 5-10 (35%), 10-30 (9%), or > 30 (7%) seconds to administer each mL of SC bortezomib injection. All nurses completely/somewhat agreed that practice guidelines would be important for standardizing SC bortezomib administration. Advanced practice registered nurses (APRNs) shared the responsibility for ordering SC bortezomib, according to 53% of respondents. These findings could help APRNs improve the quality of patient care, may help minimize adverse events and maximize effective therapy, and could help inform the development of practice guidelines. PMID:26705492

  11. Curcumin inhibits cancer stem cell phenotypes in ex vivo models of colorectal liver metastases, and is clinically safe and tolerable in combination with FOLFOX chemotherapy.

    PubMed

    James, Mark I; Iwuji, Chinenye; Irving, Glen; Karmokar, Ankur; Higgins, Jennifer A; Griffin-Teal, Nicola; Thomas, Anne; Greaves, Peter; Cai, Hong; Patel, Samita R; Morgan, Bruno; Dennison, Ashley; Metcalfe, Matthew; Garcea, Giuseppe; Lloyd, David M; Berry, David P; Steward, William P; Howells, Lynne M; Brown, Karen

    2015-08-10

    In vitro and pre-clinical studies have suggested that addition of the diet-derived agent curcumin may provide a suitable adjunct to enhance efficacy of chemotherapy in models of colorectal cancer. However, the majority of evidence for this currently derives from established cell lines. Here, we utilised patient-derived colorectal liver metastases (CRLM) to assess whether curcumin may provide added benefit over 5-fluorouracil (5-FU) and oxaliplatin (FOLFOX) in cancer stem cell (CSC) models. Combination of curcumin with FOLFOX chemotherapy was then assessed clinically in a phase I dose escalation study. Curcumin alone and in combination significantly reduced spheroid number in CRLM CSC models, and decreased the number of cells with high aldehyde dehydrogenase activity (ALDH(high)/CD133(-)). Addition of curcumin to oxaliplatin/5-FU enhanced anti-proliferative and pro-apoptotic effects in a proportion of patient-derived explants, whilst reducing expression of stem cell-associated markers ALDH and CD133. The phase I dose escalation study revealed curcumin to be a safe and tolerable adjunct to FOLFOX chemotherapy in patients with CRLM (n = 12) at doses up to 2 grams daily. Curcumin may provide added benefit in subsets of patients when administered with FOLFOX, and is a well-tolerated chemotherapy adjunct.

  12. Curcumin inhibits cancer stem cell phenotypes in ex vivo models of colorectal liver metastases, and is clinically safe and tolerable in combination with FOLFOX chemotherapy

    PubMed Central

    James, Mark I.; Iwuji, Chinenye; Irving, Glen; Karmokar, Ankur; Higgins, Jennifer A.; Griffin-Teal, Nicola; Thomas, Anne; Greaves, Peter; Cai, Hong; Patel, Samita R.; Morgan, Bruno; Dennison, Ashley; Metcalfe, Matthew; Garcea, Giuseppe; Lloyd, David M.; Berry, David P.; Steward, William P.; Howells, Lynne M.; Brown, Karen

    2015-01-01

    In vitro and pre-clinical studies have suggested that addition of the diet-derived agent curcumin may provide a suitable adjunct to enhance efficacy of chemotherapy in models of colorectal cancer. However, the majority of evidence for this currently derives from established cell lines. Here, we utilised patient-derived colorectal liver metastases (CRLM) to assess whether curcumin may provide added benefit over 5-fluorouracil (5-FU) and oxaliplatin (FOLFOX) in cancer stem cell (CSC) models. Combination of curcumin with FOLFOX chemotherapy was then assessed clinically in a phase I dose escalation study. Curcumin alone and in combination significantly reduced spheroid number in CRLM CSC models, and decreased the number of cells with high aldehyde dehydrogenase activity (ALDHhigh/CD133−). Addition of curcumin to oxaliplatin/5-FU enhanced anti-proliferative and pro-apoptotic effects in a proportion of patient-derived explants, whilst reducing expression of stem cell-associated markers ALDH and CD133. The phase I dose escalation study revealed curcumin to be a safe and tolerable adjunct to FOLFOX chemotherapy in patients with CRLM (n = 12) at doses up to 2 grams daily. Curcumin may provide added benefit in subsets of patients when administered with FOLFOX, and is a well-tolerated chemotherapy adjunct. PMID:25979230

  13. Chemotherapy for Melanoma.

    PubMed

    Wilson, Melissa A; Schuchter, Lynn M

    2016-01-01

    Prior to the recent therapeutic advances, chemotherapy was the mainstay of treatment options for advanced-stage melanoma. A number of studies have investigated various chemotherapy combinations in order to expand on the clinical responses achieved with single-agent dacarbazine, but these have not demonstrated an improvement in overall survival. Similar objective responses were observed with the combination of carboplatin and paclitaxel as were seen with single-agent dacarbazine. The combination of chemotherapy and immunotherapy, known as biochemo-therapy, has shown high clinical responses; however, biochemo-therapy has not been shown to improve overall survival and resulted in increased toxicities. In contrast, palliation and long-term responses have been observed with localized treatment with isolated limb perfusion or infusion in limb-isolated disease. Although new, improved therapeutic options exist for first-line management of advanced-stage melanoma, chemotherapy may still be important in the palliative treatment of refractory, progressive, and relapsed melanoma. We review the various chemotherapy options available for use in the treatment and palliation of advanced-stage melanoma, discuss the important clinical trials supporting the treatment recommendations, and focus on the clinical circumstances in which treatment with chemotherapy is useful.

  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. 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

  16. Introduction of online adaptive radiotherapy for bladder cancer through a multicentre clinical trial (Trans-Tasman Radiation Oncology Group 10.01): Lessons learned.

    PubMed

    Pham, Daniel; Roxby, Paul; Kron, Tomas; Rolfo, Aldo; Foroudi, Farshad

    2013-04-01

    Online adaptive radiotherapy for bladder cancer is a novel radiotherapy technique that was found feasible in a pilot study at a single academic institution. In September 2010 this technique was opened as a multicenter study through the Trans-Tasman Radiation Oncology Group (TROG 10.01 bladder online adaptive radiotherapy treatment). Twelve centers across Australia and New-Zealand registered interest into the trial. A multidisciplinary team of radiation oncologists, radiation therapists and medical physicists represented the trial credentialing and technical support team. To provide timely activation and proper implementation of the adaptive technique the following key areas were addressed at each site: Staff education/training; Practical image guided radiotherapy assessment; provision of help desk and feedback. The trial credentialing process involved face-to-face training and technical problem solving via full day site visits. A dedicated "help-desk" team was developed to provide support for the clinical trial. 26% of the workload occurred at the credentialing period while the remaining 74% came post-center activation. The workload was made up of the following key areas; protocol clarification (36%), technical problems (46%) while staff training was less than 10%. Clinical trial credentialing is important to minimizing trial deviations. It should not only focus on site activation quality assurance but also provide ongoing education and technical support. PMID:23776308

  17. [Clinical results of combination chemotherapy with cisplatin, vinblastine and bleomycin (pvb) for advanced testicular cancer: evaluation of risk criteria].

    PubMed

    Mikami, K; Nakagawa, S; Sugimoto, K; Nomoto, T; Urano, S; Watanabe, H; Iwamoto, N; Yamazaki, S; Hiratake, Y; Maegawa, M

    1997-08-01

    Between 1982 and 1991, 24 patients with advanced testicular germ cell tumor were treated by combination chemotherapy with cisplatin, vinblastine and bleomycin (PVB). Based on short-term efficacy of the PVB regimen and long-term prognosis in our patients, we evaluated 4 risk criteria proposed by Indiana University, National Cancer Institute (NCI), Memorial Sloan-Kettering Cancer Center (MSKCC) and European Organization for Research and Treatment of Cancer (EORTC). Clinical staging were IIA in 8 patients, IIB in 8, IIIA in 1, IIIB in 5 and IIIC in 2. Metastases included retroperitoneal lymph node in 20 cases (> 5 cm in 10), lung in 6, bone and liver in each 1. Complete response (CR) was obtained in 12 (50%) patients and partial response (PR) in 9 (38%). According to the stage and metastatic site, CR was achieved in 75%, 38% and 38%of the stage IIA, IIB and III tumors, respectively, and in 60% and 50% of retroperitoneal and pulmonary metastases, respectively. However, neither CR nor PR was recognized for live and bone metastases. Prognosis was assessed with a mean followup period of 88.5 months. Although all 12 patients with CR were alive, 4 of the 9 with PR and all patients on whom the drug was ineffective died of cancer. Accuracy in predicting prognosis was 82%, 75%, 74%, and 63% using the MSKCC, Indiana, NCI and EORTC risk criteria, respectively.

  18. 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

  19. [History of Oncology in Slovakia].

    PubMed

    Ondruš, D; Kaušitz, J

    2016-01-01

    The history of oncology in Slovakia is closely linked to the history of St. Elizabeth Hospital, which was set up in the mid-18th century by nuns of the St. Elizabeth Order in Bratislava. In the first half of the 20th century, a unit was set up in the hospital dedicated to diagnosis and treatment of cancer. Shortly after World War II, the unit was turned into the Institute for Cancer Research and Treatment. In 1950, St. Elizabeth Hospital was nationalized, and the Cancer Research Institute of the Slovak Academy of Science and the Institute of Clinical Oncology were located there as centers for oncological diagnosis and treatment. After the restitution of church property in the early 1990s, the hospital was returned to the Order of St. Elizabeth, which set up the St. Elisabeth Cancer Institute in the hospital premises in January of 1996. This year marks the 20th anniversary of this institute in its new premises and the 85th anniversary of the Institute of Radiumtherapy founded in Bratislava, and thus the establishment of institutional healthcare for cancer patients in Slovakia is the reason for balancing. We present a view of the consecutive changes in the organization, space and staff of the Institute and evaluate the impact of celebrities on medicine who developed oncology as a clinical, scientific and educational discipline in Bratislava and in other cities and regions of Slovakia. PMID:27296401

  20. [History of Oncology in Slovakia].

    PubMed

    Ondruš, D; Kaušitz, J

    2016-01-01

    The history of oncology in Slovakia is closely linked to the history of St. Elizabeth Hospital, which was set up in the mid-18th century by nuns of the St. Elizabeth Order in Bratislava. In the first half of the 20th century, a unit was set up in the hospital dedicated to diagnosis and treatment of cancer. Shortly after World War II, the unit was turned into the Institute for Cancer Research and Treatment. In 1950, St. Elizabeth Hospital was nationalized, and the Cancer Research Institute of the Slovak Academy of Science and the Institute of Clinical Oncology were located there as centers for oncological diagnosis and treatment. After the restitution of church property in the early 1990s, the hospital was returned to the Order of St. Elizabeth, which set up the St. Elisabeth Cancer Institute in the hospital premises in January of 1996. This year marks the 20th anniversary of this institute in its new premises and the 85th anniversary of the Institute of Radiumtherapy founded in Bratislava, and thus the establishment of institutional healthcare for cancer patients in Slovakia is the reason for balancing. We present a view of the consecutive changes in the organization, space and staff of the Institute and evaluate the impact of celebrities on medicine who developed oncology as a clinical, scientific and educational discipline in Bratislava and in other cities and regions of Slovakia.

  1. Palliative medicine and medical oncology.

    PubMed

    Maltoni, M; Amadori, D

    2001-04-01

    Traditionally, medical oncology and palliative care have been considered two distinct and separate disciplines, both as regards treatment objectives and delivery times. Palliative care in terminal stages, aimed exclusively at evaluating and improving quality of life, followed antitumor therapies, which concentrated solely on quantitative results (cure, prolongation of life, tumoral mass shrinkage). Over the years, more modern concepts have developed on the subject. Medical oncology, dealing with the skills and strategic co-ordination of oncologic interventions from primary prevention to terminal phases, should also include assessment and treatment of patients' subjective needs. Anticancer therapies should be evaluated in terms of both the quantitative and qualititative impact on patients' lives. Hence, the traditional view of palliative care has to be modified: it constitutes a philosophical and methodological approach to be adopted from the early phases of illness. It is not the evident cultural necessity of integrating medical oncology with palliative medicine that may be a matter of argument, but rather the organizational models needed to put this combined care into practice: should continuous care be guaranteed by a single figure, the medical oncologist, or rather by an interdisciplinary providers' team, including full-time doctors well-equipped for palliative care? In this paper the needs of cancer patients and the part that a complete oncologist should play to deal with such difficult and far-reaching problems are firstly described. Then, as mild provocation, data and critical considerations on the ever increasing needs of palliative care, the present shortcomings in quality of life and pain assessment and management by medical oncologists, and the uncertain efficacy of interventional programmes to change clinical practice are described. Finally, a model of therapeutic continuity is presented. which in our view is realistic and feasible: an Oncologic

  2. Chemotherapy of onchocerciasis: a controlled clinical trial of topical diethylcarbamazine (DEC) in Guatemala.

    PubMed

    Taylor, H R; Langham, M E; de Stahl, E M; Figueroa, L N; Beltranena, F

    1980-09-01

    A double-masked, controlled clinical trial was conducted in Guatemala to assess the safety and efficacy of diethylcarbamazine (DEC) lotion as compared to placebo lotion in the treatment of onchocerciasis. One hundred eighty-seven people were enrolled in this study and were followed for two months. Lotion was applied daily for seven days, then weekly for seven weeks. The decrease in mean microfilarial counts per skin snip was significantly greater in those receiving DEC lotion than for those receiving placebo lotion. The proportionate reduction in microfilarial counts was similar for people with light, moderate, or heavy microfilarial loads. Side effects were mainly related to skin changes, fever, and malaise, and occurred in nearly one-third of the people receiving DEC lotion. These reactions occurred almost as commonly in those people who were lightly infected as in those who had moderate or heavy infections.

