Radium-223 plus Enzalutamide Versus Enzalutamide in Metastatic Castration-Refractory Prostate Cancer: Final Safety and Efficacy Results

[摘要] Background. Previously, we showed the combination ofradium-223 and enzalutamide to be safe and associatedwith improved efficacy based on a concomitant decline inserum bone metabolism markers compared withenzalutamide alone in a phase II trial of men with metastatic castration-resistant prostate cancer (mCRPC) [1].Methods. Secondary endpoints were not included in our initialreport, and we include them herein, after a median follow-upof 22 months. These objectives included long-term safety,prostate-specific antigen (PSA)–progression-free survival (PFS),and radiographic progression-free survival; PSA-PFS2 (time fromstart of protocol therapy to PSA progression on subsequenttherapy); time to next therapy (TTNT); and overall survival (OS).Survival analysis and log-rank tests were performed using the Rstatistical package v.4.0.2 (https://www.r-project.org). Statisticalsignificance was defined as p < .05.Results. Of 47 patients (median age, 68 years), 35 receivedthe combination and 12 enzalutamide alone. After a medianfollow-up of 22 months, final safety results did not showany increase in fractures or other adverse events in thecombination arm. PSA-PFS2 was significantly improved, andother efficacy parameters were numerically improved in thecombination over the enzalutamide arm.

[学科分类] 地质学

[关键词] Radium-223;Enzalutamide;Metastatic castration-refractory prostate cancer