Science.gov

Sample records for community clinical oncology

  1. Detailed prospective peer review in a community radiation oncology clinic.

    PubMed

    Mitchell, James D; Chesnut, Thomas J; Eastham, David V; Demandante, Carlo N; Hoopes, David J

    In 2012, we instituted detailed prospective peer review of new cases. We present the outcomes of peer review on patient management and time required for peer review. Peer review rounds were held 3 to 4 days weekly and required 2 physicians to review pertinent information from the electronic medical record and treatment planning system. Eight aspects were reviewed for each case: 1) workup and staging; 2) treatment intent and prescription; 3) position, immobilization, and simulation; 4) motion assessment and management; 5) target contours; 6) normal tissue contours; 7) target dosimetry; and 8) normal tissue dosimetry. Cases were marked as, "Meets standard of care," "Variation," or "Major deviation." Changes in treatment plan were noted. As our process evolved, we recorded the time spent reviewing each case. From 2012 to 2014, we collected peer review data on 442 of 465 (95%) radiation therapy patients treated in our hospital-based clinic. Overall, 91 (20.6%) of the cases were marked as having a variation, and 3 (0.7%) as major deviation. Forty-two (9.5%) of the cases were altered after peer review. An overall peer review score of "Variation" or "Major deviation" was highly associated with a change in treatment plan (P < .01). Changes in target contours were recommended in 10% of cases. Gastrointestinal cases were significantly associated with a change in treatment plan after peer review. Indicators on position, immobilization, simulation, target contours, target dosimetry, motion management, normal tissue contours, and normal tissue dosimetry were significantly associated with a change in treatment plan. The mean time spent on each case was 7 minutes. Prospective peer review is feasible in a community radiation oncology practice. Our process led to changes in 9.5% of cases. Peer review should focus on technical factors such as target contours and dosimetry. Peer review required 7 minutes per case. Published by Elsevier Inc.

  2. Metro-Minnesota Community Clinical Oncology Program (MM-CCOP) | Division of Cancer Prevention

    Cancer.gov

    DESCRIPTION (provided by applicant): The Metro-Minnesota Community Clinical Oncology (MMCCOP) program has a long-standing history which clearly demonstrates the success of the consortium, as demonstrated by both the ongoing commitment of the original consortium members and the growth of the consortium from 1979 through 2014. The MMCCOP consortium represents an established community program base which began in 1979 through its NCI-funded Community Hospital Cancer Program (CHCP) Award. |

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

    PubMed Central

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

    1993-01-01

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

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

    PubMed

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

    1993-06-01

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

  5. 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

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

    PubMed Central

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

    2016-01-01

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

  7. American Society of Clinical Oncology

    MedlinePlus

    ... The 10th Joint MSKCC/HSS/IOR Course in Musculoskeletal Tumor Pathology and Clinical Oncology New York, New York, United ... The 10th Joint MSKCC/HSS/IOR Course in Musculoskeletal Tumor Pathology and Clinical Oncology Memorial Sloan Kettering Cancer Center ...

  8. Clinical trials of interventional oncology.

    PubMed

    Arai, Yasuaki

    2012-08-01

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

  9. 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 |

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

    PubMed Central

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

    2012-01-01

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

  11. 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. |

  12. Veterinary oncology clinical trials: design and implementation.

    PubMed

    Thamm, Douglas H; Vail, David M

    2015-08-01

    There has been a recent increase in interest among veterinarians and the larger biomedical community in the evaluation of novel cancer therapies in client-owned (pet) animals with spontaneous cancer. This includes novel drugs designed to be veterinary therapeutics, as well as agents for which data generated in animals with tumors may inform human clinical trial design and implementation. An understanding of the process involved in moving a therapeutic agent through the stages of clinical evaluation is critical to the successful implementation of clinical investigations, as well as interpretation of the veterinary oncology literature. This review outlines considerations in the design and conduct of the various phases of oncology clinical trials, along with recent adaptations/modifications of these basic designs that can enhance the generation of timely and meaningful clinical data. Copyright © 2014 Elsevier Ltd. All rights reserved.

  13. 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

  14. 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

  15. The business case for provider participation in clinical trials research: an application to the National Cancer Institute's community clinical oncology program.

    PubMed

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

    2013-01-01

    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. The aim of this study was to explore whether providers believe there is a business case for participating in PBRNs and what factors contribute to the business case. We use a multiple case study methodology approach to examine the National Cancer Institute's community clinical oncology program, a long-standing federally funded PBRN. Interviews with 41 key informants across five sites, selected on the basis of organizational maturity, were conducted using a semistructured interview guide. We analyzed interview transcripts using an iterative, deductive process to identify themes and subthemes in the data. 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. 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.

  16. Design of oncology clinical trials: a review.

    PubMed

    Ananthakrishnan, Revathi; Menon, Sandeep

    2013-10-01

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

  17. Sedation in clinical oncology.

    PubMed

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

    2005-08-01

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

  18. Perceptions of Cancer Care and Clinical Trials in the Black Community: Implications for Care Coordination Between Oncology and Primary Care Teams.

    PubMed

    Sprague Martinez, Linda; Freeman, Elmer R; Winkfield, Karen M

    2017-09-01

    Despite efforts to ameliorate disparities in cancer care and clinical trials, barriers persist. As part of a multiphase community-engaged assessment, an exploratory community-engaged research partnership, forged between an academic hospital and a community-based organization, set out to explore perceptions of cancer care and cancer clinical trials by black Bostonians. Key informant interviews with health care providers and patient advocates in community health centers (CHCs), organizers from grassroots coalitions focused on cancer, informed the development of a focus group protocol. Six focus groups were conducted with black residents in Boston, including groups of cancer survivors and family members. Transcripts were coded thematically and a code-based report was generated and analyzed by community and academic stakeholders. While some participants identified clinical trials as beneficial, overall perceptions conjured feelings of fear and exploitation. Participants describe barriers to clinical trial participation in the context of cancer care experiences, which included negative interactions with providers and mistrust. Primary care physicians (PCPs) reported being levied as a trusted resource for patients undergoing care, but lamented the absence of a mechanism by which to gain information about cancer care and clinical trials. Confusion about cancer care and clinical trials persists, even among individuals who have undergone treatment for cancer. Greater coordination between PCPs and CHC care teams and oncology care teams may improve patient experiences with cancer care, while also serving as a mechanism to disseminate information about treatment options and clinical trials. Inequities in cancer care and clinical trial participation persist. The findings of this study indicate that greater coordination with primary care physicians (PCPs) and community health center (CHC) providers may be an important step for both improving the quality of cancer care in

  19. NCI Community Oncology Research Program Approved | Division of Cancer Prevention

    Cancer.gov

    On June 24, 2013, the National Cancer Institute (NCI) Board of Scientific Advisors approved the creation of the NCI Community Oncology Research Program (NCORP). NCORP will bring state-of-the art cancer prevention, control, treatment and imaging clinical trials, cancer care delivery research, and disparities studies to individuals in their own communities. |

  20. 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.

  1. Establishing a minority-based community clinical oncology program: the University of Medicine and Dentistry of New Jersey, New Jersey Medical School-university Hospital Cancer Center experience.

    PubMed

    Wieder, Robert; Teal, Randall; Saunders, Tracie; Weiner, Bryan J

    2013-03-01

    The Minority-Based Community Clinical Oncology Program (MB-CCOP) at University of Medicine and Dentistry of New Jersey, New Jersey Medical School-University Hospital Cancer Center was established to serve an unmet need in a medically, educationally, and socioeconomically underserved community of primarily African American and Latino patients in Newark and Essex County, New Jersey. The MB-CCOP was built on an existing infrastructure of multidisciplinary teams of cancer specialists who collaborated in patient care and an existing clinical research program, which included multilingual staff and a breast cancer navigator. This article highlights some of the unique opportunities and challenges involved in the startup of an MB-CCOP specifically relevant to an academic setting. We present a guide to the necessary infrastructure and institutional support that must be in place before considering such a program and some of the steps an institution can take to overcome barriers preventing successful enrollment of patients onto clinical trials.

  2. Clinical oncology practice 2015: preparing for the future.

    PubMed

    Kosty, Michael P; Acheson, Anupama Kurup; Tetzlaff, Eric D

    2015-01-01

    The clinical practice of oncology has become increasingly complex. An explosion of medical knowledge, increased demands on provider time, and involved patients have changed the way many oncologists practice. What was an acceptable practice model in the past may now be relatively inefficient. This review covers three areas that address these changes. The American Society of Clinical Oncology (ASCO) National Oncology Census defines who the U.S. oncology community is, and their perceptions of how practice patterns may be changing. The National Cancer Institute (NCI)-ASCO Teams in Cancer Care Project explores how best to employ team science to improve the efficiency and quality of cancer care in the United States. Finally, how physician assistants (PAs) and nurse practitioners (NPs) might be best integrated into team-based care in oncology and the barriers to integration are reviewed.

  3. 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…

  4. 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…

  5. Clinical ethics consultation in oncology.

    PubMed

    Shuman, Andrew G; Montas, Sacha M; Barnosky, Andrew R; Smith, Lauren B; Fins, Joseph J; McCabe, Mary S

    2013-09-01

    There is limited empirical research exploring the nature of clinical ethical consultations within the oncology population. Our objective was to review and describe clinical ethics consultations at two National Cancer Institute-designated comprehensive cancer centers to identify opportunities for systems improvement in clinical care and opportunities for staff education. This case series is derived from two institutional prospectively maintained clinical ethics consultation databases. All ethics consultations from 2007 through 2011 that related to adult patients with cancer were included. A total of 208 eligible patient cases were identified. The most common primary issues leading to ethics consultation were code status and advance directives (25%), surrogate decision making (17%), and medical futility (13%). Communication lapses were identified in 45% of patient cases, and interpersonal conflict arose in 51%. Before ethics consultation, 26% of patients had do-not-resuscitate orders, which increased to 60% after ethics consultation. Palliative care consultation occurred in 41% of patient cases. Ethics consultations among patients with cancer reflect the complexities inherent to their clinical management. Appropriately honoring patients' wishes within the context of overall goals of care is crucial. Thoughtful consideration of the role of and relationship with palliative care experts, communication barriers, sources of interpersonal conflict, symptom control, and end-of-life care is paramount to optimal management strategies in this patient population.

  6. NCI Community Oncology Research Program (NCORP) | Division of Cancer Prevention

    Cancer.gov

    The NCI Community Oncology Research Program (NCORP) is a national network of cancer care investigators, providers, academia, and other organizations that care for diverse populations in health systems. View the list of publications from NCORP. | Clinical Trials network of cancer care professionals who care for diverse populations across the U.S.

  7. [Clinical prediction in medical oncology].

    PubMed

    González Barón, Manuel

    2003-01-01

    Predictive factors (PF) are variables that give information about survival, treatment response or toxicity and future complications on cancer patients. The foremost utility of PF takes root in the possibility to furnish an individualized treatment schedule with higher succeeding options. They include clinical characteristics of the patient, tumour features, treatment administrated, classical pathological and new molecular data obtained from patients clinical samples. Clinical parameters comprise age, sex, underlying diseases and performance status among others, and in concurrence with tumour pathology and clinical stage (TNM) usually define the best treatment options. Also, chemotherapy response can modify natural history of several tumours, and thus is a PF. Modifications in evolving PF typically induce a variation in patient outcome. Hence, surgical tumour size reduction or neoadjuvant down-staging improve survival in several cancers. In the other side, treatment adjustment to steady PF should offers better outcome than "standard therapies". Recent advances on cancer research have generated a great deal of biological data that help us to search new treatment and diagnostic modalities. Biotechnology offers a great amount of possibilities in the next future and probably a true individualized therapy. Conversely, there are a small amount of molecular evidences that imply a creal variation in current clinical practice. Hence, more scientific and financial efforts are necessary to exploit to the full knowledge spurting up from basic science. In summary, the prediction in oncology is a hard task derived from clinical observation, tumour behaviour, treatment schedules and biological evidences that must offer realistic predictions on a concrete cancer patient. Oncologists have a duty to know all these variables to accomplish this thorny assignment. This review will focus on classical and recent biological PF in cancer.

  8. 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.

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

    PubMed Central

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

    2015-01-01

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

  10. Major Oncologic Surgery at a Community Hospital

    PubMed Central

    Loui, Hollyann; Benyamini, Pouya

    2017-01-01

    There is a national trend to refer patients requiring complex oncologic surgery to tertiary high-volume cancer centers. However, this presents major access challenges to Hawai‘i patients seeking care. The purpose of this study is to demonstrate that complex oncologic surgery can be safely performed at community hospitals like those in Hawai‘i. From July 2007 to December 2014, 136 patients underwent complex oncologic procedures at a community hospital in Hawai'i by a single general surgeon. Cases included esophagogastric, hepatobiliary, pancreatic, rectal, and retroperitoneal resections. A database of patients was created from information extracted from the EPIC database. Complications were evaluated using the Clavien-Dindo grading system. There was 0.7% mortality rate (grade V complication). The major morbidity rate was 12.5%, including 10.3% grade III complications and 2.2% grade IV complications. The median length of stay for all operations was 8 days. The mean estimated blood loss for all operations was 708 cc. There was a 2.9% hospital readmission rate within 30 days of initial discharge, and a 5.1% reoperation rate. Complex oncologic procedures can be safely performed at a low-volume community hospital, with outcomes similar to those from high-volume cancer centers. PMID:28210527

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

    PubMed

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

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

  12. A method for analyzing the business case for provider participation in the National Cancer Institute's Community Clinical Oncology Program and similar federally funded, provider-based research networks.

    PubMed

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

    2012-09-01

    The Community Clinical Oncology Program (CCOP) plays an essential role in the efforts of the National Cancer Institute (NCI) to increase enrollment in clinical trials. Currently, there is little practical guidance in the literature to assist provider organizations in analyzing the return on investment (ROI), or business case, for establishing and operating a provider-based research network (PBRN) such as the CCOP. In this article, the authors present a conceptual model of the business case for PBRN participation, a spreadsheet-based tool and advice for evaluating the business case for provider participation in a CCOP organization. A comparative, case-study approach was used to identify key components of the business case for hospitals attempting to support a CCOP research infrastructure. Semistructured interviews were conducted with providers and administrators. Key themes were identified and used to develop the financial analysis tool. Key components of the business case included CCOP start-up costs, direct revenue from the NCI CCOP grant, direct expenses required to maintain the CCOP research infrastructure, and incidental benefits, most notably downstream revenues from CCOP patients. The authors recognized the value of incidental benefits as an important contributor to the business case for CCOP participation; however, currently, this component is not calculated. The current results indicated that providing a method for documenting the business case for CCOP or other PBRN involvement will contribute to the long-term sustainability and expansion of these programs by improving providers' understanding of the financial implications of participation. Copyright © 2011 American Cancer Society.

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

    PubMed

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

    2016-03-01

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

  14. Research-design issues in cancer-symptom-management trials using complementary and alternative medicine: lessons from the National Cancer Institute Community Clinical Oncology Program experience.

    PubMed

    Buchanan, David R; White, Jeffrey D; O'Mara, Ann M; Kelaghan, Joseph W; Smith, Wendy B; Minasian, Lori M

    2005-09-20

    To identify major research-design issues in proposals submitted by investigators in the Community Clinical Oncology Program (CCOP) for clinical trials of complementary and alternative medicine (CAM) for cancer-symptom management. We conducted content analysis of all scientific reviews of concepts and protocols submitted by the CCOP to the National Cancer Institute (NCI) to identify research challenges in conducting clinical trials designed to evaluate CAM interventions for cancer-symptom management. Since the inception of the NCI Office of Cancer Complementary and Alternative Medicine in 1998, a total of 46 symptom-management studies using CAM interventions have been proposed by CCOP investigators, with 20 studies now in progress comprising 22% of the current total CCOP symptom-management portfolio. Proposals fell into four categories: complex natural products; nutritional therapeutics; mind-body interventions; and alternative medical systems. The most significant research-design issues arose as a consequence of the lack of preclinical data for CAM interventions and the lack of quality-control standards comparable with those used in regulating new pharmaceutical agents. Across the different types of CAM interventions, the most common problems found in proposed research designs are related to unwarranted assumptions about the consistency and standardization of CAM interventions, the need for data-based justifications for the study hypotheses, and the need to implement appropriate quality control and monitoring procedures during the course of the trial. To advance the state of the science, future research must address these critical issues if CAM interventions are to be evaluated rigorously and have a consequent impact on clinical practice and general public awareness.

  15. Serum vitamin D levels among patients in a clinical oncology practice compared to primary care patients in the same community: a case–control study

    PubMed Central

    Lesko, Samuel L; Brereton, Harmar D; Klem, Mary; Donnelly, Patrick E; Peters, Christopher A

    2011-01-01

    Objectives Low serum vitamin D levels have been associated with risk for certain malignancies, but studies have not directly analysed levels between community oncology and primary care practices. The purpose of this study was to compare serum vitamin D levels in patients at a community oncology practice with non-cancer patients at a primary care practice. Design Retrospective case–control study. 25-Hydroxyvitamin D levels were ordered for screening in both cancer and non-cancer patients. Levels were compared in univariate and multivariate analyses adjusted for age, body mass index and season of blood draw. Setting A community-based radiation oncology centre and a community-based primary care practice: both located in Northeastern Pennsylvania, USA. Participants 170 newly diagnosed cancer patients referred for initial consultation at the community oncology centre from 21 November 2008 to 18 May 2010, and 170 non-cancer patients of the primary care practice who underwent screening for hypovitaminosis D for the first time from 1 January 2009 to 31 December 2009. Primary and secondary outcome measures The primary outcome measure was mean serum vitamin D level, and the secondary outcome measures were frequencies of patients with vitamin D levels <20 ng/ml and levels <30 ng/ml. Results The oncology patients had a significantly lower mean serum vitamin D level (24.9 ng/ml) relative to a cohort of non-cancer primary care patients (30.6 ng/ml, p<0.001) from the same geographical region. The relationship retained significance after adjustment for age, body mass index and season of blood draw in multivariate analysis (p=0.001). Levels <20 and <30 ng/ml were more frequent in the oncology patients (OR (95% CI)=2.59 (1.44 to 4.67) and 2.04 (1.20 to 3.46), respectively) in multivariate analysis. Conclusions Cancer patients were found to have low vitamin D levels relative to a similar cohort of non-cancer primary care patients from the same geographical region. PMID

  16. Community Oncology and Prevention Trials | Division of Cancer Prevention

    Cancer.gov

    [[{"fid":"168","view_mode":"default","fields":{"format":"default","field_file_image_alt_text[und][0][value]":"Early Detection Research Group Homepage Image","field_file_image_title_text[und][0][value]":"Early Detection Research Group Homepage Image","field_folder[und]":"15"},"type":"media","attributes":{"alt":"Early Detection Research Group Homepage Image","title":"Early Detection Research Group Homepage Image","height":"266","width":"400","class":"image-style-none media-element file-default" | Clinical oncology trials in cancer prevention and control in community settings.

  17. Clinical oncology and chemical thermodynamics.

    PubMed

    Seitz, D E; Pearce, H L

    1990-01-01

    The development of oncolytic agents for cancer chemotherapy is often based on chance discovery and intensive structure modification. A mechanistic understanding of the essential biochemistry of many anticancer drugs remains elusive because of the biological complexity of drug-drug and drug-target interactions. The potential of computational science to analyze and quantify these interactions may provide a rational basis for drug modification and clinical trial design.

  18. Clinical Trials in Your Community

    Cancer.gov

    The NCI Community Oncology Research Program (NCORP) is a national network of investigators, cancer care providers, academic institutions, and other organizations. NCORP conducts multi-site cancer clinical trials and studies in diverse populations in community-based healthcare systems across the United States and Puerto Rico.

  19. Workflow-driven clinical decision support for personalized oncology.

    PubMed

    Bucur, Anca; van Leeuwen, Jasper; Christodoulou, Nikolaos; Sigdel, Kamana; Argyri, Katerina; Koumakis, Lefteris; Graf, Norbert; Stamatakos, Georgios

    2016-07-21

    The adoption in oncology of Clinical Decision Support (CDS) may help clinical users to efficiently deal with the high complexity of the domain, lead to improved patient outcomes, and reduce the current knowledge gap between clinical research and practice. While significant effort has been invested in the implementation of CDS, the uptake in the clinic has been limited. The barriers to adoption have been extensively discussed in the literature. In oncology, current CDS solutions are not able to support the complex decisions required for stratification and personalized treatment of patients and to keep up with the high rate of change in therapeutic options and knowledge. To address these challenges, we propose a framework enabling efficient implementation of meaningful CDS that incorporates a large variety of clinical knowledge models to bring to the clinic comprehensive solutions leveraging the latest domain knowledge. We use both literature-based models and models built within the p-medicine project using the rich datasets from clinical trials and care provided by the clinical partners. The framework is open to the biomedical community, enabling reuse of deployed models by third-party CDS implementations and supporting collaboration among modelers, CDS implementers, biomedical researchers and clinicians. To increase adoption and cope with the complexity of patient management in oncology, we also support and leverage the clinical processes adhered to by healthcare organizations. We design an architecture that extends the CDS framework with workflow functionality. The clinical models are embedded in the workflow models and executed at the right time, when and where the recommendations are needed in the clinical process. In this paper we present our CDS framework developed in p-medicine and the CDS implementation leveraging the framework. To support complex decisions, the framework relies on clinical models that encapsulate relevant clinical knowledge. Next to

  20. The Johns Hopkins Oncology Clinical Information System

    PubMed Central

    Lenhard, Raymond E.; Blum, Bruce I.; Sunderland, Jeffery M.; Braine, Hayden G.; Saral, Rein

    1982-01-01

    The Johns Hopkins Oncology Center has developed and maintains a clinical information system to support patient care, education, research and administrative functions. It operates on a dedicated mini-computer (PDP-11) programmed in MUMPS. Clinical information collelcted includes patient medical status and laboratory values. Data are used daily in patient care and also in support of retrospective and prospective research. The use of the system to manage a large blood product pheresis program and to study and treat infectious disease is described. Administrative functions include patient and personnel scheduling, program evaluation and projects directed toward control of costs.

  1. Lessons Learned from Radiation Oncology Clinical Trials

    PubMed Central

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

    2014-01-01

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

  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. Strategic physician communication and oncology clinical trials.

    PubMed

    Albrecht, T L; Blanchard, C; Ruckdeschel, J C; Coovert, M; Strongbow, R

    1999-10-01

    Clinical trials are the primary means for determining new, effective treatments for cancer patients, yet the number of patients that accrue is relatively limited. The purpose of this study was to explore the relationship between physician behavior and patient accrual to a clinical trial by videotaping the interaction. Forty-eight patient-physician interactions involving 12 different oncologists were videotaped in several clinics at the H. Lee Moffitt Cancer Center and Research Institute (Tampa, FL). The purpose of each interaction was to present the possibility of a clinical trial to the patient. A coding system, the Moffitt Accrual Analysis System, was developed by the authors to code behaviors that represented both the legal-informational and social influence models of communication behavior. Thirty-two patients agreed to participate in the clinical trial. Videotaping was found to be a viable, valid, and reliable method for studying the interaction. Physicians who were observed to use both models of influence were found to enroll more patients. Thus, patients were more likely to accrue to the trial when their physician verbally presented items normally included in an informed consent document and when they behaved in a reflective, patient-centered, supportive, and responsive manner. Discussion of benefits, side effects, patient concerns and resources to manage the concerns were all associated with accrual. This research has implications for modifying physician behavior and, thus, increasing the numbers of patients accruing to oncology clinical trials.

  4. 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

  5. Selenium in oncology: from chemistry to clinics.

    PubMed

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

    2009-10-12

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

  6. An Open Letter to the Cancer Community Regarding Community Clinical Trials

    Cancer.gov

    The National Cancer Institute (NCI) is in the process of combining its two community-based research networks to create a single network that builds on the strengths of the Community Clinical Oncology Program/Minority-Based Community Clinical Oncology Prog

  7. 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.

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

    ERIC Educational Resources Information Center

    Conlon, Annemarie; Choi, Namkee G.

    2014-01-01

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

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

    ERIC Educational Resources Information Center

    Conlon, Annemarie; Choi, Namkee G.

    2014-01-01

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

  10. Prevention of Pegfilgrastim-Induced Bone Pain: A Phase III Double-Blind Placebo-Controlled Randomized Clinical Trial of the University of Rochester Cancer Center Clinical Community Oncology Program Research Base

    PubMed Central

    Kirshner, Jeffrey J.; Heckler, Charles E.; Janelsins, Michelle C.; Dakhil, Shaker R.; Hopkins, Judith O.; Coles, Charlotte; Morrow, Gary R.

    2012-01-01

    Purpose Pegfilgrastim-induced bone pain is a significant clinical problem that may result in discontinuation of pegfilgrastim and lead to less effective chemotherapy dosing. Interventions for pegfilgrastim-induced bone pain are needed. Patients and Methods The University of Rochester Cancer Center Clinical Community Oncology Program Research Base randomly assigned 510 patients at 17 sites to receive either naproxen (500 mg two times per day) or placebo on the day of pegfilgrastim administration, continuing for 5 to 8 days after pegfilgrastim. Patients recorded pain severity (using a scale of 0 to 10) and duration in daily diaries. The primary outcome measure was the area under the curve (AUC) for pain for days 1 through 5. Secondary outcome measures included the identification of risk factors for the development of pain and response to naproxen. Results Patients' mean age was 55.6 years and 86% were female. Sixty-eight percent of patients had breast cancer and 10% had lung cancer. Pain reached its peak at 3 days for both groups. The mean AUC for pain was 7.71 for the placebo group and 6.04 for the naproxen group (P = .037). Naproxen reduced maximum pain from 3.40 to 2.59 (P = .005). Naproxen also reduced overall pain incidence from 71.3% to 61.1% (P = .020) and duration from 2.40 to 1.92 days (P = .009). The reduction in severe pain (> 5 on a scale of 1 to 10) from 27.0% to 19.2% was also significant (P = .048). Risk factors could not be identified to predict incidence, severity, or ability to prevent pegfilgrastim-induced bone pain. Conclusion Our phase III randomized placebo-controlled clinical trial demonstrated that naproxen at a dose of 500 mg twice per day is effective in reducing the incidence and severity of pegfilgrastim-induced bone pain. PMID:22508813

  11. Prevention of pegfilgrastim-induced bone pain: a phase III double-blind placebo-controlled randomized clinical trial of the university of rochester cancer center clinical community oncology program research base.

    PubMed

    Kirshner, Jeffrey J; Heckler, Charles E; Janelsins, Michelle C; Dakhil, Shaker R; Hopkins, Judith O; Coles, Charlotte; Morrow, Gary R

    2012-06-01

    Pegfilgrastim-induced bone pain is a significant clinical problem that may result in discontinuation of pegfilgrastim and lead to less effective chemotherapy dosing. Interventions for pegfilgrastim-induced bone pain are needed. The University of Rochester Cancer Center Clinical Community Oncology Program Research Base randomly assigned 510 patients at 17 sites to receive either naproxen (500 mg two times per day) or placebo on the day of pegfilgrastim administration, continuing for 5 to 8 days after pegfilgrastim. Patients recorded pain severity (using a scale of 0 to 10) and duration in daily diaries. The primary outcome measure was the area under the curve (AUC) for pain for days 1 through 5. Secondary outcome measures included the identification of risk factors for the development of pain and response to naproxen. Patients' mean age was 55.6 years and 86% were female. Sixty-eight percent of patients had breast cancer and 10% had lung cancer. Pain reached its peak at 3 days for both groups. The mean AUC for pain was 7.71 for the placebo group and 6.04 for the naproxen group (P = .037). Naproxen reduced maximum pain from 3.40 to 2.59 (P = .005). Naproxen also reduced overall pain incidence from 71.3% to 61.1% (P = .020) and duration from 2.40 to 1.92 days (P = .009). The reduction in severe pain (> 5 on a scale of 1 to 10) from 27.0% to 19.2% was also significant (P = .048). Risk factors could not be identified to predict incidence, severity, or ability to prevent pegfilgrastim-induced bone pain. Our phase III randomized placebo-controlled clinical trial demonstrated that naproxen at a dose of 500 mg twice per day is effective in reducing the incidence and severity of pegfilgrastim-induced bone pain.

  12. Puerto Rico NCI Community Oncology Research Program Minority/Underserved | Division of Cancer Prevention

    Cancer.gov

    DESCRIPTION (provided by applicant): The Puerto Rico NCI Community Oncology Research Program (PRNCORP) will be the principal organization in the island that promotes cancer prevention, control and screening/post-treatment surveillance clinical trials. It will conduct cancer care delivery research and will provide access to treatment and imaging clinical trials conducted under the reorganization of the National Clinical Trials Network (NCTN). It will evaluate disparity issues and outcomes in cancer care delivery and treatments. |

  13. How to Develop a Cardio-Oncology Clinic.

    PubMed

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

    2017-04-01

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

  14. NCI Approves Funding Plan for NCI Community Oncology Research Program (NCORP) | Division of Cancer Prevention

    Cancer.gov

    On June 24, 2014, the Scientific Program Leaders (SPL) of the National Cancer Institute (NCI) approved the funding plan for the NCI Community Oncology Research Program (NCORP), a national network of investigators, cancer care providers, academic institutions, and other organizations. NCORP will conduct multi-site cancer clinical trials and studies in diverse populations in community-based healthcare systems across the United States. The program will receive $93 million a year for five years. |

  15. Toward a science of tumor forecasting for clinical oncology

    DOE PAGES

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

    2015-03-15

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

  16. 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.

  17. 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. ©2015 American Association for Cancer Research.

  18. 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

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

    PubMed

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

    2013-01-01

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

  20. Oncology clinical trials nursing: developing competencies for the novice.

    PubMed

    Lubejko, Barbara; Good, Marjorie; Weiss, Patricia; Schmieder, Linda; Leos, David; Daugherty, Penny

    2011-12-01

    Oncology clinical trials are important in the improvement of outcomes for people with or at risk for cancer. Because of the complexity of oncology clinical trials and the needs of patients with cancer, nurses play a crucial and unique role in the trial setting. However, great variability exists in how the role of the nurse on a research team is defined and implemented. An Oncology Nursing Society project team set out to identify the core competencies required of a novice oncology clinical trials nurse (CTN) across diverse settings. This article describes the process used to develop core competencies for the novice CTN, presents the final core competencies, and offers examples of how those competencies might be used in practice.

  1. The integration of BRCA testing into oncology clinics.

    PubMed

    Percival, Natalie; George, Angela; Gyertson, Jennifer; Hamill, Monica; Fernandes, Andreia; Davies, Emily; Rahman, Nazneen; Banerjee, Susana

    2016-06-23

    The PARP inhibitor, Olaparib, is approved for women with BRCA-mutated ovarian cancer. Therefore there is an urgent need to test patients and obtain results in time to influence treatment. Models of BRCA testing, such as the mainstreaming oncogenetic pathway, involving oncology health professionals are being used. The authors report on the establishment of the extended role of the clinical nurse specialist in consenting women for BRCA testing in routine gynaecology-oncology clinics using the mainstreaming model. Nurses undertook generic consent training and specific counselling training for BRCA testing in the form of a series of online videos, written materials and checklists before obtaining approval to consent patients for germline BRCA1 and BRCA2 mutations. Between July 2013 and December 2015, 108 women with ovarian cancer were counselled and consented by nurses in the medical oncology clinics at a single centre (The Royal Marsden, UK). This represented 36% of all ovarian cancer patients offered BRCA testing in the oncology clinics at the centre. Feedback from patients and nurses was encouraging with no significant issues raised in the counselling and consenting process. The mainstreaming model allows for greater access to BRCA testing for ovarian cancer patients, many of whom may benefit from personalised therapy (PARP inhibitors). This is the first report of oncology nurses in the BRCA testing pathway. Specialist oncology nurses trained in BRCA testing have an important role within a multidisciplinary team counselling and consenting patients to undergo BRCA testing.

  2. 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

  3. Regulatory and clinical considerations for biosimilar oncology drugs.

    PubMed

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

    2014-12-01

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

  4. 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

  5. Results of an Oncology Clinical Trial Nurse Role Delineation Study.

    PubMed

    Purdom, Michelle A; Petersen, Sandra; Haas, Barbara K

    2017-09-01

    To evaluate the relevance of a five-dimensional model of clinical trial nursing practice in an oncology clinical trial nurse population. 
. Web-based cross-sectional survey.
. Online via Qualtrics.
. 167 oncology nurses throughout the United States, including 41 study coordinators, 35 direct care providers, and 91 dual-role nurses who provide direct patient care and trial coordination.
. Principal components analysis was used to determine the dimensions of oncology clinical trial nursing practice.
. Self-reported frequency of 59 activities.
. The results did not support the original five-dimensional model of nursing care but revealed a more multidimensional model.
. An analysis of frequency data revealed an eight-dimensional model of oncology research nursing, including care, manage study, expert, lead, prepare, data, advance science, and ethics.
. This evidence-based model expands understanding of the multidimensional roles of oncology nurses caring for patients with cancer enrolled in clinical trials.

  6. 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.

  7. Antiemetics: American Society of Clinical Oncology clinical practice guideline update.

    PubMed

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

    2011-11-01

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

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

    PubMed

    Vioral, Anna N; Kennihan, Heather K

    2012-12-01

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

  9. 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)

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

    ERIC Educational Resources Information Center

    Morris, Carl R.; Hickman, Mary Johne

    1977-01-01

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

  11. Response Assessment in Neuro-Oncology Clinical Trials.

    PubMed

    Wen, Patrick Y; Chang, Susan M; Van den Bent, Martin J; Vogelbaum, Michael A; Macdonald, David R; Lee, Eudocia Q

    2017-07-20

    Development of novel therapies for CNS tumors requires reliable assessment of response and progression. This requirement has been particularly challenging in neuro-oncology for which contrast enhancement serves as an imperfect surrogate for tumor volume and is influenced by agents that affect vascular permeability, such as antiangiogenic therapies. In addition, most tumors have a nonenhancing component that can be difficult to accurately quantify. To improve the response assessment in neuro-oncology and to standardize the criteria that are used for different CNS tumors, the Response Assessment in Neuro-Oncology (RANO) working group was established. This multidisciplinary international working group consists of neuro-oncologists, medical oncologists, neuroradiologists, neurosurgeons, radiation oncologists, neuropsychologists, and experts in clinical outcomes assessments, working in collaboration with government and industry to enhance the interpretation of clinical trials. The RANO working group was originally created to update response criteria for high- and low-grade gliomas and to address such issues as pseudoresponse and nonenhancing tumor progression from antiangiogenic therapies, and pseudoprogression from radiochemotherapy. RANO has expanded to include working groups that are focused on other tumors, including brain metastases, leptomeningeal metastases, spine tumors, pediatric brain tumors, and meningiomas, as well as other clinical trial end points, such as clinical outcomes assessments, seizures, corticosteroid use, and positron emission tomography imaging. In an effort to standardize the measurement of neurologic function for clinical assessment, the Neurologic Assessment in Neuro-Oncology scale was drafted. Born out of a workshop conducted by the Jumpstarting Brain Tumor Drug Development Coalition and the US Food and Drug Administration, a standardized brain tumor imaging protocol now exists to reduce variability and improve reliability. Efforts by RANO

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

    PubMed

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

    2016-10-01

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

  13. Trends in medical oncology outreach clinics in rural areas.

    PubMed

    Gruca, Thomas S; Nam, Inwoo; Tracy, Roger

    2014-09-01

    To examine the long-term trends in medical oncology outreach in Iowa, a state with a high proportion of rural residents, and to assess the involvement of the 2011 Iowa oncology workforce in visiting consultant clinics using a unique data source. Outreach locations and clinic frequencies are tracked annually in the Visiting Medical Consultant Database (Carver College of Medicine) along with the physicians' primary practice locations. Growth in the number of cities served and number of clinic days from 1989 to 2011 was analyzed using joinpoint analysis. Data from 2011 were used to estimate the trip length for participating oncologists. The number of rural cities served by medical oncology outreach increased significantly between 1989 and 1996. Clinic days grew significantly in two periods: 1989 to 1998 and 2003 to 2005. In 2011, more than 2,100 clinic days were provided in 66 sites (95% of clinic days in rural areas). Almost half of all Iowa-based oncologists regularly participate in outreach. Oncologists staffing visiting consultant clinics in Iowa drive an estimated 21,000 miles per month. For more than 20 years, visiting medical oncologists have brought cancer care to rural patients in Iowa. Access to cancer care in rural Iowa (ie, clinic days) increased significantly in the post-Medicare Modernization Act period (after 2005). High participation rates and travel burdens may influence oncologist training and retention strategies. Because the Affordable Care Act seeks to expand access for vulnerable populations (eg, rural elderly), it is critical to better understand the existing system of rural cancer care delivery. Copyright © 2014 by American Society of Clinical Oncology.