  3. 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

  4. Integrative Physical Oncology

    PubMed Central

    Hatzikirou, Haralampos; Chauviere, Arnaud; Bauer, Amy L.; Leier, André; Lewis, Michael T.; Macklin, Paul; Marquez-Lago, Tatiana T.; Bearer, Elaine L.; Cristini, Vittorio

    2013-01-01

    Cancer is arguably the ultimate complex biological system. Solid tumors are micro-structured soft matter that evolves as a consequence of spatio-temporal events at the intracellular (e.g., signaling pathways, macromolecular trafficking), intercellular (e.g., cell-cell adhesion/communication), and tissue (e.g., cell-extracellular matrix interactions, mechanical forces) scales. To gain insight, tumor and developmental biologists have gathered a wealth of molecular, cellular and genetic data, including immunohistochemical measurements of cell type-specific division and death rates, lineage tracing, and gain-of-function/loss-of-function mutational analyses. These data are empirically extrapolated to a diagnosis/prognosis of tissue-scale behavior, e.g., for clinical decision. Integrative Physical Oncology (IPO) is the science that develops physically consistent mathematical approaches to address the significant challenge of bridging the nano (nm)-micro (μm) to macro (mm, cm) scales with respect to tumor development and progression. In the current literature, such approaches are referred to as multiscale modeling. In the present review, we attempt to assess recent modeling approaches on each separate scale and critically evaluate the current “hybrid-multiscale” models used to investigate tumor growth in the context of brain and breast cancers. Finally, we provide our perspective on the further development and the impact of Integrative Physical Oncology. PMID:21853537

  5. Association between dynamic features of breast DCE-MR imaging and clinical response of neoadjuvant chemotherapy: a preliminary analysis

    NASA Astrophysics Data System (ADS)

    Huang, Lijuan; Fan, Ming; Li, Lihua; Zhang, Juan; Shao, Guoliang; Zheng, Bin

    2016-03-01

    Neoadjuvant chemotherapy (NACT) is being used increasingly in the management of patients with breast cancer for systemically reducing the size of primary tumor before surgery in order to improve survival. The clinical response of patients to NACT is correlated with reduced or abolished of their primary tumor, which is important for treatment in the next stage. Recently, the dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) is used for evaluation of the response of patients to NACT. To measure this correlation, we extracted the dynamic features from the DCE- MRI and performed association analysis between these features and the clinical response to NACT. In this study, 59 patients are screened before NATC, of which 47 are complete or partial response, and 12 are no response. We segmented the breast areas depicted on each MR image by a computer-aided diagnosis (CAD) scheme, registered images acquired from the sequential MR image scan series, and calculated eighteen features extracted from DCE-MRI. We performed SVM with the 18 features for classification between patients of response and no response. Furthermore, 6 of the 18 features are selected to refine the classification by using Genetic Algorithm. The accuracy, sensitivity and specificity are 87%, 95.74% and 50%, respectively. The calculated area under a receiver operating characteristic (ROC) curve is 0.79+/-0.04. This study indicates that the features of DCE-MRI of breast cancer are associated with the response of NACT. Therefore, our method could be helpful for evaluation of NACT in treatment of breast cancer.

  6. Counterpoint: test the value of hyperthermia in patients with carcinoma of the cervix being treated with concurrent chemotherapy and radiation.

    PubMed

    Prosnitz, L; Jones, E

    2002-01-01

    Major advances in the treatment of locally advanced cervical carcinoma were reported in 1999-2000 in five studies from the Gynecologic Oncology Group, Radiation Therapy Oncology Group and Southwestern Oncology Group. Collectively these trials reported a decrease in the risk of recurrence or death from cervical cancer ranging from 30-50% with the use of concurrent chemoradiation, as compared with radiation alone. On the basis of these trials the National Cancer Institute in 1999 issued a clinical alert concluding 'Strong consideration should be given to the incorporation of concurrent cisplatin-based chemotherapy with radiation therapy in women who require radiation therapy for treatment of cervical cancer.' Concurrently with these publications there appeared the publication in the Lancet in 2000 of the Dutch Deep Hyperthermia Group trial of radiotherapy alone versus combined radiation and hyperthermia for locally advanced pelvic tumors including carcinoma of the cervix. This multi-center phase III trial demonstrated an approximate doubling of the three year survival from 27 to 51% for the addition of hyperthermia to radiotherapy in patients with locally advanced cervical carcinoma. Additional trials to test the value of hyperthermia in patients with cervical carcinoma treated with concurrent chemotherapy and radiation are imperative and take precedence over a trial to investigate the value of chemotherapy in patients treated with hyperthermia and radiation.

  7. 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

  8. 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

  9. 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

  10. Potential approaches to sustainable, long-lasting payment reform in oncology.

    PubMed

    2014-07-01

    With unsustainable and rising health care costs reaching what are regularly termed crisis levels, the United States' current fragmented and inefficient health care system is in need of reforms that will allow oncology practices to adapt to changing delivery systems that put the patient at the center of care. Oncology accounts for roughly 10% of all health care costs and is a prime target for reform-minded stakeholders, particularly in the realm of reimbursement for care. ASCO believes that successful physician payment reform will be physician led and driven. This article was developed by the ASCO Clinical Practice Committee Payment Reform Workgroup and underwent subsequent review and approval by the full Clinical Practice Committee and the ASCO Board of Directors. The following represents an abridged version of the original document, edited for length. The entire document may be found at www.asco.org/paymentreform. It includes a critical survey of the current reimbursement landscape and lays out the foundation for a comprehensive, multifaceted solution that would replace the current fee for service structure. This foundation includes quality measurements and incentives, a replacement for the current "buy and bill" system for chemotherapy drugs, value-based pathways, episodic or bundled care payments, and care coordination to decrease use of expensive resources. ASCO intends to pursue further development, modeling, and testing of these concepts and invites others in the oncology community to prepare to lead efforts to a more rational and stable payment plan that will support high-quality care for our patients.

  11. 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.

  12. Role of nuclear medicine in chemotherapy of malignant lesions

    SciTech Connect

    Kim, E.E.; Haynie, T.P.

    1985-01-01

    The major role of nuclear medicine in clinical oncology is in tumor imaging, which includes evaluating specific organs or the entire body for the presence of tumor. Nuclear medicine studies have been used clinically in the initial evaluation of the tumor extent and in the subsequent management of the cancer patient to assess response to treatment, to detect early relapse, and to assist in making decisions concerning follow-up treatment. Technetium-99m macroaggregated albumin perfusion study for intraarterial chemotherapy has been helpful in monitoring the catheter tip, providing a map of regional perfusion at the capillary level (tumor vascularity), evaluating the degree of arteriovenous shunt in tumor bed, and optimizing division of the dose of chemotherapeutic agent when bilateral arterial catheters are used. Quantitative and serial radionuclide angiocardiography has been useful in assessing doxorubicin (Adriamycin, Adria Laboratories, Columbus, Ohio) toxicity, and /sup 67/Ga-citrate imaging has been used to monitor chemotherapy effect on lungs and kidneys. Radionuclide venography can demonstrate suspected thrombus, and the delineation of the vascular anatomy also allows proper placement of another catheter for continuous effective chemotherapy. Serial bone scans have been the primary modality to assess the response of bone metastasis to systemic therapy in breast cancer patients, and nuclear hepatic imaging may show tumor response, hepatocellular dysfunction, and cholecystitis related to chemotherapeutic agents. 41 references.

  13. 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

  14. 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.

  15. 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

  16. Testing the utility of a cancer clinical trial specific Question Prompt List (QPL-CT) during oncology consultations

    PubMed Central

    Brown, Richard F.; Bylund, Carma L.; Li, Yuelin; Edgerson, Shawna; Butow, Phyllis

    2012-01-01

    Objective A Question Prompt List (QPL) is a proven, simple intervention to aid patients to be active participants in consultations with their physicians by asking questions. We aimed to further develop and test the efficacy of a targeted QPL for clinical trials (QPL-CT). Methods Breast, Lung and Genitourinary cancer patients who were facing a discussion about a therapeutic clinical trial completed short pre- and post-consultation questionnaires and used the QPL-CT in their discussions with their oncologists. Results: 30 participants were recruited from 6 oncologists All QPL-CT questions were selected by at least one-third of participants. Participants mostly wanted and asked questions about personal trial benefit. Oncologists provided information about personal benefit to varying degrees, thus patients did not ask some questions. Patients were still left with some unasked and unanswered questions. Conclusion The QPL-CT has potential as a simple, inexpensive intervention to aid such communication. Further investigation is needed to demonstrate the efficacy of the QPL-CT in improving cancer patient outcomes. Practice Implications These preliminary finding suggest that important areas of clinical trials are overlooked in clinical consultations. The QPL-CT may be an effective method to encourage oncologists to endorse patient question asking about clinical trials and prompt patient questions. PMID:22390854

  17. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS).

    PubMed

    Cherny, N I; Sullivan, R; Dafni, U; Kerst, J M; Sobrero, A; Zielinski, C; de Vries, E G E; Piccart, M J

    2015-08-01

    The value of any new therapeutic strategy or treatment is determined by the magnitude of its clinical benefit balanced against its cost. Evidence for clinical benefit from new treatment options is derived from clinical research, in particular phase III randomised trials, which generate unbiased data regarding the efficacy, benefit and safety of new therapeutic approaches. To date, there is no standard tool for grading the magnitude of clinical benefit of cancer therapies, which may range from trivial (median progression-free survival advantage of only a few weeks) to substantial (improved long-term survival). Indeed, in the absence of a standardised approach for grading the magnitude of clinical benefit, conclusions and recommendations derived from studies are often hotly disputed and very modest incremental advances have often been presented, discussed and promoted as major advances or 'breakthroughs'. Recognising the importance of presenting clear and unbiased statements regarding the magnitude of the clinical benefit from new therapeutic approaches derived from high-quality clinical trials, the European Society for Medical Oncology (ESMO) has developed a validated and reproducible tool to assess the magnitude of clinical benefit for cancer medicines, the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS). This tool uses a rational, structured and consistent approach to derive a relative ranking of the magnitude of clinically meaningful benefit that can be expected from a new anti-cancer treatment. The ESMO-MCBS is an important first step to the critical public policy issue of value in cancer care, helping to frame the appropriate use of limited public and personal resources to deliver cost-effective and affordable cancer care. The ESMO-MCBS will be a dynamic tool and its criteria will be revised on a regular basis. PMID:26026162

  18. Clinical evaluation with 18 months follow-up of new PTTM enhanced dental implants in maxillo-facial post-oncological patients

    PubMed Central

    Papi, Piero; Jamshir, Sara; Brauner, Edoardo; Di Carlo, Stefano; Ceci, Antonio; Piccoli, Luca; Pompa, Giorgio

