Laukhtina Ekaterina, Moschini Marco, Teoh Jeremy Yuen-Chun, Shariat Shahrokh F
Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Department of Urology, IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy.
Curr Opin Urol. 2025 Jan 1;35(1):35-40. doi: 10.1097/MOU.0000000000001228. Epub 2024 Sep 11.
This review explores the design and endpoints of perioperative platforms in clinical trials for muscle-invasive bladder cancer (MIBC).
The choice of clinical trial design in perioperative platforms for MIBC must align with specific research objectives to ensure robust and meaningful outcomes. Novel designs in perioperative platforms for MIBC integrate bladder-sparing approaches. Primary endpoints such as pathological complete response and disease-free survival are highlighted for their role in expediting trial results in perioperative setting. Incorporating patient-reported outcomes is important to inform healthcare decision makers about the outcomes most meaningful to patients. Given the growing body of evidence, potential biomarkers, predictive and prognostic tools should be considered and implemented when designing trials in perioperative platforms for MIBC.
Effective perioperative platforms for MIBC trials are critical in enhancing patient outcomes. The careful selection and standardization of study designs and endpoints in the perioperative platform are essential for the successful implementation of new therapies and the advancement of personalized treatment approaches in MIBC.
本综述探讨了肌肉浸润性膀胱癌（MIBC）临床试验中围手术期平台的设计和终点。
MIBC围手术期平台的临床试验设计选择必须与特定研究目标相一致，以确保获得有力且有意义的结果。MIBC围手术期平台的新型设计整合了保留膀胱的方法。病理完全缓解和无病生存等主要终点因其在加快围手术期试验结果方面的作用而受到关注。纳入患者报告的结局对于告知医疗保健决策者对患者最有意义的结局很重要。鉴于证据越来越多，在设计MIBC围手术期平台的试验时，应考虑并采用潜在的生物标志物、预测和预后工具。
有效的MIBC试验围手术期平台对于改善患者结局至关重要。围手术期平台中研究设计和终点的精心选择与标准化对于成功实施新疗法以及推进MIBC个性化治疗方法至关重要。