  14. The nature of ethical conflicts and the meaning of moral community in oncology practice.

    PubMed

    Pavlish, Carol; Brown-Saltzman, Katherine; Jakel, Patricia; Fine, Alyssa

    2014-03-01

    To explore ethical conflicts in oncology practice and the nature of healthcare contexts in which ethical conflicts can be averted or mitigated. Ethnography. Medical centers and community hospitals with inpatient and outpatient oncology units in southern California and Minnesota. 30 oncology nurses, 6 ethicists, 4 nurse administrators, and 2 oncologists. 30 nurses participated in six focus groups that were conducted using a semistructured interview guide. Twelve key informants were individually interviewed. Coding, sorting, and constant comparison were used to reveal themes. Most ethical conflicts pertained to complex end-of-life situations. Three factors were associated with ethical conflicts: delaying or avoiding difficult conversations, feeling torn between competing obligations, and the silencing of different moral perspectives. Moral communities were characterized by respectful team relationships, timely communication, ethics-minded leadership, readily available ethics resources, and provider awareness and willingness to use ethics resources. Moral disagreements are expected to occur in complex clinical practice. However, when they progress to ethical conflicts, care becomes more complicated and often places seriously ill patients at the epicenter. Practice environments as moral communities could foster comfortable dialogue about moral differences and prevent or mitigate ethical conflicts and the moral distress that frequently follows.

  15. Tracking the workforce: the American Society of Clinical Oncology workforce information system.

    PubMed

    Kirkwood, M Kelsey; Kosty, Michael P; Bajorin, Dean F; Bruinooge, Suanna S; Goldstein, Michael A

    2013-01-01

    In anticipation of oncologist workforce shortages projected as part of a 2007 study, the American Society of Clinical Oncology (ASCO) worked with a contractor to create a workforce information system (WIS) to assemble the latest available data on oncologist supply and cancer incidence and prevalence. ASCO plans to publish findings annually, reporting on new data and tracking trends over time. THE WIS REPORT IS COMPOSED OF THREE SECTIONS: supply, new entrants, and cancer incidence and prevalence. Tabulations of the number of oncologists in the United States are derived mainly from the American Medical Association Physician Masterfile. Information on fellows and residents in the oncology workforce pipeline come from published sources such as Journal of the American Medical Association. Incidence and prevalence estimates are published by the American Cancer Society and National Cancer Institute. The WIS reports a total of 13,084 oncologists working in the United States in 2011. Oncologists are defined as those physicians who designate hematology, hematology/oncology, or medical oncology as their specialty. The WIS compares the characteristics of these oncologists with those of all physicians and tracks emerging trends in the physician training pipeline. Observing characteristics of the oncologist workforce over time allows ASCO to identify, prioritize, and evaluate its workforce initiatives. Accessible figures and reports generated by the WIS can be used by ASCO and others in the oncology community to advocate for needed health care system and policy changes to help offset future workforce shortages.

  16. Tracking the Workforce: The American Society of Clinical Oncology Workforce Information System

    PubMed Central

    Kirkwood, M. Kelsey; Kosty, Michael P.; Bajorin, Dean F.; Bruinooge, Suanna S.; Goldstein, Michael A.

    2013-01-01

    Purpose: In anticipation of oncologist workforce shortages projected as part of a 2007 study, the American Society of Clinical Oncology (ASCO) worked with a contractor to create a workforce information system (WIS) to assemble the latest available data on oncologist supply and cancer incidence and prevalence. ASCO plans to publish findings annually, reporting on new data and tracking trends over time. Methods: The WIS report is composed of three sections: supply, new entrants, and cancer incidence and prevalence. Tabulations of the number of oncologists in the United States are derived mainly from the American Medical Association Physician Masterfile. Information on fellows and residents in the oncology workforce pipeline come from published sources such as Journal of the American Medical Association. Incidence and prevalence estimates are published by the American Cancer Society and National Cancer Institute. Results: The WIS reports a total of 13,084 oncologists working in the United States in 2011. Oncologists are defined as those physicians who designate hematology, hematology/oncology, or medical oncology as their specialty. The WIS compares the characteristics of these oncologists with those of all physicians and tracks emerging trends in the physician training pipeline. Conclusion: Observing characteristics of the oncologist workforce over time allows ASCO to identify, prioritize, and evaluate its workforce initiatives. Accessible figures and reports generated by the WIS can be used by ASCO and others in the oncology community to advocate for needed health care system and policy changes to help offset future workforce shortages. PMID:23633965

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

    PubMed

    Ness, Elizabeth A; Royce, Cheryl

    2017-03-01

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

  18. 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.

  19. American Society of Clinical Oncology Strategic Plan for Increasing Racial and Ethnic Diversity in the Oncology Workforce.

    PubMed

    Winkfield, Karen M; Flowers, Christopher R; Patel, Jyoti D; Rodriguez, Gladys; Robinson, Patricia; Agarwal, Amit; Pierce, Lori; Brawley, Otis W; Mitchell, Edith P; Head-Smith, Kimberly T; Wollins, Dana S; Hayes, Daniel F

    2017-08-01

    In December 2016, the American Society of Clinical Oncology (ASCO) Board of Directors approved the ASCO Strategic Plan to Increase Racial and Ethnic Diversity in the Oncology Workforce. Developed through a multistakeholder effort led by the ASCO Health Disparities Committee, the purpose of the plan is to guide the formal efforts of ASCO in this area over the next three years (2017 to 2020). There are three primary goals: (1) to establish a longitudinal pathway for increasing workforce diversity, (2) to enhance ASCO leadership diversity, and (3) to integrate a focus on diversity across ASCO programs and policies. Improving quality cancer care in the United States requires the recruitment of oncology professionals from diverse backgrounds. The ASCO Strategic Plan to Increase Racial and Ethnic Diversity in the Oncology Workforce is designed to enhance existing programs and create new opportunities that will move us closer to the vision of achieving an oncology workforce that reflects the demographics of the US population it serves.

  20. 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

  1. EMT: Present and future in clinical oncology.

    PubMed

    Santamaria, Patricia G; Moreno-Bueno, Gema; Portillo, Francisco; Cano, Amparo

    2017-07-01

    Epithelial/mesenchymal transition (EMT) has emerged as a key regulator of metastasis by facilitating tumor cell invasion and dissemination to distant organs. Recent evidences support that the reverse mesenchymal/epithelial transition (MET) is required for metastatic outgrowth; moreover, the existence of hybrid epithelial/mesenchymal (E/M) phenotypes is increasingly being reported in different tumor contexts. The accumulated data strongly support that plasticity between epithelial and mesenchymal states underlies the dissemination and metastatic potential of carcinoma cells. However, the translation into the clinics of EMT and epithelial plasticity processes presents enormous challenges and still remains a controversial issue. In this review, we will evaluate current evidences for translational applicability of EMT and depict an overview of the most recent EMT in vivo models, EMT marker analyses in human samples as well as potential EMT therapeutic approaches and ongoing clinical trials. We foresee that standardized analyses of EMT markers in solid and liquid tumor biopsies in addition to innovative tools targeting the E/M states will become promising strategies for future translation to the clinical setting. © 2017 The Authors. Published by FEBS Press and John Wiley & Sons Ltd.

  2. Computational oncology.

    PubMed

    Lefor, Alan T

    2011-08-01

    Oncology research has traditionally been conducted using techniques from the biological sciences. The new field of computational oncology has forged a new relationship between the physical sciences and oncology to further advance research. By applying physics and mathematics to oncologic problems, new insights will emerge into the pathogenesis and treatment of malignancies. One major area of investigation in computational oncology centers around the acquisition and analysis of data, using improved computing hardware and software. Large databases of cellular pathways are being analyzed to understand the interrelationship among complex biological processes. Computer-aided detection is being applied to the analysis of routine imaging data including mammography and chest imaging to improve the accuracy and detection rate for population screening. The second major area of investigation uses computers to construct sophisticated mathematical models of individual cancer cells as well as larger systems using partial differential equations. These models are further refined with clinically available information to more accurately reflect living systems. One of the major obstacles in the partnership between physical scientists and the oncology community is communications. Standard ways to convey information must be developed. Future progress in computational oncology will depend on close collaboration between clinicians and investigators to further the understanding of cancer using these new approaches.

  3. Chemotherapy safety in clinical veterinary oncology.

    PubMed

    Klahn, Shawna

    2014-09-01

    Exposure to chemotherapy is a health hazard for all personnel in facilities that store, prepare, or administer antineoplastic agents. Contamination levels have been measured as much as 15 times higher in the veterinary medicine sector than in human facilities. Recent publications in human and veterinary medicine indicate that exposure extends beyond the clinic walls to affect the patient's home and family. This article provides an update on the advances in chemotherapy safety, the current issues, and the impact on cancer management in veterinary medicine. Copyright © 2014 Elsevier Inc. All rights reserved.

  4. American Society of Clinical Oncology provisional clinical opinion: the integration of palliative care into standard oncology care.

    PubMed

    Smith, Thomas J; Temin, Sarah; Alesi, Erin R; Abernethy, Amy P; Balboni, Tracy A; Basch, Ethan M; Ferrell, Betty R; Loscalzo, Matt; Meier, Diane E; Paice, Judith A; Peppercorn, Jeffrey M; Somerfield, Mark; Stovall, Ellen; Von Roenn, Jamie H

    2012-03-10

    An American Society of Clinical Oncology (ASCO) provisional clinical opinion (PCO) offers timely clinical direction to ASCO's membership following publication or presentation of potentially practice-changing data from major studies. This PCO addresses the integration of palliative care services into standard oncology practice at the time a person is diagnosed with metastatic or advanced cancer. Palliative care is frequently misconstrued as synonymous with end-of-life care. Palliative care is focused on the relief of suffering, in all of its dimensions, throughout the course of a patient's illness. Although the use of hospice and other palliative care services at the end of life has increased, many patients are enrolled in hospice less than 3 weeks before their death, which limits the benefit they may gain from these services. By potentially improving quality of life (QOL), cost of care, and even survival in patients with metastatic cancer, palliative care has increasing relevance for the care of patients with cancer. Until recently, data from randomized controlled trials (RCTs) demonstrating the benefits of palliative care in patients with metastatic cancer who are also receiving standard oncology care have not been available. Seven published RCTs form the basis of this PCO. Based on strong evidence from a phase III RCT, patients with metastatic non-small-cell lung cancer should be offered concurrent palliative care and standard oncologic care at initial diagnosis. While a survival benefit from early involvement of palliative care has not yet been demonstrated in other oncology settings, substantial evidence demonstrates that palliative care-when combined with standard cancer care or as the main focus of care-leads to better patient and caregiver outcomes. These include improvement in symptoms, QOL, and patient satisfaction, with reduced caregiver burden. Earlier involvement of palliative care also leads to more appropriate referral to and use of hospice, and

  5. MRI Biomarkers in Oncology Clinical Trials

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2017-01-01

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

  8. 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

  9. Translating genomic discoveries to the clinic in pediatric oncology.

    PubMed

    Glade Bender, Julia; Verma, Anupam; Schiffman, Joshua D

    2015-02-01

    The present study describes the recent advances in the identification of targetable genomic alterations in pediatric cancers, along with the progress and associated challenges in translating these findings into therapeutic benefit. Each field within pediatric cancer has rapidly and comprehensively begun to define genomic targets in tumors that potentially can improve the clinical outcome of patients, including hematologic malignancies (leukemia and lymphoma), solid malignancies (neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, and osteosarcoma), and brain tumors (gliomas, ependymomas, and medulloblastomas). Although each tumor has specific and sometimes overlapping genomic targets, the translation to the clinic of new targeted trials and precision medicine protocols is still in its infancy. The first clinical tumor profiling studies in pediatric oncology have demonstrated feasibility and patient enthusiasm for the personalized medicine paradigm, but have yet to demonstrate clinical utility. Complexities influencing implementation include rapidly evolving sequencing technologies, tumor heterogeneity, and lack of access to targeted therapies. The return of incidental findings from the germline also remains a challenge, with evolving policy statements and accepted standards. The translation of genomic discoveries to the clinic in pediatric oncology continues to move forward at a brisk pace. Early adoption of genomics for tumor classification, risk stratification, and initial trials of targeted therapeutic agents has led to powerful results. As our experience grows in the integration of genomic and clinical medicine, the outcome for children with cancer should continue to improve.

  10. Can we demonstrate that breast cancer “Integrative Oncology” is effective? A methodology to evaluate the effectiveness of integrative oncology offered in community clinics

    PubMed Central

    Standish, Leanna J.; Sweet, Erin; Naydis, Eleonora; Andersen, M. Robyn

    2016-01-01

    Background Many women diagnosed with breast cancer receive both standard cancer treatment and care from providers trained in the emerging field of medicine called ‘integrative oncology’ (IO) in which science-based complementary and alternative medical1 therapies are prescribed by physicians. The effectiveness of IO services has not been fully studied, so is yet unknown. Purpose Determine if a matched case-controlled prospective outcomes study evaluating the efficacy and safety of breast cancer IO care is feasible. Methods Methodological proof of principle requires demonstration that 1) it is possible to find matched control breast cancer patients using the Surveillance, Epidemiology and End Results (SEER) Program’s western Washington Cancer Surveillance System (CSS), and 2) an IO clinic can recruit breast cancer patients into a matched controlled study. Results A pilot study was conducted in 2008 (N=14) to determine if matched controlled women could be identified in the western Washington SEER database. All 14 women who were approached agreed to participate. The cases were matched to the CSS along five variables - age and stage at diagnosis, race, marital and ER/PR status. Multiple matches were found for 12 of the 14 participants. Conclusion A prospective cohort study with a matched comparison group is a feasible and potentially rigorous study design with high patient acceptability. It may provide valuable data for the evaluation of the effectiveness of IO care on patient health, relapse rate, and health-related quality of life (HRQOL). A federally funded matched-case controlled outcomes study is currently underway at Bastyr University and the Fred Hutchinson Cancer Research Center. PMID:22740079

  11. 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

  12. 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

    2016-09-08

    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.

  13. [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.

  14. [Verbal information in clinical trials at an oncology department].

    PubMed

    Jensen, A B

    1990-11-26

    Prior to participation in clinical trials, patients must give their consent on the basis of information from the doctor. The content of the information is defined in the Helsinki Declaration. Information given in an oncological department was investigated and the patients were interviewed about the information obtained. The problems associated with the informative interviews with the patients were that these were frequently unstructured, that the patients were more concerned with their illness and treatment and that doctors had done too little to ensure that the patients had understood the information. It was most difficult for the doctors to provide thorough information about side-effects and disadvantages. Patients had greatest difficulty in understanding the principle of randomization. The patients' main reason for participation in the trial was the hope for therapeutic benefit. In departments where clinical research is undertaken, constant attention is required for how information on clinical trials is best given.

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

    PubMed

    Gharwan, Helen; Groninger, Hunter

    2016-04-01

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

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

    PubMed

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

    2011-08-01

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

  17. 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.

  18. Clinical research in surgical oncology: an analysis of ClinicalTrials.gov.

    PubMed

    Menezes, Amber S; Barnes, Alison; Scheer, Adena S; Martel, Guillaume; Moloo, Husein; Boushey, Robin P; Sabri, Elham; Auer, Rebecca C

    2013-11-01

    The objective of this study was to provide a descriptive analysis of registered clinical trials in surgical oncology at ClinicalTrials.gov. Data was extracted from ClinicalTrials.gov using the following search engine criteria: "Cancer" as Condition, "Surgery OR Operation OR Resection" as Intervention, and Non-Industry sponsored. The search was limited to Canada and the United States and included trials registered from January 1, 2001 to January 1, 2011. Of 9,961 oncology trials, 1,049 (10.5%) included any type of surgical intervention. Of these trials, 125 (11.9%, 1.3% of all oncology trials) assessed a surgical variable, 773 (73.7%) assessed adjuvant/neoadjuvant therapies, and 151 (14.4%) were observational studies. Of the trials assessing adjuvant therapies, systemic treatment (362 trials, 46.8%) and multimodal therapy (129 trials, 16.7%) comprised a large focus. Of the 125 trials where surgery was the intervention, 59 trials (47.2%) focused on surgical techniques or devices, 45 trials (36.0%) studied invasive diagnostic methods, and 21 trials (16.8%) evaluated surgery versus no surgery. The majority of the 125 trials were nonrandomized (72, 57.6%). The number of registered surgical oncology trials is small in comparison to oncology trials as a whole. Clinical trials specifically designed to assess surgical interventions are vastly outnumbered by trials focusing on adjuvant therapies. Randomized surgical oncology trials account for <1% of all registered cancer trials. Barriers to the design and implementation of randomized trials in surgical oncology need to be clarified in order to facilitate higher-level evidence in surgical decision-making.

  19. 2016 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards, Including Standards for Pediatric Oncology.

    PubMed

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

    2016-12-01

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

  20. Radiation Therapy Oncology Group clinical trials with misonidazole

    SciTech Connect

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

    1981-05-15

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

    Hesketh, Paul J; Kris, Mark G; Basch, Ethan; Bohlke, Kari; Barbour, Sally Y; Clark-Snow, Rebecca Anne; Danso, Michael A; Dennis, Kristopher; Dupuis, L Lee; Dusetzina, Stacie B; Eng, Cathy; Feyer, Petra C; Jordan, Karin; Noonan, Kimberly; Sparacio, Dee; Somerfield, Mark R; Lyman, Gary H

    2017-10-01

    Purpose To update the ASCO guideline for antiemetics in oncology. Methods ASCO convened an Expert Panel and conducted a systematic review of the medical literature for the period of November 2009 to June 2016. Results Forty-one publications were included in this systematic review. A phase III randomized controlled trial demonstrated that adding olanzapine to antiemetic prophylaxis reduces the likelihood of nausea among adult patients who are treated with high emetic risk antineoplastic agents. Randomized controlled trials also support an expanded role for neurokinin 1 receptor antagonists in patients who are treated with chemotherapy. Recommendation Key updates include the addition of olanzapine to antiemetic regimens for adults who receive high-emetic-risk antineoplastic agents or who experience breakthrough nausea and vomiting; a recommendation to administer dexamethasone on day 1 only for adults who receive anthracycline and cyclophosphamide chemotherapy; and the addition of a neurokinin 1 receptor antagonist for adults who receive carboplatin area under the curve ≥ 4 mg/mL per minute or high-dose chemotherapy, and for pediatric patients who receive high-emetic-risk antineoplastic agents. For radiation-induced nausea and vomiting, adjustments were made to anatomic regions, risk levels, and antiemetic administration schedules. Rescue therapy alone is now recommended for low-emetic-risk radiation therapy. The Expert Panel reiterated the importance of using the most effective antiemetic regimens that are appropriate for antineoplastic agents or radiotherapy being administered. Such regimens should be used with initial treatment, rather than first assessing the patient's emetic response with less-effective treatment. Additional information is available at www.asco.org/supportive-care-guidelines and www.asco.org/guidelineswiki .

  3. Phase 0 clinical trials in oncology new drug development

    PubMed Central

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

    2011-01-01

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

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

    PubMed

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

    2011-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  6. [Systemic learning planification for medical students during oncology clinical rotation].

    PubMed

    Gonçalves, Anthony; Viens, Patrice; Gilabert, Marine; Turrini, Olivier; Lambaudie, Eric; Prebet, Thomas; Farnault, Bertrand; Eisinger, François; Gorincour, Guillaume; Bertucci, François

    2011-12-01

    The expected increase in cancer incidence emphasizes the need for specific training in this area, including either family physician or specialized oncologists. In France, the fourth to sixth years of medical teaching include both theoretical classes at the university and daily actual practice at the hospital. Thus, clinical rotations are thought to play a major role in the training of medical students and also largely participate to the choice of the student of his/her final specialty. Pedagogic quality of these rotations is dependent on multiple parameters, including a rigorous planification of the expected learning. Here, we reported a systemic planification of learning activities for medical students during an oncology rotation at the Paoli-Calmettes Institute in Marseille, France, a regional comprehensive cancer center. This planification includes an evaluation of learning requirements, definition of learning objectives, selection of learning methods and choice of methods of assessment of the students' achievement of these objectives as well as the learning activity itself.

  7. Community oncology in an era of payment reform.

    PubMed

    Cox, John V; Ward, Jeffery C; Hornberger, John C; Temel, Jennifer S; McAneny, Barbara L

    2014-01-01

    Patients and payers (government and private) are frustrated with the fee-for-service system (FFS) of payment for outpatient health services. FFS rewards volume and highly valued services, including expensive diagnostics and therapeutics, over lesser valued cognitive services. Proposed payment schemes would incent collaboration and coordination of care among providers and reward quality. In oncology, new payment schemes must address the high costs of all services, particularly drugs, while preserving the robust distribution of sites of service available to patients in the United States. Information technology and personalized cancer care are changing the practice of oncology. Twenty-first century oncology will require increasing cognitive work and shared decision making, both of which are not well regarded in the FFS model. A high proportion of health care dollars are consumed in the final months of life. Effective delivery of palliative and end-of-life care must be addressed by practice and by new models of payment. Value-based reimbursement schemes will require oncology practices to change how they are structured. Lessons drawn from the principles of primary care's Patient Centered Medical Home (PCMH) will help oncology practice to prepare for new schemes. PCMH principles place a premium on proactively addressing toxicities of therapies, coordinating care with other providers, and engaging patients in shared decision making, supporting the ideal of value defined in the triple aim-to measurably improve patient experience and quality of care at less cost. Payment reform will be disruptive to all. Oncology must be engaged in policy discussions and guide rational shifts in priorities defined by new payment models.

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

    PubMed

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

    2016-05-15

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

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

    PubMed Central

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

    2011-01-01

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

  10. Quantitative Imaging in Radiation Oncology: An Emerging Science and Clinical Service.

    PubMed

    Jaffray, David Anthony; Chung, Caroline; Coolens, Catherine; Foltz, Warren; Keller, Harald; Menard, Cynthia; Milosevic, Michael; Publicover, Julia; Yeung, Ivan

    2015-10-01

    Radiation oncology has long required quantitative imaging approaches for the safe and effective delivery of radiation therapy. The past 10 years has seen a remarkable expansion in the variety of novel imaging signals and analyses that are starting to contribute to the prescription and design of the radiation treatment plan. These include a rapid increase in the use of magnetic resonance imaging, development of contrast-enhanced imaging techniques, integration of fluorinated deoxyglucose-positron emission tomography, evaluation of hypoxia imaging techniques, and numerous others. These are reviewed with an effort to highlight challenges related to quantification and reproducibility. In addition, several of the emerging applications of these imaging approaches are also highlighted. Finally, the growing community of support for establishing quantitative imaging approaches as we move toward clinical evaluation is summarized and the need for a clinical service in support of the clinical science and delivery of care is proposed. Copyright © 2015. Published by Elsevier Inc.

  11. Improving quality and decreasing cost in gynecologic oncology care. Society of gynecologic oncology recommendations for clinical practice.

    PubMed

    Rimel, B J; Burke, William M; Higgins, Robert V; Lee, Paula S; Lutman, Christopher V; Parker, Lynn

    2015-05-01

    To identify potential cost savings in gynecologic oncology care without sacrificing quality. Members of the Clinical Practice Committee of the Society of Gynecologic Oncology were asked to review current practice patterns in gynecologic oncology and assess the potential for cost savings founded on evidence-based medicine and current guidelines. Five clinical practices were identified including the following: vaginal cytology for endometrial cancer survivors; colposcopy for low grade cytologic abnormalities for cervical cancer survivors; routine imaging studies for gynecologic cancer survivors; screening for ovarian cancer with serum biomarkers and ultrasound; and improving palliative care for gynecologic cancer patients. Review of the published literature and guidelines were performed to make evidence-based recommendations for cost effective quality gynecologic oncology care. • Do not perform Pap tests of the vaginal cuff in patients with a history of endometrial cancer. • Do not perform colposcopy for low grade Pap tests in women with a history of cervical cancer. • Avoid routine imaging for cancer surveillance in asymptomatic women with gynecologic cancer, specifically ovarian, endometrial, cervical, vulvar and vaginal cancer. • Do not screen women at low risk for ovarian cancer with ultrasound or CA-125 or other biomarkers. • Do not delay basic level palliative care for women with advanced or relapsed gynecologic cancer, do refer to a palliative care specialist when needed, and avoid unnecessary treatments at life's end. Copyright © 2015 Elsevier Inc. All rights reserved.

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

    PubMed

    Diehl, V; Pfreundschuh, M

    1987-06-01

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

  13. 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

  14. Clinical neuro-oncology formal education opportunities for medical students in the United States and Canada.

    PubMed

    Dixit, Karan S; Nicholas, Martin Kelly; Lukas, Rimas V

    2014-12-01

    To develop an understanding of the availability of the formal clinical neuro-oncology educational opportunities for medical students. The curriculum websites of all medical schools accredited by the Liaison Committee on Medical Education were reviewed for the presence of clinical neuro-oncology electives as well as other relevant data. Ten (6.8%) of medical schools accredited by the Liaison Committee on Medical Education offer formal neuro-oncology electives. Half are clustered in the Midwest. Forty percent are at institutions with neuro-oncology fellowships. All are at institutions with neurosurgery and neurology residency programs. Formal clinical neuro-oncology elective opportunities for medical students in the United States and Canada are limited. Additional such opportunities may be of value in the education of medical students. Copyright © 2014 Elsevier Inc. All rights reserved.

  15. 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.

  16. Synthesis of oncological [11C]radiopharmaceuticals for clinical PET.

    PubMed

    Lodi, Filippo; Malizia, Claudio; Castellucci, Paolo; Cicoria, Gianfranco; Fanti, Stefano; Boschi, Stefano

    2012-05-01

    Positron emission tomography (PET) is a nuclear medicine modality which provides quantitative images of biological processes in vivo at the molecular level. Several PET radiopharmaceuticals labeled with short-lived isotopes such as (18)F and (11)C were developed in order to trace specific cellular and molecular pathways with the aim of enhancing clinical applications. Among these [(11)C]radiopharmaceuticals are N-[(11)C]methyl-choline ([(11)C]choline), l-(S-methyl-[(11)C])methionine ([(11)C]methionine) and 1-[(11)C]acetate ([(11)C]acetate), which have gained an important role in oncology where the application of 2-[(18)F]fluoro-2-deoxy-d-glucose ([(18)F]FDG) is suboptimal. Nevertheless, the production of these radiopharmaceuticals did not reach the same level of standardization as for [(18)F]FDG synthesis. This review describes the most recent developments in the synthesis of the above-mentioned [(11)C]radiopharmaceuticals aiming to increase the availability and hence the use of [(11)C]choline, [(11)C]methionine and [(11)C]acetate in clinical practice. Copyright © 2012 Elsevier Inc. All rights reserved.

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

    PubMed Central

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

    2004-01-01

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

  18. Integrating molecular markers into the World Health Organization classification of CNS tumors: a survey of the neuro-oncology community.

    PubMed

    Aldape, Kenneth; Nejad, Romina; Louis, David N; Zadeh, Gelareh

    2017-03-01

    Molecular markers provide important biological and clinical information related to the classification of brain tumors, and the integration of relevant molecular parameters into brain tumor classification systems has been a widely discussed topic in neuro-oncology over the past decade. With recent advances in the development of clinically relevant molecular signatures and the 2016 World Health Organization (WHO) update, the views of the neuro-oncology community on such changes would be informative for implementing this process. A survey with 8 questions regarding molecular markers in tumor classification was sent to an email list of Society for Neuro-Oncology members and attendees of prior meetings (n=5065). There were 403 respondents. Analysis was performed using whole group response, based on self-reported subspecialty. The survey results show overall strong support for incorporating molecular knowledge into the classification and clinical management of brain tumors. Across all 7 subspecialty groups, ≥70% of respondents agreed to this integration. Interestingly, some variability is seen among subspecialties, notably with lowest support from neuropathologists, which may reflect their roles in implementing such diagnostic technologies. Based on a survey provided to the neuro-oncology community, we report strong support for the integration of molecular markers into the WHO classification of brain tumors, as well as for using an integrated "layered" diagnostic format. While membership from each specialty showed support, there was variation by specialty in enthusiasm regarding proposed changes. The initial results of this survey influenced the deliberations underlying the 2016 WHO classification of tumors of the central nervous system.

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

    PubMed

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

    2016-12-20

    Purpose A joint American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology panel convened to develop a focused update of the American Society of Clinical Oncology guideline concerning use of postmastectomy radiotherapy (PMRT). Methods A recent systematic literature review by Cancer Care Ontario provided the primary evidentiary basis. The joint panel also reviewed targeted literature searches to identify new, potentially practice-changing data. Recommendations The panel unanimously agreed that available evidence shows that PMRT reduces the risks of locoregional failure (LRF), any recurrence, and breast cancer mortality for patients with T1-2 breast cancer with one to three positive axillary nodes. However, some subsets of these patients are likely to have such a low risk of LRF that the absolute benefit of PMRT is outweighed by its potential toxicities. In addition, the acceptable ratio of benefit to toxicity varies among patients and physicians. Thus, the decision to recommend PMRT requires a great deal of clinical judgment. The panel agreed clinicians making such recommendations for individual patients should consider factors that may decrease the risk of LRF, attenuate the benefit of reduced breast cancer-specific mortality, and/or increase risk of complications resulting from PMRT. When clinicians and patients elect to omit axillary dissection after a positive sentinel node biopsy, the panel recommends that these patients receive PMRT only if there is already sufficient information to justify its use without needing to know additional axillary nodes are involved. Patients with axillary nodal involvement after neoadjuvant systemic therapy should receive PMRT. The panel recommends treatment generally be administered to both the internal mammary nodes and the supraclavicular-axillary apical nodes in addition to the chest wall or reconstructed breast.

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

    PubMed

    Malan, Tina; Moodley, Keymanthri

    2016-02-01

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

  1. Charting the Future of Cancer Health Disparities Research: A Position Statement from the American Association of Cancer Research, the American Cancer Society, the American Society of Clinical Oncology, and the National Cancer Institute

    Cancer.gov

    The American Association for Cancer Research, American Cancer Society, American Society of Clinical Oncology, and NCI present a unified strategy to promote cooperation in all areas of the cancer health disparities research community.

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

    PubMed

    2013-06-01

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

  3. Developing a multidisciplinary geriatric oncology program in a community cancer center.

    PubMed

    Lynch, Mary Pat; Marcone, Dana; Kagan, Sarah H

    2007-12-01

    Cancer is a disease of older adults, and with unprecedented growth in the number of people entering late adulthood, an increasing need exists for specialized services and programs to address the needs of older adults with cancer. Few examples in the literature detail development of a geriatric oncology program. This article describes a pilot project undertaken by a community cancer center to develop a specialized program for older adults with cancer by identifying local demographics and population needs. It also describes a replicable plan for the development of a geriatric oncology program, which demonstrates how nursing can benefit from collaboration with other disciplines such as social work and psychology in service provision.

  4. [Clinical impact of locoregional hyperthermia in gynecological oncology].

    PubMed

    Bischoff, J; Lindner, L H; Issels, R D; Costa, S

    2006-10-01

    In the last decade progress in gynecological oncology has been achieved mainly by new cytotoxic drugs and advances in radiation technology. For example, the use of taxanes in the primary therapy of ovarian cancers and of combined radio-chemotherapy in cervical cancer has led to significant prolongations of survival. However, in case of relapse most gynaecological malignancies are associated with very poor prognosis. Efficacy of local and systemic therapy can be increased by combining radiotherapy and/or chemotherapy with locoregional hyperthermia (LRH). Increasing the temperature of the target tissue up to 41-43 degrees C leads to local hyperaemia and the tumor tissue becomes more responsive to cytotoxic interventions. In several prospective randomized studies the combination between LRH and radiotherapy was superior to radiotherapy alone in terms of local control (e. g. chest wall recurrence in breast cancer) and has led to longer overall survival in advanced cervical cancer. Platinum derivatives and other cytotoxic drugs have shown synergistic effects with LRH and the combination of both has elicited high response rates in recurrent cervical cancer. In phase-II-clinical trials the newly developed liposomal anthracyclines demonstrated synergistic effects with LRH in patients with refractory ovarian cancer. Our own experience has shown that adding LRH to radio- and/or chemotherapy is well tolerated by the patients. Despite of the fact, that the available data are still preliminary, the inclusion of LRH into multimodal cancer therapy concepts appears to be very promising. Well-designed comparative studies are still needed to evaluate the role of hyperthermia as an adjunct to conventional cancer therapy.

  5. Photodynamic therapy in oncology: mechanisms and clinical use.

    PubMed

    Pass, H I

    1993-03-17

    In photodynamic therapy (PDT), a sensitizer, light, and oxygen are used to cause photochemically induced cell death. The mechanism of cytotoxicity involves generation of singlet oxygen and other free radicals when the light-excited sensitizer loses or accepts an electron. Although selective retention of sensitizer by malignant tissue is seen in vivo, the mechanisms for this sensitizer targeting remain unclear. The first-generation sensitizers are porphyrin based and vary in lipophilicity and hydrophilicity. Targeting of the vasculature seems to be a prominent feature of the cytotoxic effect of these sensitizers in vivo, with resulting necrosis. Treatment depth varies with the wavelength of light that activates the sensitizer used, and the second-generation sensitizers are activated at longer wavelengths, allowing for a 30% increase in treatment depths. The selectivity of targeting can be increased when the sensitizer is delivered with the use of liposomes or monoclonal antibodies specific for tumor antigens. Studies have demonstrated direct effects of PDT on immune effector cells, specifically those with lineage from macrophages or other monocytes. Clinically, this therapy has been chiefly used for palliation of endobronchial and esophageal obstruction, as well as for treatment of bladder carcinomas, skin malignancies, and brain tumors. The future of PDT rests in defining its use either as an intraoperative adjuvant to marginal surgical procedures or as a primary treatment for superficial malignancies. Phase III trials in esophageal cancer and lung cancer are in progress and will help in evaluation of whether Photofrin II, the most widely used sensitizer, can be added to the oncologic armamentarium, pending approval from the U.S. Food and Drug Administration.

  6. Funding oncology clinical trials: are cooperative group trials sustainable?

    PubMed

    Seow, Hsien-Yeang; Whelan, Patrick; Levine, Mark N; Cowan, Kathryn; Lysakowski, Barbara; Kowaleski, Brenda; Snider, Anne; Xu, Rebecca Y; Arnold, Andrew

    2012-05-01

    Many oncology clinical trials departments (CTDs) are in serious fiscal deficit and their sustainability is in jeopardy. This study investigates whether the payment models used to fund industry versus cooperative group trials contribute to the fiscal deficit of a CTD. We examined the lifetime costs of all cooperative group and industry trials activated in the CTD of a cancer center between 2007 and 2011. A trial's lifetime is defined as being from the date the first patient was accrued until the last patient's actual or projected final follow-up visit. For each trial, we calculated the lifetime monthly net income, which was defined as monthly revenue minus monthly costs. Data sources included study protocols, trial budgets, and accrual data. Of the 97 trials analyzed, 64 (66%) were cooperative group trials. The pattern of lifetime net income for cooperative group trials has a positive peak during patient accrual followed by a negative trough during follow-up. In contrast, the pattern for industry trials resembled an "l" shape. The patterns reflect the differing payment models: upfront lump-sum payments (cooperative group) versus milestone payments (industry). The negative trough in the lifetime net income of a cooperative group trial occurs because follow-up costs are typically not funded or are underfunded. CTDs accrue more patients in new trials to offset that deficit. The CTD uses revenue from accrual to existing trials to cross-subsidize past trials in follow-up. As the number of patients on follow-up increases, the fiscal deficit grows larger each year, perpetuating the cycle.

  7. Implementing effective and sustainable multidisciplinary clinical thoracic oncology programs

    PubMed Central

    Freeman, Richard K.; Krasna, Mark J.

    2015-01-01

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

  8. 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. © 2014 by Association of Pediatric Hematology/Oncology Nurses.

  9. Prospective roles for Canadian oncology nurses in breast cancer rapid diagnostic clinics.

    PubMed

    Zanchetta, M S; Maheu, C; Baku, L; Wedderburn, P J S; Lemonde, M

    2015-01-01

    The introduction of rapid diagnostic clinics for breast cancer increases oncology nurses' (ONs) responsibility for patient education and coordination of multidisciplinary care. Developed as an outcome of the E-Mentorship Oncology Nursing Program, this paper proposes new roles for these nurses to respond effectively and competently to such diagnostic innovation. The Oslo Manual Conceptual Framework of Innovation inspired the idea of change in prospective ONs' roles, corroborated by the Canadian Association of Nurses in Oncology's Standards of Practice and Competencies. New roles for ONs that are informed by the domain of information dynamics and evidence-based care are proposed.