    2014-01-01

    Summary Aim The aim of this study is to present 18 months follow-up results of porous tantalum trabecular metal-enhanced titanium dental implant (PTTM) in implant supported prosthesis in post-oncological patients. Materials and methods A total of 25 PTTM implants were placed in each jaw of 6 patients that met specific inclusion and exclusion criteria. Resonance Frequency Analysis (RFA) was conducted and Implant stability was recorded in ISQ values (Osstell ISQ, Osstell AB, Goteborg, Sweden) at implant placement and after 2,4,6,12 and 18 months of functional loading. Mean bone loss was also evaluated at the same interval of time on each periapical radiographs, bone levels were calculated by measuring the distance from the implant shoulder to the first bone to implant contact. Results Cumulative implant survival rate is 100% (n=25/25) to date and mean ISQ values recorded were: 72.14±5.61 (range= 50–81) at surgery, 64.39±8.12 (range=44–74) after 2 months, 74.26±7.14 (range=44–74) after 4 months, 76.84±7.65 (range=60–83) after 6 months, 78.13±4.14 (range=64–84) after 12 months and 80.22±6.23 (range=68–89) after 18 months of functional loading. Mean crestal marginal bone loss was 0.19±0.25 mm after 2 months of functional loading on periapical radiographs, 0.22±0.4 mm at 4 months, 0.3±0.46 mm at 6 months, 0.57±0.62 at 1 year and 0.64±0.60 mm after 18 months. Conclusions The results of this study, even if limited by the number of implants placed indicate that PTTM dental implants have a clinical efficacy in prosthetic rehabilitation of post-oncological patients, due to trabecular structure of the porous Ta metal that increases bone-implant connection values. PMID:25774249

  19. Outcomes of Positron Emission Tomography-Staged Clinical N3 Breast Cancer Treated With Neoadjuvant Chemotherapy, Surgery, and Radiotherapy

    SciTech Connect

    Park, Hae Jin; Shin, Kyung Hwan; Cho, Kwan Ho; Park, In Hae; Lee, Keun Seok; Ro, Jungsil; Jung, So-Youn; Lee, Seeyoun; Kim, Seok Won; Kang, Han-Sung; Chie, Eui Kyu; Ha, Sung Whan

    2011-12-01

    Purpose: To evaluate the treatment outcome and efficacy of regional lymph node irradiation after neoadjuvant chemotherapy (NCT) and surgery in positron emission tomography (PET)-positive clinical N3 (cN3) breast cancer patients. Methods and Materials: A total of 55 patients with ipsilateral infraclavicular (ICL), internal mammary (IMN), or supraclavicular (SCL) lymph node involvement in the absence of distant metastases, as revealed by an initial PET scan, were retrospectively analyzed. The clinical nodal stage at diagnosis (2002 AJCC) was cN3a in 14 patients (26%), cN3b in 12 patients (22%), and cN3c in 29 patients (53%). All patients were treated with NCT, followed by mastectomy or breast-conserving surgery and subsequent radiotherapy (RT) with curative intent. Results: At the median follow-up of 38 months (range, 9-80 months), 20 patients (36%) had developed treatment failures, including distant metastases either alone or combined with locoregional recurrences that included one ipsilateral breast recurrence (IBR), six regional failures (RF), and one case of combined IBR and RF. Only 3 patients (5.5%) exhibited treatment failure at the initial PET-positive clinical N3 lymph node. The 5-year locoregional relapse-free survival, disease-free survival (DFS), and overall survival rates were 80%, 60%, and 79%, respectively. RT delivered to PET-positive IMN regions in cN3b patients and at higher doses ({>=}55 Gy) to SCL regions in cN3c patients was not associated with improved 5-year IMN/SCL relapse-free survival or DFS. Conclusion: NCT followed by surgery and RT, including the regional lymph nodes, resulted in excellent locoregional control for patients with PET-positive cN3 breast cancer. The primary treatment failure in this group was due to distant metastasis rather than RF. Neither higher-dose RT directed at PET-positive SCL nodes nor coverage of PET-positive IMN nodes was associated with additional gains in locoregional control or DFS.

  20. Symptoms: Chemotherapy-Induced Peripheral Neuropathy.

    PubMed

    Schneider, Bryan P; Hershman, Dawn L; Loprinzi, Charles

    2015-01-01

    Chemotherapy-induced peripheral neuropathy (CIPN) is a problematic, treatment-induced toxicity that has the potential to impact quality of life and limit the doses of curative intent therapy. This therapy-induced side effect is one of the most troublesome in oncology clinical practices, considering the morbidity, the frequency, and the potential irreversibility of this problem. Patients with breast cancer are particularly impacted by this side effect as multiple agents commonly used for this disease can cause neuropathy. In this chapter, we provide an overview of CIPN, including: clinical predictors, frequency, and its impact on quality of life. Further, we highlight the pathophysiology and review the literature to date for agents designed to prevent or treat CIPN. We also highlight the most important ongoing clinical and translational research questions that hope to help better predict and prevent this toxicity. This includes optimizing the methods of assessment, using host specific factors (Race and genetics) to predict those more likely to experience CIPN, and determining how CIPN might impact clinical decisions toward therapy.

  1. Demystified … Molecular pathology in oncology

    PubMed Central

    Crocker, J

    2002-01-01

    In the past 10 years, molecular biology has found major applications in pathology, particularly in oncology. This has been a field of enormous expansion, where pure science has found a place in clinical practice and is now of everyday use in any academic unit. This demystified review will discuss the techniques used in molecular pathology and then provide examples of how these can be used in oncology. PMID:12456768

  2. Sequential Metastatic Breast Cancer Chemotherapy: Should the Median be the Message?

    PubMed Central

    Jung, Su Yon; Rosenzweig, Margaret

    2013-01-01

    Background: Counseling and anticipatory guidance of the expected course of treatment for women newly diagnosed with metastatic breast cancer (MBC) are difficult due to multiple factors influencing survival following MBC therapy. In order to better tailor counseling at the onset and through the duration of MBC we used non-clinical trial data to better characterize real life experience of sequential MBC treatment. We examined the following aims: (1) What demographic and tumor characteristics are predictive of survival in MBC? (2) What is the median duration of each sequential chemotherapy regimen and subsequent survival of women following each sequence of chemotherapy regimen in MBC? Methods: Retrospective study included 792 women diagnosed from January 1999 through December 2009 at the University of Pittsburgh Cancer Institute Breast Cancer Program. Results: Median duration of sequential chemotherapy regimen and median survival from completion of sequence of chemotherapy regimens were relatively short with a wide range of treatment duration and survival. Characteristics for poor survival included hormone status, human epidermal growth factor receptor-2 (HER 2/neu) status, and increased number and type of metastatic sites. Women who took more than the second sequential chemotherapy regimens had no more than median 3 months of treatment duration and 6 months survival from treatment termination. Discussion: Median clinical response and survival shorten with sequential chemotherapy regimen but with wide ranges. The rare clinical response of the minority should not set the standard for treatment expectations. All cancer clinicians, including oncology nurses, must ensure that patients are receiving tailored counseling regarding their specific risks and benefits for sequential MBC chemotherapy. PMID:24350218

  3. Radiation oncology (Vol. 2)

    SciTech Connect

    Phillips, T.L.; Wara, W.

    1987-01-01

    This volume of the Radiation Oncology series features update reports on the current status of primary therapy for lung cancer and the role of radiation therapy in the treatment of hepatomas. Other articles describe the use of stereotaxic interstitial implantation in the treatment of malignant brain tumors and discuss the indications for and results of radiation as the primary or adjuvant treatment of large bowel cancer. Reports on new technological developments examine the biological basis and clinical potential of local-regional hyperthermia and photodynamic therapy. Included are reviews of the role of magnetic resonance imaging in the diagnostic evaluation of cancer and of three-dimensional treatment planning for high energy external beam radiotherapy.

  4. [Genomics medicine and oncology].

    PubMed

    Michielin, Olivier; Coukos, George

    2014-05-01

    Progress in genomics with, in particular, high throughput next generation sequencing is revolutionizing oncology. The impact of these techniques is seen on the one hand the identification of germline mutations that predispose to a given type of cancer, allowing for a personalized care of patients or healthy carriers and, on the other hand, the characterization of all acquired somatic mutation of the tumor cell, opening the door to personalized treatment targeting the driver oncogenes. In both cases, next generation sequencing techniques allow a global approach whereby the integrality of the genome mutations is analyzed and correlated with the clinical data. The benefits on the quality of care delivered to our patients are extremely impressive. PMID:24800772

  5. 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

  6. 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

  7. Excellent clinical outcomes and retention in care for adults with HIV-associated Kaposi sarcoma treated with systemic chemotherapy and integrated antiretroviral therapy in rural Malawi

    PubMed Central

    Herce, Michael E; Kalanga, Noel; Wroe, Emily B; Keck, James W; Chingoli, Felix; Tengatenga, Listern; Gopal, Satish; Phiri, Atupere; Mailosi, Bright; Bazile, Junior; Beste, Jason A; Elmore, Shekinah N; Crocker, Jonathan T; Rigodon, Jonas

    2015-01-01

    Introduction HIV-associated Kaposi sarcoma (HIV-KS) is the most common cancer in Malawi. In 2008, the non-governmental organization, Partners In Health, and the Ministry of Health established the Neno Kaposi Sarcoma Clinic (NKSC) to treat HIV-KS in rural Neno district. We aimed to evaluate 12-month clinical outcomes and retention in care for HIV-KS patients in the NKSC, and to describe our implementation model, which featured protocol-guided chemotherapy, integrated antiretroviral therapy (ART) and psychosocial support delivered by community health workers. Methods We conducted a retrospective cohort study using routine clinical data from 114 adult HIV-KS patients who received ART and ≥1 chemotherapy cycle in the NKSC between March 2008 and February 2012. Results At enrolment 97% of patients (n/N=103/106) had advanced HIV-KS (stage T1). Most patients were male (n/N=85/114, 75%) with median age 36 years (interquartile range, IQR: 29–42). Patients started ART a median of 77 days prior to chemotherapy (IQR: 36–252), with 97% (n/N=105/108) receiving nevirapine/lamivudine/stavudine. Following standardized protocols, we treated 20 patients (18%) with first-line paclitaxel and 94 patients (82%) with bleomycin plus vincristine (BV). Of the 94 BV patients, 24 (26%) failed to respond to BV requiring change to second-line paclitaxel. A Division of AIDS grade 3/4 adverse event occurred in 29% of patients (n/N=30/102). Neutropenia was the most common grade 3/4 event (n/N=17/102, 17%). Twelve months after chemotherapy initiation, 83% of patients (95% CI: 74–89%) were alive, including 88 (77%) retained in care. Overall survival (OS) at 12 months did not differ by initial chemotherapy regimen (p=0.6). Among patients with T1 disease, low body mass index (BMI) (adjusted hazard ratio, aHR=4.10, 95% CI: 1.06–15.89) and 1 g/dL decrease in baseline haemoglobin (aHR=1.52, 95% CI: 1.03–2.25) were associated with increased death or loss to follow-up at 12 months. Conclusions

  8. The non tumour uptake of (111)In-octreotide creates new clinical indications in benign diseases, but also in oncology.

    PubMed

    Cascini, G L; Cuccurullo, V; Mansi, L

    2010-02-01

    The use of somatostatin (SS) analogues in humans takes advantage by the availability of many related chemical forms that can be used for receptor therapy and, after radiolabelling, for diagnostic imaging and radionuclide therapy. The first proposed radiocompound, yet clinically widely diffuse, has been (111)In-octreotide (OCT), followed by positron emission tomography (PET) and beta emitter tracers. The main field of clinical applications is in neuroendocrine tumours (NET), starting by the demonstration of SS receptors (SSR) on the majority of NET, particularly on gastroenteropancreatic (GEP) tumours. Uptake of SS analogues can also be due to a SSR expression on non malignant cells when activated, as lymphocytes, macrophages, fibroblasts , vascular cells. Because of this uptake clinical indications can be found also in active benign diseases, as Grave's ophthalmopathy, rheumatoid arthritis, histiocitosis, sarcoidosis, idiopatic pulmonary fibrosis. Moreover, these cells can also determine the OCT in vivo uptake in tumours non expressing in vitro SSR, as non-snall cell lung cancer (NSCLC). Because of a different kinetic respect to SCLC a differential histotype diagnosis could be obtained. Starting from this premise OCT can also allows radioguided surgery in tumours non expressing SSR. Finally a relevant clinical role can be defined in the a priori recruitment and as marker of therapeutic efficacy in all the therapeutic strategies utilizing SSR, both in malignant and benign diseases.

  9. 2016 AAHA Oncology Guidelines for Dogs and Cats.

