Survival with Olaparib in Metastatic Castration-Resistant Prostate Cancer.
The New England journal of medicine
BACKGROUND: 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.
METHODS: 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
RESULTS: 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.
CONCLUSIONS: Among men with metastatic castration-resistant prostate cancer who had tumors with at least one alteration in
Hussain, Maha; Mateo, Joaquin; Fizazi, Karim; Saad, Fred; Shore, Neal; Sandhu, Shahneen; Chi, Kim N; Sartor, Oliver; Agarwal, Neeraj; Olmos, David; Thiery-Vuillemin, Antoine; Twardowski, Przemyslaw; Roubaud, Guilhem; Özgüroğlu, Mustafa; Kang, Jinyu; Burgents, Joseph; Gresty, Christopher; Corcoran, Claire; Adelman, Carrie A; and de Bono, Johann, "Survival with Olaparib in Metastatic Castration-Resistant Prostate Cancer." (2020). Articles, Abstracts, and Reports. 3722.