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 subgroups using full analysis set and reconstructed individual patient data (IPD).

Research design and methods: Phase III randomized clinical trials of abiraterone were selected. 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, and risk ratios (RRs) with 95% CIs were used to summarized adverse events. Survival analysis was performed using Cox hazards model based on the reconstructed IPD. Heterogeneity was assessed by Cochran's Q and I².

Results: Data for 3182 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). Heterogeneity was low except for PFS in low-volume subgroup. 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 should aim to drive more personalized therapies and validate these findings in real world setting.

Registration: PROSPERO: ;(CRD420251028079).