    PubMed

    Biller, Barb; Berg, John; Garrett, Laura; Ruslander, David; Wearing, Richard; Abbott, Bonnie; Patel, Mithun; Smith, Diana; Bryan, Christine

    2016-01-01

    All companion animal practices will be presented with oncology cases on a regular basis, making diagnosis and treatment of cancer an essential part of comprehensive primary care. Because each oncology case is medically unique, these guidelines recommend a patient-specific approach consisting of the following components: diagnosis, staging, therapeutic intervention, provisions for patient and personnel safety in handling chemotherapy agents, referral to an oncology specialty practice when appropriate, and a strong emphasis on client support. Determination of tumor type by histologic examination of a biopsy sample should be the basis for all subsequent steps in oncology case management. Diagnostic staging determines the extent of local disease and presence or absence of regional or distant metastasis. The choice of therapeutic modalities is based on tumor type, histologic grade, and stage, and may include surgery, radiation therapy, chemotherapy, immunotherapy, and adjunctive therapies, such as nutritional support and pain management. These guidelines discuss the strict safety precautions that should be observed in handling chemotherapy agents, which are now commonly used in veterinary oncology. Because cancer is often a disease of older pets, the time of life when the pet-owner relationship is usually strongest, a satisfying outcome for all parties involved is highly dependent on good communication between the entire healthcare team and the client, particularly when death or euthanasia of the patient is being considered. These guidelines include comprehensive tables of common canine and feline cancers as a resource for case management and a sample case history. PMID:27259020

  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 Schedule and Duration of Intravesical Chemotherapy in Patients with Non–Muscle-Invasive Bladder Cancer: A Systematic Review of the Published Results of Randomized Clinical Trials

    PubMed Central

    Sylvester, Richard J.; Oosterlinck, Willem; Witjes, J. Alfred

    2008-01-01

    Objectives Intravesical chemotherapy has been studied in randomized clinical trials for >30 yr; however, the optimal schedule and duration of treatment are unknown. The objective is to determine the effect of schedule and duration of intravesical chemotherapy on recurrence in patients with stage Ta T1 bladder cancer. Methods A systematic review was conducted of the published results of randomized clinical trials that compared intravesical instillations with respect to their number, frequency, timing, duration, dose, or dose intensity. Results One immediate instillation after transurethral resection (TUR) is recommended in all patients. In low-risk patients, no further treatment is recommended before recurrence. In patients with multiple tumors, one immediate instillation is insufficient treatment. Additional instillations may further reduce the recurrence rate; however, no recommendations can be made concerning their optimal duration. A short intensive schedule of instillations within the first 3–4 mo after an immediate instillation may be as effective as longer-term treatment schedules (grade C). Instillations during ≥1 yr in intermediate-risk patients seem advisable only when an immediate instillation has not been given (grade C). Higher drug concentrations and optimization of the drug's concentration in the bladder may provide better results (grade C). Conclusions The optimal schedule and duration of intravesical chemotherapy after an immediate instillation remain unknown. Future studies should focus on the eradication of residual disease after TUR and the prevention of late recurrences. PMID:18207317

  12. 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.

  13. African American Participation in Oncology Clinical Trials--Focus on Prostate Cancer: Implications, Barriers, and Potential Solutions.

    PubMed

    Ahaghotu, Chiledum; Tyler, Robert; Sartor, Oliver

    2016-04-01

    In the United States, the incidence and mortality rates of many cancers, especially prostate cancer, are disproportionately high among African American men compared with Caucasian men. Recently, mortality rates for prostate cancer have declined more rapidly in African American versus Caucasian men, but prostate cancer is still the most common cancer and the second leading cause of cancer deaths in African American men in the United States. Compared with Caucasian men, prostate cancer occurs at younger ages, has a higher stage at diagnosis, and is more likely to progress after definitive treatments in African American men. Reasons for racial discrepancies in cancer are multifactorial and potentially include socioeconomic, cultural, nutritional, and biologic elements. In addition to improving access to novel therapies, clinical trial participation is essential to adequately establish the risks and benefits of treatments in African American populations. Considering the disproportionately high mortality rates noted in these groups, our understanding of the natural history and responses to therapies is limited. This review will explore African American underrepresentation in clinical trials with a focus on prostate cancer, and potentially effective strategies to engage African American communities in prostate cancer research. Solutions targeting physicians, investigators, the community, and health care systems are identified. Improvement of African American participation in prostate cancer clinical trials will benefit all stakeholders. PMID:26786562

  14. Clinical Implications of iNOS Levels in Triple-Negative Breast Cancer Responding to Neoadjuvant Chemotherapy

    PubMed Central

    Jiang, Nan; Zhang, Lei; Li, Yiming; Xu, Xiaoyin; Cai, Shouliang; Wei, Liang; Liu, Xuhong; Chen, Guanglei; Zhou, Yizhen; Liu, Cheng; Li, Zhan; Jin, Feng; Chen, Bo

    2015-01-01

    Triple-negative breast cancer is a high-risk breast cancer with poor survival rate. To date, there is a lack of targeted therapy for this type of cancer. One unique phenomenon is that inflammatory breast cancer is frequently triple negative. However, it is still ambiguous how inflammation influences triple-negative breast cancer growth and responding to chemotherapy. Herein, we investigated the levels of inflammation-associated enzyme, iNOS, in 20 triple-negative breast cancer patients’ tumors, and examined its correlation with patients’ responses to platinum-based neoadjuvant chemotherapy. Our studies showed that triple-negative breast cancer patients with attenuated iNOS levels in tumor cells after treatment showed better responses to platinum-based neoadjuvant chemotherapy than other triple-negative breast cancer patients. Our further in vitro studies confirmed that induction of proper levels of NO increased the resistance to cisplatin in triple-negative MDA-MB-231 cells. Our data suggest that aberrant high level of iNOS/NO are associated with less effectiveness of platinum-based neoadjuvant chemotherapy in triple-negative breast cancer. Therefore, we propose to monitor iNOS levels as a new predictor for triple-negative breast cancer patient’s response to platinum-based neoadjuvant chemotherapy. Moreover, iNOS/NO is considered as a potential target for combination therapy with platinum drugs for triple-negative breast cancer. PMID:26196284

  15. Case management in oncology rehabilitation (CAMON): The effect of case management on the quality of life in patients with cancer after one year of ambulant rehabilitation. A study protocol for a randomized controlled clinical trial in oncology rehabilitation

    PubMed Central

    2011-01-01

    Background Cancer diseases and their therapies have negative effects on the quality of life. The aim of this study is to assess the effectiveness of case management in a sample of oncological outpatients with the intent of rehabilitation after cancer treatment. Case management wants to support the complex information needs of the patients in addition to the segmented structure of the health care system. Emphasis is put on support for self-management in order to enhance health - conscious behaviour, learning to deal with the burden of the illness and providing the opportunity for regular contacts with care providers. We present a study protocol to investigate the efficacy of a case management in patients following oncology rehabilitation after cancer treatment. Methods The trial is a multicentre, two-arm randomised controlled study. Patients are randomised parallel in either 'usual care' plus case management or 'usual care' alone. Patients with all types of cancer can be included in the study, if they have completed the therapy with chemo- and/or radiotherapy/surgery with curative intention and are expected to have a survival time >1 year. To determine the health-related quality of life the general questionnaire FACT G is used. The direct correlation between self-management and perceived self-efficacy is measured with the Jerusalem & Schwarzer questionnaire. Patients satisfaction with the care received is measured using the Patient Assessment of Chronic Illness Care 5 As (PACIC-5A). Data are collected at the beginning of the trial and after 3, 6 and 12 months. The power analysis revealed a sample size of 102 patients. The recruitment of the centres began in 2009. The inclusion of patients began in May 2010. Discussion Case management has proved to be effective regarding quality of life of patients with chronic diseases. When it comes to oncology, case management is mainly used in cancer treatment, but it is not yet common in the rehabilitation of cancer patients

  16. About the Community Oncology and Prevention Trials Research Group | Division of Cancer Prevention

    Cancer.gov

    The Community Oncology and Prevention Trials Research Group supports clinical oncology trials in cancer prevention and control in community settings. The group also supports investigator-initiated research projects in supportive, palliative and end-of-life care, and coordinates clinical oncology research projects with other NCI programs to be done in the community setting. |

  17. 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.

  18. Evaluation of a cloud-based local-read paradigm for imaging evaluations in oncology clinical trials for lung cancer

    PubMed Central

    Kobayashi, Naomi; Bonnard, Eric; Charbonnier, Colette; Yamamichi, Junta; Mizobe, Hideaki; Kimura, Shinya

    2015-01-01

    Background Although tumor response evaluated with radiological imaging is frequently used as a primary endpoint in clinical trials, it is difficult to obtain precise results because of inter- and intra-observer differences. Purpose To evaluate usefulness of a cloud-based local-read paradigm implementing software solutions that standardize imaging evaluations among international investigator sites for clinical trials of lung cancer. Material and Methods Two studies were performed: KUMO I and KUMO I Extension. KUMO I was a pilot study aiming at demonstrating the feasibility of cloud implementation and identifying issues regarding variability of evaluations among sites. Chest CT scans at three time-points from baseline to progression, from 10 patients with lung cancer who were treated with EGFR tyrosine kinase inhibitors, were evaluated independently by two oncologists (Japan) and one radiologist (France), through a cloud-based software solution. The KUMO I Extension was performed based on the results of KUMO I. Results KUMO I showed discordance rates of 40% for target lesion selection, 70% for overall response at the first time-point, and 60% for overall response at the second time-point. Since the main reason for the discordance was differences in the selection of target lesions, KUMO I Extension added a cloud-based quality control service to achieve a consensus on the selection of target lesions, resulting in an improved rate of agreement of response evaluations. Conclusion The study shows the feasibility of imaging evaluations at investigator sites, based on cloud services for clinical studies involving multiple international sites. This system offers a step forward in standardizing evaluations of images among widely dispersed sites. PMID:26668754

  19. Concurrent infection of hepatitis B virus negatively affects the clinical outcome and prognosis of patients with non-Hodgkin's lymphoma after chemotherapy.

    PubMed

    Chen, Jie; Wang, Jianmin; Yang, Jianmin; Zhang, Weiping; Song, Xianmin; Chen, Li

    2013-01-01

    Hepatitis B virus (HBV) is hepatotropic and lymphotropic. HBV-infected individuals have an increased risk of developing malignant lymphoma, and the HBV infection rate in lymphoma patients is significantly higher than that in the general population. However, the exact mechanism and correlation between HBV infection and lymphoma onset and progression currently remain unclear. We retrospectively analyzed clinical data from non-Hodgkin's lymphoma (NHL) patients with different HBV infection statuses. The results showed that the HBV infection rate was significantly higher in patients with B-cell type and late stage of NHL. The chemotherapy efficacy for NHL patients with chronic active HBV infection was significantly lower than that for the patients with chronic inactive HBV infection, the patients with HBV carriers and the patients without HBV infection. In addition, the NHL chemotherapy activated HBV replication and caused significant liver dysfunction, which could further reduce the chemotherapy efficacy. Through Kaplan-Meier survival curve and log-rank analysis, we found that the HBV infection status in NHL patients was significantly correlated with the patients' progression-free survival (PFS) and overall survival (OS). Compared with the patients without HBV infection (PFS: 95% CI 47.915 to 55.640; OS: 95% CI 81.324 to 86.858), the PFS and OS of the patients with chronic active HBV infection were significantly shorter (PFS: 95% CI 9.424 to 42.589, P < 0.001; OS: 95% CI 42.840 to 82.259, P = 0.006). The study demonstrated that the sustained HBV replication in patients with chronic active HBV infection could be a key factor that influences the prognosis of NHL patients after chemotherapy, and thus may provide information for designing rational clinical treatments for NHL patients with different HBV infection statuses and improve the treatment efficacy and prognosis. PMID:23861969

  20. Immuno-Positron Emission Tomography with Zirconium-89-Labeled Monoclonal Antibodies in Oncology: What Can We Learn from Initial Clinical Trials?

    PubMed Central

    Jauw, Yvonne W. S.; Menke-van der Houven van Oordt, C. Willemien; Hoekstra, Otto S.; Hendrikse, N. Harry; Vugts, Danielle J.; Zijlstra, Josée M.; Huisman, Marc C.; van Dongen, Guus A. M. S.

