The role of chemotherapy and radiotherapy in adjuvant management of optimally debulked endometrial cancer with extrauterine involvement is evolving. Recent studies have suggested an expanded role for chemotherapy and questioned the benefit of radiation therapy. Ongoing and planned clinical trials should provide clarification.
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David Scott Miller, Gini Fleming, and Marcus E. Randall
Jeffrey S. Montgomery, David C. Miller, and Alon Z. Weizer
Bladder cancer is predominantly seen in elderly patients. With the aging United States population, the incidence and prevalence of bladder cancer are on the rise, heightening the relevance of this disease as a public health issue. Despite having one of the greatest average cancer treatment costs per patient, improvements in disease-specific survival have been subtle. Clinical guidelines based predominantly on expert opinion and randomized controlled studies offer some guidance, but adherence to these guidelines is lacking. Building awareness of quality indicators to optimize patient care represents an opportunity to improve bladder cancer outcomes. Although quality indicators exist for other disease states, widely accepted quality indicators for the management of bladder cancer have not yet been established. This article proposes an initial set of quality indicators for both non–muscle-invasive and muscle-invasive bladder cancer based on established clinical guidelines and the available literature.
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.
Matthew Barth, Ana C. Xavier, Saro Armenian, Anthony N. Audino, Lindsay Blazin, David Bloom, Jong Chung, Kimberly Davies, Hilda Ding, James B. Ford, Paul J. Galardy, Rabi Hanna, Robert Hayashi, Cathy Lee-Miller, Andrea Judit Machnitz, Kelly W. Maloney, Lianna Marks, Paul L. Martin, David McCall, Martha Pacheco, Anne F. Reilly, Mikhail Roshal, Sophie Song, Joanna Weinstein, Sara Zarnegar-Lumley, Nicole McMillian, Ryan Schonfeld, and Hema Sundar
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Pediatric Aggressive Mature B-Cell Lymphomas include recommendations for the diagnosis and management of pediatric patients with primary mediastinal large B-cell lymphoma (PMBL) and sporadic variants of Burkitt lymphoma and diffuse large B-cell lymphoma. PMBL is now considered as a distinct entity arising from mature thymic B-cells accounting for 2% of mature B-cell lymphomas in children and adolescents. This discussion section includes the recommendations outlined in the NCCN Guidelines for the diagnosis and management of pediatric patients with PMBL.