Medical Oncology Branch, National Cancer Institute, NIH, Bethesda, MD 20892, USA.
J Hematol Oncol. 2012 Jul 2;5:35. doi: 10.1186/1756-8722-5-35.
Men with metastatic castration-resistant prostate cancer (mCRPC) carry poor prognosis despite the use of docetaxel-based regimens which has modest survival benefit shown by randomized clinical trials. Significant progress in the discovery of novel therapeutic agents has been made in the past few years. While sipuleucel-T, cabazitaxel, and abiraterone gained regulatory approval in 2010 and 2011, several highly promising candidates/regimens have failed in large scale clinical trials. Challenges remain to optimize the design and interpretation of clinical trial results and develop more effective strategies for mCRPC. In this review, we examined the positive and negative clinical trials in mCRPC in the past and discussed the various aspects of clinical trial design including selection of targets and appropriate outcome measures, biomarker development and implementation, and strategies for combination therapy.
尽管基于多西他赛的方案显示出随机临床试验适度的生存获益，但转移性去势抵抗性前列腺癌（mCRPC）患者的预后仍然较差。在过去的几年中，在发现新型治疗药物方面取得了重大进展。虽然 sipuleucel-T、卡巴他赛和阿比特龙分别于 2010 年和 2011 年获得监管批准，但几个很有前途的候选药物/方案在大规模临床试验中失败。优化临床试验结果的设计和解释以及开发更有效的 mCRPC 治疗策略仍然存在挑战。在这篇综述中，我们回顾了过去 mCRPC 中的阳性和阴性临床试验，并讨论了临床试验设计的各个方面，包括靶标选择和适当的结果测量、生物标志物的开发和实施，以及联合治疗策略。