    2016-01-01

    Selection of the right drug for the right patient is a promising approach to increase clinical benefit of targeted therapy with monoclonal antibodies (mAbs). Assessment of in vivo biodistribution and tumor targeting of mAbs to predict toxicity and efficacy is expected to guide individualized treatment and drug development. Molecular imaging with positron emission tomography (PET) using zirconium-89 (89Zr)-labeled monoclonal antibodies also known as 89Zr-immuno-PET, visualizes and quantifies uptake of radiolabeled mAbs. This technique provides a potential imaging biomarker to assess target expression, as well as tumor targeting of mAbs. In this review we summarize results from initial clinical trials with 89Zr-immuno-PET in oncology and discuss technical aspects of trial design. In clinical trials with 89Zr-immuno-PET two requirements should be met for each 89Zr-labeled mAb to realize its full potential. One requirement is that the biodistribution of the 89Zr-labeled mAb (imaging dose) reflects the biodistribution of the drug during treatment (therapeutic dose). Another requirement is that tumor uptake of 89Zr-mAb on PET is primarily driven by specific, antigen-mediated, tumor targeting. Initial trials have contributed toward the development of 89Zr-immuno-PET as an imaging biomarker by showing correlation between uptake of 89Zr-labeled mAbs on PET and target expression levels in biopsies. These results indicate that 89Zr-immuno-PET reflects specific, antigen-mediated binding. 89Zr-immuno-PET was shown to predict toxicity of RIT, but thus far results indicating that toxicity of mAbs or mAb-drug conjugate treatment can be predicted are lacking. So far, one study has shown that molecular imaging combined with early response assessment is able to predict response to treatment with the antibody-drug conjugate trastuzumab-emtansine, in patients with human epithelial growth factor-2 (HER2)-positive breast cancer. Future studies would benefit from a standardized criterion

  1. Immuno-Positron Emission Tomography with Zirconium-89-Labeled Monoclonal Antibodies in Oncology: What Can We Learn from Initial Clinical Trials?

    PubMed

    Jauw, Yvonne W S; Menke-van der Houven van Oordt, C Willemien; Hoekstra, Otto S; Hendrikse, N Harry; Vugts, Danielle J; Zijlstra, Josée M; Huisman, Marc C; van Dongen, Guus A M S

    2016-01-01

    Selection of the right drug for the right patient is a promising approach to increase clinical benefit of targeted therapy with monoclonal antibodies (mAbs). Assessment of in vivo biodistribution and tumor targeting of mAbs to predict toxicity and efficacy is expected to guide individualized treatment and drug development. Molecular imaging with positron emission tomography (PET) using zirconium-89 ((89)Zr)-labeled monoclonal antibodies also known as (89)Zr-immuno-PET, visualizes and quantifies uptake of radiolabeled mAbs. This technique provides a potential imaging biomarker to assess target expression, as well as tumor targeting of mAbs. In this review we summarize results from initial clinical trials with (89)Zr-immuno-PET in oncology and discuss technical aspects of trial design. In clinical trials with (89)Zr-immuno-PET two requirements should be met for each (89)Zr-labeled mAb to realize its full potential. One requirement is that the biodistribution of the (89)Zr-labeled mAb (imaging dose) reflects the biodistribution of the drug during treatment (therapeutic dose). Another requirement is that tumor uptake of (89)Zr-mAb on PET is primarily driven by specific, antigen-mediated, tumor targeting. Initial trials have contributed toward the development of (89)Zr-immuno-PET as an imaging biomarker by showing correlation between uptake of (89)Zr-labeled mAbs on PET and target expression levels in biopsies. These results indicate that (89)Zr-immuno-PET reflects specific, antigen-mediated binding. (89)Zr-immuno-PET was shown to predict toxicity of RIT, but thus far results indicating that toxicity of mAbs or mAb-drug conjugate treatment can be predicted are lacking. So far, one study has shown that molecular imaging combined with early response assessment is able to predict response to treatment with the antibody-drug conjugate trastuzumab-emtansine, in patients with human epithelial growth factor-2 (HER2)-positive breast cancer. Future studies would benefit from a

  2. Clinical ineffectiveness of IL-2 and/or IFN alpha administration after autologous PBSC transplantation in pediatric oncological patients.

    PubMed

    Vlk, V; Eckschlager, T; Kavan, P; Kabícková, E; Koutecký, J; Sobota, V; Bubenik, J; Pospísilová, D

    2000-01-01

    Clinical impact of s.c. administration of IL-2 and/or IFN alpha was studied in 23 pediatric patients with Hodgkin lymphoma (IFN alpha group) and sarcoma, non-Hodgkin lymphoma, peripheral neuroepitelioma, neuroblastoma, and embryonic carcinoma (IL-2 + IFN alpha group) after autologous PBSC transplantation. Expression of CD3, CD4, CD8, CD25, CD38, CD56, CD71, CD122, and HLA-DR antigens, serum level of the soluble IL-2R alpha, and NK activity against K562 cell line were evaluated in 11 patients representative for both types of immunotherapy. T and, more markedly, NK cell proliferation, induction of activation markers on the surface of T and NK subsets, and elevation of sIL-2R alpha concentrations were seen in the IL-2 + IFN alpha subgroup. In the IFN alpha subgroup, the total number of lymphocytes and expression of activation markers remained unchanged, but the number of CD8+ T cells increased at the expense of CD4+ T and NK cells during the therapy. Cytotoxic activity against K562 cells was not influenced by the immunotherapy in either subgroup. No significant clinical benefit of the immunotherapy was seen in these patients compared to 27 control patients with relevant diagnoses who did not receive immunotherapy.

  3. Integration of imaging into clinical practice to assess the delivery and performance of macromolecular and nanotechnology-based oncology therapies.

    PubMed

    Spence, Tara; De Souza, Raquel; Dou, Yannan; Stapleton, Shawn; Reilly, Raymond M; Allen, Christine

    2015-12-10

    Functional and molecular imaging has become increasingly used to evaluate interpatient and intrapatient tumor heterogeneity. Imaging allows for assessment of microenvironment parameters including tumor hypoxia, perfusion and proliferation, as well as tumor metabolism and the intratumoral distribution of specific molecular markers. Imaging information may be used to stratify patients for targeted therapies, and to define patient populations that may benefit from alternative therapeutic approaches. It also provides a method for non-invasive monitoring of treatment response at earlier time-points than traditional cues, such as tumor shrinkage. Further, companion diagnostic imaging techniques are becoming progressively more important for development and clinical implementation of targeted therapies. Imaging-based companion diagnostics are likely to be essential for the validation and FDA approval of targeted nanotherapies and macromolecular medicines. This review describes recent clinical advances in the use of functional and molecular imaging to evaluate the tumor microenvironment. Additionally, this article focuses on image-based assessment of distribution and anti-tumor effect of nano- and macromolecular systems.

  4. The intramuscular administration of granulocyte colony-stimulating factor as an adjunct to chemotherapy in pretreated ovarian cancer patients: an Italian Trials in Medical Oncology (ITMO) Group pilot study.

    PubMed Central

    Di Leo, A.; Bajetta, E.; Nolè, F.; Biganzoli, L.; Ferrari, L.; Oriana, S.; Riboldi, G.; Bohm, S.; Spatti, G.; Raspagliesi, F.

    1994-01-01

    No published data are available concerning the activity and tolerability of intramuscularly administered granulocyte colony-stimulating factor (G-CSF) in humans. To fill this gap, 19 patients with advanced ovarian cancer previously treated with at least one first-line chemotherapy cycle received the following myelosuppressive regimen: mitoxantrone (DHAD) 12 mg m-2 i.v. on day 1; ifosfamide (IFO) 4 g m-2 i.v. on days 1 and 2; mesna 800 mg m-2 i.v. t.i.d. on days 1 and 2. G-CSF (Filgrastim) was given at a dose of 5 micrograms/kg/day i.m. from day 6 to day 19, its pharmacokinetics being assessed in five patients. The neutrophil nadir was observed after a mean period of 8 days, and the neutrophil count was < 1.0 x 10(3) mm-3 for a mean of 6 days during the cycle of chemotherapy. The neutrophil count fell after the withdrawal of G-CSF on the 19th day of treatment. The difference in absolute neutrophil count between day 19 and day 21 was statistically significant (P = 0.0001); nevertheless, at day 21 no WHO grade 3-4 neutropenia was reported. DHAD and IFO were respectively given at 95% and 93% of the planned dose. The pharmacokinetics of G-CSF i.m. seems to be similar to that of the drug given subcutaneously. No evidence of cumulative myelosuppression was observed. G-CSF was well tolerated and no complications were observed at the injection sites. In conclusion, if the results obtained in this pilot study regarding the activity of i.m. G-CSF are confirmed by a randomised trial, the intramuscular administration of G-CSF could become a valid alternative for patients who dislike the subcutaneous route and who are being treated with chemotherapy that does not induce profound thrombocytopenia. PMID:7514030

  5. Immuno-oncology combinations: raising the tail of the survival curve

    PubMed Central

    Harris, Samuel J.; Brown, Jessica; Lopez, Juanita; Yap, Timothy A.

    2016-01-01

    There have been exponential gains in immuno-oncology in recent times through the development of immune checkpoint inhibitors. Already approved by the U.S. Food and Drug Administration for advanced melanoma and non-small cell lung cancer, immune checkpoint inhibitors also appear to have significant antitumor activity in multiple other tumor types. An exciting component of immunotherapy is the durability of antitumor responses observed, with some patients achieving disease control for many years. Nevertheless, not all patients benefit, and efforts should thus now focus on improving the efficacy of immunotherapy through the use of combination approaches and predictive biomarkers of response and resistance. There are multiple potential rational combinations using an immunotherapy backbone, including existing treatments such as radiotherapy, chemotherapy or molecularly targeted agents, as well as other immunotherapeutics. The aim of such antitumor strategies will be to raise the tail on the survival curve by increasing the number of long term survivors, while managing any additive or synergistic toxicities that may arise with immunotherapy combinations. Rational trial designs based on a clear understanding of tumor biology and drug pharmacology remain paramount. This article reviews the biology underpinning immuno-oncology, discusses existing and novel immunotherapeutic combinations currently in development, the challenges of predictive biomarkers of response and resistance and the impact of immuno-oncology on early phase clinical trial design. PMID:27458526

  6. Radiation Therapy Oncology Group Protocol 02-29: A Phase II Trial of Neoadjuvant Therapy With Concurrent Chemotherapy and Full-Dose Radiation Therapy Followed by Surgical Resection and Consolidative Therapy for Locally Advanced Non-small Cell Carcinoma of the Lung

    SciTech Connect

    Suntharalingam, Mohan; Paulus, Rebecca; Edelman, Martin J.; Krasna, Mark; Burrows, Whitney; Gore, Elizabeth; Wilson, Lynn D.; Choy, Hak

    2012-10-01

    Purpose: To evaluate mediastinal nodal clearance (MNC) rates after induction chemotherapy and concurrent, full-dose radiation therapy (RT) in a phase II trimodality trial (Radiation Therapy Oncology Group protocol 0229). Patients and Methods: Patients (n=57) with stage III non-small cell lung cancer (pathologically proven N2 or N3) were eligible. Induction chemotherapy consisted of weekly carboplatin (AUC = 2.0) and paclitaxel 50 mg/m{sup 2}. Concurrent RT was prescribed, with 50.4 Gy to the mediastinum and primary tumor and a boost of 10.8 Gy to all gross disease. The mediastinum was pathologically reassessed after completion of chemoradiation. The primary endpoint of the study was MNC, with secondary endpoints of 2-year overall survival and postoperative morbidity/mortality. Results: The grade 3/4 toxicities included hematologic 35%, gastrointestinal 14%, and pulmonary 23%. Forty-three patients (75%) were evaluable for the primary endpoint. Twenty-seven patients achieved the primary endpoint of MNC (63%). Thirty-seven patients underwent resection. There was a 14% incidence of grade 3 postoperative pulmonary complications and 1 30-day, postoperative grade 5 toxicity (3%). With a median follow-up of 24 months for all patients, the 2-year overall survival rate was 54%, and the 2-year progression-free survival rate was 33%. The 2-year overall survival rate was 75% for those who achieved nodal clearance, 52% for those with residual nodal disease, and 23% for those who were not evaluable for the primary endpoint (P=.0002). Conclusions: This multi-institutional trial confirms the ability of neoadjuvant concurrent chemoradiation with full-dose RT to sterilize known mediastinal nodal disease.

  7. [The role of microRNAs in molecular pathology of esophageal cancer and their potential usage in clinical oncology].

    PubMed

    Kovaříková, A; Héžová, R; Srovnal, J; Rédová-Lojová, M; Slabý, O

    2014-01-01

    MicroRNAs are an abundant class of noncoding RNAs (approx. 18- 25 nucleotides in length) that suppress translation through binding to their target mRNAs, eventually leading to mRNAs degradation. Sequences of these endogenous RNA molecules are highly conserved, even among unrelated species, indicating their involvement in basic bio-logical processes, such as development, differentiation, proliferation or apoptosis. MiRNAs also participate on regulation of cancer stem cell functioning, immune system and malignant transformation. This review provides a comprehensive overview of miRNAs functions in esophageal cancer, their roles in key pathogenetic pathways and disease development, as well as their potential usage in clinical routine as bio-markers improving dia-gnosis, prognosis and prediction of therapeutic response. Through regulation of signaling pathways important in malignant transformation, miRNAs present also promising therapeutic targets. PMID:24739044

  8. Chemotherapy and Your Mouth

    MedlinePlus

    ... Health > Chemotherapy and Your Mouth Chemotherapy and Your Mouth Main Content Are You Being Treated With Chemotherapy ... Back to Top How Does Chemotherapy Affect the Mouth? Chemotherapy is the use of drugs to treat ...