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

    PubMed Central

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

    2014-01-01

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

  11. Screening for domestic violence in an oncology clinic: barriers and potential solutions.

    PubMed

    Owen-Smith, Ashli; Hathaway, Jeanne; Roche, Maria; Gioiella, Marie Elena; Whall-Strojwas, Denise; Silverman, Jay

    2008-07-01

    To evaluate the implementation of a domestic violence screening protocol in an oncology clinic. A retrospective review of a random sample of clinic medical records and qualitative surveys of nursing staff. A gynecologic oncology clinic in a large teaching hospital. 204 charts were abstracted and six oncology nurses completed surveys. A random sample of patients from clinic appointment schedules was selected 6 and 12 months after the implementation of a domestic violence screening protocol. A brief written survey of nursing staff also was conducted. Documentation of domestic violence screening, barriers to screening and documentation, and potential solutions to the barriers. Sixty-three percent of the charts reviewed had a domestic violence screening record present, but only 12% of the charts with a screening record had documentation. Patients with domestic violence screening documentation were more likely to have had five or more clinic visits during the study period. The most frequent barriers to protocol implementation cited by nursing staff were forgetting to screen or document domestic violence screening. Nursing staff recommended adding domestic violence screening questions to forms and providing reminders to screen. Several barriers to successful implementation of a domestic violence screening protocol in a gynecologic oncology clinic, including documentation issues, were encountered. Nurses interested in implementing a domestic violence screening protocol in their oncology clinic should consider reviewing the barriers to domestic violence screening and documentation and the potential solutions identified in this study.

  12. Adjuvant and salvage radiotherapy after prostatectomy: American Society of Clinical Oncology clinical practice guideline endorsement.

    PubMed

    Freedland, Stephen J; Rumble, R Bryan; Finelli, Antonio; Chen, Ronald C; Slovin, Susan; Stein, Mark N; Mendelson, David S; Wackett, Colin; Sandler, Howard M

    2014-12-01

    To endorse the American Urological Association (AUA)/American Society for Radiation Oncology (ASTRO) guideline on adjuvant and salvage radiotherapy after prostatectomy. The American Society of Clinical Oncology (ASCO) has a policy and set of procedures for endorsing clinical practice guidelines developed by other professional organizations. The guideline on adjuvant and salvage radiotherapy after prostatectomy was reviewed for developmental rigor by methodologists. An ASCO endorsement panel then reviewed the content and recommendations. The panel determined that the guideline recommendations on adjuvant and salvage radiotherapy after prostatectomy, published in August 2013, are clear, thorough, and based on the most relevant scientific evidence. ASCO endorsed the guideline on adjuvant and salvage radiotherapy after prostatectomy, adding one qualifying statement that not all candidates for adjuvant or salvage radiotherapy have the same risk of recurrence or disease progression, and thus, risk-benefit ratios are not the same for all men. Those at the highest risk for recurrence after radical prostatectomy include men with seminal vesicle invasion, Gleason score 8 to 10, extensive positive margins, and detectable postoperative prostate-specific antigen (PSA). Physicians should discuss adjuvant radiotherapy with patients with adverse pathologic findings at prostatectomy (ie, seminal vesicle invasion, positive surgical margins, extraprostatic extension) and salvage radiotherapy with patients with PSA or local recurrence after prostatectomy. The discussion of radiotherapy should include possible short- and long-term adverse effects and potential benefits. The decision to administer radiotherapy should be made by the patient and multidisciplinary treatment team, keeping in mind that not all men are at equal risk of recurrence or clinically meaningful disease progression. Thus, the risk-benefit ratio will differ for each patient. © 2014 by American Society of Clinical

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

    PubMed

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

    2016-02-01

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

  14. Evaluation of Employee Vaccination Policies in Outpatient Oncology Clinics: A Pilot Study.

    PubMed

    Luthy, Karlen E; Stocksdale, Sarah L; Macintosh, Janelle L B; Eden, Lacey M; Beckstrand, Renea L; Edmonds, Katie

    2016-10-01

    All major hospital facilities in the state of Utah have employee vaccination policies. However, the presence of healthcare worker vaccination policies in outpatient oncology clinics was unknown. The objectives of this article are to identify oncology outpatient employee vaccination policies in Utah and to identify what consequences, if any, are present for unvaccinated employees. This was a cross-sectional, descriptive study design in which clinic managers from outpatient oncology clinics were asked, via questionnaire, to describe the clinic's employee vaccination policy and the consequences for refusing the policy. Most vaccination policies applied to employees primarily assigned to work in the direct patient care area. Most commonly, influenza and hepatitis B vaccines were required as part of the vaccination policy. Most managers offered free vaccinations to employees, but most managers also allowed employees to refuse to follow the vaccination policy for medical, religious, or personal reasons.

  15. Addressing the American health-care cost crisis: role of the oncology community.

    PubMed

    Ramsey, Scott D; Ganz, Patricia A; Shankaran, Veena; Peppercorn, Jeffrey; Emanuel, Ezekiel

    2013-12-04

    Health-care cost growth is unsustainable, and the current level of spending is harming our economy and our patients. This commentary describes the scope of the health-care spending problem and the particular factors in cancer care that contribute to the problem, reflecting in part presentations and discussions from an Institute of Medicine National Cancer Policy Forum Workshop held in October 2012. Presenters at the workshop identified a number of steps that the oncology community can take to reduce the rate of growth in cancer-care costs while maintaining or improving upon the quality of care. This commentary aims to highlight opportunities for the oncology community to take a leadership role in delivering affordable, high-quality cancer care.

  16. Building trust and diversity in patient-centered oncology clinical trials: An integrated model.

    PubMed

    Hurd, Thelma C; Kaplan, Charles D; Cook, Elise D; Chilton, Janice A; Lytton, Jay S; Hawk, Ernest T; Jones, Lovell A

    2017-04-01

    Trust is the cornerstone of clinical trial recruitment and retention. Efforts to decrease barriers and increase clinical trial participation among diverse populations have yielded modest results. There is an urgent need to better understand the complex interactions between trust and clinical trial participation. The process of trust-building has been a focus of intense research in the business community. Yet, little has been published about trust in oncology clinical trials or the process of building trust in clinical trials. Both clinical trials and business share common dimensions. Business strategies for building trust may be transferable to the clinical trial setting. This study was conducted to understand and utilize contemporary thinking about building trust to develop an Integrated Model of Trust that incorporates both clinical and business perspectives. A key word-directed literature search of the PubMed, Medline, Cochrane, and Google Search databases for entries dated between 1 January 1985 and 1 September 2015 was conducted to obtain information from which to develop an Integrated Model of Trust. Successful trial participation requires both participants and clinical trial team members to build distinctly different types of interpersonal trust to effect recruitment and retention. They are built under conditions of significant emotional stress and time constraints among people who do not know each other and have never worked together before. Swift Trust and Traditional Trust are sequentially built during the clinical trial process. Swift trust operates during the recruitment and very early active treatment phases of the clinical trial process. Traditional trust is built over time and operates during the active treatment and surveillance stages of clinical trials. The Psychological Contract frames the participants' and clinical trial team members' interpersonal trust relationship. The "terms" of interpersonal trust are negotiated through the psychological

  17. Metastatic Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline

    PubMed Central

    Sohal, Davendra P.S.; Mangu, Pamela B.; Khorana, Alok A.; Shah, Manish A.; Philip, Philip A.; O’Reilly, Eileen M.; Uronis, Hope E.; Ramanathan, Ramesh K.; Crane, Christopher H.; Engebretson, Anitra; Ruggiero, Joseph T.; Copur, Mehmet S.; Lau, Michelle; Urba, Susan; Laheru, Daniel

    2016-01-01

    Purpose To provide evidence-based recommendations to oncologists and others for the treatment of patients with metastatic pancreatic cancer. Methods American Society of Clinical Oncology convened an Expert Panel of medical oncology, radiation oncology, surgical oncology, gastroenterology, palliative care, and advocacy experts to conduct a systematic review of the literature from April 2004 to June 2015. Outcomes were overall survival, disease-free survival, progression-free survival, and adverse events. Results Twenty-four randomized controlled trials met the systematic review criteria. Recommendations A multiphase computed tomography scan of the chest, abdomen, and pelvis should be performed. Baseline performance status and comorbidity profile should be evaluated. Goals of care, patient preferences, treatment response, psychological status, support systems, and symptom burden should guide decisions for treatments. A palliative care referral should occur at first visit. FOLFIRINOX (leucovorin, fluorouracil, irinotecan, and oxaliplatin; favorable comorbidity profile) or gemcitabine plus nanoparticle albumin-bound (NAB) -paclitaxel (adequate comorbidity profile) should be offered to patients with Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1 based on patient preference and support system available. Gemcitabine alone is recommended for patients with ECOG PS 2 or with a comorbidity profile that precludes other regimens; the addition of capecitabine or erlotinib may be offered. Patients with an ECOG PS ≥ 3 and poorly controlled comorbid conditions should be offered cancer-directed therapy only on a case-by-case basis; supportive care should be emphasized. For second-line therapy, gemcitabine plus NAB-paclitaxel should be offered to patients with first-line treatment with FOLFIRINOX, an ECOG PS 0 to 1, and a favorable comorbidity profile; fluorouracil plus oxaliplatin, irinotecan, or nanoliposomal irinotecan should be offered to patients with

  18. 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.

  19. 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

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

    PubMed

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

    2010-07-01

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

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

    PubMed

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

    2013-10-10

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

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

    PubMed

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

    2016-11-01

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

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

    PubMed

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

    2016-12-01

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

  4. Survey of Medical Oncology Status in Korea (SOMOS-K): A National Survey of Medical Oncologists in the Korean Association for Clinical Oncology (KACO).

    PubMed

    Kim, Do Yeun; Lee, Yun Gyoo; Kim, Bong-Seog

    2017-07-01

    This study was conducted to investigate the current role of medical oncologists in cancer care with a focus on increasing the recognition of medical oncology as an independent specialty. Questionnaires modified from the Medical Oncology Status in Europe Survey dealing with oncology structure, resources, research, and patterns of care given by medical oncologists were selected. Several modifications were made to the questionnaire after feedback from the insurance and policy committee of the Korean Association for Clinical Oncology (KACO). The online survey was then sent to KACO members. A total of 214 medical oncologists (45.8% of the total inquiries), including 71 directors of medical oncology institutions, took the survey. Most institutions had various resources, including a medical oncology department (94.1%) and a department of radiation oncology (82.4%). There was an average of four medical oncologists at each institution. Medical oncologists were involved in various treatments from diagnosis to end-of-life care. They were also chemotherapy providers from a wide range of institutions that treated many types of solid cancers. In addition, 86.2% of the institutions conducted research. This is the first national survey in Korea to show that medical oncologists are involved in a wide range of cancer treatments and care. This survey emphasizes the contributions and proper roles of medical oncologists in the evolving health care environment in Korea.

  5. 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

  6. Neoadjuvant Chemotherapy for Newly Diagnosed, Advanced Ovarian Cancer: Society of Gynecologic Oncology and American Society of Clinical Oncology Clinical Practice Guideline.

    PubMed

    Wright, Alexi A; Bohlke, Kari; Armstrong, Deborah K; Bookman, Michael A; Cliby, William A; Coleman, Robert L; Dizon, Don S; Kash, Joseph J; Meyer, Larissa A; Moore, Kathleen N; Olawaiye, Alexander B; Oldham, Jessica; Salani, Ritu; Sparacio, Dee; Tew, William P; Vergote, Ignace; Edelson, Mitchell I

    2016-10-01

    To provide guidance to clinicians regarding the use of neoadjuvant chemotherapy and interval cytoreduction among women with stage IIIC or IV epithelial ovarian cancer. The Society of Gynecologic Oncology and the American Society of Clinical Oncology convened an Expert Panel and conducted a systematic review of the literature. Four phase III clinical trials form the primary evidence base for the recommendations. The published studies suggest that for selected women with stage IIIC or IV epithelial ovarian cancer, neoadjuvant chemotherapy and interval cytoreduction are noninferior to primary cytoreduction and adjuvant chemotherapy with respect to overall and progression-free survival and are associated with less perioperative morbidity and mortality. All women with suspected stage IIIC or IV invasive epithelial ovarian cancer should be evaluated by a gynecologic oncologist prior to initiation of therapy. The primary clinical evaluation should include a CT of the abdomen and pelvis, and chest imaging (CT preferred). Women with a high perioperative risk profile or a low likelihood of achieving cytoreduction to < 1 cm of residual disease (ideally to no visible disease) should receive neoadjuvant chemotherapy. Women who are fit for primary cytoreductive surgery, and with potentially resectable disease, may receive either neoadjuvant chemotherapy or primary cytoreductive surgery. However, primary cytoreductive surgery is preferred if there is a high likelihood of achieving cytoreduction to < 1 cm (ideally to no visible disease) with acceptable morbidity. Before neoadjuvant chemotherapy is delivered, all patients should have confirmation of an invasive ovarian, fallopian tube, or peritoneal cancer. Additional information is available at www.asco.org/NACT-ovarian-guideline and www.asco.org/guidelineswiki. © 2016 Society of Gynecologic Oncology and American Society of Clinical Oncology.

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

    PubMed

    Tobisu, Kenichi

    2012-05-01

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

  8. 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.

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

    PubMed

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

    2008-08-20

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

  10. 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…

  11. 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…

  12. Medication Reconciliation in Oncological Patients: A Randomized Clinical Trial.

    PubMed

    Vega, Triana González-Carrascosa; Sierra-Sánchez, Jesús Francisco; Martínez-Bautista, María José; García-Martín, Fátima; Suárez-Carrascosa, Francisco; Baena-Cañada, Jose Manuel

    2016-06-01

    Medication reconciliation is considered to be an important strategy for increasing the safety of medication use. However, few studies have been carried out showing the effect of a medication reconciliation program on the incidence of reconciliation errors (REs) in oncological patients treated in the outpatient setting. To measure the effect of a medication reconciliation program on the incidence of reconciliation error that reached the patient (RERP) in cancer patients receiving chemotherapy as outpatients. A randomized, prospective, controlled study was carried out to identify the proportion of patients with at least 1 RERP. Medication reconciliation (intervention group) was compared with standard practice (control group) in patients starting new chemotherapy and who were receiving at least 1 home medication before the start of chemotherapy. A prespecified analysis of factors capable of influencing the occurrence of RE in oncological patients was also carried out. A total of 147 patients were included (76 in the intervention group and 71 controls) in this study. There were 3 (4%) patients with RERP (primary endpoint) in the intervention group and 21 (30%) patients in the control group (relative risk [RR] = 0.13, 95% CI = 0.04-0.43; P = 0.0009). The prespecified analysis of the effects of the Eastern Cooperative Oncology Group performance status (ECOG), Charlson Comorbidity Index score, and degree of poly-medication upon the number of patients with RE showed the Charlson Comorbidity Index to be unrelated to RE occurrence. However, the risk of RE was greater in patients with ECOG ≥ 2 (RR = 2.18, 95% CI = 1.4-3.4; P = 0.018) and among patients with major poly-medication (RR = 2.49, 95% CI = 1.52-4.09; P <0.001). Medication reconciliation results in a marked decrease in RERP in cancer patients. The factors that may influence RE occurrence in oncological patients have not been fully established, although parameters such as the degree of poly-medication and

  13. Early phase clinical trials in pediatric hematology and oncology.

    PubMed

    Corbacioglu, S

    2012-04-01

    Pediatric oncology is an unrivaled success story in the recent history of medicine. This success is mostly based on a persistent refinement of evidence based therapeutic concepts. With that regard physicians and their staff are highly experience in the conduct of prospective evidence based trials and are therefore competent partners for the pharmaceutical industry. In times of personalized medicine the individual target population is diminishing and the borders of indications are not more disease based. A situation that requires new concepts from the industry. Therefore children with cancer could benefit early from the current developments as well as the pharmaceutical industry could benefit from the legislative incentives through highly recruiting and well conducted prospective trials. Pivotal is a functional platform of communication in order to maintain a close dialogue between academia and pharmaceutical companies. © Georg Thieme Verlag KG Stuttgart · New York.

  14. 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

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

    PubMed Central

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

    2016-01-01

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

  16. 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…

  17. 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…

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

    PubMed Central

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

    2016-01-01

    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 raise 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. PMID:26825023

  19. 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.

  20. 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.

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

    PubMed

    Wesselmann, Simone

    2015-01-01

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

  2. 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

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

    PubMed

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

    2016-01-01

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

  4. 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.

  5. Quantitative assessment of workload and stressors in clinical radiation oncology.

    PubMed

    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

    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). 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). 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). Workload level and sources of stressors vary

  6. 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

  7. Making Molecular Imaging a Clinical Tool for Precision Oncology: A Review.

    PubMed

    Mankoff, David A; Farwell, Michael D; Clark, Amy S; Pryma, Daniel A

    2017-05-01

    Individualized cancer treatment, tailored to a particular patient and the tumor's biological features (precision oncology), requires a detailed knowledge of tumor biology. Biological characterization is typically performed on biopsy material, but this approach can present challenges for widespread and/or heterogeneous disease and for performing serial assays to infer changes in response to therapy. Molecular imaging is a complementary approach that provides noninvasive and quantitative measures of the in vivo biology of the full disease burden and is well suited to serial assay. Molecular imaging can provide unique information to guide precision oncology that includes measuring the regional expression of therapeutic targets, measuring drug pharmacokinetics, measuring therapy pharmacodynamics, and providing a marker of therapeutic efficacy that is highly indicative of outcome. Thus far, most trials of novel molecular imaging in oncology have been small, single-center trials. Only a few methods have progressed to multicenter trials and even fewer have become part of clinical practice. Molecular imaging holds great promise for precision oncology, complementing tissue-based markers to guide more effective, less toxic, and more cost-effective cancer treatments. Beyond logistical and technical challenges, moving new imaging tests from the laboratory to the clinic requires a compelling use case that will benefit patients and/or improve cost-effectiveness, and it requires the collaboration of imagers, oncologists, and industry to reach its true clinical potential.

  8. [Low grade parosteal osteosarcoma. Clinical and oncological outcomes].

    PubMed

    Albergo, José I; Farfalli, Germán L; Ayerza, Miguel A; Muscolo, Domingo L; Aponte-Tinao, Luis A

    2015-01-01

    The objective of the study was to analyze a group of patients with low grade parosteal osteosarcoma treated with limb salvage surgery and reconstructed with bone allograft. A retrospective review from our oncologic data base between 1980 and 2010 was done and all patients with diagnosis of low grade parosteal osteosarcoma, treated with limb salvage surgery and reconstructed with allograft were included. Twenty-two patients were included for the analysis. The mean age was 32±11 years (10-59) y the mean follow-up 93±69 months (8-237). Ten year overall survival of the series was 91% (95% CI: 79-100). Four patients developed local recurrence, 2 of them histological classified after the resection dedifferentiated parosteal osteosarcoma. Two patients developed distant recurrence, being the lung the only site of metastasis. Ten year limb salvage reconstruction survival was 65% (95% CI: 44-86). Long term survival rate in low grade parosteal osteosarcoma is over 90%. Surgical resection wide margin should be the elective treatment and biological limb salvage reconstruction is a good alternative.

  9. Evaluation of clinical pharmacists' follow-up service in an oncology pain clinic.

    PubMed

    Ryan, Nikki; Chambers, Carole; Ralph, Christopher; England, Dean; Cusano, Frances

    2013-06-01

    Patients who present with pain in an oncology setting are often complex and require a multidisciplinary approach for symptom control. The Pain and Symptom Control Clinic at Tom Baker Cancer Center includes two pharmacists who participate in weekly multidisciplinary clinics and provide a follow-up service to patients. This study will assess the impact of the pharmacists' follow-up service with respect to activities performed as well as patient and health care professional satisfaction. The activities performed will also be compared to defined objectives for pharmacy practice in a hospital setting. Activities performed by the pharmacists over a 10-week period were recorded and tabulated. Online surveys were completed by health care professionals and telephone surveys were completed by patients 1 month post clinic visit. Over 6 weeks, 44 patients assessed in clinic required follow-up from a pharmacist. There was an average of 2.3 interactions per patient and an average time of 85 min was spent on each patient outside of clinic. The three activities that occurred most frequently included: (1) interacting with other health care professionals, (2) making alterations to patients' medication regimens, and (3) organizing refills. All health care professionals surveyed felt that the pharmacists' follow-up service was a valuable component of the Pain and Symptom Control Clinic and nearly all patients surveyed reported a positive experience with the service received. The inclusion of pharmacists in the Pain and Symptom Control Clinic is favored by patients and health care professionals and provides increased efficiency to the clinic.

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

    PubMed

    Leskosek, Branimir L

    2008-11-06

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

  11. 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.

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

    PubMed Central

    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.

    2016-01-01

    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

  13. 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. © 2013 John Wiley & Sons Ltd.

  14. The role of clinical trials in veterinary oncology.

    PubMed

    Burton, Jenna; Khanna, Chand

    2014-09-01

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

  15. 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.

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

    PubMed

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

    2015-01-01

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

  17. Precision medicine ethics: selected issues and developments in next-generation sequencing, clinical oncology, and ethics.

    PubMed

    Fiore, Robin N; Goodman, Kenneth W

    2016-01-01

    In early 2015 the National Institutes of Health launched a new, national Precision Medicine Initiative with the primary goal of rapidly improving the prevention, diagnosis, and treatment of cancers. The first-stage emphasis on oncology presents unique opportunities for clinical oncology to influence how the ethical challenges of precision medicine are to be articulated and addressed. Thus, a review of recent developments in connection with the Initiative, in particular on core ethics issues in clinical genomics, is a useful starting point. Unique ethical issues arise in precision medicine because of the enormous amounts of data generated by clinical whole-genome or whole-exome sequencing and the extent of current uncertainties with respect to data interpretations and disease associations. Among the most ethically challenging issues for clinicians are complicated informed consent processes, returning results - particularly secondary and incidental findings-and privacy and confidentiality. The first tests of precision medicine ethics in practice will be in clinical oncology, providing a rare opportunity to shape the agenda and integrate practical ethics considerations. These efforts can benefit from pre-existing research ethics analyses and recommendations from clinical and translational genetics research.

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

    PubMed

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

    2009-08-10

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

  19. Assessing the Eventual Publication of Clinical Trial Abstracts Submitted to a Large Annual Oncology Meeting.

    PubMed

    Massey, Paul R; Wang, Ruibin; Prasad, Vinay; Bates, Susan E; Fojo, Tito

    2016-03-01

    Despite the ethical imperative to publish clinical trials when human subjects are involved, such data frequently remain unpublished. The objectives were to tabulate the rate and ascertain factors associated with eventual publication of clinical trial results reported as abstracts in the Proceedings of the American Society of Clinical Oncology (American Society of Clinical Oncology). Abstracts describing clinical trials for patients with breast, lung, colorectal, ovarian, and prostate cancer from 2009 to 2011 were identified by using a comprehensive online database (http://meetinglibrary.asco.org/abstracts). Abstracts included reported results of a treatment or intervention assessed in a discrete, prospective clinical trial. Publication status at 4-6 years was determined by using a standardized search of PubMed. Primary outcomes were the rate of publication for abstracts of randomized and nonrandomized clinical trials. Secondary outcomes included factors influencing the publication of results. A total of 1,075 abstracts describing 378 randomized and 697 nonrandomized clinical trials were evaluated. Across all years, 75% of randomized and 54% of nonrandomized trials were published, with an overall publication rate of 61%. Sample size was a statistically significant predictor of publication for both randomized and nonrandomized trials (odds ratio [OR] per increase of 100 participants = 1.23 [1.11-1.36], p < .001; and 1.64 [1.15-2.34], p = .006, respectively). Among randomized studies, an industry coauthor or involvement of a cooperative group increased the likelihood of publication (OR 2.37, p = .013; and 2.21, p = .01, respectively). Among nonrandomized studies, phase II trials were more likely to be published than phase I (p < .001). Use of an experimental agent was not a predictor of publication in randomized (OR 0.76 [0.38-1.52]; p = .441) or nonrandomized trials (OR 0.89 [0.61-1.29]; p = .532). This is the largest reported study examining why oncology trials are

  20. HER2-Positive Metastatic Breast Cancer Patients Receiving Pertuzumab in a Community Oncology Practice Setting: Treatment Patterns and Outcomes.

    PubMed

    Robert, Nicholas J; Goertz, Hans-Peter; Chopra, Pooja; Jiao, Xiaolong; Yoo, Bongin; Patt, Debra; Antao, Vincent

    2017-03-01

    Pertuzumab (Perjeta(®)), a HER2/neu receptor antagonist, was approved by the US Food and Drug Administration in June 2012 for use in the first-line setting for patients with HER2-positive metastatic breast cancer (mBC). This retrospective study investigated the clinical and demographic characteristics, treatment patterns, safety, and clinical outcomes for patients with HER2-positive mBC who received pertuzumab in the first-line setting in US community oncology practices. Patients with HER2-positive mBC, who initiated pertuzumab within 60 days of mBC diagnosis between June 2012 and June 2014, followed through December 2014, had ≥2 visits within the McKesson Specialty Health/US Oncology Network, and were not on clinical trials during the study period, were eligible. This study utilized iKnowMed electronic health records, Claims Data Warehouse, and Social Security Death Index. Progression-free survival (PFS) was assessed by Kaplan-Meier methods. A total of 266 patients met the selection criteria. A vast majority of the patients (249/266, 93.6%) received a trastuzumab + pertuzumab + taxane (H + P + T) regimen. The number of patients with prior adjuvant/neoadjuvant therapy was higher than the CLEOPATRA trial, but age (median 57 years) and percentage of visceral disease (74.8%) were similar. The most common adverse events were fatigue (50.8%), diarrhea (44.7%), nausea (35.3%), peripheral neuropathy (33.5%), neutropenia (24.9%), and rash (24.4%). The median PFS was 16.9 months (95% CI 14.2-19.7). In this retrospective study of patients with HER2-positive mBC receiving pertuzumab in the first-line setting, most patients were treated with H + P + T. The safety and PFS of H + P + T were consistent with those observed in the pivotal trial.

  1. Fertility preservation for patients with cancer: American Society of Clinical Oncology clinical practice guideline update.

    PubMed

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

    2013-07-01

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

  2. 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

    -time information that can inform the care of every patient with cancer as well as connect patients with their entire medical teams. The rapid learning system will form a continuous cycle of learning: securely capturing data from every patient at the point of care, drawing on evidence-based guidelines, and evaluating quality of care against those standards and the outcomes of other patients. Clinical trials are another area in which collaboration is critical. Increasing clinical trial participation will require commitment across the cancer community from physicians, patients, insurers, hospitals, and industry. A 2010 report by the Institute of Medicine described challenges to participation in trials by both physicians and patients and provided recommendations for revitalizing clinical trials conducted through the National Cancer Institute's Cooperative Group Program. ASCO has pledged its support for the full implementation of these recommendations. More broadly, ASCO recently outlined a bold vision for translational and clinical cancer research for the next decade and made recommendations to achieve that vision. Accelerating Progress Against Cancer: ASCO's Blueprint for Transforming Clinical and Translational Research, released in November, calls for a research system that takes full advantage of today's scientific and technologic opportunities and sets a high-level agenda for policy makers, regulators, and advocates. Cancer research has transformed cancer care in the past forty years, and this year's Clinical Cancer Advances illustrates how far we have come in the past year alone. We now have a tremendous opportunity to use today's knowledge and collaborate across all facets of cancer care to conquer this deadly disease. Michael P. Link, MD President American Society of Clinical Oncology.

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

    PubMed Central

    Li, Chun; Wallace, Sidney

    2008-01-01

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

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

    PubMed

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

    2008-01-01

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

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

    PubMed Central

    Valluru, Keerthi S.; Wilson, Katheryne E.

    2016-01-01

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

  6. Preliminary report: the development of the NCCN Comparative Therapeutic Index™ as a clinical evaluative process for existing data in oncology.

    PubMed

    Li, Edward C; DeMartino, Jessica

    2010-08-01

    The National Comprehensive Cancer Network (NCCN) develops and communicates the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) to oncologists and other clinicians. The NCCN Guidelines are widely recognized and applied as the standard for clinical policy in the United States. These guidelines and related documents, such as the NCCN Drugs & Biologics Compendium (NCCN Compendium), are used extensively by public and private payors as the basis for the setting of coverage policies. Given the demand for comparative effectiveness (CE) analyses, as described and discussed in this report, the NCCN has begun work on a paradigm to integrate evidence-based CE analysis into the NCCN Guidelines deliberative process. This report presents NCCN's initial thinking on the use of NCCN expert panel members in developing a process that can be used to compare health care technologies (e.g., radiation modalities, chemotherapy regimens) in a formal, systematic way. Draft considerations are provided to stimulate discussion and feedback, particularly in the oncology community, as NCCN moves through processes such as methodologic review, validation of rating scales, and review of implications for public policy, toward finalization of an NCCN CE analytic paradigm.

  7. Clinically relevant drug–drug interactions in oncology

    PubMed Central

    McLeod, Howard L

    1998-01-01

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

  8. CHARACTERISTICS OF DRUG COMBINATION THERAPY IN ONCOLOGY BY ANALYZING CLINICAL TRIAL DATA ON CLINICALTRIALS.GOV

    PubMed Central

    WU, MENGHUA; SIROTA, MARINA; BUTTE, ATUL J.

    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. PMID:25592569

  9. American Society of Clinical Oncology Technology Assessment: chemotherapy sensitivity and resistance assays.

    PubMed

    Schrag, Deborah; Garewal, Harinder S; Burstein, Harold J; Samson, David J; Von Hoff, Daniel D; Somerfield, Mark R

    2004-09-01

    To develop a technology assessment of chemotherapy sensitivity and resistance assays in order to define the role of these tests in routine oncology practice. The American Society of Clinical Oncology (ASCO) established a Working Group to develop the technology assessment. The Working Group collaborated with the Blue Cross and Blue Shield Association (BCBSA) Technology Evaluation Center. The Working Group developed independent criteria for selecting articles for inclusion in the ASCO assessment, and developed a structured data abstraction tool to facilitate review of selected manuscripts. One Working Group member and an ASCO staff member independently reviewed the 1,139 abstracts identified by the BCBSA comprehensive literature search, and by an updated literature search performed by ASCO using the BCBSA search strategy (1966 to January 2004). Of the 12 articles included in this technology assessment, eight were identified by the original BCBSA systematic review, one was provided by industry, and three were identified by the ASCO updated literature review. Review of the literature does not identify any CSRAs for which the evidence base is sufficient to support use in oncology practice. The use of chemotherapy sensitivity and resistance assays to select chemotherapeutic agents for individual patients is not recommended outside of the clinical trial setting. Oncologists should make chemotherapy treatment recommendations on the basis of published reports of clinical trials and a patient's health status and treatment preferences. Because the in vitro analytic strategy has potential importance, participation in clinical trials evaluating these technologies remains a priority.

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

    PubMed

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

    2017-04-11

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

  11. Identifying Health Information Technology Needs of Oncologists to Facilitate the Adoption of Genomic Medicine: Recommendations From the 2016 American Society of Clinical Oncology Omics and Precision Oncology Workshop.

    PubMed

    Hughes, Kevin S; Ambinder, Edward P; Hess, Gregory P; Yu, Peter Paul; Bernstam, Elmer V; Routbort, Mark J; Clemenceau, Jean Rene; Hamm, John T; Febbo, Phillip G; Domchek, Susan M; Chen, James L; Warner, Jeremy L

    2017-09-20

    At the ASCO Data Standards and Interoperability Summit held in May 2016, it was unanimously decided that four areas of current oncology clinical practice have serious, unmet health information technology needs. The following areas of need were identified: 1) omics and precision oncology, 2) advancing interoperability, 3) patient engagement, and 4) value-based oncology. To begin to address these issues, ASCO convened two complementary workshops: the Omics and Precision Oncology Workshop in October 2016 and the Advancing Interoperability Workshop in December 2016. A common goal was to address the complexity, enormity, and rapidly changing nature of genomic information, which existing electronic health records are ill equipped to manage. The subject matter experts invited to the Omics and Precision Oncology Workgroup were tasked with the responsibility of determining a specific, limited need that could be addressed by a software application (app) in the short-term future, using currently available genomic knowledge bases. Hence, the scope of this workshop was to determine the basic functionality of one app that could serve as a test case for app development. The goal of the second workshop, described separately, was to identify the specifications for such an app. This approach was chosen both to facilitate the development of a useful app and to help ASCO and oncologists better understand the mechanics, difficulties, and gaps in genomic clinical decision support tool development. In this article, we discuss the key challenges and recommendations identified by the workshop participants. Our hope is to narrow the gap between the practicing oncologist and ongoing national efforts to provide precision oncology and value-based care to cancer patients.

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

    PubMed Central

    Javle, Milind; Hsueh, Chung-Tsen

    2009-01-01

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

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed

    Marconato, Laura; Buracco, Paolo; Aresu, Luca

    2015-08-01

    The field of oncology research has undergone major changes in recent years. Progress in molecular and cellular biology has led to a greater understanding of the cellular pathways and mechanisms of cell proliferation and tissue invasion associated with cancer. New classes of cancer therapies are becoming available or are in development but these new agents require a paradigm shift in the design of oncology clinical trials. This review provides an overview of clinical trial designs for the development of tumour vaccines and targeted therapeutic agents. In addition, some of the successes, limitations and challenges of these trials are discussed, with a special emphasis on the difficulties and particularities that are encountered in veterinary medicine compared to similar work in human patients. Copyright © 2015 Elsevier Ltd. All rights reserved.

  15. Novel dose-finding designs and considerations on practical implementations in oncology clinical trials.

    PubMed

    Huang, Bo; Bycott, Paul; Talukder, Enayet

    2017-01-01

    One of the main objectives in phase I oncology trials is to evaluate safety and tolerability of an experimental treatment by estimating the maximum tolerated dose (MTD) based on the rate of dose-limiting toxicities (DLT). To meet emerging challenges in dose-finding studies, over the past two decades, extensive research has been conducted by statistical and medical researchers to create innovative dose finding designs that perform better than the standard 3 + 3 design, which often exhibits undesirable statistical and operational properties. However, clinical implementation and practical usage of these new designs have been limited. This article begins with a review of the most recent literature and then provides some perspectives on implementing novel adaptive dose finding designs in oncology phase I trials from a pharmaceutical industry perspective. Statistical planning and logistical considerations on how to effectively execute such designs in multi-center clinical trials are discussed using two recent case studies.

  16. Factors associated with clinical trial screening failures in gynecologic oncology.

    PubMed

    Manders, Dustin B; Paulsen, Annette; Richardson, Debra L; Kehoe, Siobhan M; Miller, David S; Lea, Jayanthi S

    2014-09-01

    Low enrollment of adult cancer patients in clinical trials is an ongoing challenge in cancer research. We sought to determine factors associated with clinical trial screening failures in women with gynecologic malignancies at a large urban university health system. A retrospective review was conducted of women with gynecologic malignancies who presented to an urban university system between 12/2009 and 12/2012. Data collected included demographic, clinico-pathologic and trial-related factors, as well as reasons for non-participation. Two hundred twenty-one patients were eligible for a clinical trial. Of these, 44% participated while 56% did not. There were more screening failures when trials were offered at the time of primary treatment than at recurrence (62% vs. 38%, p=0.001). There was no significant difference in participation based on age, ethnicity, hospital setting, payor status, family history, comorbidities, prior treatment, substance abuse, recent surgery or trial type. Of the non-participants, 62% declined the study due to perceived harm and 10% due to socio-economic barriers while 20% were excluded due to co-morbidities and 8% due to noncompliance. Significantly more screening failures for clinical trials occurred when trials were offered at the time of primary treatment. The majority of patients declined based on perceived harm from enrolling in a clinical trial, although 20% of eligible patients were not offered enrollment despite not meeting any exclusion criteria. Our findings underscore the importance of appropriate counseling when offering clinical trials, as well as overcoming physician biases in deciding who is an appropriate candidate. Copyright © 2014 Elsevier Inc. All rights reserved.

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

    PubMed Central

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

    2016-01-01

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

  18. Screening and community outreach programs for priority populations: considerations for oncology managers.

    PubMed

    Meade, Cathy D; Calvo, Arlene; Rivera, Marlene

    2002-01-01

    The goals of screening and community outreach efforts are to translate knowledge into relevant interventions to enhance health, prevent disease and manage chronic illness. Despite recent progress in the fight against cancer, a disproportionate share of the cancer burden is observed among ethnic minorities and medically underserved populations. Studies consistently link low socioeconomic status to low survival rates for nearly all types of cancer. Cultural differences, low literacy skills, language barriers and limited access to health care pose additional barriers to preventative health care for priority populations. Reaching priority populations with effective, appropriate and measurable ways to reduce cancer morbidity and mortality are key considerations for oncology managers seeking to provide comprehensive screening and community outreach care. This article addresses the importance of culture and literacy when developing screening and community outreach programs for at-risk populations, highlights the value of community partnerships to achieve programmatic goals, and outlines key considerations for creating successful breast screening and community outreach among Hispanic farmworker and rural women.

