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Survival with Olaparib in Metastatic Castration-Resistant Prostate Cancer

奥拉帕尼 医学 恩扎鲁胺 危险系数 前列腺癌 肿瘤科 内科学 队列 临床终点 无进展生存期 雄激素剥夺疗法 癌症 外科 置信区间 随机对照试验 化疗 雄激素受体 聚ADP核糖聚合酶 化学 基因 聚合酶 生物化学
作者
Johann S. de Bono,Joaquı́n Mateo,Karim Fizazi,Fred Saad,Neal D. Shore,Shahneen Sandhu,Kim N.,Oliver Sartor,Neeraj Agarwal,David Olmos,Antoine Thiery-Vuillemin,Przemyslaw Twardowski,Guilhem Roubaud,Mustafa Özgüroğlu,Jinyu Kang,Joseph E. Burgents,Christopher Gresty,Claire Corcoran,Carrie A. Adelman,Johann S. de Bono
出处
期刊:The New England Journal of Medicine [Massachusetts Medical Society]
卷期号:383 (24): 2345-2357 被引量:497
标识
DOI:10.1056/nejmoa2022485
摘要

We previously reported that olaparib led to significantly longer imaging-based progression-free survival than the physician's choice of enzalutamide or abiraterone among men with metastatic castration-resistant prostate cancer who had qualifying alterations in homologous recombination repair genes and whose disease had progressed during previous treatment with a next-generation hormonal agent. The results of the final analysis of overall survival have not yet been reported.In an open-label, phase 3 trial, we randomly assigned patients in a 2:1 ratio to receive olaparib (256 patients) or the physician's choice of enzalutamide or abiraterone plus prednisone as the control therapy (131 patients). Cohort A included 245 patients with at least one alteration in BRCA1, BRCA2, or ATM, and cohort B included 142 patients with at least one alteration in any of the other 12 prespecified genes. Crossover to olaparib was allowed after imaging-based disease progression for patients who met certain criteria. Overall survival in cohort A, a key secondary end point, was analyzed with the use of an alpha-controlled, stratified log-rank test at a data maturity of approximately 60%. The primary and other key secondary end points were reported previously.The median duration of overall survival in cohort A was 19.1 months with olaparib and 14.7 months with control therapy (hazard ratio for death, 0.69; 95% confidence interval [CI], 0.50 to 0.97; P = 0.02). In cohort B, the median duration of overall survival was 14.1 months with olaparib and 11.5 months with control therapy. In the overall population (cohorts A and B), the corresponding durations were 17.3 months and 14.0 months. Overall, 86 of 131 patients (66%) in the control group crossed over to receive olaparib (56 of 83 patients [67%] in cohort A). A sensitivity analysis that adjusted for crossover to olaparib showed hazard ratios for death of 0.42 (95% CI, 0.19 to 0.91) in cohort A, 0.83 (95% CI, 0.11 to 5.98) in cohort B, and 0.55 (95% CI, 0.29 to 1.06) in the overall population.Among men with metastatic castration-resistant prostate cancer who had tumors with at least one alteration in BRCA1, BRCA2, or ATM and whose disease had progressed during previous treatment with a next-generation hormonal agent, those who were initially assigned to receive olaparib had a significantly longer duration of overall survival than those who were assigned to receive enzalutamide or abiraterone plus prednisone as the control therapy, despite substantial crossover from control therapy to olaparib. (Funded by AstraZeneca and Merck Sharp and Dohme; PROfound ClinicalTrials.gov number, NCT02987543.).
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