  9. Combination chemotherapy-radiotherapy with and without the methanol-extraction residue of bacillus Calmette-Guerin (MER) in small cell carcinoma of the lung: a prospective randomized trial of the Piedmont Oncology Association

    SciTech Connect

    Jackson, D.V.; Paschal, B.R.; Ferree, C.

    1982-07-01

    The effect of addition of the nonspecific immunostimulant, MER, to combined treatment with chemotherapy and radiotherapy in small cell carcinoma of the lung was evaluated in a prospective randomized trial involving 102 evaluable patients. Chemotherapy consisted of cyclophosphamide, Adriamycin, vincristine, methotrexate, and CCNU; and radiotherapy was administered to the primary lesion, mediastinum, supraclavicular areas, and whole brain. Of 47 patients administered MER 400 mcg intradermally every six weeks, 12 (26%) attained complete remission with a median survival of 22.9 months. Complete remission was observed in 17 (31%) of 55 patients who received no MER with a median survival of 20.0 months (p > 0.05). Survival greater than or equal to 2 years has been observed in five patients who received MER and two patients who did not receive MER. The response rate and duration, survival, and toxicity of the two treatment arms were similar with the exception of cutaneous and occasional systemic reaction to MER. MER as used in this study has not influenced the overall results of a combined modality treatment program for patients with small cell carcinoma of the lung.

  10. Ethical problems experienced by oncology nurses1

    PubMed Central

    da Luz, Kely Regina; Vargas, Mara Ambrosina de Oliveira; Schmidtt, Pablo Henrique; Barlem, Edison Luiz Devos; Tomaschewski-Barlem, Jamila Geri; da Rosa, Luciana Martins

    2015-01-01

    Objective: to know the ethical problems experienced by oncology nurses. Method: descriptive and exploratory study with a qualitative approach, performed in inpatient units and in chemotherapy out-patients units that provide assistance to oncological patients in two capitals in the South region of Brazil. Eighteen nurses participated in this study, selected by snowball sampling type. For data collection, semi-structured interviews were carried out, which were recorded and transcribed, and then analyzed by thematic analysis. Results: two categories were established: when informing or not becomes a dilemma - showing the main difficulties related to oncological treatment information regarding health staff, health system, and infrastructure; to invest or not - dilemmas related to finitude - showing situations of dilemmas related to pain and confrontation with finitude. Conclusion: for the effective confrontation of the ethical problems experienced by oncology nurses to occur, it is important to invest in the training of these professionals, preparing them in an ethical and human way to act as lawyers of the patient with cancer, in a context of dilemmas related mainly to the possibility of finitude. PMID:26626012

  11. Anticancer chemotherapy

    SciTech Connect

    Weller, R.E.

    1991-10-01

    This document examines chemotherapeutic agents for use in veterinary oncology. It lists some of the most common categories of chemotherapeutic drugs, such as alkylating agents and corticosteroids. For each category, the paper lists some example drugs, gives their mode of action, tumors usually susceptible to the drug, and common side effects. A brief discussion of mechanisms of drug resistance is also provided. (MHB)

  12. [Postoperative Adjuvant Chemotherapy for Stage III Colon Cancer--Drug Selection, Tolerability, and Safety in Clinical Practice].

    PubMed

    Okada, Kazutake; Sadahiro, Sotaro; Saito, Gota; Tanaka, Akira; Suzuki, Toshiyuki

    2016-05-01

    In the National Comprehensive Cancer Network (NCCN) guidelines, oxaliplatin (L-OHP)-based chemotherapeutic regimens, including 5-fluorouracil, Leucovorin (LV), and L-OHP (FOLFOX); capecitabine and L-OHP (CapeOX); and 5-fluorouracil, folinic acid, and L-OHP (FLOX) are designated as category 1 recommendations for postoperative adjuvant chemotherapy in Stage III colon cancer, followed by capecitabine and 5-fluorouracil plus LV as category 2A recommendations. We studied the selection of drugs for adjuvant chemotherapy and assessed the tolerability and safety of CapeOX and tegafur-uracil (UFT) plus LV (UFT/LV) in patients with Stage III colon cancer. The study group included 104 consecutive patients with Stage III colon cancer who underwent curative surgery. One patient changed hospitals immediately after surgery. Among the remaining 103 patients, 82 (80%) received adjuvant chemotherapy and 21 (20%) did not. CapeOX was administered to 32 patients (31%), UFT/LV to 49 patients (48%), and capecitabine to 1 patient (1%). In 59 patients, the treatment choice was determined according to the patient's preference; 32 patients (54%) selected CapeOX, 26 (44%) selected UFT/LV, and 1 (2%) selected no chemotherapy. The treatment completion rate was 80% for CapeOX and 84% for UFT/LV. Among patients who completed chemotherapy, dose reduction and drug withdrawal were not required in 22% of patients who received CapeOX and 80% of those who received UFT/LV. Neither CapeOX nor UFT/LV was associated with any serious adverse events. The tolerability and safety of CapeOX and UFT/LV were acceptable. However, CapeOX dose had to be carefully adjusted according to each patient's condition.

  13. Submission of the entire lymph node dissection for histologic examination in gynecologic-oncologic specimens. Clinical and pathologic relevance

    PubMed Central

    Mhawech-Fauceglia, Paulette; Herrmann, Francois R.; Wagner, Heidi; Godoy, Heidi; Odunsi, Kunle; Cheney, Richard T.; Lele, Shashikant

    2016-01-01

    Background and aims Lymph node (LN) status in gynecologic malignancies plays an important role in patient staging, management, and prognosis. Therefore, an adequacy of LN harvest is crucial. The aim of this study is to determine whether the submission of the entire LN dissection for histologic examination will affect patients’ outcome or clinical stage. We also evaluated the time required and cost-effectiveness for the laboratory. Materials and methods A prospective study of 134 surgical cases from various gynecologic malignancies was conducted. The LN dissection specimen was performed using a conventional manual node dissection method with all the remaining fat being submitted in additional cassettes. One pathologist evaluated (1) the number and status of palpable LNs identified by the conventional method as well as the number of tissue cassettes and (2) the number, size, and status of the non-palpable LNs as well as the number of tissue cassettes. Results The palpable LNs ranged from 0 to 36 with average 14.8 LNs per case (Poisson 95% CI: 14.1–15.4). The additional non-palpable LNs ranged from 0 to 16 with an average of 3.1 (Poisson 95% CI: 2.8–3.4). In only one case, a 3-mm non-palpable LN with metastasis was identified; however, it did not affect tumor staging or patient management. Conclusion The impact on patient outcome is minimal and it does not prove to be cost and time effective when submitting the entire LN dissection specimen in gynecologic malignancies. However, this method could be justified in selective cases in which the manual node dissection does not reveal an adequate number of LNs. PMID:19811809

  14. Induction Chemotherapy With Gemcitabine, Oxaliplatin, and 5-Fluorouracil/Leucovorin Followed by Concomitant Chemoradiotherapy in Patients With Locally Advanced Pancreatic Cancer: A Taiwan Cooperative Oncology Group Phase II Study

    SciTech Connect

    Ch'ang, Hui-Ju; Lin, Yu-Lin; Wang, Hsiu-Po; Chiu, Yen-Feng; Chang, Ming-Chu; Hsu, Chih-Hung; Tien, Yu-Wen; Chen, Jen-Shi; Hsieh, Ruey-Kuen; Lin, Pin-Wen; Shan, Yan-Shen; Cheng, Ann-Lii; Chang, Jang-Yang; Whang-Peng, Jacqueline; Hwang, Tsann-Long; and others

    2011-12-01

    Purpose: To evaluate the therapeutic efficacy of 3-month triplet induction chemotherapy (ICT) followed by concomitant chemoradiotherapy (CCRT) in patients with locally advanced pancreatic cancer (LAPC). Patients and Methods: Chemonaieve patients with measurable, histologically confirmed LAPC were eligible. The ICT consisted of biweekly gemcitabine (800 mg/m{sup 2}) infusion at a fixed dose rate (10 mg/m{sup 2}/min), followed by 85 mg/m{sup 2} oxaliplatin and 48-h infusion of 5-fluorouracil/leucovorin (3000/150 mg/m{sup 2}) for 6 cycles. Patients without disease progression 4 weeks after ICT would receive weekly 400 mg/m{sup 2} gemcitabine and 5040 cGy radiation in 28 fractions. After CCRT, patients were subjected for surgical intervention and/or maintenance chemotherapy until progression or intolerable toxicity. Results: Between December 2004 and August 2008, 50 patients were enrolled. The best responses after ICT were partial response (PR) in 9, stable disease in 26, and progressive disease or not evaluable in 15. Among the former 35 patients, 2 had disease progression before CCRT, and 3 declined to have CCRT. Of the 30 patients receiving CCRT, an additional 4 and 1 patient(s) achieved PR at the end of CCRT and during maintenance chemotherapy, respectively. On intent-to-treat analysis, the overall best response was PR in 14 patients and stable disease in 21. The overall response rate and disease control rate were 28% (95% confidence interval [CI], 16.2-42.5%) and 70% (95% CI, 44.4-99.2%), respectively. The median time to progression and overall survival of the intent-to-treat population was 9.3 (95% CI, 5.8-12.8) months and 14.5 (95% CI, 11.9-17.1) months, respectively. One- and two-year survival rates were 68% (95% CI, 55.1-80.9%) and 20.6% (95% CI, 8.7-32.5%), respectively. Neutropenia was the most common Grade 3-4 toxicity of both ICT and CCRT, with a frequency of 28% and 26.7%, respectively. Significant sensory neuropathy occurred in 9 patients (18

  15. Rasburicase in the prevention of laboratory/clinical tumour lysis syndrome in children with advanced mature B-NHL: A Children’s Oncology Group Report

    PubMed Central

    Galardy, Paul; Hochberg, Jessica; Perkins, Sherrie L.; Harrison, Lauren; Goldman, Stanton; Cairo, Mitchell S.

    2013-01-01

    Summary Laboratory (LTLS) and clinical (CTLS) tumour lysis syndrome (TLS) are frequent complications in newly diagnosed children with advanced mature B cell non-Hodgkin lymphoma (B-NHL). Rasburicase, compared to allopurinol, results in more rapid reduction of uric acid in paediatric patients at risk for TLS. However, the safety and efficacy of rasburicase for the treatment or or prevention of TLS has not been prospectively evaluated. Children with newly diagnosed stage III–IV, bone marrow+ and/or central nervous system+ mature B-NHL received hydration and rasburicase prior to cytoreductive therapy. Rasburicase was safe and well-tolerated and there were no grade III–IV toxicities probably or directly related to rasburicase. Patients with an initial lactate dehydrogenase ≥2x upper limit of normal had a significantly elevated uric acid level (P=0.005), increased incidence of TLS (p-0.005) and lower glomerular filtration rate (GFR; p<0.001). Following rasburicase, there was only a 9% and 5% incidence of LTLS and CTLS, respectively. Furthermore, there was a significant improvement in estimated GFR from Day 0 to Day 7 following rasburicase (p=0.0007) and only 1.3% of patients required new onset renal assisted support after rasburicase administration. A TLS strategy incorporating rasburicase prior to cytoreductive chemotherapy proved safe and effective in preventing new onset renal failure and was associated with a significant improvement in GFR. PMID:24032600

  16. A non-randomized confirmatory study regarding selection of fertility-sparing surgery for patients with epithelial ovarian cancer: Japan Clinical Oncology Group Study (JCOG1203).

