The efficacy of abiraterone in metastatic hormone-sensitive prostate cancer: a stratified meta-analysis based on subgroups of low or high disease volume and reconstructed individual patient data.

INTRODUCTION

The efficacy of abiraterone in metastatic hormone-sensitive prostate cancer (mHSPC) across different disease volumes remains uncertain. This meta-analysis aims to clarify benefit of abiraterone in low- and high-volume mHSPC.

RESEARCH DESIGN AND

METHODS

Phase III randomized clinical trials of abiraterone were selected. Individual patient data (IPD) for overall survival (OS), progression-free survival (PFS), and cancer-specific survival were reconstructed. Hazard ratios (HRs) with 95% confidence intervals (CIs) were pooled to assess the efficacy. Survival analysis was performed using Cox hazards model.

RESULTS

Data for 3374 patients were analyzed. In the overall population, abiraterone improved OS (HR: 0.66, 95% CI 0.59-0.73) and PFS (HR: 0.51, 95% CI 0.45-0.58). Subgroup analyses showed consistent OS benefit of abiraterone across low- and high-volume subgroups (HR: 0.71 and 0.64), and PFS benefit in counterparts (HR: 0.49 and 0.46). Grade 1-2 adverse events were reduced in abiraterone group (RR 0.66), while grade 3-4 events increased (RR 1.33). The Kaplan-Meier curves showed that abiraterone significantly improved OS and PFS across all subgroups (All p < 0.05).

CONCLUSIONS

Adding abiraterone provided significant survival benefits in patients with mHSPC regardless of disease volume. Future investigation shouldvalidate these findings in real world setting.

REGISTRATION: PROSPERO: (CRD420251028079).