Final Analysis of PROfound Trial: Olaparib in Metastatic Castration-Resistant Prostate Cancer
Posted: Tuesday, January 19, 2021
For patients with metastatic castration-resistant prostate cancer whose tumors had at least one alteration in BRCA1, BRCA2, or ATM, olaparib improved overall survival compared with enzalutamide or abiraterone plus prednisone, according to the final analysis of the phase III PROfound trial, published in The New England Journal of Medicine. Johann de Bono, MD, PhD, of the Institute of Cancer Research and Royal Marsden, London, and colleagues suggested this improvement was noted “despite substantial crossover from control therapy to olaparib.”
“These findings support the previously reported result of a significantly longer duration of imaging-based progression-free survival with olaparib than with control therapy in the same patient population,” the authors commented.
In this study, the patients were randomly assigned in a 2:1 ratio to receive olaparib (256 patients) or enzalutamide or abiraterone plus prednisone as the control (131 patients). Cohort A had 245 patients with at least one alteration in BRCA1, BRCA2, or ATM. A total of 142 patients were in cohort B and had at least one alteration in any other 12 preidentified genes. Patients in the control group could decide to cross over to the olaparib group if they had disease progression and had not received other cancer treatment.
In cohort A, the median duration of overall survival was 19.1 months with olaparib and 14.7 months in the control group (hazard ratio for death = 0.69; P = .02). For cohort B, the median duration of overall survival was 14.1 months with olaparib and 11.5 months in the control group. In the overall population, the duration of median overall survival was 17.3 months and 14.0 months, respectively. A total of 86 patients (67%) crossed over from the control therapy to receive olaparib.
Disclosure: The study authors’ disclosure information can be found at nejm.org.