    PubMed

    Satoh, Toyomi; Tsuda, Hitoshi; Kanato, Keisuke; Nakamura, Kenichi; Shibata, Taro; Takano, Masashi; Baba, Tsukasa; Ishikawa, Mitsuya; Ushijima, Kimio; Yaegashi, Nobuo; Yoshikawa, Hiroyuki

    2015-06-01

    Fertility-sparing treatment has been accepted as a standard treatment for epithelial ovarian cancer in stage IA non-clear cell histology grade 1/grade 2. In order to expand an indication of fertility-sparing treatment, we have started a non-randomized confirmatory trial for stage IA clear cell histology and stage IC unilateral non-clear cell histology grade 1/grade 2. The protocol-defined fertility-sparing surgery is optimal staging laparotomy including unilateral salpingo-oophorectomy, omentectomy, peritoneal cytology and pelvic and para-aortic lymph node dissection or biopsy. After fertility-sparing surgery, four to six cycles of adjuvant chemotherapy with paclitaxel and carboplatin are administered. We plan to enroll 250 patients with an indication of fertility-sparing surgery, and then the primary analysis is to be conducted for 63 operated patients with pathologically confirmed stage IA clear cell histology and stage IC unilateral non-clear cell histology grade 1/grade 2. The primary endpoint is 5-year overall survival. Secondary endpoints are other survival endpoints and factors related to reproduction. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000013380. PMID:26059697

  17. A non-randomized confirmatory study regarding selection of fertility-sparing surgery for patients with epithelial ovarian cancer: Japan Clinical Oncology Group Study (JCOG1203).

    PubMed

    Satoh, Toyomi; Tsuda, Hitoshi; Kanato, Keisuke; Nakamura, Kenichi; Shibata, Taro; Takano, Masashi; Baba, Tsukasa; Ishikawa, Mitsuya; Ushijima, Kimio; Yaegashi, Nobuo; Yoshikawa, Hiroyuki

    2015-06-01

    Fertility-sparing treatment has been accepted as a standard treatment for epithelial ovarian cancer in stage IA non-clear cell histology grade 1/grade 2. In order to expand an indication of fertility-sparing treatment, we have started a non-randomized confirmatory trial for stage IA clear cell histology and stage IC unilateral non-clear cell histology grade 1/grade 2. The protocol-defined fertility-sparing surgery is optimal staging laparotomy including unilateral salpingo-oophorectomy, omentectomy, peritoneal cytology and pelvic and para-aortic lymph node dissection or biopsy. After fertility-sparing surgery, four to six cycles of adjuvant chemotherapy with paclitaxel and carboplatin are administered. We plan to enroll 250 patients with an indication of fertility-sparing surgery, and then the primary analysis is to be conducted for 63 operated patients with pathologically confirmed stage IA clear cell histology and stage IC unilateral non-clear cell histology grade 1/grade 2. The primary endpoint is 5-year overall survival. Secondary endpoints are other survival endpoints and factors related to reproduction. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000013380.

  18. Clinical symptoms and chemotherapy completion in elderly patients with newly diagnosed acute leukemia: a retrospective comparison study with a younger cohort

    PubMed Central

    2011-01-01

    Background Cancer affects older adults disproportionately. The disease is often difficult to diagnose and treat due to co-morbidities and performance status, and patients tend to discontinue chemotherapy prematurely. There are no systemic studies of the reasons and factors that create a higher withdrawal rate in older acute leukemia patients. This study tried to understand the initial characteristics, blood counts and bone marrow measurements in older acute leukemia patients by comparing them with a younger group to provide information and assistance in early clinical diagnosis, treatment and reasons for treatment withdrawal. Methods Using retrospective medical record reviews, we examined clinical characteristics and chemotherapy completion status in the patients of two groups (age ≥ 60, n = 183 and age <60, n = 183) who were diagnosed with acute leukemia for the first time and were hospitalized in Union Hospital Affiliated with Fujian Medical University from 2004 to 2008. Results There were no statistical differences in initial presenting symptoms of fatigue (67.2% vs. 57.9%, P>0.05) and pallor (53% vs. 59.6%, P>0.05) between the two groups, but older patients demonstrated more underlying diseases including lung infections (25.7%, P = <0.001), cardiovascular disease (4.4%, P = 0.007), and hypertension (20.8%, P =< 0.001). The complete remission rate after chemotherapy (1 to 2 courses) was 49.5% in the older group and 66.7% in the younger group (χ2 = 6.202, P = 0.013). The percentage of patients age 60 and older who prematurely discontinued chemotherapy (50.3%), mainly due to the influences of traditional Chinese concept of critical illness, financial difficulties, and intolerance to adverse reactions to chemotherapy, was significantly higher than that of younger patients (37.7%) (χ2 = 5.866, P = 0.015). Conclusions A comprehensive approach to diagnosis, treatment selection, and toxicity management, and implementing strategies to enhance treatment compliance

  19. Oncology Nursing Society

    MedlinePlus

    ... ONS Journal CNE Activity: Women’s Educational Needs and Perceptions about Survivorship Following Bilateral Mastectomy ONS/ONCC Chemotherapy ... ONS Journal CNE Activity: Women’s Educational Needs and Perceptions about Survivorship Following Bilateral Mastectomy ONS/ONCC Chemotherapy ...

  20. A Phase 2 Trial of Radiation Therapy With Concurrent Paclitaxel Chemotherapy After Surgery in Patients With High-Risk Endometrial Cancer: A Korean Gynecologic Oncologic Group Study

    SciTech Connect

    Cho, Hanbyoul; Nam, Byung-Ho; Kim, Seok Mo; Cho, Chi-Heum; Kim, Byoung Gie; Ryu, Hee-Sug; Kang, Soon Beom; Kim, Jae-Hoon

    2014-09-01

    Purpose: A phase 2 study was completed by the Korean Gynecologic Oncologic Group to evaluate the efficacy and toxicity of concurrent chemoradiation with weekly paclitaxel in patients with high-risk endometrial cancer. Methods and Materials: Pathologic requirements included endometrial endometrioid adenocarcinoma stages III and IV. Radiation therapy consisted of a total dose of 4500 to 5040 cGy in 5 fractions per week for 6 weeks. Paclitaxel 60 mg/m{sup 2} was administered once weekly for 5 weeks during radiation therapy. Results: Fifty-seven patients were enrolled between January 2006 and March 2008. The median follow-up time was 60.0 months (95% confidence interval [CI], 51.0-58.2). All grade 3/4 toxicities were hematologic and usually self-limited. There was no life-threatening toxicity. The cumulative incidence of intrapelvic recurrence sites was 1.9% (1/52), and the cumulative incidence of extrapelvic recurrence sites was 34.6% (18/52). The estimated 5-year disease-free and overall survival rates were 63.5% (95% CI, 50.4-76.5) and 82.7% (95% CI, 72.4-92.9), respectively. Conclusions: Concurrent chemoradiation with weekly paclitaxel is well tolerated and seems to be effective for high-risk endometrioid endometrial cancers. This approach appears reasonable to be tested for efficacy in a prospective, randomized controlled study.

  1. Sensitizing Effects of Pretreatment Measures on Cancer Chemotherapy Nausea and Vomiting.

    ERIC Educational Resources Information Center

    Gard, Diane; And Others

    1988-01-01

    Explored sensitizing effects of pretreatment assessment on posttreatment chemotherapy nausea and vomiting and interactive effects of personal dispositions for information seeking. Oncology patients rated side effects experienced previously (experimental condition), or parking conditions (control). Posttreatment, nausea of experimentals was…

  2. The modern trends of the evolution laser information technology in oncology

    NASA Astrophysics Data System (ADS)

    Mikov, A. A.; Svirin, V. N.

    2008-04-01

    Laser-optical information technologies and devices develop since the 70- years at the end of 20 century and are broadly used for diagnostics and treatment of oncological diseases to date. Although such methods as photodynamic therapy (PDT), laser-induce thermotherapy (LITT), fluorescent diagnostics and spectrophotometry already more than 30 years are used for treatment and diagnostics of oncological diseases, nevertheless, they are enough new methods and, as a rule, are used in large scientific centers and medical institutions. This is bound, first of all, with lack of information on modern method of cancer treatment, the absence of widely available laser procedures and corresponding devices in the polyclinics and even in district hospitals, as well as insufficient understanding of application areas, where laser methods has an advantage by comparison, for instance, with beam or chemotherapy. At present day laser methods are fast upcoming direction of the treatment oncological diseases. This is explained by progress in development essentially laser, particularly diode, improvement electronic and computing components and broad introduction software-algorithmic methods of control the undertaking therapeutic and diagnostic procedures. In article are considered new laser methods of the undertaking diagnostic and therapeutic procedures and is shown that introduction multiwave laser radiation for probe and influences on tissue, the different methods of the determination of the functional state of tissues, realization of the on-line diagnostics when carrying out the therapeutic procedures, automatic control systems of the power laser radiation, which depends on state patient tissue, as well as software-algorithmic methods of management session therapeutic and diagnostic procedures greatly raises efficiency of the treatment oncological diseases. On an example of the multipurpose laser therapeutic devices("MLTA") developed and introduced in clinical practice and multipurpose

  3. Nine-year change in statistical design, profile, and success rates of Phase II oncology trials.

    PubMed

    Ivanova, Anastasia; Paul, Barry; Marchenko, Olga; Song, Guochen; Patel, Neerali; Moschos, Stergios J

    2016-01-01

    We investigated nine-year trends in statistical design and other features of Phase II oncology clinical trials published in 2005, 2010, and 2014 in five leading oncology journals: Cancer, Clinical Cancer Research, Journal of Clinical Oncology, Annals of Oncology, and Lancet Oncology. The features analyzed included cancer type, multicenter vs. single-institution, statistical design, primary endpoint, number of treatment arms, number of patients per treatment arm, whether or not statistical methods were well described, whether the drug was found effective based on rigorous statistical testing of the null hypothesis, and whether the drug was recommended for future studies.

  4. Psycho-oncology: Searching for practical wisdom?

    PubMed

    Butlin, Helen

    2015-10-01

    The debate is vigorous in psycho-oncology about whether spiritual, existential, and psychosocial are the most comprehensive terms for academic research discourses investigating meaning and purpose. A call-to-action email from the International Society of Psycho-Oncology included the term soul. The current essay highlights the historical and contemporary uses of "soul" to suggest that the re-emergent soul signifies a tacit quest for an "intangible" that seems missing in current constructs of clinical domains reflected in the vigor of the debates. It is suggested that the re-emergence of the pre-Medieval meaning(s) of the notion of soul affirms a growing need for integrative paradigms on "being human" to guide psycho-oncology practitioners and their research. As a paradigmatic example, a clinical support group entitled Soul Medicine is described as employing the term soul to open up the more marginal discourses about experiences of illness arising from philosophical reflection, arts, humanities, and spirituality within a clinical oncology context. A link between soul and wisdom is suggested for further exploration with the view that phronesis ("the virtue of practical wisdom"), an emerging concept in health professional education research, is of ultimate value to the people psycho-oncology seeks to serve. This group holds that garnering wisdom from the expertise of those living with cancer should be a central aim of our field.

  5. Psycho-oncology: Searching for practical wisdom?

    PubMed

    Butlin, Helen

    2015-10-01

    The debate is vigorous in psycho-oncology about whether spiritual, existential, and psychosocial are the most comprehensive terms for academic research discourses investigating meaning and purpose. A call-to-action email from the International Society of Psycho-Oncology included the term soul. The current essay highlights the historical and contemporary uses of "soul" to suggest that the re-emergent soul signifies a tacit quest for an "intangible" that seems missing in current constructs of clinical domains reflected in the vigor of the debates. It is suggested that the re-emergence of the pre-Medieval meaning(s) of the notion of soul affirms a growing need for integrative paradigms on "being human" to guide psycho-oncology practitioners and their research. As a paradigmatic example, a clinical support group entitled Soul Medicine is described as employing the term soul to open up the more marginal discourses about experiences of illness arising from philosophical reflection, arts, humanities, and spirituality within a clinical oncology context. A link between soul and wisdom is suggested for further exploration with the view that phronesis ("the virtue of practical wisdom"), an emerging concept in health professional education research, is of ultimate value to the people psycho-oncology seeks to serve. This group holds that garnering wisdom from the expertise of those living with cancer should be a central aim of our field. PMID:26399749

  6. Chemotherapy prescribing errors: an observational study on the role of information technology and computerized physician order entry systems

    PubMed Central

    2013-01-01

    Background Chemotherapy administration is a high-risk process. Aim of this study was to evaluate the frequency, type, preventability, as well as potential and actual severity of outpatient chemotherapy prescribing errors in an Oncology Department where electronic prescribing is used. Methods Up to three electronic prescriptions per patient record were selected from the clinical records of consecutive patients who received cytotoxic chemotherapy between January 2007 and December 2008. Wrong prescriptions were classified as incomplete, incorrect or inappropriate. Error preventability was classified using a four-point scale. Severity was defined according to the Healthcare Failure Mode and Effect Analysis Severity Scale. Results Eight hundred and thirty-five prescriptions were eligible. The overall error rate was 20%. Excluding systematic errors (i.e. errors due to an initially faulty implementation of chemotherapy protocols into computerized dictionaries) from the analysis, the error rate decreased to 8%. Incomplete prescriptions were the majority. Most errors were deemed definitely preventable. According to error presumptive potential for damage, 72% were classified as minor; only 3% had the potential to produce major or catastrophic injury. Sixty-eight percent were classified as near misses; adverse drug events had no or little effect on clinical outcome. Conclusions Chemotherapy prescribing errors may arise even using electronic prescribing. Although periodic audits may be useful to detect common errors and guide corrective actions, it is crucial to get the computerized physician order entry system and set-ups correct before implementation. PMID:24344973

  7. Oncology Advanced Practitioners Bring Advanced Community Oncology Care.

    PubMed

    Vogel, Wendy H

    2016-01-01

    Oncology care is becoming increasingly complex. The interprofessional team concept of care is necessary to meet projected oncology professional shortages, as well as to provide superior oncology care. The oncology advanced practitioner (AP) is a licensed health care professional who has completed advanced training in nursing or pharmacy or has completed training as a physician assistant. Oncology APs increase practice productivity and efficiency. Proven to be cost effective, APs may perform varied roles in an oncology practice. Integrating an AP into an oncology practice requires forethought given to the type of collaborative model desired, role expectations, scheduling, training, and mentoring. PMID:27249776

  8. Durable clinical benefit to trastuzumab and chemotherapy in a patient with metastatic colon adenocarcinoma harboring ERBB2 amplification

    PubMed Central

    Disel, Umut; Germain, Alexis; Yilmazel, Bahar; Abali, Huseyin; Bolat, Filiz Aka; Yelensky, Roman; Elvin, Julia A.; Lipson, Doron; Chmielecki, Juliann; Wang, Kai; Stephens, Philip J.; Ross, Jeffrey S.; Miller, Vincent A.; Ali, Siraj M.; George, Thomas J.