  19. Vienna Summer School on Oncology: how to teach clinical decision making in a multidisciplinary environment.

    PubMed

    Lütgendorf-Caucig, Carola; Kaiser, Philipp A; Machacek, Alexandra; Waldstein, Cora; Pötter, Richard; Löffler-Stastka, Henriette

    2017-06-06

    Clinical decision making in oncology is based on both inter- and multidisciplinary approach. Hence teaching future doctors involved in oncology or general health practice is crucial. The aim of the Vienna Summer School on Oncology (VSSO) as an international, integrated, undergraduate oncology course is to teach medical students interdisciplinary team communication and application of treatment concepts/algorithms in a multidisciplinary setting. The teaching is based on an inter- and multidisciplinary faculty and a multimodal education approach to address different learning styles. The participants rated their satisfaction of the program voluntarily after finishing the course according to a grading scale from one (not good) to five (very good). The learning success was assessed by a compulsory pre-VSSO and post-VSSO single choice questionnaire. Program organisation was rated with a mean score of 4.47 out of 5.0 (SD 0.51), composition of the program and range of topics with a mean score of 4.68 (SD 0.58) and all teachers with a mean score of 4.36 (SD 0.40) points. Student evaluation at the beginning and end of the program indicated significant knowledge acquisition -i.e., general aspects of cancer: median 8.75 points (IQR 7.5-9.4) vs.10.0 points (IQR 9.4-10.0) p = 0.005; specific aspects of cancer: median 4.87 points (IQR 3.33-5.71) vs. 8.72 points (IQR 6.78-9.49) p ≤ 0.001, respectively. Even though the participants represent a selection of students with special interest in cancer, the results of the VSSO indicate the benefit of an inter- and multidisciplinary teaching approach within an oncology module.

  20. Experiences and preferences of patients visiting a head and neck oncology outpatient clinic: a qualitative study.

    PubMed

    Bisschop, Jeroen A S; Kloosterman, Fabienne R; van Leijen-Zeelenberg, Janneke E; Huismans, Geert Willem; Kremer, Bernd; Kross, Kenneth W

    2017-05-01

    The objective of this study is to report on an in-depth evaluation of patient experiences and preferences at a Head and Neck Oncology outpatient clinic. A qualitative research design was used to determine the experiences and preferences of Head and Neck Cancer patients in an Oncology Outpatient Clinic, Maastricht University Medical Center, The Netherlands. Head and Neck Cancer Patients, treated for at least 6 months at the Oncology Clinic, were included. A qualitative research design with patient interviews was used. All interviews were recorded and transcribed verbatim to increase validity. Analysis was done with use of the template approach and qualitative data analysis software. Three of the six dimensions predominated in the interview: (1) respect for patients' values, preferences and expressed need, (2) information, communication and education and (3) involvement of family and friends. The dimensions physical comfort; emotional support; coordination and integration of care were considered to be of less significance. The findings from this study resulted in a deeper understanding of patients' experiences and preferences and can be useful in the transition towards a more patient-centered approach of health care.

  1. American Society of Clinical Oncology policy statement: oversight of clinical research.

    PubMed

    2003-06-15

    Well-publicized lapses in the review or implementation of clinical research studies have raised public questions about the integrity of the clinical research process. Public trust in the integrity of research is critical not only for funding and participation in clinical trials but also for confidence in the treatments that result from the trials. The questions raised by these unfortunate cases pose an important opportunity to reassess the clinical trials oversight system to ensure the integrity of clinical research and the safety of those who enroll in clinical trials. Since its inception, the American Society of Clinical Oncology (ASCO) has worked for the advancement of cancer treatments through clinical research and to help patients gain prompt access to scientifically excellent and ethically unimpeachable clinical trials. As an extension of its mission, ASCO is affirming with this policy statement the critical importance of a robust review and oversight system to ensure that clinical trials participants give fully informed consent and that their safety is a top priority. Ensuring the integrity of research cannot be stressed enough because of its seminal connection to the advancement of clinical cancer treatment. The overall goal of this policy is to enhance public trust in the cancer clinical trials process. To achieve this, the following elements are essential: 1. Ensure safety precautions for clinical trial participants and their fully informed consent. 2. Ensure the validity and integrity of scientific research. 3. Enhance the educational training of clinical scientists and research staff to ensure the highest standards of research conduct. 4. Promote accountability and responsibility among all those involved in clinical research (not just those serving on institutional review boards [IRBs], but also institutional officials, researchers, sponsors, and participants) and ensure support for an effective oversight process. 5. Enhance the professional and public

  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.

  3. Using Patient Reported Outcomes in Oncology Clinical Practice.

    PubMed

    Kelleher, Sarah A; Somers, Tamara J; Locklear, Tracie; Crosswell, Alexandra D; Abernethy, Amy P

    2016-10-01

    Patient reported outcomes (PROs) are increasingly being implemented into the care of patients with cancer. The use of a standard set of PROs (e.g., pain) in cancer is becoming established and there is interest in what additional PROs might provide valuable information. The goal of this observational study was to examine how the PROs of self-efficacy for pain and other symptoms assessed at the point of service were associated with pain, symptom severity and distress, and physical and psychosocial functioning in a sample of breast and gastrointestinal patients. We also sought to examine differences in these relationships by cancer type (breast and gastrointestinal) as well as understand differences in self-assessment mode (paper/pencil or electronic tablet). 178 patients with breast (n=65) and gastrointestinal cancer (n = 113) completed the Chronic Pain Self Efficacy Scale, M.D. Anderson Symptom Inventory, and Functional Assessment of Cancer Therapy-General questionnaires. Measures were completed with paper and pencil and electronically using a tablet computer while patients waited for their clinical appointment. Responses from the initial completed questionnaires on both the paper and electronic instruments were analyzed. Patients' self-efficacy scores for pain and other symptoms correlated positively with pain, symptom severity and distress, and physical and psychosocial functioning; patients with lower levels of self-efficacy reported poorer outcomes and functioning overall. The results were independent of cancer type and mode of assessment. No statistically significant differences were found in the PROs when collected by electronic technology versus paper-pencil mode; patients were very satisfied with using the tablet computer to complete the PRO measures. Our results suggest that self-efficacy for pain and symptom management may be a beneficial addition to clinic-based PRO assessment batteries for patients with cancer and other chronic diseases. Existing short

  4. Recent trends for drug lag in clinical development of oncology drugs in Japan: does the oncology drug lag still exist in Japan?

    PubMed

    Maeda, Hideki; Kurokawa, Tatsuo

    2015-12-01

    This study exhaustively and historically investigated the status of drug lag for oncology drugs approved in Japan. We comprehensively investigated oncology drugs approved in Japan between April 2001 and July 2014, using publicly available information. We also examined changes in the status of drug lag between Japan and the United States, as well as factors influencing drug lag. This study included 120 applications for approval of oncology drugs in Japan. The median difference over a 13-year period in the approval date between the United States and Japan was 875 days (29.2 months). This figure peaked in 2002, and showed a tendency to decline gradually each year thereafter. In 2014, the median approval lag was 281 days (9.4 months). Multiple regression analysis identified the following potential factors that reduce drug lag: "Japan's participation in global clinical trials"; "bridging strategies"; "designation of priority review in Japan"; and "molecularly targeted drugs". From 2001 to 2014, molecularly targeted drugs emerged as the predominant oncology drug, and the method of development has changed from full development in Japan or bridging strategy to global simultaneous development by Japan's taking part in global clinical trials. In line with these changes, the drug lag between the United States and Japan has significantly reduced to less than 1 year.

  5. [American Society of Clinical Oncology (ASCO) 2011 essential data: the editorial board of the Bulletin du Cancer point of view].

    PubMed

    Vignot, Stéphane; Bay, Jacques-Olivier; Blay, Jean-Yves; Gonçalves, Anthony; Massard, Christophe; Thariat, Juliette; Wislez, Marie; André, Thierry

    2011-12-01

    Many data are presented each year during the American Society of Clinical Oncology meeting, redrawing the state of knowledge in oncology and hematology. This article proposed by the editorial board of the Bulletin du Cancer proposes to discuss new information with a drop of a few months with the aim of trying to identify the results that can have an immediate or future impact on clinical practice.

  6. Clinical practice audit concerning antimicrobial prophylaxis in paediatric neurosurgery: results from a German paediatric oncology unit.

    PubMed

    Weiss, Katja; Simon, Arne; Graf, Norbert; Schöpe, Jakob; Oertel, Joachim; Linsler, Stefan

    2017-01-01

    Perioperative antimicrobial prophylaxis (PAP) has been identified as an important target for internal audits, concerning the judicious use of antibiotics. Paediatric oncology patients with brain tumours face an increased risk of surgical site infection (SSI) after neurosurgery and receive routine PAP in this setting. All patients younger than 18 years admitted to the paediatric oncology centre (POC) with a neurosurgical intervention. Systematic audit of routine clinical data is divided in two groups: retrospective (Jan 01, 2012-March 31, 2014) and prospective (April 01, 2014-March 31, 2015) referring to an internal PAP guideline, invented in Jan. 2014). Surveillance of SSI up to 30 days after the operation with standard criteria (Centres for Disease Control and Prevention, USA). In total, 53 neurosurgical operations were analysed in 33 paediatric oncology patients. Twelve patients received more than one operation. The detailed analysis of PAP revealed prophylactic cefuroxim doses about 30 mg/kg instead of 50 mg/kg and no repeated dosing in operations lasting longer than 4 h. In addition, Cefotaxim, which is not indicated as PAP in neurosurgery, was used instead of Cefuroxim (or Ampicillin-Sulbactam) in 23 % of all cases in the retrospective and 18 % of all cases in the prospective audit. PAP for more than 3 doses (>24 h) was administered in 66 % in the retrospective group and in 60 % in the prospective group (p = n.s.). In both groups, no SSI was detected. This first comprehensive audit of PAP in paediatric oncology patients undergoing neurosurgery outlines significant opportunities to improve clinical practice in terms of correct dosing, the correct choice of the antibiotic, a correct timing schedule and a shorter duration of PAP. In addition, our results illustrate in detail the challenges in clinical practice when an evidence-based approach to improve a standard workflow has to be implemented.

  7. Assessing the Eventual Publication of Clinical Trial Abstracts Submitted to a Large Annual Oncology Meeting

    PubMed Central

    Wang, Ruibin; Prasad, Vinay; Bates, Susan E.; Fojo, Tito

    2016-01-01

    Background. Despite the ethical imperative to publish clinical trials when human subjects are involved, such data frequently remain unpublished. The objectives were to tabulate the rate and ascertain factors associated with eventual publication of clinical trial results reported as abstracts in the Proceedings of the American Society of Clinical Oncology (American Society of Clinical Oncology). Materials and Methods. Abstracts describing clinical trials for patients with breast, lung, colorectal, ovarian, and prostate cancer from 2009 to 2011 were identified by using a comprehensive online database (http://meetinglibrary.asco.org/abstracts). Abstracts included reported results of a treatment or intervention assessed in a discrete, prospective clinical trial. Publication status at 4−6 years was determined by using a standardized search of PubMed. Primary outcomes were the rate of publication for abstracts of randomized and nonrandomized clinical trials. Secondary outcomes included factors influencing the publication of results. Results. A total of 1,075 abstracts describing 378 randomized and 697 nonrandomized clinical trials were evaluated. Across all years, 75% of randomized and 54% of nonrandomized trials were published, with an overall publication rate of 61%. Sample size was a statistically significant predictor of publication for both randomized and nonrandomized trials (odds ratio [OR] per increase of 100 participants = 1.23 [1.11–1.36], p < .001; and 1.64 [1.15–2.34], p = .006, respectively). Among randomized studies, an industry coauthor or involvement of a cooperative group increased the likelihood of publication (OR 2.37, p = .013; and 2.21, p = .01, respectively). Among nonrandomized studies, phase II trials were more likely to be published than phase I (p < .001). Use of an experimental agent was not a predictor of publication in randomized (OR 0.76 [0.38–1.52]; p = .441) or nonrandomized trials (OR 0.89 [0.61–1.29]; p = .532). Conclusion

  8. Clinically Meaningful Use of Blood Tumor Markers in Oncology

    PubMed Central

    Pagliaro, Lance

    2016-01-01

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

  9. A clinical oncologic perspective on breast magnetic resonance imaging.

    PubMed

    Bloom, Sara; Morrow, Monica

    2010-05-01

    Magnetic resonance (MR) imaging identifies cancer not found by clinical examination or other breast imaging studies, but its effect on patient outcomes is controversial. To date, its use has not been shown to increase the likelihood of obtaining negative surgical margins, decrease the rate of conversion from lumpectomy to mastectomy, or decrease local recurrence. The rate of tumor identification with MR imaging is 2 to 3 times higher than the incidence of local recurrence, resulting in mastectomies that may not be beneficial to the patient. This is also a concern with the use of MR imaging for contralateral cancer detection. The use of MR imaging for early detection of local recurrence does not take into account what is known about the biology of local recurrence because a short interval to local recurrence is associated with poor prognosis. In problem areas, such as evaluation of response to neoadjuvant therapy and detection of cancer presenting as axillary adenopathy, MR imaging provides information that is useful for clinical management. Copyright 2010 Elsevier Inc. All rights reserved.

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

    PubMed

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

    2016-07-01

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

  11. Community dental clinics: providers' perspectives.

    PubMed

    Wallace, Bruce B; MacEntee, Michael I; Harrison, Rosamund; Hole, Rachelle; Mitton, Craig

    2013-06-01

    Not-for-profit community dental clinics attempt to address the inequities of oral health care for disadvantaged communities, but there is little information about how they operate. The objective of this article is to explain from the perspective of senior staff how five community dental clinics in British Columbia, Canada, provide services. The mixed-methods case study included the five not-for-profit dental clinics with full-time staff who provided a wide range of dental services. We conducted open-ended interviews to saturation with eight senior administrative staff selected purposefully because of their comprehensive knowledge of the development and operation of the clinics and supplemented their information with a year's aggregated data on patients, treatments, and operating costs. The interview participants described the benefits of integrating dentistry with other health and social services usually within community health centres, although they doubted the sustainability of the clinics without reliable financial support from public funds. Aggregated data showed that 75% of the patients had either publically funded or no coverage for dental services, while the others had employer-sponsored dental insurance. Financial subsidies from regional health authorities allowed two of the clinics to treat only patients who are economically vulnerable and provide all services at reduced costs. Clinics without government subsidies used the fees paid by some patients to subsidize treatment for others who could not afford treatment. Not-for-profit dental clinics provide dental services beyond pain relief for underserved communities. Dental services are integrated with other health and community services and located in accessible locations. However, all of the participants expressed concerns about the sustainability of the clinics without reliable public revenues. © 2012 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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

    PubMed

    Andrew, Peter; Vickers, Michael M; O'Connor, Stephen; Valdes, Mario; Tang, Patricia A

    2016-03-01

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

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

    PubMed Central

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

    2013-01-01

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

  14. 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

  15. 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

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

    PubMed

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

    2014-12-01

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

  17. A combined PET/CT scanner for clinical oncology.

    PubMed

    Beyer, T; Townsend, D W; Brun, T; Kinahan, P E; Charron, M; Roddy, R; Jerin, J; Young, J; Byars, L; Nutt, R

    2000-08-01

    The availability of accurately aligned, whole-body anatomical (CT) and functional (PET) images could have a significant impact on diagnosing and staging malignant disease and on identifying and localizing metastases. Computer algorithms to align CT and PET images acquired on different scanners are generally successful for the brain, whereas image alignment in other regions of the body is more problematic. A combined PET/CT tomograph with the unique capability of acquiring accurately aligned functional and anatomical images for any part of the human body has been designed and built. The PET/CT scanner was developed as a combination of a Siemens Somatom AR.SP spiral CT and a partial-ring, rotating ECAT ART PET scanner. All components are mounted on a common rotational support within a single gantry. The PET and CT components can be operated either separately, or in combined mode. In combined mode, the CT images are used to correct the PET data for scatter and attenuation. Fully quantitative whole-body images are obtained for an axial extent of 100 cm in an imaging time of less than 1 h. When operated in PET mode alone, transmission scans are acquired with dual 137Cs sources. The scanner is fully operational and the combined device has been operated successfully in a clinical environment. Over 110 patients have been imaged, covering a range of different cancers, including lung, esophageal, head and neck, melanoma, lymphoma, pancreas, and renal cell. The aligned PET and CT images are used both for diagnosing and staging disease and for evaluating response to therapy. We report the first performance measurements from the scanner and present some illustrative clinical studies acquired in cancer patients. A combined PET and CT scanner is a practical and effective approach to acquiring co-registered anatomical and functional images in a single scanning session.

  18. Neoadjuvant chemotherapy for newly diagnosed, advanced ovarian cancer: Society of Gynecologic Oncology and American Society of Clinical Oncology Clinical Practice Guideline.

    PubMed

    Wright, Alexi A; Bohlke, Kari; Armstrong, Deborah K; Bookman, Michael A; Cliby, William A; Coleman, Robert L; Dizon, Don S; Kash, Joseph J; Meyer, Larissa A; Moore, Kathleen N; Olawaiye, Alexander B; Oldham, Jessica; Salani, Ritu; Sparacio, Dee; Tew, William P; Vergote, Ignace; Edelson, Mitchell I

    2016-10-01

    To provide guidance to clinicians regarding the use of neoadjuvant chemotherapy and interval cytoreduction among women with stage IIIC or IV epithelial ovarian cancer. The Society of Gynecologic Oncology and the American Society of Clinical Oncology convened an Expert Panel and conducted a systematic review of the literature. Four phase III clinical trials form the primary evidence base for the recommendations. The published studies suggest that for selected women with stage IIIC or IV epithelial ovarian cancer, neoadjuvant chemotherapy and interval cytoreduction are non-inferior to primary cytoreduction and adjuvant chemotherapy with respect to overall and progression-free survival and are associated with less perioperative morbidity and mortality. All women with suspected stage IIIC or IV invasive epithelial ovarian cancer should be evaluated by a gynecologic oncologist prior to initiation of therapy. The primary clinical evaluation should include a CT of the abdomen and pelvis, and chest imaging (CT preferred). Women with a high perioperative risk profile or a low likelihood of achieving cytoreduction to <1cm of residual disease (ideally to no visible disease) should receive neoadjuvant chemotherapy. Women who are fit for primary cytoreductive surgery, and with potentially resectable disease, may receive either neoadjuvant chemotherapy or primary cytoreductive surgery. However, primary cytoreductive surgery is preferred if there is a high likelihood of achieving cytoreduction to <1cm (ideally to no visible disease) with acceptable morbidity. Before neoadjuvant chemotherapy is delivered, all patients should have confirmation of an invasive ovarian, fallopian tube, or peritoneal cancer. Additional information is available at www.asco.org/NACT-ovarian-guideline and www.asco.org/guidelineswiki. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

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

    PubMed

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

    2015-06-01

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

  20. 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

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

    PubMed

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

    2016-06-01

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

  2. American Society of Clinical Oncology position statement on obesity and cancer.

    PubMed

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

    2014-11-01

    Rates of obesity have increased significantly over the last three decades in the United States and globally. In addition to contributing to heart disease and diabetes, obesity is a major unrecognized risk factor for cancer. Obesity is associated with worsened prognosis after cancer diagnosis and also negatively affects the delivery of systemic therapy, contributes to morbidity of cancer treatment, and may raise the risk of second malignancies and comorbidities. Research shows that the time after a cancer diagnosis can serve as a teachable moment to motivate individuals to adopt risk-reducing behaviors. For this reason, the oncology care team--the providers with whom a patient has the closest relationships in the critical period after a cancer diagnosis--is in a unique position to help patients lose weight and make other healthy lifestyle changes. The American Society of Clinical Oncology is committed to reducing the impact of obesity on cancer and has established a multipronged initiative to accomplish this goal by 1) increasing education and awareness of the evidence linking obesity and cancer; 2) providing tools and resources to help oncology providers address obesity with their patients; 3) building and fostering a robust research agenda to better understand the pathophysiology of energy balance alterations, evaluate the impact of behavior change on cancer outcomes, and determine the best methods to help cancer survivors make effective and useful changes in lifestyle behaviors; and 4) advocating for policy and systems change to address societal factors contributing to obesity and improve access to weight management services for patients with cancer. © 2014 by American Society of Clinical Oncology.

  3. [Approval procedures for clinical trials in the field of radiation oncology].

    PubMed

    Simon, Monique; Habeck, Matthias; Büttner, Daniel; Habeck, Uta; Nölling, Torsten; Krause, Mechthild; Brix, Gunnar; Willich, Normann; Wenz, Frederik; Schmidberger, Heinz; Debus, Jürgen; Baumann, Michael

    2015-12-01

    Application of ionizing radiation for the purpose of medical research in Germany needs to be approved by the national authority for radiation protection (Bundesamt für Strahlenschutz, BfS). For studies in the field of radiation oncology, differentiation between use of radiation for "medical care (Heilkunde)" versus "medical research" frequently leads to contradictions. The aim of this article is to provide principle investigators, individuals, and institutions involved in the process, as well as institutional review or ethics committees, with the necessary information for this assessment. Information on the legal frame and the approval procedures are also provided. A workshop was co-organized by the German Society for Radiation Oncology (DEGRO), the Working Party for Radiation Oncology (ARO) of the German Cancer Society (DKG), the German Society for Medical Physics (DGMP), and the German Cancer Consortium (DKTK) in October 2013. This paper summarizes the results of the workshop and the follow-up discussions between the organizers and the BfS. Differentiating between "Heilkunde" which does not need to be approved by the BfS and "medical research" is whether the specific application of radiation (beam quality, dose, schedule, target volume, etc.) is a clinically established and recognized procedure. This must be answered by the qualified physician(s) ("fachkundiger Arzt" according to German radiation protection law) in charge of the study and the treatments of the patients within the study, taking into consideration of the best available evidence from clinical studies, guidelines and consensus papers. Among the important parameters for assessment are indication, total dose, and fractionation. Radiation treatments applied outside clinical trials do not require approval by the BfS, even if they are applied within a randomized or nonrandomized clinical trial. The decision-making by the "fachkundigem Arzt" may be supported on request by an opinion given by the DEGRO

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

    PubMed

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

    2007-07-01

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

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

    PubMed

    Manne, S; Kashy, D; Albrecht, T; Wong, Y-N; Lederman Flamm, A; 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. © 2014 John Wiley & Sons Ltd.

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

    PubMed Central

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

    2015-01-01

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

  7. [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.

  8. 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.

  9. 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.

  10. Developing emotional intelligence ability in oncology nurses: a clinical rounds approach.

    PubMed

    Codier, Estelle; Freitas, Beth; Muneno, Lynn

    2013-01-01

    To explore the feasibility and impact of an emotional intelligence ability development program on staff and patient care. A mixed method, pre/post-test design. A tertiary care hospital in urban Honolulu, HI. Rounds took place on a 24-bed inpatient oncology unit. 33 RNs in an oncology unit. After collection of baseline data, the emotional intelligence rounds were conducted in an inpatient oncology nursing unit on all shifts during a 10-month period. Demographic information, emotional intelligence scores, data from rounds, chart reviews of emotional care documentation, and unit-wide satisfaction and safety data. The ability to identify emotions in self and others was demonstrated less frequently than expected in this population. The low test response rate prevented comparison of scores pre- and postintervention. The staff's 94% participation in rounds, the positive (100%) evaluation of rounds, and poststudy improvements in emotional care documentation and emotional care planning suggest a positive effect from the intervention. Additional research is recommended over a longer period of time to evaluate the impact emotional intelligence specifically has on the staff's identification of emotions. Because the intervention involved minimal time and resources, feasibility for continuation of the intervention poststudy was rated "high" by the research team. Research in other disciplines suggests that improvement in emotional intelligence ability in clinical staff nurses may improve retention, performance, and teamwork in nursing, which would be of particular significance in high-risk clinical practice environments. Few research studies have explored development of emotional intelligence abilities in clinical staff nurses. Evidence from this study suggests that interventions in the clinical environment may be used to develop emotional intelligence ability. Impact from such development may be used in the future to not only improve the quality of nursing care, but also

  11. 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

  12. A qualitative study evaluating causality attribution for serious adverse events during early phase oncology clinical trials.

    PubMed

    Mukherjee, Som D; Coombes, Megan E; Levine, Mitch; Cosby, Jarold; Kowaleski, Brenda; Arnold, Andrew

    2011-10-01

    In early phase oncology trials, novel targeted therapies are increasingly being tested in combination with traditional agents creating greater potential for enhanced and new toxicities. When a patient experiences a serious adverse event (SAE), investigators must determine whether the event is attributable to the investigational drug or not. This study seeks to understand the clinical reasoning, tools used and challenges faced by the researchers who assign causality to SAE's. Thirty-two semi-structured interviews were conducted with medical oncologists and trial coordinators at six Canadian academic cancer centres. Interviews were recorded and transcribed verbatim. Individual interview content analysis was followed by thematic analysis across the interview set. Our study found that causality assessment tends to be a rather complex process, often without complete clinical and investigational data at hand. Researchers described using a common processing strategy whereby they gather pertinent information, eliminate alternative explanations, and consider whether or not the study drug resulted in the SAE. Many of the interviewed participants voiced concern that causality assessments are often conducted quickly and tend to be highly subjective. Many participants were unable to identify any useful tools to help in assigning causality and welcomed more objectivity in the overall process. Attributing causality to SAE's is a complex process. Clinical trial researchers apply a logical system of reasoning, but feel that the current method of assigning causality could be improved. Based on these findings, future research involving the development of a new causality assessment tool specifically for use in early phase oncology clinical trials may be useful.

  13. Implementation of electronic checklists in an oncology medical record: initial clinical experience.

    PubMed

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

    2011-07-01

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

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

    PubMed Central

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

    2011-01-01

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

  15. Hot topics and landmark studies from the 43rd annual meeting of the American Society of Clinical Oncology.

    PubMed

    Puglisi, Fabio; Aprile, Giuseppe; Fasola, Gianpiero

    2008-02-01

    The results of several preclinical and clinical studies were reported by oncology professionals at the 43rd American Society of Clinical Oncology (ASCO) meeting, the largest international forum in which the latest achievements in cancer research are annually presented. The central theme this year was 'Translating Research into Practice', emphasizing the goal of forging stronger links between basic research and clinical practice. This review offers a critical, summarized selection of several of the foremost studies presented at the meeting. The focus is on the findings from randomized phase III trials that, in the authors' opinion, are most likely to have an immediate effect on clinical practice.

  16. Relationships Between Authorship Contributions and Authors' Industry Financial Ties Among Oncology Clinical Trials

    PubMed Central

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

    2010-01-01

    Purpose To test the hypothesis that authors who play key scientific roles in oncology clinical trials, and who therefore have increased influence over the design, analysis, interpretation or reporting of trials, are more likely than those who do not play such roles to have financial ties to industry. Methods Data were abstracted from all trials (n = 235) of drugs or biologic agents published in the Journal of Clinical Oncology between January 1, 2006 and June 30, 2007. Article-level data included sponsorship, age group (adult v pediatric), phase, single versus multicenter, country (United States v other), and number of authors. Author-level data (n = 2,927) included financial ties (eg, employment, consulting) and performance of key scientific roles (ie, conception/design, analysis/interpretation, or manuscript writing). Associations between performance of key roles and financial ties, adjusting for article-level covariates, were examined using generalized linear mixed models. Results One thousand eight hundred eighty-one authors (64%) reported performing at least one key role, and 842 authors (29%) reported at least one financial tie. Authors who reported performing a key role were more likely than other authors to report financial ties to industry (adjusted odds ratio [OR], 4.3; 99% CI, 3.0 to 6.0; P < .0001). The association was stronger among trials with, compared with those without, industry funding (OR, 5.0 [99% CI, 3.4 to 7.5] v OR, 2.5 [99% CI, 1.3 to 4.8]), but was present regardless of sponsorship. Conclusion Authors who perform key roles in the conception and design, analysis, and interpretation, or reporting of oncology clinical trials are more likely than authors who do not perform such roles to have financial ties to industry. PMID:20065190

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

    PubMed

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

    2010-03-10

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

  18. Gastric Cancer, Version 3.2016, NCCN Clinical Practice Guidelines in Oncology.

    PubMed

    Ajani, Jaffer A; D'Amico, Thomas A; Almhanna, Khaldoun; Bentrem, David J; Chao, Joseph; Das, Prajnan; Denlinger, Crystal S; Fanta, Paul; Farjah, Farhood; Fuchs, Charles S; Gerdes, Hans; Gibson, Michael; Glasgow, Robert E; Hayman, James A; Hochwald, Steven; Hofstetter, Wayne L; Ilson, David H; Jaroszewski, Dawn; Johung, Kimberly L; Keswani, Rajesh N; Kleinberg, Lawrence R; Korn, W Michael; Leong, Stephen; Linn, Catherine; Lockhart, A Craig; Ly, Quan P; Mulcahy, Mary F; Orringer, Mark B; Perry, Kyle A; Poultsides, George A; Scott, Walter J; Strong, Vivian E; Washington, Mary Kay; Weksler, Benny; Willett, Christopher G; Wright, Cameron D; Zelman, Debra; McMillian, Nicole; Sundar, Hema

    2016-10-01

    Gastric cancer is the fifth most frequently diagnosed cancer and the third leading cause of death from cancer in the world. Several advances have been made in the staging procedures, imaging techniques, and treatment approaches. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Gastric Cancer provide an evidence- and consensus-based treatment approach for the management of patients with gastric cancer. This manuscript discusses the recommendations outlined in the NCCN Guidelines for staging, assessment of HER2 overexpression, systemic therapy for locally advanced or metastatic disease, and best supportive care for the prevention and management of symptoms due to advanced disease. Copyright © 2016 by the National Comprehensive Cancer Network.

  19. 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

  20. Robotic surgery for rectal cancer: Current immediate clinical and oncological outcomes

    PubMed Central

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

    2014-01-01

    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

  1. Generating and evaluating evidence of the clinical utility of molecular diagnostic tests in oncology.

    PubMed

    Deverka, Patricia; Messner, Donna A; McCormack, Robert; Lyman, Gary H; Piper, Margaret; Bradley, Linda; Parkinson, David; Nelson, David; Smith, Mary Lou; Jacques, Louis; Dutta, Tania; Tunis, Sean R

    2016-08-01

    Enthusiasm for molecular diagnostic (MDx) testing in oncology is constrained by the gaps in required evidence regarding its impact on patient outcomes (clinical utility (CU)). This effectiveness guidance document proposes recommendations for the design and evaluation of studies intended to reflect the evidence expectations of payers, while also reflecting information needs of patients and clinicians. Our process included literature reviews and key informant interviews followed by iterative virtual and in-person consultation with an expert technical working group and an advisory group comprising life-sciences industry experts, public and private payers, patients, clinicians, regulators, researchers, and other stakeholders. Treatment decisions in oncology represent high-risk clinical decision making, and therefore the recommendations give preference to randomized controlled trials (RCTs) for demonstrating CU. The guidance also describes circumstances under which alternatives to RCTs could be considered, specifying conditions under which test developers could use prospective-retrospective studies with banked biospecimens, single-arm studies, prospective observational studies, or decision-analytic modeling techniques that make a reasonable case for CU. Using a process driven by multiple stakeholders, we developed a common framework for designing and evaluating studies of the clinical validity and CU of MDx tests, achieving a balance between internal validity of the studies and the relevance, feasibility, and timeliness of generating the desired evidence.Genet Med 18 8, 780-787.

  2. Lack of timely accrual information in oncology clinical trials: a cross-sectional analysis.

    PubMed

    Mitchell, Aaron P; Hirsch, Bradford R; Abernethy, Amy P

    2014-03-25

    Poor accrual is a significant barrier to the successful completion of oncology clinical trials; half of all phase 3 oncology trials close due to insufficient accrual. Timely access to accrual data fosters an understanding of successful trial design and can be used to inform the design of new clinical trials prospectively. Accrual statistics are available within research networks, such as the cancer cooperative groups, but comprehensive data reflecting the overall portfolio of cancer clinical trials are lacking. As a demonstration case, the purpose of this study was to quantify the public availability of accrual data across all recent renal cell carcinoma (RCC) trials. The database for the Aggregate Analysis of ClinicalTrials.gov (AACT) summarizes all trials registered between October 2007 and September 2010. In total, 108 trials of pharmacologic therapy for RCC were included. Accrual data on these trials were gathered via ClinicalTrials.gov (CTG), a manual review of resulting publications, and online surveys sent to principle investigators or trial coordinators. In total, 26% (20 of 76) of trials listing a government, academic, or cooperative group (GAC) sponsor responded to the survey vs 0% (0 of 32) of those listing only industry sponsors. Across all methods, accrual data were available for only 40% (43 of 108) of trials, including 37% (28 of 76) of GAC trials and 47% (15 of 32) of industry trials. Moreover, 87% (66 of 76) of GAC trials were ongoing (open, actively recruiting, or of unknown status) vs 75% (24 of 32) of industry trials, while 9% (10 of 108) of trials were terminated or suspended. Despite extensive efforts (surveys, phone calls, CTG abstraction, publication searches), accurate accrual data remained inaccessible for 60% of the RCC trial cohort. While CTG reports trial results, ongoing accrual data are also critically needed. Poor access to accrual data will continue to limit attempts to develop a national summary of clinical trials metrics and to

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

    PubMed

    Venkatakrishnan, K; Ecsedy, J A

    2017-01-01

    Clinical pharmacodynamic evaluation is a key component of the "pharmacologic audit trail" in oncology drug development. We posit that its value can and should be greatly enhanced via application of a robust quantitative pharmacology framework informed by biologically mechanistic considerations. Herein, we illustrate examples of intersectional blindspots across the disciplines of quantitative pharmacology and translational science and offer a roadmap aimed at enhancing the caliber of clinical pharmacodynamic research in the development of oncology therapeutics. © 2016 American Society for Clinical Pharmacology and Therapeutics.

  4. 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.

  5. 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.

  6. Effect and Efficiency of an Embedded Palliative Care Nurse Practitioner in an Oncology Clinic.

    PubMed

    Walling, Anne M; D'Ambruoso, Sarah F; Malin, Jennifer L; Hurvitz, Sara; Zisser, Ann; Coscarelli, Anne; Clarke, Robin; Hackbarth, Andrew; Pietras, Christopher; Watts, Frances; Ferrell, Bruce; Skootsky, Samuel; Wenger, Neil S

    2017-09-01

    To test a simultaneous care model for palliative care for patients with advanced cancer by embedding a palliative care nurse practitioner (NP) in an oncology clinic. We evaluated the effect of the intervention in two oncologists' clinics beginning March 2014 by using implementation strategies, including use of a structured referral mechanism, routine symptom screening, integration of a psychology-based cancer supportive care center, implementation team meetings, team training, and a metrics dashboard for continuous quality improvement. After 1 year of implementation, we evaluated key process and outcome measures for supportive oncology and efficiency of the model by documenting tasks completed by the NP during a subset of patient visits and time-motion studies. Of approximately 10,000 patients with active cancer treated in the health system, 2,829 patients had advanced cancer and were treated by 42 oncologists. Documentation of advance care planning increased for patients of the two intervention oncologists compared with patients of the other oncologists. Hospice referral before death was not different at baseline, but was significantly higher for patients of intervention oncologists compared with patients of control oncologists (53% v 23%; P = .02) over the intervention period. Efficiency evaluation revealed that approximately half the time spent by the embedded NP potentially could have been completed by other staff (eg, a nurse, a social worker, or administrative staff). An embedded palliative care NP model using scalable implementation strategies can improve advance care planning and hospice use among patients with advanced cancer.

  7. Quality management for clinical trials within the German Competence Network Paediatric Oncology and Haematology.

    PubMed

    Creutzig, Ursula; Zimmermann, Martin; Hannemann, Julia; Krämer, Irene; Pfistner, Beate; Herold, Ralf; Henze, Günter

    2005-06-01

    The German 'Competence Network Paediatric Oncology and Haematology' aims at improving the structure of paediatric oncology and haematology as a whole, focussing in particular on the quality of clinical trials and study co-ordinating centres. This comprises the following measures: (1) Employment of research and trial assistants in order to improve the quality of documentation and study management in the participating hospitals. (2) Development of an internet portal to provide medical information for non-professionals, for patients and their families as well as for health professionals. (3) The project group 'Central Trial Support' supports study centres during the process of writing and examining new treatment protocols so that they are in compliance with the Good Clinical Practice criteria, formal criteria, legal requirements and statutory provisions. This group currently produces a structural standardisation of study protocols and case record forms in order to improve their usability. The 'Competence Network Malignant Lymphomas' is a project with similar aims and will be outlined for comparison.

