Division of Hematology and Medical Oncology, Department of Medicine, Director of Genitourinary Medical Oncology, The Tisch Cancer Institute, Mount Sinai School of Medicine, New York, NY 10029, USA.
CA Cancer J Clin. 2012 Sep-Oct;62(5):299-308. doi: 10.3322/caac.21141. Epub 2012 Apr 24.
There have been more drugs approved by the US Food and Drug Administration for the treatment of castration-resistant prostate cancer in the past 3 years than in the prior 3 decades, with additional drugs on the verge of approval based on the results of recently reported randomized trials. While an improvement in the understanding of the pathogenesis of castration-resistant prostate cancer has undeniably accelerated the transition of novel approaches from "bench to bedside," the recent successes in the treatment of prostate cancer are also a result of the efforts of clinical investigators to redefine the framework in which drugs for castration-resistant disease are evaluated. This review will explore the shifting paradigm in drug development for castration-resistant prostate cancer over the past several decades, and highlight how new definitions, trial designs, and endpoints have facilitated the emergence of new therapies for this challenging disease.
在过去的 3 年里，美国食品和药物管理局批准了更多的药物用于治疗去势抵抗性前列腺癌，比前 30 年批准的药物还要多，还有更多的药物基于最近报告的随机试验结果即将批准。虽然对去势抵抗性前列腺癌发病机制的认识的提高无疑加速了新方法从“实验室到病床”的转变，但前列腺癌治疗的最近成功也是临床研究人员努力重新定义评估去势抵抗性疾病药物的框架的结果。这篇综述将探讨过去几十年中治疗去势抵抗性前列腺癌的药物开发模式的转变，并强调新的定义、试验设计和终点如何为这种具有挑战性的疾病的新疗法的出现提供了便利。
