Advancing clinical trials for rare renal cell carcinoma subtypes: Consensus statements from the International Kidney Cancer Symposium North America 2025 think tank.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Msaouel Pavlos, La Rosa Salvatore, Abel Edwin Jason, Albiges Laurence, Barata Pedro C, Berg Stephanie A, Braun David A, Brugarolas James, Campbell Matthew T, Carlo Marie I, Coleman Katie, Cost Nicholas G, Das Arighno, Desai Arpita, Dizman Nazli, Drago Daniela, Economides Minas, Geynisman Daniel M, Griffith Meghan, Hall Tasha, Henske Elizabeth P, Jonasch Eric, Khanna Prateek, Kotecha Ritesh R, Luckenbaugh Amy, Maranchie Jodi K, Master Viraj, May Allison M, Motzer Robert J, Ornstein Moshe C, Ortiz Michael V, Pal Sumanta K, Perez Jose R, Rini Brian, Shapiro Daniel D, Shuch Brian M, Singer Adam E, Singer Eric A, Stadler Walter M, Staehler Michael, Tannir Nizar M, Vaishampayan Ulka N, Xu Wenxin, Yip Wesley, Zacharias Niki M, Voss Martin H
Аннотация
METHODS: A modified Delphi method was employed to develop consensus statements among a multidisciplinary panel of 46 experts in urologic oncology, medical oncology, radiation oncology, molecular biology, genetics, and biostatistics, with representatives from pharmaceutical industry, regulatory affairs, and patient advocacy. Over multiple rounds, including an in-person meeting on November 13, 2025, 20 initial statements were proposed, evaluated, refined, and voted on. Consensus was defined a priori as a median Likert score ≥8 out of 10.
RESULTS: Twenty final consensus statements were endorsed across 5 thematic domains: (1) Trial Design and Endpoints; (2) Perioperative Trials; (3) Operations and Accrual; (4) Biology-driven and Histology/molecular Strategy Trials; and (5) Preclinical Efforts, Target Identification, and Early Signal Testing. Key recommendations include prioritizing histology-specific trial designs over pooled "non-clear cell" approaches, adopting innovative single-arm and adaptive designs for ultra-rare subtypes, leveraging patient advocacy collaborations and natural history registries, and pursuing mechanism-informed therapeutic development.
CONCLUSIONS: These recommendations provide a framework to guide researchers, cooperative groups, regulatory bodies, and pharmaceutical industry partners in advancing evidence generation and therapeutic development for patients with rare kidney cancer variants.