  8. 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. © 2014 by American Society of Clinical Oncology.

  9. Revisions to the 2009 American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards: expanding the scope to include inpatient settings.

    PubMed

    Jacobson, Joseph O; Polovich, Martha; Gilmore, Terry R; Schulmeister, Lisa; Esper, Peg; Lefebvre, Kristine B; Neuss, Michael N

    2012-01-01

    In November 2009, the American Society of Clinical Oncology (ASCO) and the Oncology Nursing Society (ONS) jointly published a set of 31 voluntary chemotherapy safety standards for adult patients with cancer, as the end result of a highly structured, multistakeholder process. The standards were explicitly created to address patient safety in the administration of parenteral and oral chemotherapeutic agents in outpatient oncology settings. In January 2011, a workgroup consisting of ASCO and ONS members was convened to review feedback received since publication of the standards, to address interim changes in practice, and to modify the standards as needed. The most significant change to the standards is to extend their scope to the inpatient setting. This change reflects the conviction that the same standards for chemotherapy administration safety should apply in all settings. The proposed set of standards has been approved by the Board of Directors for both ASCO and ONS and has been posted for public comment. Comments were used as the basis for final editing of the revised standards. The workgroup recognizes that the safety of oral chemotherapy usage, nononcology medication reconciliation, and home chemotherapy administration are not adequately addressed in the original or revised standards. A separate process, cosponsored by ASCO and ONS, will address the development of safety standards for these areas.

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

    Horak, Peter; Fröhling, Stefan; Glimm, Hanno

    2016-01-01

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

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

    PubMed

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

    2016-06-01

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

  13. 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.

  14. Presentation and subsequent publication rates of phase I oncology clinical trials.

    PubMed

    Camacho, Luis H; Bacik, Jennifer; Cheung, Alexander; Spriggs, David R

    2005-10-01

    Many trials submitted to scientific meetings are not reported in peer-reviewed journals. Results may vary substantially and the lack of final publication constitutes a form of reporting bias. The authors sought to determine the presentation and publication rates of Phase I trials submitted to a major oncology meeting and the factors impeding their subsequent publication. The authors identified all Phase I studies submitted to the annual meeting of the American Society of Clinical Oncology in 1997, categorizing them as novel (agents not approved by the Food and Drug Administration at the time of submission) or nonnovel (at least one agent approved), and as industry sponsored or not. MEDLINE searches and an E-mailed questionnaire confirmed publication in peer-reviewed literature and the reasons for nonpublication. Approximately 54% of the 275 Phase I studies were selected for presentation. Abstracts reporting novel agents were more likely selected for presentation than those reporting nonnovel compounds (68% vs. 38%; P < 0.0001). Seventy-two percent of the presented abstracts were subsequently published, compared with 62% of those not presented (P = 0.08). The overall publication rate was 67% at 7.5 years. Presentation status was associated with time to publication (P = 0.01), with abstracts chosen for presentation being published sooner. The median time from presentation to publication was found to be 3.4 years. Lack of time and author relocation were the major obstacles to publication. The underreporting of final results of Phase I oncology trials remains a serious problem. In the future, investigators must commit to the publication of final results in a timely manner. Journals should provide mechanisms for rapid reporting of Phase I trials.

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

    PubMed Central

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

    2014-01-01

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

  16. The Childhood Solid Tumor Network: A new resource for the developmental biology and oncology research communities.

    PubMed

    Stewart, Elizabeth; Federico, Sara; Karlstrom, Asa; Shelat, Anang; Sablauer, Andras; Pappo, Alberto; Dyer, Michael A

    2016-03-15

    Significant advances have been made over the past 25 years in our understanding of the most common adult solid tumors such as breast, colon, lung and prostate cancer. Much less is known about childhood solid tumors because they are rare and because they originate in developing organs during fetal development, childhood and adolescence. It can be very difficult to study the cellular origins of pediatric solid tumors in developing organs characterized by rapid proliferative expansion, growth factor signaling, developmental angiogenesis, programmed cell death, tissue reorganization and cell migration. Not only has the etiology of pediatric cancer remained elusive because of their developmental origins, but it also makes it more difficult to treat. Molecular targeted therapeutics that alter developmental pathway signaling may have devastating effects on normal organ development. Therefore, basic research focused on the mechanisms of development provides an essential foundation for pediatric solid tumor translational research. In this article, we describe new resources available for the developmental biology and oncology research communities. In a companion paper, we present the detailed characterization of an orthotopic xenograft of a pediatric solid tumor derived from sympathoadrenal lineage during development.

  17. Characterizing distress, the 6th vital sign, in an oncology pain clinic

    PubMed Central

    Waller, A.; Groff, S.L.; Hagen, N.; Bultz, B.D.; Carlson, L.E.

    2012-01-01

    Context The delineation of populations of cancer patients with complex symptoms can inform the planning and delivery of supportive care services. Objectives We explored the physical, psychosocial, and practical concerns experienced by patients attending an ambulatory oncology symptom control clinic. Methods Patients attending a Pain Clinic at a large tertiary cancer centre were invited to complete screening measures assessing distress, pain, fatigue, anxiety, depression, and practical and psychosocial problems. A matched sample of patients who did not attend the Pain Clinic were selected as a comparison group. Results Of all eligible Pain Clinic patients, 46 (77%) completed the measures; so did 46 comparison group patients. The percentages of patients reporting distress (78.3%), pain (93.5%), and fatigue (93.5%) were higher among Pain Clinic patients than among the comparison patients. A higher percentage of Pain Clinic patients also reported multiple, severe, concurrent symptoms: 87% scored 7 or higher in at least one of the pain, fatigue, or distress scales, and 30.4% of the patients scored 7 or higher on all three. The most common problem areas were feeling a burden to others, trouble talking with friends and family, spirituality, and sleep difficulties. Conclusions Higher levels of multiple, concurrent symptoms and psychosocial problems were found in Pain Clinic patients than in a group of patients who did not attend the Pain Clinic. Routine screening and triaging of cancer patients using a comprehensive and standardized panel of questions can facilitate symptom assessment and management, and can inform program planning. PMID:22514497

  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. Outbreak of Tsukamurella species bloodstream infection among patients at an oncology clinic, West Virginia, 2011-2012.

    PubMed

    See, Isaac; Nguyen, Duc B; Chatterjee, Somu; Shwe, Thein; Scott, Melissa; Ibrahim, Sherif; Moulton-Meissner, Heather; McNulty, Steven; Noble-Wang, Judith; Price, Cindy; Schramm, Kim; Bixler, Danae; Guh, Alice Y

    2014-03-01

    To determine the source and identify control measures of an outbreak of Tsukamurella species bloodstream infections at an outpatient oncology facility. Epidemiologic investigation of the outbreak with a case-control study. A case was an infection in which Tsukamurella species was isolated from a blood or catheter tip culture during the period January 2011 through June 2012 from a patient of the oncology clinic. Laboratory records of area hospitals and patient charts were reviewed. A case-control study was conducted among clinic patients to identify risk factors for Tsukamurella species bloodstream infection. Clinic staff were interviewed, and infection control practices were assessed. Fifteen cases of Tsukamurella (Tsukamurella pulmonis or Tsukamurella tyrosinosolvens) bloodstream infection were identified, all in patients with underlying malignancy and indwelling central lines. The median age of case patients was 68 years; 47% were male. The only significant risk factor for infection was receipt of saline flush from the clinic during the period September-October 2011 (P = .03), when the clinic had been preparing saline flush from a common-source bag of saline. Other infection control deficiencies that were identified at the clinic included suboptimal procedures for central line access and preparation of chemotherapy. Although multiple infection control lapses were identified, the outbreak was likely caused by improper preparation of saline flush syringes by the clinic. The outbreak demonstrates that bloodstream infections among oncology patients can result from improper infection control practices and highlights the critical need for increased attention to and oversight of infection control in outpatient oncology settings.

  20. The geography of clinical cancer research: analysis of abstracts presented at the American Society of Clinical Oncology Annual Meetings.

    PubMed

    Saad, E D; Mangabeira, A; Masson, A L; Prisco, F E

    2010-03-01

    The American Society of Clinical Oncology Annual Meeting is the largest forum for presentation of clinical research in oncology. We quantified the contribution of countries and assessed correlates of their presence at such meetings. After stratifying abstracts according to category of presentation (oral, poster, and 'publication only'), we took a random sample of 10% of the studies presented at years 2001-2003 and 2006-2008. We assigned abstract nationality using the affiliation of authors. For multinational studies, we developed an algorithm to assign nationality. Of the 22 045 eligible abstracts, 2206 were analyzed and represented 71 countries: 905 (41%) abstracts were from a single institution, 969 (44%) were multicenter, uninational studies, and 332 (15%) were multinational studies. United States nationality was assigned to 49% of all abstracts and the next 14 countries with a higher number of studies accounted for 41%. There was a statistically significant temporal trend in the proportion of multinational studies. Also, multinational studies and abstracts with United States nationality were more frequently presented in oral and poster fashion and had more frequent involvement of the pharmaceutical industry. This study provides a geographic overview of clinical cancer research and indicates that multinational collaboration is increasing.

  1. Pharmacogenomic biomarkers as inclusion criteria in clinical trials of oncology-targeted drugs: a mapping of ClinicalTrials.gov.

    PubMed

    Vivot, Alexandre; Li, Jacques; Zeitoun, Jean-David; Mourah, Samia; Crequit, Perrine; Ravaud, Philippe; Porcher, Raphaël

    2016-08-01

    The aim of this study was to describe pharmacogenomics-based inclusion criteria (enrichment) and the main characteristics of clinical trials involving oncology-targeted therapies. Clinical trials of oncology-targeted therapies approved after 2005 with pharmacogenomic testing required or recommended in their label were retrieved from a mapping of the ClinicalTrials.gov database. We examined information for 12 drugs and 858 trials. Overall, 434 trials (51%) were enriched on the biomarker first mentioned in the label and 145 (17%) were enriched on another biomarker, whereas 270 trials (31%) included all patients. The median proportion of trials corresponding to both the drug's indication and drug's target was 35%. Of the 361 trials that tested drugs in another disease than the first one in the label, 219 (61%) were without enrichment and 87 (24%) were actually enriched but on another biomarker than the first one in the label. Several drugs have been tested in trials enriched on many different biomarkers. Nonetheless, most targeted therapies have been developed only using biomarker-positive patients; therefore, exclusion of biomarker-negative patients from treatment relies on only preclinical data and on biological understanding of the disease and target.Genet Med 18 8, 796-805.

  2. Hidden outpatient oncology clinical nursing minimum data set: findings from an Italian multi-method study.

    PubMed

    Palese, Alvisa; Zanini, Antonietta; Carlevaris, Erika; Morandin, Annalisa; Carpanelli, Ivana; Dante, Angelo

    2013-08-01

    The main aim of this study was to present the hidden Clinical Nursing Minimum Data Set adopted by Italian nurses in outpatient oncology settings. A multi-method study design articulated in three phases was conducted from November 2009 to December 2010. A cross-sectional study design involving outpatient oncology centres located in the 20 Italian regions was undertaken in order to collect structured nursing records used by nurses in the documentation of daily nursing care. An evaluation of the items contained in each nursing record was performed in order to individuate homogeneities. A content analysis of the items was therefore undertaken in order to categorise them in assessment, problems, intervention, and outcomes. A total of 1080 different items from the structured nursing records were counted, comprising on average 29 items (range 8-175; ±40.4) for each record. A total of 330 (30.6%) out of 1080 were categorised as assessment items, 146 (13.5%) as problems, 583 (54.0%) as interventions and 21 (1.9%) as outcomes items. Italian nurses have developed a micro-system Clinical Nursing Minimum Data Set capturing and documenting several types of clinical data, following their implicit representation of what it is important to document: much consideration is given to nursing surveillance/monitoring and to at-risk problems, indicating the importance of the nursing role in the prevention and early recognition of a patient's clinical deterioration. However, there is a need to develop a macro-system national NMDS which will be useful for evaluating nursing outcomes and making decisions on workforce resources. Copyright © 2012 Elsevier Ltd. All rights reserved.

  3. [Galen's oncology].

    PubMed

    Vigliani, R

    1995-10-01

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

  4. Patient-Clinician Communication: American Society of Clinical Oncology Consensus Guideline.

    PubMed

    Gilligan, Timothy; Coyle, Nessa; Frankel, Richard M; Berry, Donna L; Bohlke, Kari; Epstein, Ronald M; Finlay, Esme; Jackson, Vicki A; Lathan, Christopher S; Loprinzi, Charles L; Nguyen, Lynne H; Seigel, Carole; Baile, Walter F

    2017-09-11

    Purpose To provide guidance to oncology clinicians on how to use effective communication to optimize the patient-clinician relationship, patient and clinician well-being, and family well-being. Methods ASCO convened a multidisciplinary panel of medical oncology, psychiatry, nursing, hospice and palliative medicine, communication skills, health disparities, and advocacy experts to produce recommendations. Guideline development involved a systematic review of the literature and a formal consensus process. The systematic review focused on guidelines, systematic reviews and meta-analyses, and randomized controlled trials published from 2006 through October 1, 2016. Results The systematic review included 47 publications. With the exception of clinician training in communication skills, evidence for many of the clinical questions was limited. Draft recommendations underwent two rounds of consensus voting before being finalized. Recommendations In addition to providing guidance regarding core communication skills and tasks that apply across the continuum of cancer care, recommendations address specific topics, such as discussion of goals of care and prognosis, treatment selection, end-of-life care, facilitating family involvement in care, and clinician training in communication skills. Recommendations are accompanied by suggested strategies for implementation. Additional information is available at www.asco.org/supportive-care-guidelines and www.asco.org/guidelineswiki .

  5. The contribution of limited-resource countries to the American Society of Clinical Oncology annual meetings.

    PubMed

    Masmoudi, Amine

    2009-10-01

    Limited-resource countries (LRCs) are underrepresented in biomedical research, and data with respect to oncology are lacking. The aim of the present study was to assess the participation of LRCs in the American Society of Clinical Oncology (ASCO) annual meetings. We analyzed the characteristics of abstracts originating from LRCs presented at the 2005-2007 ASCO meetings. We used a logistic regression model to identify country characteristics associated with contributions to the meetings. Eight percent of abstracts were generated by authors from LRCs. Abstracts from LRCs, compared with abstracts originating from high-income countries (HICs), were less commonly scheduled for oral and poster presentations (1.4% and 26.8% vs 8.8% and 52.8%, respectively; P < 0.001), and were less likely to report industry-provided funding (2.0% vs 12.7%; P < 0.001). However, the presentation type and the rate of reporting industry funding did not significantly differ between HIC abstracts and LRC abstracts involving one or more coauthors from HICs. In multivariate analysis, ASCO-related characteristics, but not geoeconomic parameters, were significantly predictive of country participation in the meetings. These data show that the contribution of LRCs to ASCO annual meetings is very low. Although abstracts originating from LRCs involving authors from HICs were associated with a higher-impact type of presentation, their relevance to the cancer care concerns of LRCs remains to be ascertained.

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

    PubMed

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

    2017-01-01

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

  7. Effect of the clinical support nurse role on work-related stress for nurses on an inpatient pediatric oncology unit.

    PubMed

    Chang, Ann; Kicis, Jennifer; Sangha, Gurjit

    2007-01-01

    High patient acuity, heavy workload, and patient deaths can all contribute to work-related stress for pediatric oncology nurses. A new leadership role, the clinical support nurse (CSN), was recently initiated on the oncology unit of a large Canadian pediatric hospital to support frontline staff and reduce some of the stresses related to clinical activity. The CSN assists nurses with complex patient care procedures, provides hands-on education at the bedside, and supports staff in managing challenging family situations. This study explores the effect of the CSN role on the nurses' work-related stress using the Stressor Scale for Pediatric Oncology Nurses. A total of 58 nurses participated in this study for a response rate of 86%. The results show that the intensity of work-related stress experienced by nurses in this study is significantly less (P < .001) on shifts staffed with a CSN compared with shifts without a CSN.

  8. American Society of Clinical Oncology policy statement: the role of the oncologist in cancer prevention and risk assessment.

    PubMed

    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

    2009-02-20

    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.

  9. Precision Oncology Medicine: The Clinical Relevance of Patient-Specific Biomarkers Used to Optimize Cancer Treatment.

    PubMed

    Schmidt, Keith T; Chau, Cindy H; Price, Douglas K; Figg, William D

    2016-12-01

    Precision medicine in oncology is the result of an increasing awareness of patient-specific clinical features coupled with the development of genomic-based diagnostics and targeted therapeutics. Companion diagnostics designed for specific drug-target pairs were the first to widely utilize clinically applicable tumor biomarkers (eg, HER2, EGFR), directing treatment for patients whose tumors exhibit a mutation susceptible to an FDA-approved targeted therapy (eg, trastuzumab, erlotinib). Clinically relevant germline mutations in drug-metabolizing enzymes and transporters (eg, TPMT, DPYD) have been shown to impact drug response, providing a rationale for individualized dosing to optimize treatment. The use of multigene expression-based assays to analyze an array of prognostic biomarkers has been shown to help direct treatment decisions, especially in breast cancer (eg, Oncotype DX). More recently, the use of next-generation sequencing to detect many potential "actionable" cancer molecular alterations is further shifting the 1 gene-1 drug paradigm toward a more comprehensive, multigene approach. Currently, many clinical trials (eg, NCI-MATCH, NCI-MPACT) are assessing novel diagnostic tools with a combination of different targeted therapeutics while also examining tumor biomarkers that were previously unexplored in a variety of cancer histologies. Results from ongoing trials such as the NCI-MATCH will help determine the clinical utility and future development of the precision-medicine approach. © 2016, The American College of Clinical Pharmacology.

  10. Implementation and evaluation of medicine and therapeutic information service by clinical pharmacists in oncology care setting.

    PubMed

    Patel, Himanshu; Gurumurthy, Parthasarathi

    2017-01-01

    Background This study was conducted to explore the role of clinical pharmacists in providing medicine and therapeutic information service in oncology care setting. Methods It was a prospective study conducted for a period of three years after implementation of medicine and therapeutic information service as an integral part of oncology pharmacy services. The medicine and therapeutic information queries were received during ward rounds, at ambulatory care and via telephone by clinical pharmacists. All the medicine and therapeutic information requests were reviewed and answered to the concerned requester(s). Answered medicine and therapeutic information requests were electronically documented in the hospital drug information database and analyzed further. Results A total of 484 medicine and therapeutic information requests were received by clinical pharmacists during period of August 2013 to June 2016. Majority of medicine and therapeutic information queries were requested by radiation oncologists (27.2%) followed by medical oncologists (26.4%), general physicians (14.04%), resident medical officers (11.7%), ambulatory care nurses (8.6%), in-patient nurses (5.1%) and patients and care takers (6.6%). Majority of the medicine and therapeutic information queries were asked for the purpose of improving patient care (48.3%) followed by to update knowledge (30.9%) and training sessions to nurses (6.6%). The most common categories of medicine and therapeutic information were adverse drug reactions and its management (21.4%) followed by dosage adjustments of chemotherapy and biologicals (15.5%), supportive care related (14.6%), contraindications (14%), drug-drug interactions (11.9%), management of co-morbidities (7.8%), chemotherapy selection in special populations (4.5%). Conclusion The provision of medicine and therapeutic information was found to be useful in providing medicine information to improve patient care and to update knowledge of health care professionals at the

  11. Lean methodology improves efficiency in outpatient academic uro-oncology clinics.

    PubMed

    Skeldon, Sean C; Simmons, Andrea; Hersey, Karen; Finelli, Antonio; Jewett, Michael A; Zlotta, Alexandre R; Fleshner, Neil E

    2014-05-01

    To determine if lean methodology, an industrial engineering tool developed to optimize manufacturing efficiency, can successfully be applied to improve efficiencies and quality of care in a hospital-based high-volume uro-oncology clinic. Before the lean initiative, baseline data were collected on patient volumes, wait times, cycle times (patient arrival to discharge), nursing assessment time, patient teaching, and physician ergonomics (via spaghetti diagram). Value stream analysis and a rapid improvement event were carried out, and significant changes were made to patient check-in, work areas, and nursing face time. Follow-up data were obtained at 30, 60, and 90 days. The Student t test was used for analysis to compare performance metrics with baseline. The median cycle time before the lean initiative was 46 minutes. This remained stable at 46 minutes at 30 days but improved to 35 minutes at 60 days and 41 minutes at 90 days. Shorter wait times allowed for increased nursing and physician face time. The average length of the physician assessment increased from 7.5 minutes at baseline to 10.6 minutes at 90 days. The average proportion of value-added time compared with the entire clinic visit increased from 30.6% at baseline to 66.3% at 90 days. Using lean methodology, we were able to shorten the patient cycle time and the time to initial assessment as well as integrate both an initial registered nurse assessment and registered nurse teaching to each visit. Lean methodology can effectively be applied to improve efficiency and patient care in an academic outpatient uro-oncology clinic setting. Copyright © 2014 Elsevier Inc. All rights reserved.

  12. 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. Copyright © 2016 Elsevier Ltd. All rights reserved.

  13. [Early clinical trials in paediatric oncology in Spain: a nationwide perspective].

    PubMed

    Bautista, Francisco; Gallego, Soledad; Cañete, Adela; Mora, Jaume; Díaz de Heredia, Cristina; Cruz, Ofelia; Fernández, José María; Rives, Susana; Berlanga, Pablo; Hladun, Raquel; Juan Ribelles, Antonio; Madero, Luis; Ramírez, Manuel; Fernández Delgado, Rafael; Pérez-Martínez, Antonio; Mata, Cristina; Llort, Anna; Martín Broto, Javier; Cela, María Elena; Ramírez, Gema; Sábado, Constantino; Acha, Tomás; Astigarraga, Itziar; Sastre, Ana; Muñoz, Ascensión; Guibelalde, Mercedes; Moreno, Lucas

    2017-09-01

    Cancer is the leading cause of death between the first year of life and adolescence, and some types of diseases are still a major challenge in terms of cure. There is, therefore, a major need for new drugs. Recent findings in cancer biology open the door to the development of targeted therapies against individual molecular changes, as well as immunotherapy. Promising results in adult anti-cancer drug development have not yet been translated into paediatric clinical practice. A report is presented on the activity in early paediatric oncology trials (phase I-II) in Spain. All members of the Spanish Society of Paediatric Haematology Oncology (SEHOP) were contacted in order to identify early clinical trials in paediatric cancer opened between 2005 and 2015. A total of 30 trials had been opened in this period: 21 (70%) in solid tumours, and 9 (30%) in malignant haemopathies. A total of 212 patients have been enrolled. The majority was industry sponsored (53%). Since 2010, four centres have joined the international consortium of Innovative Therapies for Children with Cancer (ITCC), which has as its aim to develop novel therapies for paediatric tumours. A significant number of new studies have opened since 2010, improving the treatment opportunities for our children. Results of recently closed trials show the contribution of Spanish investigators, the introduction of molecularly targeted agents, and their benefits. The activity in clinical trials has increased in the years analysed. The SEHOP is committed to develop and participate in collaborative academic trials, in order to help in the advancement and optimisation of existing therapies in paediatric cancer. Copyright © 2016 Asociación Española de Pediatría. Publicado por Elsevier España, S.L.U. All rights reserved.

  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. © The Author(s) 2016. Published by Oxford University Press on behalf of the Society for Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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

    PubMed

    Cassinelli, Giuseppe

    2016-06-02

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

  16. Correlative Studies in Clinical Trials: A Position Statement From the International Thyroid Oncology Group

    PubMed Central

    Bible, Keith C.; Cote, Gilbert J.; Demeure, Michael J.; Elisei, Rossella; Jhiang, Sissy

    2015-01-01

    Objective: Patients with progressive thyroid cancer in distant metastatic sites represent a population with a need for new therapeutic options. Aspiring to improve the treatment of such patients, the objective of this position statement from the International Thyroid Oncology Group (ITOG) is to clarify the importance of incorporating high-quality correlative studies into clinical trials. Participants: ITOG was formed to develop and support high-quality multicenter and multidisciplinary clinical trials for patients with aggressive forms of thyroid cancer. The Correlative Sciences Committee of the ITOG focuses on the quality and types of correlative studies included in ITOG-associated clinical trials. Evidence: This document represents expert consensus from ITOG regarding this issue based on extensive collective experience in clinical and translational trials informed by basic science. Consensus Process: The Correlative Studies Committee identified an international writing group representative of diverse specialties, including basic sciences. Drafts were reviewed by all members of the writing group, the larger committee, and the ITOG board. After consideration of all comments by the writing group and modification of the document, the final document was then approved by the authors and the ITOG board. Conclusions: High-quality correlative studies, which include variety in the types of correlates, should be intrinsic to the design of thyroid cancer clinical trials to offer the best opportunity for each study to advance treatment for patients with advanced and progressive thyroid cancer. PMID:26418285

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

    PubMed

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

    2013-08-01

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

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

    PubMed Central

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

    2017-01-01

    Chromogranin A, due to its primary expression throughout the neuroendocrine system, is a widely accepted biomarker for the assessment of neuro-endocrine tumors. It has been traditionally used in the management of patients with tumors of gastro-enteropancreatic origin. Lately, it has also been implicated in various conditions and diseases, both benign and malignant. However, the paucity of data of adequate strength, as well as its relation with common physiologic conditions and its interaction with commonly prescribed medications, limit its clinical use in only a narrow spectrum. Herein, we present a thorough review to the most frequent conditions where its levels are affected, focusing specifically on its potential use as a prognostic and predictive biomarker in oncology. PMID:28396845

  19. Clinical and oncological outcomes after surgical excision of pigmented villonodular synovitis at the foot and ankle.

    PubMed

    Korim, M T; Clarke, D R; Allen, P E; Richards, C J; Ashford, R U

    2014-06-01

    Pigmented villonodular synovitis (PVNS) is a rare benign neoplastic disease of the synovium of joints and tendon sheaths, which may be locally aggressive. It can be broadly classified into localised disease or more diffuse forms, with the latter more prone to recurrence after surgical excision. We describe our experience in the management of foot and ankle PVNS, focusing on the diffuse type. Patients with PVNS were identified from a histology database from 2000 to 2010 at the University Hospitals of Leicester. The primary aim was to determine oncological outcomes and evaluate clinical outcomes with the Toronto Extremity Salvage Score (TESS) and the American Academy of Foot and Ankle Surgeons (AOFAS) scores. 30 patients, 16 males and 14 females with a mean age of 37±15 years, who underwent surgery, were identified. There were 22 nodular PVNS and 8 diffuse PVNS. The diffuse PVNS was more likely to be in the hindfoot (75%, 6/8), of which 50% (3/6) had osteoarthritis at presentation. The localised PVNS was mostly located in the forefoot (91%, 20/22). None of the localised PVNS had a recurrence. The surgical recurrence rate in this series was similar to the pooled recurrence rate from the literature [12.5% (1/8) compared to 12.2% (6/49)]. The mean TESS and AOFAS scores were 86 and 78, respectively. Diffuse PVNS is more likely to occur in the hindfoot and nodular PVNS is more common in the forefoot. Aggressive synovectomy alone is an effective treatment for diffuse PVNS, with good oncological and clinical outcomes. Copyright © 2014 European Foot and Ankle Society. Published by Elsevier Ltd. All rights reserved.

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

    PubMed Central

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

    2009-01-01

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

  1. ENRICH: A promising oncology nurse training program to implement ASCO clinical practice guidelines on fertility for AYA cancer patients.

    PubMed

    Vadaparampil, Susan T; Gwede, Clement K; Meade, Cathy; Kelvin, Joanne; Reich, Richard R; Reinecke, Joyce; Bowman, Meghan; Sehovic, Ivana; Quinn, Gwendolyn P

    2016-11-01

    We describe the impact of ENRICH (Educating Nurses about Reproductive Issues in Cancer Healthcare), a web-based communication-skill-building curriculum for oncology nurses regarding AYA fertility and other reproductive health issues. Participants completed an 8-week course that incorporated didactic content, case studies, and interactive learning. Each learner completed a pre- and post-test assessing knowledge and a 6-month follow-up survey assessing learner behaviors and institutional changes. Out of 77 participants, the majority (72%) scored higher on the post-test. Fifty-four participants completed the follow-up survey: 41% reviewed current institutional practices, 20% formed a committee, and 37% gathered patient materials or financial resources (22%). Participants also reported new policies (30%), in-service education (37%), new patient education materials (26%), a patient navigator role (28%), and workplace collaborations with reproductive specialists (46%). ENRICH improved nurses' knowledge and involvement in activities addressing fertility needs of oncology patients. Our study provides a readily accessible model to prepare oncology nurses to integrate American Society of Clinical Oncology guidelines and improve Quality Oncology Practice Initiative measures related to fertility. Nurses will be better prepared to discuss important survivorship issues related to fertility and reproductive health, leading to improved quality of life outcomes for AYAs. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  2. 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.

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

    PubMed

    Cho, William Chi-Shing

    2008-03-01

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

  4. 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

  5. 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

  6. Pain in clinical oncology: patient satisfaction with management of cancer pain.

    PubMed

    Antón, A; Montalar, J; Carulla, J; Jara, C; Batista, N; Camps, C; Cassinello, J; Sanz-Ortiz, J; Díaz-Rubio, E; Martínez, C; Ledesma, F; Zubillaga, E

    2012-03-01

    Despite effective analgesic therapy, inadequate pain control is frequently perceived by patients and caregivers. To assess satisfaction with management of pain in cancer patients. Between January and May 2007, a cross-sectional multicentre study was conducted in 64 Medical Oncology Departments throughout Spain. A total of 525 outpatients with oncological diseases completed a questionnaire with demographic data, characteristics and intensity of pain, and perceptions and attitudes towards pain management at the time of a routine clinical visit. Physicians also completed a questionnaire with tumour-related and treatment-related data. Cluster analysis was used to classify patients into three groups (satisfied, neither satisfied nor dissatisfied or neutral, dissatisfied) according to pain intensity and satisfaction with treatment. Patients satisfied with their analgesic treatment (33%) had lower pain intensities and, when regularly asked about their pain, considered their physicians to be more involved in their treatment. Neither satisfied nor dissatisfied patients (neutral) (44%) had higher mean pain intensities. Two-thirds of them achieved marked relief of their pain and also thought that physicians were aware of their situation. Dissatisfied patients (23%) had moderate to severe pain intensities, and said that they were asked less frequently about their pain, and thought that their physicians were less involved in their analgesic treatment. Physician-patient communication and information provided to patients are essential aspects of patient perceptions and attitudes towards control of cancer-related pain. Pain is seen as a condition that may be controlled but affects the capacity to lead a normal life. © 2011 European Federation of International Association for the Study of Pain Chapters.

  7. American Society of Clinical Oncology technology assessment on breast cancer risk reduction strategies: tamoxifen and raloxifene.

    PubMed

    Chlebowski, R T; Collyar, D E; Somerfield, M R; Pfister, D G

    1999-06-01

    To conduct an evidence-based technology assessment to determine whether tamoxifen and raloxifene as breast cancer risk-reduction strategies are appropriate for broad-based conventional use in clinical practice. Tamoxifen and raloxifene. Outcomes of interest include breast cancer incidence, breast cancer-specific survival, overall survival, and net health benefits. A comprehensive, formal literature review was conducted for tamoxifen and raloxifene on the following topics: breast cancer risk reduction; tamoxifen side effects and toxicity, including endometrial cancer risk; tamoxifen influences on nonmalignant diseases, including coronary heart disease and osteoporosis; and decision making by women at risk for breast cancer. Testimony was collected from invited experts and interested parties. More weight was given to publications that described randomized trials. BENEFITS/HARMS/COSTS: The American Society of Clinical Oncology (ASCO) Working Group acknowledges that a woman's decision regarding breast cancer risk-reduction strategies will depend on the importance and weight attributed to the information provided regarding both cancer and non-cancer-related risks. For women with a defined 5-year projected risk of breast cancer of >/= 1.66%, tamoxifen (at 20 mg/d for up to 5 years) may be offered to reduce their risk. It is premature to recommend raloxifene use to lower the risk of developing breast cancer outside of a clinical trial setting. On the basis of available information, use of raloxifene should currently be reserved for its approved indication to prevent bone loss in postmenopausal women. Conclusions are based on single-agent use of the drugs. At the present time, the effect of using tamoxifen or raloxifene with other medications (such as hormone replacement therapy), or using tamoxifen and raloxifene in combination or sequentially, has not been studied adequately. The continuing use of placebo-controlled trials in other risk-reduction trials highlights the

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

    PubMed Central

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

    2017-01-01

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

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

    PubMed

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

    2017-01-01

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

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

    PubMed

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

    2017-03-01

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

  11. Nurse-led outpatient clinics in oncology care - Patient satisfaction, information and continuity of care.

    PubMed

    Berglund, Catharina Bau; Gustafsson, Eva; Johansson, Hemming; Bergenmar, Mia

    2015-12-01

    The aims of the present study were to investigate patients' satisfaction with nurse-led clinics, patients' perception of received information and associations between continuity of care and satisfaction with information. Questionnaires on patient satisfaction were sent to consecutive samples of patients after they attended a nurse-led clinic at the Department of Oncology, Karolinska University Hospital in 2007, 2009, 2011 and 2013. Patients' perceptions of received information were evaluated in 2011 and 2013, by the EORTC QLQ-INFO25. Data on registered continuity of care were retrieved from the patients' medical record. A total of 962 patients responded (79%) to one of the four surveys. Patients' satisfaction with nurse-led clinics was stable over time. More than 90% rated nurses' interpersonal manners and the care at the clinic as "good", the waiting time as "acceptable", and the length of appointments as "sufficient". Over 90% responded that it was important to meet the same nurse and 62% reported they actually did so and 52% stated they were assigned a named nurse navigator. More than 75% rated the information at their latest visit at a nurse-led clinic as "completely" sufficient. However, 48% expressed wish for more information "during the current disease". No statistical significant associations were found between "satisfaction with information" and continuity of care. Patients' satisfaction with nurse-led clinics was stable over time with generally high figures with the exception for continuity of care and information, areas in which improvements are needed. The wide variety in information needs might require a person-centred approach. Copyright © 2015 Elsevier Ltd. All rights reserved.

  12. Treatment Patterns and Health Resource Utilization Among Patients Diagnosed With Early Stage Resected Non-Small Cell Lung Cancer at US Community Oncology Practices.

    PubMed

    Buck, Philip O; Saverno, Kimberly R; Miller, Paul J E; Arondekar, Bhakti; Walker, Mark S

    2015-11-01

    Data on adjuvant therapy in resected non-small cell lung cancer (NSCLC) in routine practice are lacking in the United States. This retrospective observational database study included 609 community oncology patients with resected stage IB to IIIA NSCLC. Use of adjuvant therapy was 39.1% at disease stage IB and 64.9% to 68.2% at stage II to IIIA. The most common regimen at all stages was carboplatin and paclitaxel. Platin-based adjuvant chemotherapy has extended survival in clinical trials in patients with completely resected non-small cell lung cancer (NSCLC). There are few data on the use of adjuvant therapy in community-based clinical practice in the United States. This was a retrospective observational study using electronic medical record and billing data collected during routine care at US community oncology sites in the Vector Oncology Data Warehouse between January 2007 and January 2014. Patients aged ≥ 18 years with a primary diagnosis of stage IB to IIIA NSCLC were eligible if they had undergone surgical resection. Treatment patterns, health care resource use, and cost were recorded, stratified by stage at diagnosis. The study included 609 patients (mean age, 64.8 years, 52.9% male), of whom 215 had stage IB disease, 130 stage IIA/II, 110 stage IIB, and 154 stage IIIA. Adjuvant systemic therapy after resection was provided to 345 (56.7%) of 609 patients, with lower use in patients with stage IB disease (39.1%) than stage II to IIIA disease (64.9-68.2%) (P < .0001). The most common adjuvant regimen at all stages was the combination of carboplatin and paclitaxel. There were no statistically significant differences in office visits or incidence of hospitalization by disease stage. During adjuvant treatment, the total monthly median cost per patient was $17,389.75 (interquartile range, $8,815.61 to $23,360.85). Adjuvant systemic therapy was used in some patients with stage IB NSCLC and in the majority of patients with stage IIA to IIIA disease. There were few

  13. 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

  14. Clinical Cancer Advances 2013: Annual Report on Progress Against Cancer from the American Society of Clinical Oncology.

