Darolutamide versus abiraterone acetate-based triplets in patients with hormone-sensitive prostate cancer: real-world, head-to-head comparison from the ARON-3 study

Abstract

The therapeutic landscape of metastatic hormone-sensitive prostate cancer (mHSPC) has expanded significantly with triplet regimens, raising questions about their real-world applicability. This study evaluates the efficacy and safety of darolutamide- and abiraterone-based triplets using real-world data from the ARON-3 study. METHODS: A retrospective analysis was conducted on 247 mHSPC patients treated with DARO+DOCE+ADT or ABI+DOCE+ADT across 37 institutions in 14 countries. Key outcomes included progression-free survival (PFS), overall survival (OS), PSA kinetics, and safety. A propensity score was estimated based on key clinical variables and included as a covariate in Cox regression models to adjust for baseline imbalances between treatment groups. RESULTS: Data from 247 patients receiving triplet therapy were analyzed. The median OS for the entire cohort was not reached (NR). The median PFS was 24.8 months (95% CI: 18.7-33.6), with NR for DARO+DOCE+ADT and 21.5 months (95% CI: 13.1-25.2) for ABI+DOCE+ADT (P=0.007). In patients with visceral metastases, DARO+DOCE+ADT demonstrated superior outcomes, achieving higher OS rates at 6 months (97% vs. 83%, P=0.002) and 12 months (92% vs. 74%, P