ESMO 2020: Survival Analysis From PROfound Trial in Metastatic Prostate Cancer
Posted: Thursday, September 24, 2020
Patients with metastatic castration-resistant prostate cancer who possess mutations of some homologous recombination–repair genes appear to derive an overall survival benefit from treatment with the PARP inhibitor olaparib, according to Maha Hussain, MD, FACP, FASCO, of the Robert H. Lurie Comprehensive Cancer Center, Chicago, and colleagues. The final overall survival analysis of the PROfound phase III trial, which was published in The New England Journal of Medicine, was also presented during the European Society for Medical Oncology (ESMO) Virtual Congress 2020 (Abstract 610O).
“The PROfound trial met its primary endpoint of significantly prolonged radiographic progression-free survival with olaparib versus physician’s choice of enzalutamide or abiraterone,” the investigators commented. “Despite extensive crossover from the control arm, olaparib conferred a statistically significant and clinically meaningful prolongation of overall survival versus sequential therapy with enzalutamide or abiraterone, with a 31% reduction in the risk for death.”
Patients with metastatic castration-resistant disease who experienced disease progression while being treated with either enzalutamide or abiraterone were enrolled. Cohort A comprised of 245 patients who possessed mutations in BRCA1, BRCA2, or ATM. A total of 142 patients with mutations in any of 12 other prespecified homologous recombination–repair genes were assigned to cohort B. Men in each cohort were randomly assigned in a 2:1 ratio to receive olaparib or a control treatment of either enzalutamide or abiraterone plus prednisone.
Based upon an analysis of cohort A, the investigators reported an increased median overall survival in the experimental group, compared with the control group (19.1 vs. 14.7 months; P = .0175); there seemed to be a trend toward an improvement in the overall population (17.3 vs. 14.0 months; P = .0515). More than half (66%) of patients in the control group crossed over to receive olaparib, including 67% of those in cohort A. The safety profile appeared to be congruent with previous reports.
Disclosure: For full disclosures of the study authors, visit oncologypro.esmo.org.