• Fred Saad, Neal Shore, Hendrik Van Poppel, Dana E Rathkopf, Matthew R Smith, Johann S de Bono, Christopher J Logothetis, Paul de Souza, Karim Fizazi, Peter F A Mulders, Paul Mainwaring, John D Hainsworth, Tomasz M Beer, Scott North, Yves Fradet, Thomas A Griffin, Peter De Porre, Anil Londhe, Thian Kheoh, Eric J Small, Howard I Scher, Arturo Molina, and Charles J Ryan.
• University of Montréal, Montréal, Québec, Canada. Electronic address: fredsaad@videotron.ca.
• Eur. Urol. 2015 Oct 1; 68 (4): 570-7.

BackgroundMetastatic castration-resistant prostate cancer (mCRPC) often involves bone, and bone-targeted therapy (BTT) has become part of the overall treatment strategy.ObjectiveInvestigation of outcomes for concomitant BTT in a post hoc analysis of the COU-AA-302 trial, which demonstrated an overall clinical benefit of abiraterone acetate (AA) plus prednisone over placebo plus prednisone in asymptomatic or mildly symptomatic chemotherapy-naïve mCRPC patients.Design, Setting, And ParticipantsThis report describes the third interim analysis (prespecified at 55% overall survival [OS] events) for the COU-AA-302 trial.InterventionPatients were grouped by concomitant BTT use or no BTT use.Outcome Measurements And Statistical AnalysisRadiographic progression-free survival and OS were coprimary end points. This report describes the third interim analysis (prespecified at 55% OS events) and involves patients treated with or without concomitant BTT during the COU-AA-302 study. Median follow-up for OS was 27.1 mo. Median time-to-event variables with 95% confidence intervals (CIs) were estimated using the Kaplan-Meier method. Adjusted hazard ratios (HRs), 95% CIs, and p values for concomitant BTT versus no BTT were obtained via Cox models.Results And LimitationsWhile the post hoc nature of the analysis is a limitation, superiority of AA and prednisone versus prednisone alone was demonstrated for clinical outcomes with or without BTT use. Compared with no BTT use, concomitant BTT significantly improved OS (HR 0.75; p=0.01) and increased the time to ECOG deterioration (HR 0.75; p<0.001) and time to opiate use for cancer-related pain (HR 0.80; p=0.036). The safety profile of concomitant BTT with AA was similar to that reported for AA in the overall intent-to-treat population. Osteonecrosis of the jaw (all grade 1/2) with concomitant BTT use was reported in <3% of patients.ConclusionsAA with concomitant BTT was safe and well tolerated in men with chemotherapy-naïve mCRPC. The benefits of AA on clinical outcomes were increased with concomitant BTT.Patient SummaryTreatment of advanced prostate cancer often includes bone-targeted therapy. This post hoc analysis showed that in patients with advanced prostate cancer who were treated with abiraterone acetate and prednisone in combination with bone-targeted therapy, there was a continued trend in prolongation of life when compared with patients treated with prednisone alone.Trial RegistrationClinicalTrials.gov NCT00887198.Copyright © 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.

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