    PubMed

    Patel, Jyoti D; Krilov, Lada; Adams, Sylvia; Aghajanian, Carol; Basch, Ethan; Brose, Marcia S; Carroll, William L; de Lima, Marcos; Gilbert, Mark R; Kris, Mark G; Marshall, John L; Masters, Gregory A; O'Day, Steven J; Polite, Blasé; Schwartz, Gary K; Sharma, Sunil; Thompson, Ian; Vogelzang, Nicholas J; Roth, Bruce J

    2014-01-10

    Since its founding in 1964, the American Society of Clinical Oncology (ASCO) has been committed to improving cancer outcomes through research and the delivery of quality care. Research is the bedrock of discovering better treatments--providing hope to the millions of individuals who face a cancer diagnosis each year. The studies featured in "Clinical Cancer Advances 2013: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology" represent the invaluable contributions of thousands of patients who participate in clinical trials and the scientists who conduct basic and clinical research. The insights described in this report, such as how cancers hide from the immune system and why cancers may become resistant to targeted drugs, enable us to envision a future in which cancer will be even more controllable and preventable. The scientific process is thoughtful, deliberate, and sometimes slow, but each advance, while helping patients, now also points toward new research questions and unexplored opportunities. Both dramatic and subtle breakthroughs occur so that progress against cancer typically builds over many years. Success requires vision, persistence, and a long-term commitment to supporting cancer research and training. Our nation's longstanding investment in federally funded cancer research has contributed significantly to a growing array of effective new treatments and a much deeper understanding of the drivers of cancer. But despite this progress, our position as a world leader in advancing medical knowledge and our ability to attract the most promising and talented investigators are now threatened by an acute problem: Federal funding for cancer research has steadily eroded over the past decade, and only 15% of the ever-shrinking budget is actually spent on clinical trials. This dismal reality threatens the pace of progress against cancer and undermines our ability to address the continuing needs of our patients. Despite this

  15. Venous thromboembolism prophylaxis and treatment in patients with cancer: american society of clinical oncology clinical practice guideline update 2014.

    PubMed

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

    2015-02-20

    To provide current recommendations about the prophylaxis and treatment of venous thromboembolism (VTE) in patients with cancer. PubMed and the Cochrane Library were searched for randomized controlled trials, systematic reviews, meta-analyses, and clinical practice guidelines from November 2012 through July 2014. An update committee reviewed the identified abstracts. Of the 53 publications identified and reviewed, none prompted a change in the 2013 recommendations. Most hospitalized patients with active cancer require thromboprophylaxis throughout hospitalization. Routine thromboprophylaxis is not recommended for patients with cancer in the outpatient setting. It may be considered for selected high-risk patients. Patients with multiple myeloma receiving antiangiogenesis agents with chemotherapy and/or dexamethasone should receive prophylaxis with either low-molecular weight heparin (LMWH) or low-dose aspirin. Patients undergoing major surgery should receive prophylaxis starting before surgery and continuing for at least 7 to 10 days. Extending prophylaxis up to 4 weeks should be considered in those undergoing major abdominal or pelvic surgery with high-risk features. LMWH is recommended for the initial 5 to 10 days of treatment for deep vein thrombosis and pulmonary embolism as well as for long-term secondary prophylaxis (at least 6 months). Use of novel oral anticoagulants is not currently recommended for patients with malignancy and VTE because of limited data in patients with cancer. Anticoagulation should not be used to extend survival of patients with cancer in the absence of other indications. Patients with cancer should be periodically assessed for VTE risk. Oncology professionals should educate patients about the signs and symptoms of VTE. © 2015 by American Society of Clinical Oncology.

  16. Dental school and community clinic financial arrangements.

    PubMed

    Piskorowski, Wilhelm; Bailit, Howard L; McGowan, Taegen L; Krell, Rachel E

    2011-10-01

    In community-based dental education programs, student-provided services can be an important source of community clinic and practice revenues. The University of Michigan School of Dentistry has developed a revenue-sharing arrangement with multiple community clinics and practices. During their ten-week externship, senior students produce at least $800 a day in patient care revenues, and the school receives an average of $165 per student per day from community sites. These funds are used to cover program costs and enrich the curriculum. Revenue-sharing with community clinics and practices helps to ensure program longevity and is an increasingly significant source of school revenues.

  17. Colorectal cancer surveillance: 2005 update of an American Society of Clinical Oncology practice guideline.

    PubMed

    Desch, Christopher E; Benson, Al B; Somerfield, Mark R; Flynn, Patrick J; Krause, Carol; Loprinzi, Charles L; Minsky, Bruce D; Pfister, David G; Virgo, Katherine S; Petrelli, Nicholas J

    2005-11-20

    To update the 2000 American Society of Clinical Oncology guideline on colorectal cancer surveillance. Based on results from three independently reported meta-analyses of randomized controlled trials that compared low-intensity and high-intensity programs of colorectal cancer surveillance, and on recent analyses of data from major clinical trials in colon and rectal cancer, the Panel recommends annual computed tomography (CT) of the chest and abdomen for 3 years after primary therapy for patients who are at higher risk of recurrence and who could be candidates for curative-intent surgery; pelvic CT scan for rectal cancer surveillance, especially for patients with several poor prognostic factors, including those who have not been treated with radiation; colonoscopy at 3 years after operative treatment, and, if results are normal, every 5 years thereafter; flexible proctosigmoidoscopy [corrected] every 6 months for 5 years for rectal cancer patients who have not been treated with pelvic radiation; history and physical examination every 3 to 6 months for the first 3 years, every 6 months during years 4 and 5, and subsequently at the discretion of the physician; and carcinoembryonic antigen every 3 months postoperatively for at least 3 years after diagnosis, if the patient is a candidate for surgery or systemic therapy. Chest x-rays, CBCs, and liver function tests are not recommended, and molecular or cellular markers should not influence the surveillance strategy based on available evidence.

  18. 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.

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

    PubMed

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

    2005-07-01

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

  20. 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

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

    NASA Astrophysics Data System (ADS)

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

    2016-12-01

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

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

    PubMed

    Scrivani, Peter V; Erb, Hollis N

    2013-01-01

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

  3. Modernizing Clinical Trial Eligibility: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Minimum Age Working Group.

    PubMed

    Gore, Lia; Ivy, S Percy; Balis, Frank M; Rubin, Eric; Thornton, Katherine; Donoghue, Martha; Roberts, Samantha; Bruinooge, Suanna; Ersek, Jennifer; Goodman, Nancy; Schenkel, Caroline; Reaman, Gregory

    2017-10-02

    Purpose Children have historically been excluded from first-in-human studies of promising new cancer drugs and later phase adult clinical trials. Delays in evaluation may result in off-label use without dosing information as the only access to new drugs. A multistakeholder workshop was convened in May 2016 by ASCO and Friends of Cancer Research to identify opportunities for when it would be scientifically appropriate to expand trial eligibility to include children younger than age 18 years in first-in-human and other adult cancer clinical trials. Methods This group convened experts from academia, government, and industry to review barriers to enrolling children and adolescents in oncology clinical trials. We evaluated the historical context, published literature, regulatory considerations, and myriad risks and benefits associated with lowering the age of enrollment on oncology clinical trials. Results We conclude that many of the historical concerns about including children early in oncology clinical trials do not apply in the current scientific and clinical environment of pediatric oncology and drug development; we provide specific recommendations for how the inclusion of children in early-phase investigational cancer drug trials might be accomplished. Automatic inclusion of pediatric patients is appropriate in early-phase trials that assess dose, safety, and pharmacokinetics in a variety of tumor types and later phase trials that assess efficacy in a specific disease that spans adult and pediatric populations. Conclusion Including children in appropriately designed adult clinical oncology trials is feasible and can be done in a way that enhances their access to these agents without compromising safety or development strategies.

  4. The script concordance test in radiation oncology: validation study of a new tool to assess clinical reasoning

    PubMed Central

    Lambert, Carole; Gagnon, Robert; Nguyen, David; Charlin, Bernard

    2009-01-01

    Background The Script Concordance test (SCT) is a reliable and valid tool to evaluate clinical reasoning in complex situations where experts' opinions may be divided. Scores reflect the degree of concordance between the performance of examinees and that of a reference panel of experienced physicians. The purpose of this study is to demonstrate SCT's usefulness in radiation oncology. Methods A 90 items radiation oncology SCT was administered to 155 participants. Three levels of experience were tested: medical students (n = 70), radiation oncology residents (n = 38) and radiation oncologists (n = 47). Statistical tests were performed to assess reliability and to document validity. Results After item optimization, the test comprised 30 cases and 70 questions. Cronbach alpha was 0.90. Mean scores were 51.62 (± 8.19) for students, 71.20 (± 9.45) for residents and 76.67 (± 6.14) for radiation oncologists. The difference between the three groups was statistically significant when compared by the Kruskall-Wallis test (p < 0.001). Conclusion The SCT is reliable and useful to discriminate among participants according to their level of experience in radiation oncology. It appears as a useful tool to document the progression of reasoning during residency training. PMID:19203358

  5. Screening for prostate cancer with prostate-specific antigen testing: American Society of Clinical Oncology Provisional Clinical Opinion.

    PubMed

    Basch, Ethan; Oliver, Thomas K; Vickers, Andrew; Thompson, Ian; Kantoff, Philip; Parnes, Howard; Loblaw, D Andrew; Roth, Bruce; Williams, James; Nam, Robert K

    2012-08-20

    An American Society of Clinical Oncology (ASCO) provisional clinical opinion (PCO) offers timely clinical direction to the ASCO membership after publication or presentation of potentially practice-changing data from major studies. This PCO addresses the role of prostate-specific antigen (PSA) testing in the screening of men for prostate cancer. Prostate cancer is the second leading cause of cancer deaths among men in the United States. The rationale for screening men for prostate cancer is the potential to reduce the risk of death through early detection. Evidence from a 2011 Agency for Healthcare Research and Quality systematic review primarily informs this PCO on the benefits and harms of PSA-based screening. An update search was conducted to March 16, 2012, for additional evidence related to the topic. In one randomized trial, PSA testing in men who would not otherwise have been screened resulted in reduced death rates from prostate cancer, but it is uncertain whether the size of the effect was worth the harms associated with screening and subsequent unnecessary treatment. Although there are limitations to the existing data, there is evidence to suggest that men with longer life expectancy may benefit from PSA testing. Adverse events associated with prostate biopsy are low for the majority of men; however, several population-based studies have shown increasing rates of infectious complications after prostate biopsy, which is a concern.

  6. Publication of interventional phase 3 and 4 clinical trials in radiation oncology: an observational study.

    PubMed

    Pérez-Alija, Jaime; Gallego, Pedro; Linares, Isabel; Ambroa, Eva; Pedro, Agustí

    2017-09-21

    Clinical trials produce the best data available for decision-making in modern evidence-based medicine. We aimed to determine the rate of non-publication of interventional phase 3 and 4 clinical trials involving patients with cancer undergoing radiotherapy. The ClinicalTrials.gov database was searched for interventional phase 3 and 4 trials in radiotherapy with a primary completion date before 1 January 2013. We determined how many of these registry entries have not published the compulsory deposition of their results in the database and performed a systematic search for published studies in peer-reviewed journals. Of 576 trials, 484 (84.0%) did not deposit a summary result in the registry. In addition, 44.9% of them did not publish their results in a peer-reviewed journal. Similar percentages were found for most cancer subtypes: brain (41%), breast (38%), cervical (66%), colorectal (38%), lung (48%), prostate (45%), bladder (56%), head and neck (56%) and lymphoma (33%). Our results show that most trials in radiation oncology did not report the results in the registry. Almost half of these trials have not been published in the biomedical literature. This means that a large number of study participants were exposed to the risks of trial participation without the supposed benefits that sharing and publishing of results would offer to future generations of patients. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  7. Treatment Prices at the Point of Care in a Clinical Oncology Service: Pilot Project.

    PubMed

    Henrikson, Nora B; Lau, Rebecca W; Tuzzio, Leah; Christianson, Matthew; Phan, Thanh-Hien; Chen, Eric

    2016-10-01

    Patients with cancer increasingly wish to discuss cancer care costs with clinicians. We aimed to improve clinician access to treatment prices. We developed a pilot tool and accompanying workflow for four oncology clinics in an integrated care system. The online tool included 50 printable worksheets for cancer treatment protocols and was accessible directly from the electronic health record. Each sheet included codes and prices for all drugs and services for one treatment cycle in patient-friendly language. The worksheets did not provide patient-level cost-shares. We evaluated the resource's launch, initial use, and acceptability through a convenience survey of initial users. The project was successfully launched. Initial Web traffic to price sheets exceeded the number of treatments ordered during the launch period. One third of survey respondents reported use of the cost sheets at least once a week. The most useful features were improved access to cost information, treatment protocol-based layout, and ability to meet patient needs. The resource was rated as generally high value to patients, staff, and the organization. Suggested improvements included provision of patient-level cost sharing (63%) followed by expansion of the project to include more protocols (33%). These improvements are in progress. The pilot was feasible, built capacity to locate price data, and did not adversely affect staff workload. It addressed a clear need and demonstrated high potential overall value, especially with its protocol-based format. The resource's lack of personalized estimates of out-of-pocket charges was the biggest gap reported.

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

    PubMed

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

    2009-01-01

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

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

    PubMed

    Wood, Paul L

    2014-01-01

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

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

    PubMed

    Hoffmann, Jens

    2014-06-01

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

  11. Sample Size Calculation in Oncology Trials: Quality of Reporting and Implications for Clinical Cancer Research.

    PubMed

    Bariani, Giovanni M; de Celis Ferrari, Anezka C R; Precivale, Maristela; Arai, Roberto; Saad, Everardo D; Riechelmann, Rachel P

    2015-12-01

    Sample size calculation (SSC) is a pivotal step in clinical trial conception and design. Herein, we describe the frequency with which oncology phase III trials report the parameters required for SSC. We systematically searched for phase III trials published in 6 leading journals, which were accompanied by editorials from January 2008 to October 2011. Two blinded investigators extracted required and optional parameters for SSC according to the primary endpoint. We retrieved 140 eligible phase III trials. The median target sample size was 596 subjects (50 to 40,000); in 66.4% of cases, the number of enrolled subjects was at least 90% of the target. The primary endpoint was a continuous variable in 5.7%, categorical in 30.0%, and a time-to-event variable in 64.3% of phase III trials. Although nearly 80% reported a target sample size, only 27.9% of the trials provided all the required parameters for proper SSC. The most commonly reported parameters for sample size computation were α (93.6%) and β (90.7%) errors. The parameters least reported were the expected outcomes in the control or experimental groups, each provided in only 57.9% of trials. The quality of SSC reporting in phase III cancer trials is poor. Such incomplete reporting may compromise future study designs, pooling of data, and interpretation of results. Lack of transparency in SSC reporting may also have ethical implications.

  12. Community Hospital Model for Postgraduate Clinical Education.

    ERIC Educational Resources Information Center

    Scalley, Robert D.

    1982-01-01

    A clinical clerkship for graduate pharmacists was developed in a 200-bed community hospital at the request of community practitioners, and offered through the University of Wyoming adult education and community service division. Basic competency is gained in history-taking and interviewing skills, and evaluation of drug therapy. (MSE)

  13. Tobacco control: reducing cancer incidence and saving lives. American Society of Clinical Oncology.

    PubMed

    1996-06-01

    The American Society of Clinical Oncology (ASCO) supports the elimination of tobacco products. Toward that goal, ASCO urges the adoption of national policy that strengthens regulation of the sale, promotion, and distribution of such products. To reduce cancer mortality, our regulatory policies must recognize that the nicotine within tobacco is an addictive substance, the use of which leads to 30% of all cancer deaths and a total of 419,000 deaths each year. Tobacco-related advertising and promotion should be banned. At a minimum, national policies should: ban billboards; limit advertising to black and white text only; prohibit the sale or giveaway of products that contain tobacco brand names or logos; prohibit brand name sponsorship of sporting or entertainment events; and require stronger and more prominent warning labels on all tobacco products. Despite existing state laws prohibiting sale of tobacco products to minors, children are able to buy such products easily. National regulation of the sale and distribution of tobacco products is necessary to eliminate children's access to tobacco. Where sales are permitted, they should be limited to face-to-face purchases by individuals 18 and older. Vending machines and other means of distributing tobacco without a face-to-face purchase should be outlawed. To the extent tobacco sales are allowed to continue, the federal government should mandate that the tobacco industry contribute substantial funds for a national public education campaign to prevent young people from smoking and other tobacco use. ASCO has long advocated a substantial increase (in the range of $2) in the federal excise tax on cigarettes and other tobacco products- a measure known to decrease consumption, particularly among children. Revenue from a tax on tobacco products should be used to support retraining for tobacco farmers, biomedical research, health care delivery, and antitobacco education. United State trade policies should discourage the export

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

    PubMed

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

    2017-01-01

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

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

    PubMed Central

    2017-01-01

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

  16. 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

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

    PubMed Central

    McVie, Gordon; Nailor, Audrey

    2014-01-01

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

  18. [Experience in data management of the clinical retrospective project in Czech and Slovak oncology centres (IKARUS Project)].

    PubMed

    Chroust, K; Fínek, J; Zemánek, P; Brabec, P; Dusek, L

    2009-01-01

    The retrospective part of the IKARUS Project (Incidence of Skeletal Related Events in Breast Cancer) was focused on monitoring the incidence of skeletal related events in patients with metastatic breast cancer treated in the Czech and Slovak Republics.The aim was to describe the experience with data collection management in the conditions of the Czech and Slovak Republics. Retrospective collection of data in multi-centre, non-interventional, epidemiological and explorative studies. Female patients diagnosed since 2000 were involved in the project in order to respect the five-year period of monitoring and to describe the treatment of the period. During the initiation phase of the retrospective study each of the 18 Complex Cancer Centres in the Czech Republic (see www.linkos.cz) and 18 chosen oncology centres in the Slovak Republic were addressed. In the end, data were collected from 13 oncology centres in the Czech Republic and 12 oncology centres in the Slovak Republic. The initial plan to enrol 650 patients was not completed; data on 254 patients from the Czech Republic and 125 patients from the Slovak Republic were finally analysed.The effectiveness of retrospective data collection in the conditions of Czech and Slovak oncology corresponded with the possibilities of access to data of formerly diagnosed and treated patients. In searching for retrospective data the present hospital information systems could not be used in most oncology centres.Therefore, the cost of retrospective data collection was estimated and was shown to be relatively high. The binding methodical conclusion is that unless a systemic change is made in the functionality of hospital information systems and standardised electronic documentation is introduced, the retrospective collection of clinical data in our conditions will be associated with high costs and a relatively low recovery factor.

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

    PubMed

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

    2014-01-01

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

  20. The contents and readability of informed consent forms for oncology clinical trials.

    PubMed

    Cheung, Winson Y; Pond, Gregory R; Heslegrave, Ronald J; Enright, Katherine; Potanina, Larissa; Siu, Lillian L

    2010-08-01

    To compare the quality of informed consent forms (ICF) for different trial phases, funding sources, oncology subspecialties, disease settings, and intervention modalities. ICF for prospectively conducted clinical trials were examined for their descriptions of benefits and risks, study alternatives, voluntary participation, and confidentiality. Readability was assessed with Flesch Reading Ease (FRE) score and Flesch-Kincaid Reading Grade Level. Among 262 evaluable trials, ICF contained an average of 3982 words, 379 sentences, and 10.5 pages. The mean FRE score and Reading Grade Level were 61.2 and 7.4, respectively. All ICF explicitly stated that the intervention was investigational. Only 2 (1%) promised direct personal benefits, 16 (6%) suggested the chance of cure or prolonged survival, and 89 (34%) indicated a potential for tumor response. Conversely, 239 (91%) mentioned the risk of serious harms, 217 (83%) admitted that some side effects could be unknown or unpredictable, and 126 (48%) reported hospitalization or death as a possibility. Alternatives to participation, right to withdraw from study, and data confidentiality were addressed in 242 (92%), 254 (97%), and 260 (99%) ICF, respectively. Hematology, industry-funded, metastatic, and systemic therapy trials were most likely to highlight major risks (P < 0.05). Readability was better in phase I trials and in studies, which were performed by medical oncologists, sponsored by governmental agencies, conducted in the metastatic setting, and involved systemic therapy (P < 0.05). ICF had acceptable readability and provided a realistic overview of the benefits and risks of clinical trials, but the potential for hospitalization or fatality was underreported.

  1. American Society of Clinical Oncology 1998 update of recommended breast cancer surveillance guidelines.

    PubMed

    Smith, T J; Davidson, N E; Schapira, D V; Grunfeld, E; Muss, H B; Vogel, V G; Somerfield, M R

    1999-03-01

    To determine an effective, evidence-based, postoperative surveillance strategy for the detection and treatment of recurrent breast cancer. Tests are recommended only if they have an impact on the outcomes specified by American Society of Clinical Oncology (ASCO) for clinical practice guidelines. All tests described in the literature for postoperative monitoring were considered. In addition, the data were critically evaluated to determine the optimal frequency of monitoring. Outcomes of interest include overall and disease-free survival, quality of life, toxicity reduction, and secondarily cost-effectiveness. A search was performed to determine all relevant articles published over the past 20 years on the efficacy of surveillance testing for breast cancer recurrence. These publications comprised both retrospective and prospective studies. Levels of evidence and guideline grades were rated by a standard process. More weight was given to studies that tested a hypothesis directly relating testing to one of the primary outcomes in a randomized design. The possible consequences of false-positive and -negative tests were considered in evaluating a preference for one of two tests providing similar information. Cost alone was not a determining factor. The attached guidelines and text summarize the updated recommendations of the ASCO breast cancer expert panel. Data are sufficient to recommend monthly breast self-examination, annual mammography of the preserved and contralateral breast, and a careful history and physical examination every 3 to 6 months for 3 years, then every 6 to 12 months for 2 years, then annually. Data are not sufficient to recommend routine bone scans, chest radiographs, hematologic blood counts, tumor markers (carcinoembryonic antigen, cancer antigen [CA] 15-5, and CA 27.29), liver ultrasonograms, or computed tomography scans. The recommendations of the breast cancer expert panel were evaluated and supported by the ASCO Health Services Research

  2. 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. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  3. 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

  4. Recommendations on disease management for patients with advanced human epidermal growth factor receptor 2-positive breast cancer and brain metastases: American Society of Clinical Oncology clinical practice guideline.

    PubMed

    Ramakrishna, Naren; Temin, Sarah; Chandarlapaty, Sarat; Crews, Jennie R; Davidson, Nancy E; Esteva, Francisco J; Giordano, Sharon H; Gonzalez-Angulo, Ana M; Kirshner, Jeffrey J; Krop, Ian; Levinson, Jennifer; Modi, Shanu; Patt, Debra A; Perez, Edith A; Perlmutter, Jane; Winer, Eric P; Lin, Nancy U

    2014-07-01

    To provide formal expert consensus-based recommendations to practicing oncologists and others on the management of brain metastases for patients with human epidermal growth factor receptor 2 (HER2) -positive advanced breast cancer. The American Society of Clinical Oncology (ASCO) convened a panel of medical oncology, radiation oncology, guideline implementation, and advocacy experts and conducted a systematic review of the literature. When that failed to yield sufficiently strong quality evidence, the Expert Panel undertook a formal expert consensus-based process to produce these recommendations. ASCO used a modified Delphi process. The panel members drafted recommendations, and a group of other experts joined them for two rounds of formal ratings of the recommendations. No studies or existing guidelines met the systematic review criteria; therefore, ASCO conducted a formal expert consensus-based process. Patients with brain metastases should receive appropriate local therapy and systemic therapy, if indicated. Local therapies include surgery, whole-brain radiotherapy, and stereotactic radiosurgery. Treatments depend on factors such as patient prognosis, presence of symptoms, resectability, number and size of metastases, prior therapy, and whether metastases are diffuse. Other options include systemic therapy, best supportive care, enrollment onto a clinical trial, and/or palliative care. Clinicians should not perform routine magnetic resonance imaging (MRI) to screen for brain metastases, but rather should have a low threshold for MRI of the brain because of the high incidence of brain metastases among patients with HER2-positive advanced breast cancer. © 2014 by American Society of Clinical Oncology.

  5. 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

  6. High stathmin expression is a marker for poor clinical outcome in endometrial cancer: An NRG oncology group/gynecologic oncology group study.

    PubMed

    Reyes, Henry D; Miecznikowski, Jeffrey; Gonzalez-Bosquet, Jesus; Devor, Eric J; Zhang, Yuping; Thiel, Kristina W; Samuelson, Megan I; McDonald, Megan; Stephan, Jean-Marie; Hanjani, Parviz; Guntupalli, Saketh; Tewari, Krishnansu S; Backes, Floor; Ramirez, Nilsa; Fleming, Gini F; Filiaci, Virginia; Birrer, Michael J; Leslie, Kimberly K

    2017-08-01

    Gynecologic Oncology Group (GOG) 177 demonstrated that addition of paclitaxel to a backbone of adriamycin/cisplatin improves overall survival (OS) and progression-free survival (PFS) for patients with advanced or recurrent endometrial cancer. Using patient specimens from GOG-177, our objective was to identify potential mechanisms underlying the improved clinical response to taxanes. Stathmin (STMN1) is a recognized poor prognostic marker in endometrial cancer that functions as a microtubule depolymerizing protein, allowing cells to transit rapidly through mitosis. Therefore, we hypothesized that one possible mechanism underlying the beneficial effects of paclitaxel could be to counter the impact of stathmin. We analyzed the expression of stathmin by immunohistochemistry (IHC) in 69 specimens from patients enrolled on GOG-177. We also determined the correlation between stathmin mRNA expression and clinical outcomes in The Cancer Genome Atlas (TCGA) dataset for endometrial cancer. We first established that stathmin expression was significantly associated with shorter PFS and OS for all analyzed cases in both GOG-177 and TCGA. However, subgroup analysis from GOG-177 revealed that high stathmin correlated with poor PFS and OS particularly in patients who received adriamycin/cisplatin only. In contrast, there was no statistically significant association between stathmin expression and OS or PFS in patients treated with paclitaxel/adriamycin/cisplatin. Our findings demonstrate that high stathmin expression is a poor prognostic marker in endometrial cancer. Paclitaxel may help to negate the impact of stathmin overexpression when treating high risk endometrial cancer cases. Copyright © 2017 Elsevier Inc. All rights reserved.

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

    PubMed

    Lange, Stefan

    2015-01-01

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

  8. Assessing the Quality of a Radiation Oncology Case-Based, Peer-Review Program in an Integrated Academic and Community Cancer Center Network.

    PubMed

    Thaker, Nikhil G; Sturdevant, Laurie; Jhingran, Anuja; Das, Prajnan; Delclos, Marc E; Gunn, Gary B; McAleer, Mary Frances; Tereffe, Welela; Choi, Seungtaek L; Frank, Steven J; Simeone, William J; Martinez, Wendi; Hahn, Stephen M; Famiglietti, Robin; Kuban, Deborah A

    2016-04-01

    Academic centers increasingly find a need to define a comprehensive peer-review program that can translate high-quality radiation therapy (RT) to community network sites. In this study, we describe the initial results of a quarterly quality audit program that aims to improve RT peer-review and provider educational processes across community sites. An electronic tool was used by community-based certified member (CM) sites to enter clinical treatment information about patients undergoing peer review. At least 10% of the patient load for each CM physician was selected for audit on a quarterly basis by expert academic faculty. Quality metrics included the review of the management plan, technical plan, and other indicators. RT was scored as being concordant or nonconcordant with institutional guidelines, national standards, or expert judgment. A total of 719 patients were entered into the peer-review database by the first four CM sites. Of 14% of patients audited, 17% (18 of 104) were deemed nonconcordant. Nonconcordance rates were lowest in prevalent disease sites, such as breast (16%), colorectal (14%), and lung (12%), whereas rates were highest in lymphoma (50%), brain (44%), and gynecology (27%). Deficiencies included incomplete staging work-up, incorrect target and normal tissue delineation, and nonadherence to accepted dose-volume constraints. Given the high rate of nonconcordance, we recommend prospective, pre-RT peer review of all patients, and, in particular, expert review of patients that are from low-volume or complex disease sites. An integrated approach to peer review holds a promise of improving the quality, safety, and value of cancer therapy in the community setting. Copyright © 2016 by American Society of Clinical Oncology.

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

    PubMed

    Mross, K; März, W

    2001-02-01

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

  10. The clinical and financial impact of a pediatric surgical neuro-oncology clinical trial.

    PubMed

    Thompson, Eric M; Gururangan, Sridharan; Grant, Gerald; Mitchell, Duane; Sampson, John H

    2017-03-01

    Pediatric surgical trials are rare and the impact of such trials on the institutions in which they are conducted is unknown. The purpose of this study was to analyze the clinical and financial impact of The Re-MATCH trial, a Phase I clinical trial requiring the biopsy or resection of recurrent medulloblastoma or PNET for enrollment. Inpatient financial and clinical volume information was collected during the 3 years of trial enrollment and the years preceding and following it. The primary endpoints were the difference in direct contribution margin (DCM), or net gain, of study and non-study patients and the difference in surgical volume during the study and non-study periods. The trial enrolled 18 patients; 15 had surgery at the sponsor institution and three had surgery at their home institution, then transferred tumor material to the sponsor institution. There were no differences between the two groups for potentially confounding variables such as neurosurgical procedure work relative value units (P = 0.13) or insurance provider (P = 0.26). There was no difference between the inpatient DCM per case for the institution for non-study patients (mean ± SD, $9039 ± $28,549) and study patients ($14,332 ± $20,231) (P = 0.4819). During the non-study period, there were a mean of 2.78 ± 1.65 pediatric brain tumor resections per month compared to 3.34 ± 1.66 cases per month during the study period, a 17% increase. When the 15 study patients were excluded, there were 2.97 ± 1.64 cases per month, a 7% increase. However, this increase in total case volume including study and non-study patients was not significant (P = 0.121). Phase I investigator-initiated surgically-based clinical trials may increase institutional surgical volume without imposing a financial burden. Finances are unlikely to be a barrier for researchers negotiating for resources to conduct such trials.

  11. Clinical Implications of TiGRT Algorithm for External Audit in Radiation Oncology.

    PubMed

    Shahbazi-Gahrouei, Daryoush; Saeb, Mohsen; Monadi, Shahram; Jabbari, Iraj

    2017-01-01

    Performing audits play an important role in quality assurance program in radiation oncology. Among different algorithms, TiGRT is one of the common application software for dose calculation. This study aimed to clinical implications of TiGRT algorithm to measure dose and compared to calculated dose delivered to the patients for a variety of cases, with and without the presence of inhomogeneities and beam modifiers. Nonhomogeneous phantom as quality dose verification phantom, Farmer ionization chambers, and PC-electrometer (Sun Nuclear, USA) as a reference class electrometer was employed throughout the audit in linear accelerators 6 and 18 MV energies (Siemens ONCOR Impression Plus, Germany). Seven test cases were performed using semi CIRS phantom. In homogeneous regions and simple plans for both energies, there was a good agreement between measured and treatment planning system calculated dose. Their relative error was found to be between 0.8% and 3% which is acceptable for audit, but in nonhomogeneous organs, such as lung, a few errors were observed. In complex treatment plans, when wedge or shield in the way of energy is used, the error was in the accepted criteria. In complex beam plans, the difference between measured and calculated dose was found to be 2%-3%. All differences were obtained between 0.4% and 1%. A good consistency was observed for the same type of energy in the homogeneous and nonhomogeneous phantom for the three-dimensional conformal field with a wedge, shield, asymmetric using the TiGRT treatment planning software in studied center. The results revealed that the national status of TPS calculations and dose delivery for 3D conformal radiotherapy was globally within acceptable standards with no major causes for concern.

  12. Can Patient Comorbidities Be Included in Clinical Performance Measures for Radiation Oncology?

    PubMed Central

    Owen, Jean B.; Khalid, Najma; Ho, Alex; Kachnic, Lisa A.; Komaki, Ritsuko; Tao, May Lin; Currey, Adam; Wilson, J. Frank

    2014-01-01

    Purpose: Patient comorbidities may affect the applicability of performance measures that are inherent in multidisciplinary cancer treatment guidelines. This article describes the distribution of common comorbid conditions by disease site and by patient and facility characteristics in patients who received radiation therapy as part of treatment for cancer of the breast, cervix, lung, prostate, and stomach, and investigates the association of comorbidities with treatment decisions. Materials and Methods: Stratified two-stage cluster sampling provided a random sample of radiation oncology facilities. Eligible patients were randomly sampled from each participating facility for each disease site, and data were abstracted from medical records. The Adult Comorbidity Evaluation Index (ACE-27) was used to measure comorbid conditions and their severity. National estimates were calculated using SUDAAN statistical software. Results: Multivariable logistic regression models predicted the dependent variable “treatment changed or contraindicated due to comorbidities.” The final model showed that ACE-27 was highly associated with change in treatment for patients with severe or moderate index values compared to those with none or mild (P < .001). Two other covariates, age and medical coverage, had no (age) or little (medical coverage) significant contribution to predicting treatment change in the multivariable model. Disease site was associated with treatment change after adjusting for other covariates in the model. Conclusions: ACE-27 is highly predictive of treatment modifications for patients treated for these cancers who receive radiation as part of their care. A standardized tool identifying patients who should be excluded from clinical performance measures allows more accurate use of these measures. PMID:24643573

  13. Incorporating patient-reported outcomes to improve emotional distress screening and assessment in an ambulatory oncology clinic.

    PubMed

    Chiang, Anne C; Buia Amport, Stephanie; Corjulo, Diane; Harvey, Katherine L; McCorkle, Ruth

    2015-05-01

    Assessment of distress and well-being of patients with cancer is not always documented or addressed in a clinical visit, reflecting a need for improved psychosocial screening. A multidisciplinary team completed process mapping for emotional distress assessment in two clinics. Barriers were identified through cause-and-effect analysis, and an intervention was chosen. Patient-reported outcomes were collected over 6 months using the validated National Comprehensive Cancer Network Emotional Distress Thermometer (EDT) paper tool. The American Society of Clinical Oncology Quality Oncology Practice Initiative (QOPI) measures were compared before and after intervention. During 6 months, a total of 864 tools were collected from 1,344 patients in two ambulatory clinics (64%). Electronic medical record documentation of distress increased from 19.2% to 34% during the 6 months before and after intervention. QOPI measures showed an increase in emotional well-being documentation. Of 29 new and 835 return patients, 62% indicated mild distress (EDT, 0 to 3), 18% moderate (EDT, 4 to 6), and 11% severe (EDT, 7 to 10). The average distress score of new patients was significantly higher than that of return patients (5.39 [n = 26] v 2.52 [n = 754]; P < .001). The top problems for patients with moderate and severe distress were worry, fatigue, pain, and nervousness; depression and sadness were particularly noted in patients reporting severe distress. Eleven percent of patients were referred to the social worker on site. A pilot intervention collecting Patient-reported outcomes in two ambulatory clinics led to increase in psychosocial distress screening followed by sustained improvement, indicated by both process and QOPI measures. Copyright © 2015 by American Society of Clinical Oncology.

  14. Reducing Unplanned Medical Oncology Readmissions by Improving Outpatient Care Transitions: A Process Improvement Project at the Cleveland Clinic.

    PubMed

    Montero, Alberto J; Stevenson, James; Guthrie, Amy E; Best, Carolyn; Goodman, Lindsey Martin; Shrotriya, Shiva; Azzouqa, Abdel-Ghani; Parala, Armida; Lagman, Ruth; Bolwell, Brian J; Kalaycio, Matt E; Khorana, Alok A

    2016-05-01

    Reducing 30-day unplanned hospital readmissions is a national policy priority. We examined the impact of a quality improvement project focused on reducing oncology readmissions among patients with cancer who were admitted to palliative and general medical oncology services at the Cleveland Clinic. Baseline rates of readmissions were gathered during the period from January 2013 to April 2014. A quality improvement project designed to improve outpatient care transitions was initiated during the period leading to April 1, 2014, including: (1) provider education, (2) postdischarge nursing phone calls within 48 hours, and (3) postdischarge provider follow-up appointments within 5 business days. Nursing callback components included symptom management, education, medication review/compliance, and follow-up appointment reminder. During the baseline period, there were 2,638 admissions and 722 unplanned 30-day readmissions for an overall readmission rate of 27.4%. Callbacks and 5-day follow-up appointment monitoring revealed a mean monthly compliance of 72% and 78%, respectively, improving over time during the study period. Readmission rates declined by 4.5% to 22.9% (P < .01; relative risk reduction, 18%) during the study period. The mean direct cost of one readmission was $10,884, suggesting an annualized cost savings of $1.04 million with the observed reduction in unplanned readmissions. Modest readmission reductions can be achieved through better systematic transitions to outpatient care (including follow-up calls and early provider visits), thereby leading to a reduction in use of inpatient resources. These data suggest that efforts focused on improving outpatient care transition were effective in reducing unplanned oncology readmissions. Copyright © 2016 by American Society of Clinical Oncology.

