建立反映患者利益的适当中间终点的挑战和机遇：非转移性前列腺癌研究和临床应用路线图。
Challenges and Opportunities in Establishing Appropriate Intermediate Endpoints Reflecting Patient Benefit: A Roadmap for Research and Clinical Application in Nonmetastatic Prostate Cancer.
发表日期：2024 Aug
作者：
Sabine D Brookman-May, Marc Buyse, Stephen J Freedland, Branko Miladinovic, Ke Zhang, Wolfgang P Fendler, Felix Feng, Oliver Sartor, Christopher J Sweeney
来源：
EUROPEAN UROLOGY
摘要：
为早期高危前列腺癌的研究定义有意义的终点具有挑战性，因为总体生存率和无转移生存率等既定指标面临着可行性和充分反映患者相关性的限制。制定终点必须迎合科学、临床、监管和患者观点的不同观点。病理学完全缓解、无疾病证据和预防前列腺特异性抗原复发等终点可能通过考虑诊断和治疗负担来反映患者获益。版权所有 © 2024 欧洲泌尿外科协会。由 Elsevier B.V. 出版。保留所有权利。
Defining meaningful endpoints for research of early-stage high-risk prostate cancer is challenging, with established measures such as overall survival and metastasis-free survival facing limitations related to feasibility and adequate reflection of patient relevance. Developing endpoints must cater to diverse perspectives across scientific, clinical, regulatory, and patient viewpoints. Endpoints such as pathological complete response, no evidence of disease, and prevention of prostate-specific antigen relapse may reflect patient benefit by accounting for diagnostic and treatment burdens.Copyright © 2024 European Association of Urology. Published by Elsevier B.V. All rights reserved.