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

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

doi:10.1200/jop.2013.001119

Cited by 129 publications

(120 citation statements)

References 149 publications

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“…Many factors weigh into low accrual, including trials available, sufficient clinical research staffing, and low accrual of minority populations. 71 Accrual of patients with metastatic breast cancer to early-phase trials is particularly low, despite data suggesting patients with metastatic TNBC enrolling in phase 1 trials may have improved survival outcomes. 72 Advances in tumor genetics have changed the landscape of how we treat breast cancer, and identifying targetable mutations may help select which drugs are more likely to have efficacy in specific intrinsic tumor types.…”

Section: Expanding Treatment Optionsmentioning

confidence: 98%

Changing Treatment Paradigms in Metastatic Breast Cancer

Santa-Maria

Gradishar

2015

JAMA Oncol

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Advances in understanding tumor biology, particularly signaling pathways, have led to the development and approval of many novel agents and have changed the landscape of therapy for patients with metastatic breast cancer. This review highlights some of the recent successes and failures in breast cancer drug development, including strategies to overcome endocrine and human epidermal growth factor 2-neu (HER2) resistance, targeting triple-negative breast cancers (which do not express the HER2, estrogen, and progesterone receptors) through novel receptors, harnessing the immune system, and new ways of targeting angiogenesis. For patients with metastatic breast cancer, expanding therapeutic options through clinical trial participation is a crucial part of modern oncology practice. As we continue to learn how to use targeted therapies in the context of genomic medicine, analysis of the tumor in real-time may become increasingly important, giving researchers the information needed to start combining therapies in a biologically informed manner.

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Section: Expanding Treatment Optionsmentioning

confidence: 98%

Changing Treatment Paradigms in Metastatic Breast Cancer

Santa-Maria

Gradishar

2015

JAMA Oncol

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“…Yet well under five percent of U.S. adult cancer patients are enrolled in cancer clinical trials [9, 10]. Increasingly numerous and stringent eligibility criteria represent a major barrier to clinical trial accrual [11, 12]. For instance, over 80 percent of lung cancer clinical trials sponsored or endorsed by the National Cancer Institute (NCI)-affiliated Eastern Cooperative Oncology Group (ECOG) exclude patients with prior cancer, resulting in exclusion of up to 18% of potential participants for this reason alone [13].…”

Section: Introductionmentioning

confidence: 99%

Prior cancer does not adversely affect survival in locally advanced lung cancer: A national SEER-medicare analysis

et al. 2016

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Introduction Management of locally advanced non-small cell lung cancer is among the most highly contested areas in thoracic oncology. In this population, a history of prior cancer frequently results in exclusion from clinical trials and may influence therapeutic decisions. We therefore determined prevalence and prognostic impact of prior cancer among these patients. Materials and Methods We identified patients >65 years of age diagnosed 1992–2009 with locally advanced lung cancer in the Surveillance, Epidemiology, and End Results-Medicare linked dataset. We characterized prior cancer by prevalence, type, stage, and timing. We compared all-cause and lung cancer-specific survival between patients with and without prior cancer using propensity score-adjusted Cox regression. Results 51,542 locally advanced lung cancer patients were included; 15.8% had a history of prior cancer. Prostate (25%), gastrointestinal (17%), breast (16%), and other genitourinary (15%) were the most common types of prior cancer, and 76% percent of prior cancers were localized or in situ stage. Approximately half (54%) of prior cancers were diagnosed within 5 years of the index lung cancer date. Patients with prior cancer had similar (propensity-score adjusted hazard ratio [HR] 0.96; 95% CI, 0.94–0.99; P=0.005) and improved lung cancer-specific (HR 0.84; 95% CI, 0.81–0.86; P<0.001) survival compared to patients with no prior cancer. Conclusions For patients with locally advanced lung cancer, prior cancer does not adversely impact clinical outcomes. Patients with locally advanced lung cancer and a history of prior cancer should not be excluded from clinical trials, and should be offered aggressive, potentially curative therapies if otherwise appropriate.

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“…Stensland et al reported that 1 in 4 cancer clinical trials were stopped early with 1 in 10 being stopped for poor accrual [2]. Data are somewhat limited, but a panel of experts convened by the NCI and ASCO to discuss barriers to clinical trial enrollment in 2013 [3] cited barriers in three areas as most significant: 1) patient/community -2) physician/provider level -3) site/organizational. Physician/provider level barriers include willingness to refer a patient for study, lack of knowledge about available clinical trials and concern regarding a patient's ability to participate [3][4][5].…”

Section: Introductionmentioning

confidence: 96%

“…Data are somewhat limited, but a panel of experts convened by the NCI and ASCO to discuss barriers to clinical trial enrollment in 2013 [3] cited barriers in three areas as most significant: 1) patient/community -2) physician/provider level -3) site/organizational. Physician/provider level barriers include willingness to refer a patient for study, lack of knowledge about available clinical trials and concern regarding a patient's ability to participate [3][4][5]. Patient/community barriers have been noted to include being unaware of trial opportunities and complexity and stringency of the protocol [6] Both of these barriers could be addressed by providing a research registry to inform and match patients for study.…”

Section: Introductionmentioning

confidence: 99%