  15. Weaving Clinical Expertise in Online Health Communities.

    PubMed

    Huh, Jina; Pratt, Wanda

    Many patients visit online health communities to receive support. In face-to-face support groups, health professionals facilitate peer-patients exchanging experience while adding their clinical expertise when necessary. However, the large scale of online health communities makes it challenging for such health professional moderators' involvement to happen. To address this challenge of delivering clinical expertise to where patients need them, we explore the idea of semi-automatically providing clinical expertise in online health communities. We interviewed 14 clinicians showing them example peer-patient conversation threads. From the interviews, we examined the ideal practice of clinicians providing expertise to patients. The clinicians continuously assessed when peer-patients were providing appropriate support, what kinds of clinical help they could give online, and when to defer to patients' healthcare providers. The findings inform requirements for building a semi-automated system delivering clinical expertise in online health communities.

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

    PubMed Central

    Carter, Jonathan

    2012-01-01

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

  17. Oncology and medical education—past, present and future

    PubMed Central

    Cave, Judith

    2016-01-01

    Oncologists should contribute to the undergraduate curriculum whenever they can, and should teach communication skills, acute oncology, prescribing, and other transferable skills. Newly qualified doctors will care for many patients with cancer in their first years of work, and all doctors need to know when an urgent oncology referral is required and to be aware of the pace of change in oncology. Oncologists should involve their patients in teaching whenever it is appropriate. We should aim to inspire junior doctors to consider a career in oncology. The oncology education community should adopt new teaching methods, for example simulation, mock MDTs and student led clinics. CPD provided by honorable organisations, including online learning, is becoming more important for oncologists to keep up to date. PMID:27350792

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

    PubMed

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

    2016-12-01

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

  19. Serving Inland Rural Communities through University Clinics

    ERIC Educational Resources Information Center

    Allan, Julaine; Pope, Rod; O'Meara, Peter; Higgs, Joy; Kent, Jenny

    2011-01-01

    Aim: To effectively provide clinical placements for students and increase healthcare options for rural communities, an investigation of university clinics was conducted. Method: This project adopted a consultative inquiry strategy and involved two processes: (1) a review of literature; and (2) interviews with existing health sciences clinic staff.…

  20. Serving Inland Rural Communities through University Clinics

    ERIC Educational Resources Information Center

    Allan, Julaine; Pope, Rod; O'Meara, Peter; Higgs, Joy; Kent, Jenny

    2011-01-01

    Aim: To effectively provide clinical placements for students and increase healthcare options for rural communities, an investigation of university clinics was conducted. Method: This project adopted a consultative inquiry strategy and involved two processes: (1) a review of literature; and (2) interviews with existing health sciences clinic staff.…

  1. 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.

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

    PubMed

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

    2016-05-21

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

  3. HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma: Guideline From the College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology.

    PubMed

    Bartley, Angela N; Washington, Mary Kay; Ventura, Christina B; Ismaila, Nofisat; Colasacco, Carol; Benson, Al B; Carrato, Alfredo; Gulley, Margaret L; Jain, Dhanpat; Kakar, Sanjay; Mackay, Helen J; Streutker, Catherine; Tang, Laura; Troxell, Megan; Ajani, Jaffer A

    2016-12-01

    ERBB2 (erb-b2 receptor tyrosine kinase 2 or HER2) is currently the only biomarker established for selection of a specific therapy for patients with advanced gastroesophageal adenocarcinoma (GEA). However, there are no comprehensive guidelines for the assessment of HER2 in patients with GEA. To establish an evidence-based guideline for HER2 testing in patients with GEA, to formalize the algorithms for methods to improve the accuracy of HER2 testing while addressing which patients and tumor specimens are appropriate, and to provide guidance on clinical decision making. The College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology convened an expert panel to conduct a systematic review of the literature to develop an evidence-based guideline with recommendations for optimal HER2 testing in patients with GEA. The panel is proposing 11 recommendations with strong agreement from the open-comment participants. The panel recommends that tumor specimen(s) from all patients with advanced GEA, who are candidates for HER2-targeted therapy, should be assessed for HER2 status before the initiation of HER2-targeted therapy. Clinicians should offer combination chemotherapy and a HER2-targeted agent as initial therapy for all patients with HER2-positive advanced GEA. For pathologists, guidance is provided for morphologic selection of neoplastic tissue, testing algorithms, scoring methods, interpretation and reporting of results, and laboratory quality assurance. This guideline provides specific recommendations for assessment of HER2 in patients with advanced GEA while addressing pertinent technical issues and clinical implications of the results. © 2016 College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  4. 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.

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

    PubMed

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

    2017-02-20

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

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

    SciTech Connect

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

    2011-06-01

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

  7. Breast cancer follow-up and management after primary treatment: American Society of Clinical Oncology clinical practice guideline update.

    PubMed

    Khatcheressian, James L; Hurley, Patricia; Bantug, Elissa; Esserman, Laura J; Grunfeld, Eva; Halberg, Francine; Hantel, Alexander; Henry, N Lynn; Muss, Hyman B; Smith, Thomas J; Vogel, Victor G; Wolff, Antonio C; Somerfield, Mark R; Davidson, Nancy E

    2013-03-01

    To provide recommendations on the follow-up and management of patients with breast cancer who have completed primary therapy with curative intent. To update the 2006 guideline of the American Society of Clinical Oncology (ASCO), a systematic review of the literature published from March 2006 through March 2012 was completed using MEDLINE and the Cochrane Collaboration Library. An Update Committee reviewed the evidence to determine whether the recommendations were in need of updating. There were 14 new publications that met inclusion criteria: nine systematic reviews (three included meta-analyses) and five randomized controlled trials. After its review and analysis of the evidence, the Update Committee concluded that no revisions to the existing ASCO recommendations were warranted. Regular history, physical examination, and mammography are recommended for breast cancer follow-up. Physical examinations should be performed every 3 to 6 months for the first 3 years, every 6 to 12 months for years 4 and 5, and annually thereafter. For women who have undergone breast-conserving surgery, a post-treatment mammogram should be obtained 1 year after the initial mammogram and at least 6 months after completion of radiation therapy. Thereafter, unless otherwise indicated, a yearly mammographic evaluation should be performed. The use of complete blood counts, chemistry panels, bone scans, chest radiographs, liver ultrasounds, pelvic ultrasounds, computed tomography scans, [(18)F]fluorodeoxyglucose-positron emission tomography scans, magnetic resonance imaging, and/or tumor markers (carcinoembryonic antigen, CA 15-3, and CA 27.29) is not recommended for routine follow-up in an otherwise asymptomatic patient with no specific findings on clinical examination.

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

    SciTech Connect

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

    2013-02-01

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

  9. Racial disparities in cancer survival among randomized clinical trials patients of the Southwest Oncology Group.

    PubMed

    Albain, Kathy S; Unger, Joseph M; Crowley, John J; Coltman, Charles A; Hershman, Dawn L

    2009-07-15

    Racial disparities in cancer outcomes have been observed in several malignancies. However, it is unclear if survival differences persist after adjusting for clinical, demographic, and treatment variables. Our objective was to determine whether racial disparities in survival exist among patients enrolled in consecutive trials conducted by the Southwest Oncology Group (SWOG). We identified 19 457 adult cancer patients (6676 with breast, 2699 with lung, 1244 with colon, 1429 with ovarian, and 1843 with prostate cancers; 1291 with lymphoma; 2067 with leukemia; and 2208 with multiple myeloma) who were treated on 35 SWOG randomized phase III clinical trials from October 1, 1974, through November 29, 2001. Patients were grouped according to studies of diseases with similar histology and stage. Cox regression was used to evaluate the association between race and overall survival within each disease site grouping, controlling for available prognostic factors plus education and income, which are surrogates for socioeconomic status. Median and ten-year overall survival estimates were derived by the Kaplan-Meier method. All statistical tests were two-sided. Of 19 457 patients registered, 2308 (11.9%, range = 3.9%-21.6%) were African American. After adjustment for prognostic factors, African American race was associated with increased mortality in patients with early-stage premenopausal breast cancer (hazard ratio [HR] for death = 1.41, 95% confidence interval [CI] = 1.10 to 1.82; P = .007), early-stage postmenopausal breast cancer (HR for death = 1.49, 95% CI = 1.28 to 1.73; P < .001), advanced-stage ovarian cancer (HR for death = 1.61, 95% CI = 1.18 to 2.18; P = .002), and advanced-stage prostate cancer (HR for death = 1.21, 95% CI = 1.08 to 1.37; P = .001). No statistically significant association between race and survival for lung cancer, colon cancer, lymphoma, leukemia, or myeloma was observed. Additional adjustments for socioeconomic status did not substantially change

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

    PubMed

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

    2016-10-25

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

  11. Using the New ASCO Clinical Practice Guideline for Palliative Care Concurrent With Oncology Care Using the TEAM Approach.

    PubMed

    Smith, Cardinale B; Phillips, Tanyanika; Smith, Thomas J

    2017-01-01

    Palliative care alongside usual oncology care is now recommended by ASCO as the standard of care for any patient with advanced cancer on the basis of multiple randomized trials that show better results with concurrent care than with usual oncology care. Some benefits include better quality of life, better symptom management, reduced anxiety and depression, less caregiver distress, more accordance of care with the wishes of the patient, and less aggressive end-of-life care. Several studies show a survival advantage of several months, and many show considerable cost savings: better care at an affordable cost. However, there are not enough palliative care specialists available, so oncologists must practice exemplary primary palliative care. Protocols used in the clinical trials, similar to those designed for new chemotherapy agents, help oncologists use the TEAM approach of extra time, typically an hour a month spent with the palliative care team; education, especially about prognostic awareness and realistic options, which include formal setting of goals of care and discussion of advance directives; formal assessments for symptoms and for spiritual and psychosocial health; and management by an interdisciplinary team. These are all potentially accomplished by an oncology practice to replicate the services provided by concurrent palliative care.

  12. The experiences of undergraduate nursing students and self-reflective accounts of first clinical rotation in pediatric oncology.

    PubMed

    Mirlashari, Jila; Warnock, Fay; Jahanbani, Jahanfar

    2017-07-01

    The clinical practicum is one of the most anticipated components of the nursing program for nursing students. However, the practicum can be anxiety producing for students, especially when it is their first placement in an emotional demanding setting like pediatric oncology unit. Taking care of children with cancer and who are facing the death trajectory is complex and demanding not only for students but also for the experienced nurse. In this qualitative research, the purpose was to explore senior student perceptions and self-reflective accounts of what it was like to care for children with cancer and their family throughout the course of their first practicum on a pediatric oncology unit that also provided children palliative care as needed. Data from the self-reflective journals and interviews were analyzed together using conventional content analysis. The three resultant categories that emerged: state of shock and getting lost, walking in to a mind shaking world and finding the way provided in-depth novel insight on the perceptions of senior undergraduate nursing students as they journey through their first time practicum on a pediatric oncology unit. The findings also confirmed the importance and benefit of reflective journaling to student integrated learning and adjustment in nursing practice. Copyright © 2017 Elsevier Ltd. All rights reserved.

  13. 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)

  14. 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)

  15. Research Areas - Clinical Trials

    Cancer.gov

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  16. 01. Interprofessional, Integrative Treatment of Oncology Patients at a Large Midwestern Community Health System

    PubMed Central

    Piant, Patricia; Walker, Charlotte; Beck, Carole; Chamness, John

    2013-01-01

    Focus Area: Integrative Approaches to Care The Integrative Medicine team at NorthShore University Health System has practiced together for the past 12 years, with a majority of our clientele dealing with oncology issues. We follow patients through the various stages of their cancer treatments, from prevention of cancer, to time of diagnosis, chemotherapy, radiation, surgery, rehabilitation, survivorship, recurrence, and hospice and palliative care. Based on the framework of treating a patient with cancer, our panelists will discuss each of their treatment strategies, ranging from bodywork, energy work, traditional Chinese medicine, counseling, guided imagery, herbal and nutritional supplements, and hospice and palliative care. We also will discuss the administrative and financial miracles that make it all happen as seamlessly as possible while increasing access to care for those who cannot afford these services.

  17. Real-world treatment patterns and associated progression-free survival in relapsed/refractory multiple myeloma among US community oncology practices.

    PubMed

    Jagannath, Sundar; Roy, Anuja; Kish, Jonathan; Lunacsek, Orsolya; Globe, Denise; Eaddy, Michael; Kuriakose, Emil T; Willey, Joanne; Butler-Bird, Stephanie; Siegel, David

    2016-07-01

    Evidence supporting optimal treatment sequencing in relapsed/refractory multiple myeloma (RRMM) patients requiring multiple therapy lines is lacking. Using retrospective chart data, this study describes real-world RRMM treatment patterns and related progression-free survival (PFS) in US community oncology clinics. Bortezomib ± a non-immunomodulatory drug (IMiD), lenalidomide ± a non-proteasome inhibitor (PI), bortezomib + an IMiD were the most commonly used regimens in early lines of therapy. Median PFS was similar in 1(st) (11.1 months) and 2(nd) line (10.5) and decreased in lines 3 through 5 (3(rd): 7.9; 4(th): 7.2, 5(th): 5.4). Longest PFS (12.5 months) in first line was with bortezomib + ImiD; longest PFS in second line was with lenalidomide ± a non-PI was (13.2 months). Re-treatment with bortezomib was common; novel agents were reserved for later therapy lines. Overall, the observed PFS associated with real-world treatment sequences were shorter than those reported in clinical trials.

  18. Aggregate/community-centered undergraduate community health nursing clinical experience.

    PubMed

    Flick, L H; Reese, C; Harris, A

    1996-02-01

    Debate continues about the appropriateness of clinical experiences targeting aggregates in undergraduate community health nursing education. This paper describes a practical model to teach, through experience, the concepts of aggregate/community-centered practice at the baccalaureate level. As a voluntary alternative to the usual community assessment paper, groups of students worked in partnership with community groups to define health needs and to address one need. Sequential student groups focused the assessment and implemented a plan. The required time for each project varied. One project is described to illustrate the model. While independent community-centered practice is not expected of the B.S.N. graduate, the model described here develops comprehension of the concepts and process of such practice.

  19. 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

  20. Reconstruction-Incorporated Respiratory Motion Correction in Clinical Simultaneous PET/MR Imaging for Oncology Applications.

    PubMed

    Fayad, Hadi; Schmidt, Holger; Wuerslin, Christian; Visvikis, Dimitris

    2015-06-01

    Simultaneous PET and MR imaging is a promising new technique allowing the fusion of functional (PET) and anatomic/functional (MR) information. In the thoracic-abdominal regions, respiratory motion is a major challenge leading to reduced quantitative and qualitative image accuracy. Correction methodologies include the use of gated frames that lead to low signal-to-noise ratio considering the associated low statistics. More advanced correction approaches, previously developed for PET/CT imaging, consist of either registering all the reconstructed gated frames to the reference frame or incorporating motion parameters into the iterative reconstruction process to produce a single motion-compensated PET image. The goal of this work was to compare these two—previously implemented in PET/CT—correction approaches within the context of PET/MR motion correction for oncology applications using clinical 4-dimensional PET/MR acquisitions. Two different correction approaches were evaluated comparing the incorporation of elastic transformations extracted from 4-dimensional MR imaging datasets during PET list-mode image reconstruction to a postreconstruction image-based approach. Eleven patient datasets acquired on a PET/MR system were used. T1-weighted 4D MR images were registered to the end-expiration image using a nonrigid B-spline registration algorithm to derive deformation matrices accounting for respiratory motion. The derived matrices were subsequently incorporated within a PET image reconstruction of the original emission list-mode data (reconstruction space [RS] method). The corrected images were compared with those produced by applying the deformation matrices in the image space (IS method) followed by summing the realigned gated frames, as well as with uncorrected motion-averaged images. Both correction techniques led to significant improvement in accounting for respiratory motion artifacts when compared with uncorrected motion-averaged images. These improvements

  1. Clinical and laboratory parameter dynamics as markers of blood stream infections in pediatric oncology patients with fever and neutropenia.

    PubMed

    Hazan, Guy; Ben-Shimol, Shalom; Fruchtman, Yariv; Abu-Quider, Abed; Kapelushnik, Joseph; Moser, Asher; Falup-Pecurariu, Oana; Greenberg, David

    2014-07-01

    Identifying markers associated with blood stream infection (BSI) in children with fever and neutropenia (FN) could lead to a substantial reduction in unnecessary treatment. The aim of this study was to determine the association between clinical/laboratory parameters and BSI in pediatric oncology patients with FN. This prospective study was conducted between 2007 and 2010 at the Pediatric oncology unit. Clinical and laboratory parameters were obtained from all hospitalized FN patients. Linear regression and trends were calculated to determine the association between clinical/laboratory parameters and BSI. Of the 195 FN episodes in 73 children, BSIs were identified in 38 (19%) episodes. Gram-positive bacteria, gram-negative bacteria, and fungi caused 47%, 43%, and 10% of all BSIs, respectively. Mean fever duration was longer in the BSI group (5 d) compared with the non-BSI group (2 d, P=0.01). Mean (±SD) monocyte count at admission was lower in the BSI group compared with the non-BSI group (0.06±0.1 vs. 0.14±0.33 cells/mm, respectively, P=0.05). Mean C-reactive protein (CRP) levels at hospitalization days 5 to 8 were higher in children with BSI (P<0.001). Increment trends of monocyte and platelet levels and decrement trend of CRP levels were noted in the BSI group but not in the non-BSI group (P<0.01 for all). Prolonged fever, lower monocyte count at admission, higher CRP levels between the fifth and the eighth hospitalization days, increment trends of monocyte and platelet levels, and CRP level decrement were associated with BSI. These factors may serve as markers for BSI in pediatric oncology patients with FN.

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

    PubMed Central

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

    2015-01-01

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

  3. Oncology Nursing Society

    MedlinePlus

    ... Account Login Cart Search the ONS website Continuing Nursing Education Courses and Activities Access Devices: The Virtual ... Vomiting Chemotherapy for Non-Oncology Conditions Clinical Trials Nursing 101 Cognitive Impairment Fundamentals of Blood and Marrow ...

  4. Diagnosis of Upper-Quadrant Lymphedema Secondary to Cancer: Clinical Practice Guideline From the Oncology Section of APTA

    PubMed Central

    Levenhagen, Kimberly; Davies, Claire; Perdomo, Marisa; Ryans, Kathryn

    2017-01-01

    Introduction: The Oncology Section of APTA developed a clinical practice guideline to aid the clinician in diagnosing secondary upper-quadrant cancer-related lymphedema. Methods: Following a systematic review of published studies and a structured appraisal process, recommendations were written to guide the physical therapist and other health care clinicians in their diagnostic process. Overall, clinical practice recommendations were formulated on the basis of the evidence for each diagnostic method and were assigned a grade based on the strength of the evidence for different patient presentations and clinical utility. Recommendations: In an effort to make these clinically applicable, recommendations were based on the characteristics as to the location and stage of a patient's upper-quadrant lymphedema. PMID:28748128

  5. [New trends and novel possibilities in the management of oncologic patients: clinical uses of PET/MRI].

    PubMed

    Borbély, Katalin

    2015-03-01

    The most recent multimodality technique, the hybrid positron emission tomography/magnetic resonance imaging (PET/MRI) combines two very different technologies, which is a great result of human creativity. The combined PET/MRI has significant potentials in clinical oncology providing new perspectives of functional and anatomical information. PET/MRI offers simultaneous measurements of multifunctional data such as PET mapping by different specific tracers or MRI morphologic, MR molecular (MR spectroscopy, MRS), or MR functional (fMR) information of a living system.

  6. Liquid dynamic medicine and N-of-1 clinical trials: a change of perspective in oncology research.

    PubMed

    Silvestris, Nicola; Ciliberto, Gennaro; De Paoli, Paolo; Apolone, Giovanni; Lavitrano, Maria Luisa; Pierotti, Marco A; Stanta, Giorgio

    2017-09-13

    The increasing use of genomics to define the pattern of actionable mutations and to test and validate new therapies for individual cancer patients, and the growing application of liquid biopsy to dynamically track tumor evolution and to adapt molecularly targeted therapy according to the emergence of tumor clonal variants is shaping modern medical oncology., In order to better describe this new therapeutic paradigm we propose the term "Liquid dynamic medicine" in the place of "Personalized or Precision medicine". Clinical validation of the "Liquid dynamic medicine" approach is best captured by N-of-1 trials where each patient acts as tester and control of truly personalized therapies.

  7. 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.

  8. Clinical skill development for community pharmacists.

    PubMed

    Barnette, D J; Murphy, C M; Carter, B L

    1996-09-01

    The importance of establishing clinical pharmacy services in the community cannot be understated in light of current challenges to the traditional dispensing role as the primary service of the community pharmacist. Advancements in automated dispensing technology and declining prescription fee reimbursement are rapidly forcing pharmacists to seek alternative sources of revenue. Providing pharmaceutical care is a viable option to increase customer loyalty job satisfaction, and reimbursement. To support the development of clinical services, academic institutions are forming partnerships with individual community practitioners to overcome perceived educational and training barriers. The authors describe the design and development of two unique clinical skill development programs at the University of Illinois at Chicago. This paper also outlines the patient focused services that the participants have established upon completing the training. These programs successfully enhanced participants' therapeutic knowledge base and facilitated development of the clinical skills necessary for direct patient care.

  9. Omics AnalySIs System for PRecision Oncology (OASISPRO): A Web-based Omics Analysis Tool for Clinical Phenotype Prediction.

    PubMed

    Yu, Kun-Hsing; Fitzpatrick, Michael R; Pappas, Luke; Chan, Warren; Kung, Jessica; Snyder, Michael

    2017-09-12

    Precision oncology is an approach that accounts for individual differences to guide cancer management. Omics signatures have been shown to predict clinical traits for cancer patients. However, the vast amount of omics information poses an informatics challenge in systematically identifying patterns associated with health outcomes, and no general-purpose data-mining tool exists for physicians, medical researchers, and citizen scientists without significant training in programming and bioinformatics. To bridge this gap, we built the Omics AnalySIs System for PRecision Oncology (OASISPRO), a web-based system to mine the quantitative omics information from The Cancer Genome Atlas (TCGA). This system effectively visualizes patients' clinical profiles, executes machine-learning algorithms of choice on the omics data, and evaluates the prediction performance using held-out test sets. With this tool, we successfully identified genes strongly associated with tumor stage, and accurately predicted patients' survival outcomes in many cancer types, including mesothelioma and adrenocortical carcinoma. By identifying the links between omics and clinical phenotypes, this system will facilitate omics studies on precision cancer medicine and contribute to establishing personalized cancer treatment plans. This web-based tool is available at http://tinyurl.com/oasispro ;source codes are available at http://tinyurl.com/oasisproSourceCode .

  10. SU-F-P-13: NRG Oncology Medical Physics Manpower Survey Quantifying Support Demands for Multi Institutional Clinical Trials

    SciTech Connect

    Monroe, J; Boparai, K; Xiao, Y; Followill, D; Galvin, J; Sohn, J

    2016-06-15

    Purpose: A survey was taken by NRG Oncology to assess Full Time Equivalent (FTE) contributions to multi institutional clinical trials by medical physicists.No current quantification of physicists’ efforts in FTE units associated with clinical trials is available. The complexity of multi-institutional trials increases with new technologies and techniques. Proper staffing may directly impact the quality of trial data and outcomes. The demands on physics time supporting clinical trials needs to be assessed. Methods: The NRG Oncology Medical Physicist Subcommittee created a sixteen question survey to obtain this FTE data. IROC Houston distributed the survey to their list of 1802 contact physicists. Results: After three weeks, 363 responded (20.1% response). 187 (51.5%) institutions reporting external beam participation were processed. There was a wide range in number of protocols active and supported at each institution. Of the 187 clinics, 134 (71.7%) participate in 0 to 10 trials, 28 (15%) in 11 to 20 trials, 10 (5.3%) in 21 to 30 trials, 9 (4.8%) had 40 to 75 trials. On average, physicist spent 2.7 hours (SD: 6.0) per week supervising or interacting with clinical trial staff. 1.25 hours (SD: 3.37), 1.83 hours (SD: 4.13), and 0.64 hours(SD: 1.13) per week were spent on patient simulation, reviewing treatment plans, and maintaining a DICOM server, respectively. For all protocol credentialing activities, physicist spent an average of 37.05 hours (SD: 96.94) yearly. To support dosimetrists, clinicians, and therapists, physicist spend on average 2.07 hours (SD: 3.52) per week just reading protocols. Physicist attended clinical trial meetings for on average 1.13 hours (SD: 1.85) per month. Conclusion: Responding physicists spend a nontrivial amount of time: 8.8 hours per week (0.22 FTE) supporting, on average, 9 active multi-institutional clinical trials.

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

    PubMed Central

    Mendonsa, Rohan Dilip; Appaya, Prakash

    2010-01-01

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

  12. ANMCO/AIOM/AICO Consensus Document on clinical and management pathways of cardio-oncology: executive summary.

    PubMed

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

    2017-05-01

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

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

    PubMed

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

    2015-06-01

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

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

    PubMed Central

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

    2015-01-01

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

  15. Training oncology and palliative care clinical nurse specialists in psychological skills: evaluation of a pilot study.

    PubMed

    Clark, Jane E; Aitken, Susan; Watson, Nina; McVey, Joanne; Helbert, Jan; Wraith, Anita; Taylor, Vanessa; Catesby, Sarah

    2015-06-01

    National guidelines in the United Kingdom recommend training Clinical Nurse Specialists in psychological skills to improve the assessment and intervention with psychological problems experienced by people with a cancer diagnosis (National Institute for Health and Clinical Excellence, 2004). This pilot study evaluated a three-day training program combined with supervision sessions from Clinical Psychologists that focused on developing skills in psychological assessment and intervention for common problems experienced by people with cancer. Questionnaires were developed to measure participants' levels of confidence in 15 competencies of psychological skills. Participants completed these prior to the program and on completion of the program. Summative evaluation was undertaken and results were compared. In addition, a focus group interview provided qualitative data of participants' experiences of the structure, process, and outcomes of the program. Following the program, participants rated their confidence in psychological assessment and skills associated with providing psychological support as having increased in all areas. This included improved knowledge of psychological theories, skills in assessment and intervention and accessing and using supervision appropriately. The largest increase was in providing psycho-education to support the coping strategies of patients and carers. Thematic analysis of interview data identified two main themes including learning experiences and program enhancements. The significance of the clinical supervision sessions as key learning opportunities, achieved through the development of a community of practice, emerged. Although this pilot study has limitations, the results suggest that a combined teaching and supervision program is effective in improving Clinical Nurse Specialists' confidence level in specific psychological skills. Participants' experiences highlighted suggestions for refinement and development of the program

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

    PubMed

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

    2016-12-01

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

  17. Validation workflow for a clinical Bayesian network model in multidisciplinary decision making in head and neck oncology treatment.

    PubMed

    Cypko, Mario A; Stoehr, Matthaeus; Kozniewski, Marcin; Druzdzel, Marek J; Dietz, Andreas; Berliner, Leonard; Lemke, Heinz U

    2017-02-15

    Oncological treatment is being increasingly complex, and therefore, decision making in multidisciplinary teams is becoming the key activity in the clinical pathways. The increased complexity is related to the number and variability of possible treatment decisions that may be relevant to a patient. In this paper, we describe validation of a multidisciplinary cancer treatment decision in the clinical domain of head and neck oncology. Probabilistic graphical models and corresponding inference algorithms, in the form of Bayesian networks, can support complex decision-making processes by providing a mathematically reproducible and transparent advice. The quality of BN-based advice depends on the quality of the model. Therefore, it is vital to validate the model before it is applied in practice. For an example BN subnetwork of laryngeal cancer with 303 variables, we evaluated 66 patient records. To validate the model on this dataset, a validation workflow was applied in combination with quantitative and qualitative analyses. In the subsequent analyses, we observed four sources of imprecise predictions: incorrect data, incomplete patient data, outvoting relevant observations, and incorrect model. Finally, the four problems were solved by modifying the data and the model. The presented validation effort is related to the model complexity. For simpler models, the validation workflow is the same, although it may require fewer validation methods. The validation success is related to the model's well-founded knowledge base. The remaining laryngeal cancer model may disclose additional sources of imprecise predictions.

  18. 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

  19. Adoption of an integrated radiology reading room within a urologic oncology clinic: initial experience in facilitating clinician consultations.

    PubMed

    Rosenkrantz, Andrew B; Lepor, Herbert; Taneja, Samir S; Recht, Michael P

    2014-05-01

    The authors describe their initial experience in implementing an integrated radiology reading room within a urologic oncology clinic, including the frequency and nature of clinician consultations and the perceived impact on patient management by clinicians. A radiology reading room was established within an office-based urologic oncology clinic in proximity to the surgeon's work area. A radiologist was present in this reading room for a 3-hour shift each day. The frequency and nature of consultations during these shifts were recorded. Also, the clinic's staff completed a survey assessing perceptions of the impact of the integrated reading room on patient management. One hundred two consultations occurred during 57 included dates (average, 1.8 consultations per shift): 52% for review of external cases brought in by patients on discs, 43% for review of internal cases, and 5% for direct review by the radiologist of imaging with patients. The maximum number of consultations during a single shift was 8. All of the clinic's urologists indicated that >90% of consultations benefited patient care. The clinicians indicated tendencies to view consultations as affecting management in the majority of cases, to be more likely to seek consultation for outside imaging when the radiologist was on site, and to be less likely to repeat outside imaging when the radiologist was on site. The integrated reading room within the clinic has potential to improve the quality of care, for instance by facilitating increased review of outside imaging studies and thereby potentially reducing duplicate ordering and by enabling occasional direct image review with patients by radiologists. Copyright © 2014 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  20. 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

  1. Communities of clinical practice: the social organization of clinical learning.

    PubMed

    Egan, Tony; Jaye, Chrystal

    2009-01-01

    The social organization of clinical learning is under-theorized in the sociological literature on the social organization of health care. Professional scopes of practice and jurisdictions are formally defined by professional principles and standards and reflected in legislation; however, these are mediated through the day-to-day clinical activities of social groupings of clinical teams. The activities of health service providers typically occur within communities of clinical practice. These are also major sites for clinical curriculum delivery, where clinical students learn not only clinical skills but also how to be health professionals. In this article, we apply Wenger's model of social learning within organizations to curriculum delivery within a health service setting. Here, social participation is the basis of learning. We suggest that it offers a powerful framework for recognizing and explaining paradox and incongruence in clinical teaching and learning, and also for recognizing opportunities, and devising means, to add value to students' learning experiences.

  2. "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.

  3. To Friend or Not to Friend: The Use of Social Media in Clinical Oncology

    PubMed Central

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

    2012-01-01

    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. PMID:23077437

  4. 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.

  5. 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. Copyright 2016 Prous Science, S.A.U. or its licensors. All rights reserved.

  6. 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

  7. A multisite, community oncology-based randomized trial of a brief educational intervention to increase communication regarding complementary and alternative medicine.

    PubMed

    Parker, Patricia A; Urbauer, Diana; Fisch, Michael J; Fellman, Bryan; Hough, Holly; Miller, Jessica; Lanzotti, Victor; Whisnant, Mindy; Weiss, Matthias; Fellenz, Lori; Bury, Martin; Kokx, Patricia; Finn, Kathleen; Daily, Maureen; Cohen, Lorenzo

    2013-10-01

    The use of complementary and alternative medicine (CAM) is widespread, yet there is relatively little discussion regarding its use between oncology patients and their health care practitioners. This multisite randomized trial examined the efficacy of an educational intervention designed to encourage oncology nurses to discuss CAM use with their patients. A total of 175 nurses completed questionnaires about discussing CAM use with patients at baseline and 2 months after the intervention. Patients at baseline (N = 699) and different patients at follow-up (N = 650) completed questionnaires regarding CAM. At the 2-month follow-up, nurses in the intervention reported they were more likely to ask about CAM use than those in the control group (odds ratio, 4.2; P = .005). However, no significant effect was found for the percentage of patients who indicated that they were asked about CAM use (odds ratio, 2.1; P > .10). Approximately 40% of patients reported using CAM after their cancer diagnosis, yet the majority of nurses estimated that < 25% of their patients were using CAM. CAM use in community-based oncology patients is common and is underestimated by oncology nurses. The brief, low-intensity intervention presented herein was found to be sufficiently powerful to change nurses' perceptions of their behavior but may not have been intensive enough to yield changes that were evident to patients. Copyright © 2013 UT MD Anderson Cancer Center. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.

  8. Clinical evaluation of dental and periodontal status in a group of oncological patients before chemotherapy.

    PubMed

    López-Galindo, Mónica Paula; Bagán, José V; Jiménez-Soriano, Yolanda; Alpiste, Francisco; Camps, Carlos

    2006-01-01

    To evaluate the dental status of 88 cancer patients before chemotherapy. Eighty-eight patients with cancer in different body locations were studied and compared with a control group. Dental plaque was assessed by means of the Silness and Löe index, dental status with the DMFT index, and periodontal status with the modified CPI index. In the oncological patients the mean Silness and Löe index was 1.28-/+0.11. Patients showed multiple missing teeth (mean number 7.55-/+0.80); the mean number of decayed teeth was 2.10-/+0.36; and the mean number of filled teeth was 2.27-/+0.37. As to periodontal status, the mean modified CPI index was 1.45-/+0.11. In the control group, the mean Silness and Löe index was 0.94-/+0.00. The mean number of decayed teeth was 1.21-/+0.25; the mean number of missing teeth was 4.97-/+0.67; and the mean number of filled teeth was 4.82-/+0.44. The mean modified CPI index was 1.29-/+0.10. Oncological patients in our study showed more dental plaque versus healthy patients and more decayed and missing teeth. However, patients in the control group showed more filled teeth than cancer patients. Periodontal status as determined by the modified CPI index was similar in both patient groups.

  9. 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.

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

    PubMed

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

    2017-01-01

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

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

    PubMed Central

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

    2016-01-01

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

  12. 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

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

    2016-01-01

    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. 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. 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. 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 access to research opportunity are needed; the perception

  13. 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

  14. Advancing performance measurement in oncology.

    PubMed

    Campion, Francis X; Larson, Leanne R; Kadlubek, Pamela J; Earle, Craig C; Neuss, Michael N

    2011-05-01

    The American healthcare system, including the cancer care system, is under pressure to improve patient outcomes and lower the cost of care. Government payers have articulated an interest in partnering with the private sector to create learning communities to measure quality and improve the value of healthcare. In 2006, the American Society of Clinical Oncology (ASCO) unveiled the Quality Oncology Practice Initiative (QOPI), which has become a key component of the measurement system to promote quality cancer care. QOPI is a physician-led, voluntary, practice-based, quality-improvement program, using performance measurement and benchmarking among oncology practices across the United States. Since its inception, ASCO's QOPI has grown steadily to include 973 practices as of November 2010. One key area that QOPI has addressed is end-of-life care. During the most recent data collection cycle in the fall of 2010, those practices completing multiple data collection cycles had better performance on care of pain compared with sites participating for the first time (62.61% vs 46.89%). Similarly, repeat QOPI participants demonstrated meaningfully better performance than their peers in the rate of documenting discussions of hospice and palliative care (62.42% vs 54.65%) and higher rates of hospice enrollment. QOPI demonstrates how a strong performance measurement program can lead to improved quality and value of care for patients.

  15. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update.

    PubMed

    Wolff, Antonio C; Hammond, M Elizabeth H; Hicks, David G; Dowsett, Mitch; McShane, Lisa M; Allison, Kimberly H; Allred, Donald C; Bartlett, John M S; Bilous, Michael; Fitzgibbons, Patrick; Hanna, Wedad; Jenkins, Robert B; Mangu, Pamela B; Paik, Soonmyung; Perez, Edith A; Press, Michael F; Spears, Patricia A; Vance, Gail H; Viale, Giuseppe; Hayes, Daniel F

    2013-11-01

    To update the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for human epidermal growth factor receptor 2 (HER2) testing in breast cancer to improve the accuracy of HER2 testing and its utility as a predictive marker in invasive breast cancer. ASCO/CAP convened an Update Committee that included coauthors of the 2007 guideline to conduct a systematic literature review and update recommendations for optimal HER2 testing. The Update Committee identified criteria and areas requiring clarification to improve the accuracy of HER2 testing by immunohistochemistry (IHC) or in situ hybridization (ISH). The guideline was reviewed and approved by both organizations. The Update Committee recommends that HER2 status (HER2 negative or positive) be determined in all patients with invasive (early stage or recurrence) breast cancer on the basis of one or more HER2 test results (negative, equivocal, or positive). Testing criteria define HER2-positive status when (on observing within an area of tumor that amounts to > 10% of contiguous and homogeneous tumor cells) there is evidence of protein overexpression (IHC) or gene amplification (HER2 copy number or HER2/CEP17 ratio by ISH based on counting at least 20 cells within the area). If results are equivocal (revised criteria), reflex testing should be performed using an alternative assay (IHC or ISH). Repeat testing should be considered if results seem discordant with other histopathologic findings. Laboratories should demonstrate high concordance with a validated HER2 test on a sufficiently large and representative set of specimens. Testing must be performed in a laboratory accredited by CAP or another accrediting entity. The Update Committee urges providers and health systems to cooperate to ensure the highest quality testing. This guideline was developed through a collaboration between the American Society of Clinical Oncology and the College of American Pathologists and

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

    PubMed

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

    2010-03-01

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

  17. Status of oncologic specialties: global survey of physicians treating cancer.

    PubMed

    Komiya, Takefumi; Mackay, Christine B; Chalise, Prabhakar

    2017-04-01

    In the United States, medical oncologists play a central role in the management of systemic therapy for cancer patients. Medical oncology as a specialty is not as established in Japan and several other European nations according to recent surveys, and little is known about this specialty in developing nations. We aimed to identify global differences in the roles of physicians treating cancer; specifically, how the management of advanced disease differs among nations. In March 2016, a self-administered internet survey was conducted with degreed physicians who prescribed systemic agents for adult cancer treatment within the past 5 years. Physicians were identified from the American Society of Clinical Oncology active member online directory. Among 3907 members in 55 nations, 376 (9.6%) responded to the survey. The 310 respondents who provided an answer to the recognition of medical oncology were dominated by male MDs that have practiced for more than 5 years at academic centers, and ~60% were medical oncologists. A majority of the respondents in all four regions reported that medical oncology was established in their corresponding nations. However, there are several outlying nations where oncologic specialties play a minimal role in the management of systemic therapy. Despite general recognition of medical oncology, the role is not globally established as the primary point of care for delivery of systemic therapy. Nations lacking this specialty should be assisted by the international community to develop medical oncology.

