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Reshma Jagsi, Grace Huang, Kent Griffith, Brian J. Zikmund-Fisher, Nancy K. Janz, Jennifer J. Griggs, Steven J. Katz, and Sarah T. Hawley

Physician attitudes toward and lack of familiarity with guidelines have been identified as potential barriers to adherence in general, but little is known about their attitudes toward and use of cancer management guidelines specifically. This study surveyed 1500 surgeons and medical oncologists drawn from the AMA Masterfile in 2012. This report describes and compares the attitudes of medical oncologists and surgeons who treat patients with breast cancer regarding guidelines in general and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) in particular, and their familiarity, use, and compliance with these guidelines. Of 896 respondents, responses were analyzed from the 766 who had seen at least one new patient with breast cancer in the past year. Mean participant age was 52 years; 25% worked in a teaching setting. Attitudes toward guidelines were generally favorable. Medical oncologists were more likely than surgeons to be aware that NCCN issues guidelines for cancer management (100% vs 74%; P<.001) and more likely to state that these guidelines generally influence their decisions (96% vs 70%; P<.001). Among those aware of NCCN Guidelines, 96% reported that they often agreed with NCCN recommendations, and 75% reported that almost all of their breast cancer treatment recommendations were consistent with these guidelines. Still, most providers (77%) also reported that they refer one-fourth or fewer of their patients with breast cancer to the NCCN Guidelines for Patients. Attitudes toward physician-directed cancer management guidelines are generally positive, and they are frequently used. However, existing guidelines seem to have greater visibility to the medical oncology audience than to surgeons, and patient versions are infrequently recommended.

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Joseph Abi Jaoude, Ramez Kouzy, Walker Mainwaring, Timothy A. Lin, Austin B. Miller, Amit Jethanandani, Andres F. Espinoza, Dario Pasalic, Vivek Verma, Noam A. VanderWalde, Benjamin D. Smith, Grace L. Smith, C. David Fuller, Prajnan Das, Bruce D. Minsky, Claus Rödel, Emmanouil Fokas, Reshma Jagsi, Charles R. Thomas Jr, Ishwaria M. Subbiah, Cullen M. Taniguchi, and Ethan B. Ludmir

Background: Patients with good performance status (PS) tend to be favored in randomized clinical trials (RCTs), possibly limiting the generalizability of trial findings. We aimed to characterize trial-related factors associated with the use of PS eligibility criteria and analyze patient accrual breakdown by PS. Methods: Adult, therapeutic, multiarm phase III cancer-specific RCTs were identified through ClinicalTrials.gov. PS data were extracted from articles. Trials with a PS restriction ECOG score ≤1 were identified. Factors associated with PS restriction were determined, and the use of PS restrictions was analyzed over time. Results: In total, 600 trials were included and 238,213 patients had PS data. Of those trials, 527 studies (87.8%) specified a PS restriction cutoff, with 237 (39.5%) having a strict inclusion criterion (ECOG PS ≤1). Enrollment criteria restrictions based on PS (ECOG PS ≤1) were more common among industry-supported trials (P<.001) and lung cancer trials (P<.001). Nearly half of trials that led to FDA approval included strict PS restrictions. Most patients enrolled across all trials had an ECOG PS of 0 to 1 (96.3%). Even among trials that allowed patients with ECOG PS ≥2, only 8.1% of those enrolled had a poor PS. Trials of lung, breast, gastrointestinal, and genitourinary cancers all included <5% of patients with poor PS. Finally, only 4.7% of patients enrolled in trials that led to subsequent FDA approval had poor PS. Conclusions: Use of PS restrictions in oncologic RCTs is pervasive, and exceedingly few patients with poor PS are enrolled. The selective accrual of healthier patients has the potential to severely limit and bias trial results. Future trials should consider a wider cancer population with close toxicity monitoring to ensure the generalizability of results while maintaining patient safety.

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Arti Hurria, Tanya Wildes, Sarah L. Blair, Ilene S. Browner, Harvey Jay Cohen, Mollie deShazo, Efrat Dotan, Barish H. Edil, Martine Extermann, Apar Kishor P. Ganti, Holly M. Holmes, Reshma Jagsi, Mohana B. Karlekar, Nancy L. Keating, Beatriz Korc-Grodzicki, June M. McKoy, Bruno C. Medeiros, Ewa Mrozek, Tracey O’Connor, Hope S. Rugo, Randall W. Rupper, Rebecca A. Silliman, Derek L. Stirewalt, William P. Tew, Louise C. Walter, Alva B. Weir III, Mary Anne Bergman, and Hema Sundar

Cancer is the leading cause of death in older adults aged 60 to 79 years. The biology of certain cancers and responsiveness to therapy changes with the patient’s age. Advanced age alone should not preclude the use of effective treatment that could improve quality of life or extend meaningful survival. The challenge of managing older patients with cancer is to assess whether the expected benefits of treatment are superior to the risk in a population with decreased life expectancy and decreased tolerance to stress. These guidelines provide an approach to decision-making in older cancer patients based on comprehensive geriatric assessment and also include diseasespecific issues related to age in the management of some cancer types in older adults.

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Noam VanderWalde, Reshma Jagsi, Efrat Dotan, Joel Baumgartner, Ilene S. Browner, Peggy Burhenn, Harvey Jay Cohen, Barish H. Edil, Beatrice Edwards, Martine Extermann, Apar Kishor P. Ganti, Cary Gross, Joleen Hubbard, Nancy L. Keating, Beatriz Korc-Grodzicki, June M. McKoy, Bruno C. Medeiros, Ewa Mrozek, Tracey O'Connor, Hope S. Rugo, Randall W. Rupper, Dale Shepard, Rebecca A. Silliman, Derek L. Stirewalt, William P. Tew, Louise C. Walter, Tanya Wildes, Mary Anne Bergman, Hema Sundar, and Arti Hurria

Cancer is the leading cause of death in older adults aged 60 to 79 years. Older patients with good performance status are able to tolerate commonly used treatment modalities as well as younger patients, particularly when adequate supportive care is provided. For older patients who are able to tolerate curative treatment, options include surgery, radiation therapy (RT), chemotherapy, and targeted therapies. RT can be highly effective and well tolerated in carefully selected patients, and advanced age alone should not preclude the use of RT in older patients with cancer. Judicious application of advanced RT techniques that facilitate normal tissue sparing and reduce RT doses to organs at risk are important for all patients, and may help to assuage concerns about the risks of RT in older adults. These NCCN Guidelines Insights focus on the recent updates to the 2016 NCCN Guidelines for Older Adult Oncology specific to the use of RT in the management of older adults with cancer.