    2015-01-01

    Somatic ERBB2 amplification or activating mutations occur in approximately 2–5% of metastatic colorectal adenocarcinomas and are presumed to be oncogenic drivers, but limited evidence exists to suggest these lesions are sensitive to targeted monotherapy in patients. Here we present the case of a patient with advanced CRC with pulmonary metastases, who had progressed on both standard of care cytotoxic chemotherapy and anti-EGFR targeted therapy. Comprehensive genomic profiling (FoundationOne®) identified amplification of ERBB2 and a TP53 mutation in the metastatic lesion. Treatment with trastuzumab with a chemotherapy backbone elicited stable disease/minor response in the patient over a one year course of therapy, reducing tumor burden and significantly improving quality of life. This report demonstrates the application of personalized targeted therapy guided by comprehensive genomic profiling in metastatic colorectal adenocarcinoma. PMID:26244165

  9. Durable clinical benefit to trastuzumab and chemotherapy in a patient with metastatic colon adenocarcinoma harboring ERBB2 amplification.

    PubMed

    Disel, Umut; Germain, Alexis; Yilmazel, Bahar; Abali, Huseyin; Bolat, Filiz Aka; Yelensky, Roman; Elvin, Julia A; Lipson, Doron; Chmielecki, Juliann; Wang, Kai; Stephens, Philip J; Ross, Jeffrey S; Miller, Vincent A; Ali, Siraj M; George, Thomas J

    2015-01-01

    Somatic ERBB2 amplification or activating mutations occur in approximately 2-5% of metastatic colorectal adenocarcinomas and are presumed to be oncogenic drivers, but limited evidence exists to suggest these lesions are sensitive to targeted monotherapy in patients. Here we present the case of a patient with advanced CRC with pulmonary metastases, who had progressed on both standard of care cytotoxic chemotherapy and anti-EGFR targeted therapy. Comprehensive genomic profiling (FoundationOne(®)) identified amplification of ERBB2 and a TP53 mutation in the metastatic lesion. Treatment with trastuzumab with a chemotherapy backbone elicited stable disease/minor response in the patient over a one year course of therapy, reducing tumor burden and significantly improving quality of life. This report demonstrates the application of personalized targeted therapy guided by comprehensive genomic profiling in metastatic colorectal adenocarcinoma. PMID:26244165

  10. Genetic Variations in ABCG2 Gene Predict Breast Carcinoma Susceptibility and Clinical Outcomes after Treatment with Anthracycline-Based Chemotherapy

    PubMed Central

    Wu, Huizhe; Liu, Yong; Kang, Hui; Xiao, Qinghuan; Yao, Weifan; Zhao, Haishan; Wang, Enhua; Wei, Minjie

    2015-01-01

    The genetic variants of the ATP-binding cassette, subfamily G, member 2 (ABCG2) are known to be involved in developing cancer risk and interindividual differences in chemotherapeutic response. The polymorphisms in ABCG2 gene were genotyped by using PCR-RFLP assays. We found that ABCG2 G34A GA/AA genotype, C421A AA genotype, and haplotypes 34A-421C and 34G-421A were significantly associated with increased risk for developing breast carcinoma. Furthermore, ABCG2 C421A AA homozygote had a significant enhanced therapeutic response in patients with neoadjuvant anthracycline-based chemotherapy. Moreover, ABCG2 G34A AA genotype carriers displayed a longer OS in ER positive patients or PR positive patients after postoperative anthracycline-based chemotherapy. These results suggested that the ABCG2 polymorphisms might be a candidate pharmacogenomic factor to assess susceptibility and prognosis for breast carcinoma patients. PMID:26634205

  11. Epidermal growth factor, oestrogen and progesterone receptor expression in primary ovarian cancer: correlation with clinical outcome and response to chemotherapy.

    PubMed Central

    Scambia, G.; Benedetti-Panici, P.; Ferrandina, G.; Distefano, M.; Salerno, G.; Romanini, M. E.; Fagotti, A.; Mancuso, S.

    1995-01-01

    The expression of epidermal growth factor receptor (EGFR), oestrogen receptor (ER) and progesterone receptor (PR) was assayed by a radioreceptor method in 117 primary ovarian cancers. EGFR was not significantly related to any of the clinicopathological parameters examined. In patients with stage II-IV disease who underwent second-look surgery after primary chemotherapy, a significant correlation between high EGFR levels and poor response to chemotherapy was demonstrated (P = 0.031). Moreover, post-operative residual tumour showed an independent role in predicting chemotherapy response (P = 0.0007) and EGFR status showed a borderline significance (P = 0.052) in the multivariate analysis. No correlation between steroid hormone receptors and clinicopathological parameters was observed. Whereas a significant relationship was shown between EGFR positivity and a shorter overall survival (OS) (P = 0.0022) and progression-free survival (PFS) (P = 0.0033), patient survival was not related to steroid hormone receptor status. Among the parameters tested only stage, ascites and EGFR status retained an independent prognostic value in the multivariate analysis. PMID:7640219

  12. Integrative oncology in North America.

    PubMed

    Sagar, Stephen M

    2006-01-01

    Integrative oncology is an evolving evidence-based specialty that uses complementary therapies in concert with medical treatment to enhance its efficacy, improve symptom control, alleviate patient distress and reduce suffering. In North America the evolution of research into complementary therapies was delayed by the narrow focus of the Flexner Report. A government-funded research agenda and incorporation of complementary therapies into medical school curricula have been driven by early evidence of efficacy and patient demand. Integrative oncology focuses on the role of natural health products (botanicals, vitamins, and minerals), nutrition, acupuncture, meditation and other mind-body approaches, music therapy, touch therapies, fitness therapies, and more. Some natural health products, such as herbs and their constituent phytochemicals, may be biologic response modifiers that could increase cancer control. Current research stretches from the laboratory to health services. Institutions are exploring the effectiveness gap in their clinical services and are determining efficacy of complementary therapies through randomized controlled trials. Eventually, the goal is to establish practice guidelines through determining relative effectiveness and value through cost-utility studies. The aim of integrative oncology should be one medicine, not alternative; it should be patient-focused; it should be evidence-based; and it should provide the best care for cancer cure, prevention, symptom control, and quality of life.

  13. Major milestones in translational oncology.

    PubMed

    Dragani, Tommaso A; Castells, Antoni; Kulasingam, Vathany; Diamandis, Eleftherios P; Earl, Helena; Iams, Wade T; Lovly, Christine M; Sedelaar, J P Michiel; Schalken, Jack A

    2016-01-01

    Translational oncology represents a bridge between basic research and clinical practice in cancer medicine. Today, translational research in oncology benefits from an abundance of knowledge resulting from genome-scale studies regarding the molecular pathways involved in tumorigenesis. In this Forum article, we highlight the state of the art of translational oncology in five major cancer types. We illustrate the use of molecular profiling to subtype colorectal cancer for both diagnosis and treatment, and summarize the results of a nationwide screening program for ovarian cancer based on detection of a tumor biomarker in serum. Additionally, we discuss how circulating tumor DNA can be assayed to safely monitor breast cancer over the course of treatment, and report on how therapy with immune checkpoint inhibitors is proving effective in advanced lung cancer. Finally, we summarize efforts to use molecular profiling of prostate cancer biopsy specimens to support treatment decisions. Despite encouraging early successes, we cannot disregard the complex genetics of individual susceptibility to cancer nor the enormous complexity of the somatic changes observed in tumors, which urge particular attention to the development of personalized therapies. PMID:27469586

  14. A clinical prognostic scoring system for resectable gastric cancer to predict survival and benefit from paclitaxel- or oxaliplatin-based adjuvant chemotherapy

    PubMed Central

    Qian, Jing; Qian, Yingying; Wang, Jian; Gu, Bing; Pei, Dong; He, Shaohua; Zhu, Fang; Røe, Oluf Dimitri; Xu, Jin; Liu, Lianke; Gu, Yanhong; Guo, Renhua; Yin, Yongmei; Shu, Yongqian; Chen, Xiaofeng

    2016-01-01

    Background Gastrectomy with D2 lymphadenectomy is a standard procedure of curative resection for gastric cancer (GC). The aim of this study was to develop a simple and reliable prognostic scoring system for GC treated with D2 gastrectomy combined with adjuvant chemotherapy. Methods A prognostic scoring system was established based on clinical and laboratory data from 579 patients with localized GC without distant metastasis treated with D2 gastrectomy and adjuvant chemotherapy. Results From the multivariate model for overall survival (OS), five factors were selected for the scoring system: ≥50% metastatic lymph node rate, positive lymphovascular invasion, pathologic TNM Stage II or III, ≥5 ng/mL preoperative carcinoembryonic antigen level, and <110 g/L preoperative hemoglobin. Two models were derived using different methods. Model A identified low- and high-risk patients for OS (P<0.001), while Model B differentiated low-, intermediate-, and high-risk patients for OS (P<0.001). Stage III patients in the low-risk group had higher survival probabilities than Stage II patients. Both Model A (area under the curve [AUC]: 0.74, 95% confidence interval [CI]: 0.69–0.78) and Model B (AUC: 0.79, 95% CI: 0.72–0.83) were better predictors compared with the pathologic TNM classification (AUC: 0.62, 95% CI: 0.59–0.71, P<0.001). Adjuvant paclitaxel- or oxaliplatin-based or triple chemotherapy showed significantly better outcomes in patients classified as high risk, but not in those with low and intermediate risk. Conclusion A clinical three-tier prognostic risk scoring system was established to predict OS of GC treated with D2 gastrectomy and adjuvant chemotherapy. The potential advantage of this scoring system is that it can identify high-risk patients in Stage II or III who may benefit from paclitaxel- or oxaliplatin-based regimens. Prospective studies are needed to confirm these results before they are applied clinically. PMID:26966350

  15. The Future of Precision Medicine in Oncology.

    PubMed

    Millner, Lori M; Strotman, Lindsay N

    2016-09-01

    Precision medicine in oncology focuses on identifying which therapies are most effective for each patient based on genetic characterization of the cancer. Traditional chemotherapy is cytotoxic and destroys all cells that are rapidly dividing. The foundation of precision medicine is targeted therapies and selecting patients who will benefit most from these therapies. One of the newest aspects of precision medicine is liquid biopsy. A liquid biopsy includes analysis of circulating tumor cells, cell-free nucleic acid, or exosomes obtained from a peripheral blood draw. These can be studied individually or in combination and collected serially, providing real-time information as a patient's cancer changes. PMID:27514468

  16. A Phase II Clinical Trial of Concurrent Helical Tomotherapy plus Cetuximab Followed by Adjuvant Chemotherapy with Cisplatin and Docetaxel for Locally Advanced Nasopharyngeal Carcinoma

    PubMed Central

    Zhang, Xinxin; Du, Lei; Zhao, Feifang; Wang, Qiuju; Yang, Shiming; Ma, Lin

    2016-01-01

    Purpose: The present clinical trial was designed to evaluate the efficacy and safety