Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy
Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy
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DOI：
10.1056/nejmoa1207506
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发表时间：
2012-09-27
影响因子：
158.5
通讯作者：
de Bono, Johann S.
中科院分区：
文献类型：
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作者：
Scher, Howard I.;Fizazi, Karim;de Bono, Johann S.
denzalutamide（以前称为MDV3100）靶向雄激素受体信号通路中的多个步骤，雄激素受体信号通路是前列腺癌生长的主要驱动因素。我们的目的是评估恩杂鲁胺是否延长化疗后去势抵抗性前列腺癌患者的生存期。方法在我们的3期、双盲、安慰剂对照试验中，我们根据东方合作肿瘤组的表现状态评分和疼痛强度对1199名化疗后去势抵抗的前列腺癌患者进行分层。我们随机分配他们，以2:1的比例，接受口服enzalutamide剂量160毫克/天（800例患者）或安慰剂（399例患者）。主要终点为总生存期。结果在520例死亡时，该研究在计划的中期分析后停止。恩杂鲁胺组的中位总生存期为18.4个月（95%可信区间[CI]， 17.3至尚未达到），而安慰剂组的中位总生存期为13.6个月（95% CI， 11.3至15.8）(恩杂鲁胺组死亡风险比为0.63;95% CI， 0.53至0.75；P
BACKGROUNDEnzalutamide (formerly called MDV3100) targets multiple steps in the androgen-receptor-signaling pathway, the major driver of prostate-cancer growth. We aimed to evaluate whether enzalutamide prolongs survival in men with castration-resistant prostate cancer after chemotherapy.METHODSIn our phase 3, double-blind, placebo-controlled trial, we stratified 1199 men with castration-resistant prostate cancer after chemotherapy according to the Eastern Cooperative Oncology Group performance-status score and pain intensity. We randomly assigned them, in a 2: 1 ratio, to receive oral enzalutamide at a dose of 160 mg per day (800 patients) or placebo (399 patients). The primary end point was overall survival.RESULTSThe study was stopped after a planned interim analysis at the time of 520 deaths. The median overall survival was 18.4 months (95% confidence interval [CI], 17.3 to not yet reached) in the enzalutamide group versus 13.6 months (95% CI, 11.3 to 15.8) in the placebo group (hazard ratio for death in the enzalutamide group, 0.63; 95% CI, 0.53 to 0.75; P