  18. Assessing clinical significance in measuring oncology patient quality of life: introduction to the symposium, content overview, and definition of terms.

    PubMed

    Sloan, Jeff A; Cella, David; Frost, Marlene; Guyatt, Gordon H; Sprangers, Mirjam; Symonds, Tara

    2002-04-01

    The Clinical Significance Consensus Meeting Group of the Symposium on the Clinical Significance of Quality-of-Life Measures in Cancer Patients produced 6 articles regarding the clinical significance of quality of life (QOL) assessments in oncology. The 6 articles deal with the methods used to date: group-vs-individual clinical significance; single items vs summated scores; patient, clinician, and population perspectives; assessment of changes over time; and communication of results. The articles were produced by a team of 30 QOL research experts assembled in a consensus writing meeting held at the Mayo Clinic, Rochester, Minn, October 6 and 7, 2000. This introduction describes the need for the articles, definitions of key terms, and plans for the future. It is hoped that this series of articles will serve as a resource for individuals conducting cancer QOL research and for clinicians considering incorporation of QOL assessment in the treatment of patients with neoplastic diseases. A secondary goal is to stimulate further discussion and research in the interpretation of QOL assessments.

  19. Current status of patient-reported outcomes in industry-sponsored oncology clinical trials and product labels.

    PubMed

    Gondek, Kathleen; Sagnier, Pierre-Philippe; Gilchrist, Kim; Woolley, J Michael

    2007-11-10

    Assessing patient-reported outcomes (PROs) in clinical trials is of interest to clinicians, patients, regulators, and industry. The use and impact of PROs is a growing area of methodologic research, particularly as they relate to tumor types, biomarkers, and various patient populations and cultures. Both the US Food and Drug Administration (FDA) and European Agency for the Evaluation of Medicinal Products in recent guidance have acknowledged the need to account for treatment-related impact on patient symptoms and/or health-related quality of life (HRQOL). Clinical research likely reflects the informative value of PROs. A search of www.clinicaltrials.gov, the FDA Web site, and product package inserts was conducted to assess the inclusion of symptom assessment and HRQOL within industry-sponsored clinical trials in cancer and approved cancer therapies and their respective product labels. Overall, there were 2,704 industry-sponsored oncology trials, of which 322 (12%) included a PRO measure. Of the 70 FDA new or revised labels, only six package inserts include PRO data. Symptoms were assessed uniformly across the phases of clinical trials, whereas HRQOL assessment increased in the later phases of clinical trials. Collecting PRO data can enhance our understanding of cancer burden and the impact of interventions on patients' lives.

  20. HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma: Guideline From the College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology.

    PubMed

    Bartley, Angela N; Washington, Mary Kay; Ventura, Christina B; Ismaila, Nofisat; Colasacco, Carol; Benson, Al B; Carrato, Alfredo; Gulley, Margaret L; Jain, Dhanpat; Kakar, Sanjay; Mackay, Helen J; Streutker, Catherine; Tang, Laura; Troxell, Megan; Ajani, Jaffer A

    2016-12-01

    - ERBB2 (erb-b2 receptor tyrosine kinase 2 or HER2) is currently the only biomarker established for selection of a specific therapy for patients with advanced gastroesophageal adenocarcinoma (GEA). However, there are no comprehensive guidelines for the assessment of HER2 in patients with GEA. - To establish an evidence-based guideline for HER2 testing in patients with GEA, to formalize the algorithms for methods to improve the accuracy of HER2 testing while addressing which patients and tumor specimens are appropriate, and to provide guidance on clinical decision making. - The College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology convened an expert panel to conduct a systematic review of the literature to develop an evidence-based guideline with recommendations for optimal HER2 testing in patients with GEA. - The panel is proposing 11 recommendations with strong agreement from the open-comment participants. - The panel recommends that tumor specimen(s) from all patients with advanced GEA, who are candidates for HER2-targeted therapy, should be assessed for HER2 status before the initiation of HER2-targeted therapy. Clinicians should offer combination chemotherapy and a HER2-targeted agent as initial therapy for all patients with HER2-positive advanced GEA. For pathologists, guidance is provided for morphologic selection of neoplastic tissue, testing algorithms, scoring methods, interpretation and reporting of results, and laboratory quality assurance. - This guideline provides specific recommendations for assessment of HER2 in patients with advanced GEA while addressing pertinent technical issues and clinical implications of the results.

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

    PubMed

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

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

  2. Radiation terrorism: what society needs from the radiobiology-radiation protection and radiation oncology communities.

    PubMed

    Coleman, C Norman; Parker, Gerald W

    2009-06-01

    Society's and individuals' concerns about the adverse effects from radiation are logically amplified many times when radiological terrorism is considered. The spectrum of events include industrial sabotage, the use of an explosive or non-explosive radiological dispersal device, the placement of a radiological exposure device in a public facility and the use of an improvised nuclear device. The consequences of an event relate to the physical and medical damage of the event itself, the financial impact, and the acute and long-term medical consequences, including fear of radiation-induced cancer. The magnitude of a state-sponsored nuclear event is so great that limited detailed response planning had been done in the past, as compared to the work now ongoing. Planning is done on the basis of scenario modelling. Medical response planning includes medical triage, distribution of victims to care by experienced physicians, developing medical countermeasures to mitigate or treat radiation injury, counselling and appropriately following exposed or potentially exposed people, and helping the local community develop confidence in their own response plan. Optimal response must be based on the best available science. This requires scientists who can define, prioritise and address the gaps in knowledge with the range of expertise from basic physics to biology to translational research to systems expertise to response planning to healthcare policy to communications. Not only are there unique needs and career opportunities, but there is also the opportunity for individuals to serve their communities and country with education regarding radiation effects and by formulating scientifically based government policy.

  3. Quantitative PET/CT scanner performance characterization based upon the society of nuclear medicine and molecular imaging clinical trials network oncology clinical simulator phantom.

    PubMed

    Sunderland, John J; Christian, Paul E

    2015-01-01

    The Clinical Trials Network (CTN) of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) operates a PET/CT phantom imaging program using the CTN's oncology clinical simulator phantom, designed to validate scanners at sites that wish to participate in oncology clinical trials. Since its inception in 2008, the CTN has collected 406 well-characterized phantom datasets from 237 scanners at 170 imaging sites covering the spectrum of commercially available PET/CT systems. The combined and collated phantom data describe a global profile of quantitative performance and variability of PET/CT data used in both clinical practice and clinical trials. Individual sites filled and imaged the CTN oncology PET phantom according to detailed instructions. Standard clinical reconstructions were requested and submitted. The phantom itself contains uniform regions suitable for scanner calibration assessment, lung fields, and 6 hot spheric lesions with diameters ranging from 7 to 20 mm at a 4:1 contrast ratio with primary background. The CTN Phantom Imaging Core evaluated the quality of the phantom fill and imaging and measured background standardized uptake values to assess scanner calibration and maximum standardized uptake values of all 6 lesions to review quantitative performance. Scanner make-and-model-specific measurements were pooled and then subdivided by reconstruction to create scanner-specific quantitative profiles. Different makes and models of scanners predictably demonstrated different quantitative performance profiles including, in some cases, small calibration bias. Differences in site-specific reconstruction parameters increased the quantitative variability among similar scanners, with postreconstruction smoothing filters being the most influential parameter. Quantitative assessment of this intrascanner variability over this large collection of phantom data gives, for the first time, estimates of reconstruction variance introduced into trials from allowing

  4. 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…

  5. 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…

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

    PubMed Central

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

    2016-01-01

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

  7. The PEDRO (Pocketable Electronic Devices in Radiation Oncology) project: how clinical practice is changing among young radiation oncologists.

    PubMed

    De Bari, Berardino; Franco, Pierfrancesco; Ciammella, Patrizia; Peruzzo Cornetto, Andrea; Greto, Daniela; Fundoni, Carla; Filippi, Andrea Riccardo; Alongi, Filippo

    2014-01-01

    To evaluate the impact of mobile devices and apps on the daily clinical activity of young radiation oncologists. A web-based questionnaire was sent to 382 young (≤ 40 years) members of the Italian Association of Radiation Oncology (AIRO). The 14 items investigated the diffusion of mobile devices (smartphones and/or tablets), their impact on daily clinical activity, and possible differences perceived by the participants over time. A total of 158 questionnaires were available for statistical evaluation (response rate 41%). Up to 75% of respondents declared they used an electronic device during their clinical activity. Conversely, 82% considered the impact of smartphones/tables on daily practice low to moderate. Daily device use increased significantly from 2009 to 2012, with high daily use rates rising from 5% to 39.9%. Fulfillment of professional needs was declared by less than 42% of respondents and compliance with app indications by 32%. Almost all physicians desired in 2012 a comprehensive website concerning a variety of apps covering radiation oncologists' needs. Mobile devices are widely used by young Italian radiation oncologists in their daily clinical practice, while the indications so obtained are not always followed. Nevertheless, it would be important to verify the consistency of information found within apps, in order to avoid potential errors that might be detrimental to patients.

  8. Paediatric oncology patient preference for oral nutritional supplements in a clinical setting.

    PubMed

    Cohen, Jennifer; Rosen, Kate; Russell, Ken K; Wakefield, Claire E; Goodenough, Belinda

    2011-09-01

    Oral nutrition supplements are commonly used to increase the nutrient intake of children who are undergoing treatment for cancer. However, little research has been conducted systematically examining preferences for oral supplements in this population. This study aims to address a gap in the literature by examining taste preferences of oral nutrition supplements routinely recommended for children undergoing treatment for cancer. Twenty-one children undergoing treatment for cancer and 38 healthy control subjects participated in an acute double-blinded feeding trial. A variety of energy drinks, available both commercially and in the hospital, were sampled. Patients rated the taste of the drinks on a 10-cm coloured analogue scale. A commercially-based drink (Moove™) rated the highest in the blinded and branded tests for the treatment (mean rating out of 10, 6.44±2.69 and 7.26±2.33, respectively) and control groups (mean rating, 7.61±1.91 and 7.70±2.32, respectively). Taste ratings were significantly higher for commercially available supplements over the hospital-prepared supplements, (p=0.041), with no main effect for tasting condition (i.e. blinded versus branded, p=0.902). There was a statistically significant trend such that ratings, when the brand that was known decreased for hospital supplements, while ratings for commercially available supplements increased (p=0.014). Fresh milk-based supplements were the preferred type of oral nutrition supplement in a cohort of paediatric oncology patients. The data also suggest that commercially available products are more likely to be accepted than hospital-prepared supplements. This pilot study supports the need for further research in the area of oral nutrition supplements for paediatric oncology patients as a way of determining a reliable way to estimate preferences and therefore maximise compliance. Results from this research could be also used as the basis for designing research to study the effects of flavour

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

    PubMed

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

    2017-02-01

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

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

    PubMed

    Schwappach, D L B; Pfeiffer, Yvonne; Taxis, Katja

    2016-06-13

    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. 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. 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. 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. 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 transferred more actively into clinical practice. The

  11. Merging of the National Cancer Institute-funded cooperative oncology group data with an administrative data source to develop a more effective platform for clinical trial analysis and comparative effectiveness research: a report from the Children's Oncology Group.

    PubMed

    Aplenc, R; Fisher, B T; Huang, Y S; Li, Y; Alonzo, T A; Gerbing, R B; Hall, M; Bertoch, D; Keren, R; Seif, A E; Sung, L; Adamson, P C; Gamis, A

    2012-05-01

    The National Cancer Institute-funded cooperative oncology group trials have improved overall survival for children with cancer from 10% to 85% and have set standards of care for adults with malignancies. Despite these successes, cooperative oncology groups currently face substantial challenges. We are working to develop methods to improve the efficiency and effectiveness of these trials. Specifically, we merged data from the Children's Oncology Group (COG) and the Pediatric Health Information Systems (PHIS) to improve toxicity monitoring, to estimate treatment-associated resource utilization and costs, and to address important clinical epidemiology questions. COG and PHIS data on patients enrolled on a phase III COG trial for de novo acute myeloid leukemia at 43 PHIS hospitals were merged using a probabilistic algorithm. Resource utilization summary statistics were then tabulated for the first chemotherapy course based on PHIS data. Of 416 patients enrolled on the phase III COG trial at PHIS centers, 392 (94%) were successfully matched. Of these, 378 (96%) had inpatient PHIS data available beginning at the date of study enrollment. For these, daily blood product usage and anti-infective exposures were tabulated and standardized costs were described. These data demonstrate that patients enrolled in a cooperative group oncology trial can be successfully identified in an administrative data set and that supportive care resource utilization can be described. Further work is required to optimize the merging algorithm, map resource utilization metrics to the National Cancer Institute Common Toxicity Criteria for monitoring toxicity, to perform comparative effectiveness studies, and to estimate the costs associated with protocol therapy. Copyright © 2012 John Wiley & Sons, Ltd.

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

    PubMed

    MacKay, Lyndsay Jerusha; Bellamy-Stack, Catherine

    2010-01-01

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

  13. Need for a paradigm shift in cancer prevention and clinical oncology.

    PubMed

    Ebert, Matthias P; Schmid, Roland; Röcken, Christoph

    2007-10-01

    Every year approximately 3 million Europeans develop a cancer. Of these patients, 20-25% will suffer from cancer of the hepatogastrointestinal tract (the largest cancer group) and most of these individuals will die from the disease. Recent analysis from the American Cancer Society indicates that disease-related mortality from heart, cerebrovascular and infectious disease has decreased dramatically in the last 60 years, whereas the mortality of cancer remains unchanged. Despite recent improvements in the understanding of the biology, development and progression of human cancers, and the development of novel diagnostic and therapeutic approaches, most cancer patients are diagnosed in an advanced stage with a limited chance of cure. We hypothesize that there has been a dramatic shift in the treatment and, more importantly, prevention of heart, cerebrovascular and infectious diseases that has not yet reached oncology practice. We think that the shift from local to systemic therapy in combination with biomarker-guided detection of patients at risk leads to a reversion of current medical management: we do not treat the end-stage disease but rather follow the course of cancer development starting with risk assessment, followed by disease treatment and prevention of disease progression. Thus, we can prevent end-stage disease that cannot be treated curatively. Our two-step hypothesis should lead to a dramatic improvement of the prognosis of cancer patients.

  14. Assessment of audit methodologies for bias evaluation of tumor progression in oncology clinical trials.

    PubMed

    Zhang, Jenny J; Zhang, Lijun; Chen, Huanyu; Murgo, Anthony J; Dodd, Lori E; Pazdur, Richard; Sridhara, Rajeshwari

    2013-05-15

    As progression-free survival (PFS) has become increasingly used as the primary endpoint in oncology phase III trials, the U.S. Food and Drug Administration (FDA) has generally required a complete-case blinded independent central review (BICR) of PFS to assess and reduce potential bias in the investigator or local site evaluation. However, recent publications and FDA analyses have shown a high correlation between local site evaluation and BICR assessments of the PFS treatment effect, which questions whether complete-case BICR is necessary. One potential alternative is to use BICR as an audit tool to detect evaluation bias in the local site evaluation. In this article, the performance characteristics of two audit methods proposed in the literature are evaluated on 26 prospective, randomized phase III registration trials in nonhematologic malignancies. The results support that a BICR audit to assess potential bias in the local site evaluation is a feasible approach. However, implementation and logistical challenges need further consideration and discussion. ©2013 AACR

  15. International survey of awareness of genetic risk in the clinical sarcoma community.

    PubMed

    McBride, Kate A; Schlub, Timothy E; Ballinger, Mandy L; Thomas, David M; Tattersall, Martin Hn

    2016-06-01

    Integration of clinical genetics into oncology is variable. Sarcomas have a strong genetic component, with up to 1/30 patients carrying germline TP53 mutations. This study aimed to define genetic risk awareness among sarcoma physicians. Outcomes were attitudes toward genetic testing, level of cancer risk and awareness of risk reduction measures. An online survey was administered to members of the Connective Tissue Oncology Society and the Australasian Sarcoma Study Group. Sarcoma physicians (N = 124) from 21 countries participated, 40% of whom favored TP53 mutation testing in children regardless of family history, increasing to ∼83% for all age groups if a family history was present and ∼85% if multiple primary cancers were present. However, 33% were not aware that risk reduction strategies might identify some cancers at a more curable stage in carriers. Clinical genetics is not yet standard of care for multidisciplinary management of sarcoma. Awareness of genetic risk is important among sarcoma physicians. Attitudes among the sarcoma community were generally positive, but education on genetic risk in sarcoma patients and collaboration with clinical genetics services might improve quality of care. Sarcoma physicians need routine access to clinical genetics services so that potential germline TP53 mutation carriers are recognized. © 2016 John Wiley & Sons Australia, Ltd.

  16. 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

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

    PubMed Central

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

    2016-01-01

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

  18. Revisions to the 2009 american society of clinical oncology/oncology nursing society chemotherapy administration safety standards: expanding the scope to include inpatient settings.

    PubMed

    Jacobson, Joseph O; Polovich, Martha; Gilmore, Terry R; Schulmeister, Lisa; Esper, Peg; Lefebvre, Kristine B; Neuss, Michael N

    2012-01-01

    In November 2009, ASCO and the Oncology Nursing Society (ONS) jointly published a set of 31 voluntary chemotherapy safety standards for adult patients with cancer, as the end result of a highly structured, multistakeholder process. The standards were explicitly created to address patient safety in the administration of parenteral and oral chemotherapeutic agents in outpatient oncology settings. In January 2011, a workgroup consisting of ASCO and ONS members was convened to review feedback received since publication of the standards, to address interim changes in practice, and to modify the standards as needed. The most significant change to the standards is to extend their scope to the inpatient setting. This change reflects the conviction that the same standards for chemotherapy administration safety should apply in all settings. The proposed set of standards has been approved by the Board of Directors for both ASCO and ONS and has been posted for public comment. Comments were used as the basis for final editing of the revised standards. The workgroup recognizes that the safety of oral chemotherapy usage, nononcology medication reconciliation, and home chemotherapy administration are not adequately addressed in the original or revised standards. A separate process, cosponsored by ASCO and ONS, will address the development of safety standards for these areas.

  19. Racial Differences in Information Needs During and After Cancer Treatment: a Nationwide, Longitudinal Survey by the University of Rochester Cancer Center National Cancer Institute Community Oncology Research Program.

    PubMed

    Asare, Matthew; Peppone, Luke J; Roscoe, Joseph A; Kleckner, Ian R; Mustian, Karen M; Heckler, Charles E; Guido, Joseph J; Sborov, Mark; Bushunow, Peter; Onitilo, Adedayo; Kamen, Charles

    2016-04-21

    Before treatment, cancer patients need information about side effects and prognosis, while after treatment they need information to transition to survivorship. Research documenting these needs is limited, especially among racial and ethnic minorities. This study evaluated cancer patients' needs according to race both before and after treatment. We compared white (n = 904) to black (n = 52) patients receiving treatment at 17 National Cancer Institute Community Oncology Research Program (NCORP) sites on their cancer-related concerns and need for information before and after cancer treatment. Two-sample t test and chi-squared analyses were used to assess group differences. Compared to white patients, black patients reported significantly higher concerns about diet (44.3 vs. 25.4 %,) and exercise (40.4 vs. 19.7 %,) during the course of treatment. Compared to whites, blacks also had significantly higher concern about treatment-related issues (white vs. black mean, 25.52 vs. 31.78), self-image issues (7.03 vs. 8.60), family-related issues (10.44 vs. 12.84), and financial concerns (6.42 vs. 8.90, all p < 0.05). Blacks, compared to whites, also had significantly greater post-treatment information needs regarding follow-up tests (8.17 vs. 9.44), stress management (4.12 vs. 4.89), and handling stigma after cancer treatment (4.21 vs. 4.89) [all p < 0.05]. Pre-treatment concerns and post-treatment information needs differed by race, with black patients reporting greater information needs and concerns. In clinical practice, tailored approaches may work particularly well in addressing the needs and concerns of black patients.

  20. 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. © 2013 Special Care Dentistry Association and Wiley Periodicals, Inc.

  1. Neuro-Oncology Branch Appointment - what happens at the clinical center | Center for Cancer Research

    Cancer.gov

    What Happens When I Get To The Clinical Center at NIH? 1. Visit the Admissions Department Registering is the first step to being evaluated by the Brain Tumor Clinic. Visit Admissions to get registered as a patient. They will ask you for your contact information and provide you with a patient identification number. 2. Proceed to the NOB Clinic Proceed to the Brain Tumor Clinic on the 13th floor.

  2. Medication Therapy Management for Patients Receiving Oral Chemotherapy Agents at a Community Oncology Center: A Pilot Study.

    PubMed

    Bertsch, Nathan S; Bindler, Ross J; Wilson, Poppy L; Kim, Anne P; Ward, Beverly

    2016-10-01

    Purpose: To determine the impact of a pharmacist-driven medication therapy management (MTM) program for patients receiving oral chemotherapy agents. Methods: We assessed the impact of MTM consultations with a pharmacist for patients who were receiving a new prescription for an oral chemotherapy agent. Data were assessed for outcomes including (1) number of medication errors identified in electronic medical records (EMRs), (2) number of interventions performed by the pharmacist, (3) time spent on the MTM process, and (4) patient satisfaction. Data were compared between patients who received their oral chemotherapy agents from the onsite specialty pharmacy or from a mail-order pharmacy. The data were also examined for correlations, and logistic regression was utilized to determine the largest variant cofactor to create an equation for estimating the number of errors in a patient's EMR. Results: Fifteen patients received an MTM consultation, and the pharmacists identified an average of 6 medication EMR errors per patient. There was an average of 3 pharmacist-led interventions per patient. Multiple significant correlations were noted between the variables: (1) total number of prescriptions a patient was taking, (2) total number of medication errors identified, (3) time spent on the MTM process, and (4) total number of interventions performed by the pharmacist. Patient satisfaction was favorable for the program. Conclusion: The implementation of a pharmacist-driven MTM program for patients receiving a prescription for an oral chemotherapy agent had a significant impact on patient care by improving medication reconciliation, identifying drug-related problems, and strengthening pharmacist-patient interactions in the oncology clinic.

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

    PubMed

    Ligibel, Jennifer A; Wollins, Dana

    2016-12-10

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

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

    PubMed

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

    2016-11-01

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

  5. Active Surveillance for the Management of Localized Prostate Cancer (Cancer Care Ontario Guideline): American Society of Clinical Oncology Clinical Practice Guideline Endorsement.

    PubMed

    Chen, Ronald C; Rumble, R Bryan; Loblaw, D Andrew; Finelli, Antonio; Ehdaie, Behfar; Cooperberg, Matthew R; Morgan, Scott C; Tyldesley, Scott; Haluschak, John J; Tan, Winston; Justman, Stewart; Jain, Suneil

    2016-06-20

    To endorse Cancer Care Ontario's guideline on Active Surveillance for the Management of Localized Prostate Cancer. The American Society of Clinical Oncology (ASCO) has a policy and set of procedures for endorsing clinical practice guidelines developed by other professional organizations. The Active Surveillance for the Management of Localized Prostate Cancer guideline was reviewed for developmental rigor by methodologists. The ASCO Endorsement Panel then reviewed the content and the recommendations. The ASCO Endorsement Panel determined that the recommendations from the Active Surveillance for the Management of Localized Prostate Cancer guideline, published in May 2015, are clear, thorough, and based upon the most relevant scientific evidence. ASCO endorsed the Active Surveillance for the Management of Localized Prostate Cancer guideline with added qualifying statements. The Cancer Care Ontario recommendation regarding 5-alpha reductase inhibitors was not endorsed by the ASCO panel. For most patients with low-risk (Gleason score ≤ 6) localized prostate cancer, active surveillance is the recommended disease management strategy. Factors including younger age, prostate cancer volume, patient preference, and ethnicity should be taken into account when making management decisions. Select patients with low-volume, intermediate-risk (Gleason 3 + 4 = 7) prostate cancer may be offered active surveillance. Active surveillance protocols should include prostate-specific antigen testing, digital rectal examinations, and serial prostate biopsies. Ancillary radiologic and genomic tests are investigational but may have a role in patients with discordant clinical and/or pathologic findings. Patients who are reclassified to a higher-risk category (Gleason score ≥ 7) or who have significant increases in tumor volume on subsequent biopsies should be offered active therapy. © 2016 by American Society of Clinical Oncology.

  6. CCCT - NCTN Steering Committees - Clinical Imaging

    Cancer.gov

    The Clinical Imaging Steering Committee serves as a forum for the extramural imaging and oncology communities to provide strategic input to the NCI regarding its significant investment in imaging activities in clinical trials.

  7. A peer review process as part of the implementation of clinical pathways in radiation oncology: Does it improve compliance?

    PubMed

    Gebhardt, Brian J; Heron, Dwight E; Beriwal, Sushil

    Clinical pathways are patient management plans that standardize evidence-based practices to ensure high-quality and cost-effective medical care. Implementation of a pathway is a collaborative process in our network, requiring the active involvement of physicians. This approach promotes acceptance of pathway recommendations, although a peer review process is necessary to ensure compliance and to capture and approve off-pathway selections. We investigated the peer review process and factors associated with time to completion of peer review. Our cancer center implemented radiation oncology pathways for every disease site throughout a large, integrated network. Recommendations are written based upon national guidelines, published literature, and institutional experience with evidence evaluated hierarchically in order of efficacy, toxicity, and then cost. Physicians enter decisions into an online, menu-driven decision support tool that integrates with medical records. Data were collected from the support tool and included the rate of on- and off-pathway selections, peer review decisions performed by disease site directors, and time to complete peer review. A total of 6965 treatment decisions were entered in 2015, and 605 (8.7%) were made off-pathway and were subject to peer review. The median time to peer review decision was 2 days (interquartile range, 0.2-6.8). Factors associated with time to peer review decision >48 hours on univariate analysis include disease site (P < .0001) with a trend toward significance (P = .066) for radiation therapy modality. There was no difference between recurrent and non-recurrent disease (P = .267). Multivariable analysis revealed disease site was associated with time to peer review (P < .001), with lymphoma and skin/sarcoma most strongly influencing decision time >48 hours. Clinical pathways are an integral tool for standardizing evidence-based care throughout our large, integrated network, with 91.3% of all treatment decisions being

  8. 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

  9. 2013 Updated American Society of Clinical Oncology/Oncology Nursing Society Chemotherapy Administration Safety Standards Including Standards for the Safe Administration and Management of Oral Chemotherapy

    PubMed Central

    Neuss, Michael N.; Polovich, Martha; McNiff, Kristen; Esper, Peg; Gilmore, Terry R.; LeFebvre, Kristine B.; Schulmeister, Lisa; Jacobson, Joseph O.

    2013-01-01

    In 2009, ASCO and the Oncology Nursing Society (ONS) published standards for the safe use of parenteral chemotherapy in the outpatient setting, including issues of practitioner orders, preparation, and administration of medication. In 2011, these were updated to include inpatient facilities. In December 2011, a multistakeholder workgroup met to address the issues associated with orally administered antineoplastics, under the leadership of ASCO and ONS. The workgroup participants developed recommended standards, which were presented for public comment. Public comments informed final edits, and the final standards were reviewed and approved by the ASCO and ONS Boards of Directors. Significant newly identified recommendations include those associated with drug prescription and the necessity of ascertaining that prescriptions are filled. In addition, the importance of patient and family education regarding administration schedules, exception procedures, disposal of unused oral medication, and aspects of continuity of care across settings were identified. This article presents the newly developed standards. PMID:23914148

  10. Computer-assisted bar-coding system significantly reduces clinical laboratory specimen identification errors in a pediatric oncology hospital.

    PubMed

    Hayden, Randall T; Patterson, Donna J; Jay, Dennis W; Cross, Carl; Dotson, Pamela; Possel, Robert E; Srivastava, Deo Kumar; Mirro, Joseph; Shenep, Jerry L

    2008-02-01

    To assess the ability of a bar code-based electronic positive patient and specimen identification (EPPID) system to reduce identification errors in a pediatric hospital's clinical laboratory. An EPPID system was implemented at a pediatric oncology hospital to reduce errors in patient and laboratory specimen identification. The EPPID system included bar-code identifiers and handheld personal digital assistants supporting real-time order verification. System efficacy was measured in 3 consecutive 12-month time frames, corresponding to periods before, during, and immediately after full EPPID implementation. A significant reduction in the median percentage of mislabeled specimens was observed in the 3-year study period. A decline from 0.03% to 0.005% (P < .001) was observed in the 12 months after full system implementation. On the basis of the pre-intervention detected error rate, it was estimated that EPPID prevented at least 62 mislabeling events during its first year of operation. EPPID decreased the rate of misidentification of clinical laboratory samples. The diminution of errors observed in this study provides support for the development of national guidelines for the use of bar coding for laboratory specimens, paralleling recent recommendations for medication administration.

  11. Clinical Oncology Society of Australia position statement on the use of complementary and alternative medicine by cancer patients.

    PubMed

    Braun, Lesley; Harris, Jessica; Katris, Paul; Cain, Michael; Dhillon, Haryana; Koczwara, Bogda; Olver, Ian; Robotin, Monica

    2014-12-01

    Health professionals involved in the clinical management of cancer are becoming increasingly aware that their patients use complementary and alternative medicine (CAM). As cancer incidence and survival rates increase, use of CAM is also likely to increase. This paper outlines the position of the Clinical Oncology Society of Australia (COSA) on the use of CAM by cancer patients and provides guidance for health professionals involved with the treatment of cancer patients who are using or wish to use CAM. Key definitions and common communication scenarios are presented along with evidence-based recommended steps for health professionals when discussing CAM use. COSA encourages health professionals to focus on open discussion with their patients regarding CAM, to become familiar with reputable resources for CAM information, to discuss with patients the concept of evidence-based medicine, to recognize limitations to their knowledge of CAM and seek further advice when necessary, and to be respectful of the patients' right to autonomy. © 2014 Wiley Publishing Asia Pty Ltd.

  12. Comprehensive analysis of clinical development and regulatory submission promotion schemes for oncologic drugs as the Japanese national projects.

    PubMed

    Nagai, Sumimasa; Ozawa, Keiya

    2016-12-01

    To reduce the delay in marketing authorization of drugs in Japan, four Japanese national projects were instituted. We examined all oncologic drugs for adult patients approved or discussed through these schemes, for the first time. All the data are publicly available. In total, 197 applications/demands (181 indications and 16 dosages/uses) were collected. As of December 31, 2015, 64 indications and 10 dosages/uses were approved as off-label drugs through these schemes without conducting additional registration trials in Japan. Furthermore, 46 indications and two dosages/uses were approved after registration trials in Japan requested by the national scheme councils. Regarding the following 23 indications of the 197 applications/demands, registration trials in Japan were commenced after the national scheme council's request: 17 hematological malignancies and six orphan solid tumors. Moreover, 54 indications and three dosages/uses, for which demands were submitted, were regarded as not a high medical priority by the national scheme council. Regarding two hematological malignancy indications, the dosage approved in foreign countries was intolerable for the Japanese patients in Japanese registration trials and this stopped the clinical development in Japan. Our analysis showed that 110 indications and 12 dosages/uses were approved in Japan through these schemes. These national projects have provided numerous therapeutic options for Japanese patients and may be meaningful for promoting clinical development and regulatory approval especially in orphan diseases in countries other than Japan.

  13. Screening, assessment, and management of fatigue in adult survivors of cancer: an American Society of Clinical oncology clinical practice guideline adaptation.

    PubMed

    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

    2014-06-10

    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. 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. 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. 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. © 2014 by American Society of Clinical Oncology.

  14. Bayesian hierarchical modeling of patient subpopulations: Efficient designs of Phase II oncology clinical trials

    PubMed Central

    Berry, Scott M; Broglio, Kristine R; Groshen, Susan; Berry, Donald A

    2015-01-01

    Background In oncology, the treatment paradigm is shifting toward personalized medicine, where the goal is to match patients to the treatments most likely to deliver benefit. Treatment effects in various subpopulations may provide some information about treatment effects in other subpopulations. Purpose We compare different approaches to Phase II trial design where a new treatment is being investigated in several groups of patients. We compare considering each group in an independent trial to a single trial with hierarchical modeling of the patient groups. Methods We assume four patient groups with different background response rates and simulate operating characteristics of three trial designs, Simon’s Optimal Two-Stage design, a Bayesian adaptive design with frequent interim analyses, and a Bayesian adaptive design with frequent interim analyses and hierarchical modeling across patient groups. Results Simon’s designs are based on 10% Type I and Type II error rates. The independent Bayesian designs are tuned to have similar error rates, but may have a slightly smaller mean sample size due to more frequent interim analyses. Under the null, the mean sample size is 2–4 patients smaller. A hierarchical model across patient groups can provide additional power and a further reduction in mean sample size. Under the null, the addition of the hierarchical model decreases the mean sample size an additional 4–7 patients in each group. Under the alternative hypothesis, power is increased to at least 98% in all groups. Limitations Hierarchical borrowing can make finding a single group in which the treatment is promising, if there is only one, more difficult. In a scenario where the treatment is uninteresting in all but one group, power for that one group is reduced to 65%. When the drug appears promising in some groups and not in others, there is potential for borrowing to inflate the Type I error rate. Conclusions The Bayesian hierarchical design is more likely to

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

    PubMed

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

    2016-01-01

    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. 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. 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. 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.

  16. 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

  17. Testing the nursing outcomes classification in three clinical units in a community hospital.

    PubMed

    Moorhead, Sue; Johnson, Marion; Maas, Meridean; Reed, David

    2003-01-01

    The testing of the Nursing Outcomes Classification (NOC) was the focus of a 4-year study to evaluate the use of the outcomes and measurement scales developed by the Iowa Outcomes Project, a research team at the University of Iowa. Three units in a Midwest community hospital collected data as part of the larger (ten) clinical site study to test the reliability, validity, and sensitivity of the NOC. This article focuses on the results of sensitivity testing obtained in a birth center, behavioral health center, and an oncology unit in a midwestern community hospital. Methods used in this study focused on change scores from initial assessment to post-treatment status for the outcomes studied in each unit. Average baseline ratings, average follow-up ratings, average change scores, and range of change are reported. Thirty-five outcomes are reported for the behavioral health unit, 21 outcomes are reported for the Birth Center, and 8 outcomes for the Oncology Unit. The overall average baseline for the behavioral health unit was 1.89 with an average follow-up rating of 3.22. For the Birth Center, the average baseline rating was 3.23 with an average follow-up score of 3.88. For the Oncology Unit, the average baseline score was 3.01 with an average follow-up rating of 3.12. The results of this study suggest that the NOC outcomes are able to identify change in some outcome ratings through time and in a direction expected for the populations studied in these three specialty units.

  18. 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

  19. Roadmap to a Comprehensive Clinical Data Warehouse for Precision Medicine Applications in Oncology

    PubMed Central

    Foran, David J; Chen, Wenjin; Chu, Huiqi; Sadimin, Evita; Loh, Doreen; Riedlinger, Gregory; Goodell, Lauri A; Ganesan, Shridar; Hirshfield, Kim; Rodriguez, Lorna; DiPaola, Robert S

    2017-01-01

    Leading institutions throughout the country have established Precision Medicine programs to support personalized treatment of patients. A cornerstone for these programs is the establishment of enterprise-wide Clinical Data Warehouses. Working shoulder-to-shoulder, a