Niraparib and Abiraterone Acetate plus Prednisone in Metastatic Castration-resistant Prostate Cancer: Final Overall Survival Analysis for the Phase 3 MAGNITUDE Trial

作者：Kim N., Elena Castro, G. Attard, Matthew R. Smith, Shahneen Sandhu, Eleni Efstathiou, Guilhem Roubaud, Eric J. Small, A Gomes, Dana E. Rathkopf, Marniza Saad, Howard Gurney, Wonho Jung, Won Kim, Shiva Dibaj, Daphne Wu, Jenny Zhang, Angela Lopez‐Gitlitz, Peter Francis, David Olmos · 发表于：European Urology Oncology · 年份：2025 · DOI：10.1016/j.euo.2025.04.012 · 被引用次数：29 · 研究领域：Prostate Cancer Treatment and Research、PARP inhibition in cancer therapy、Prostate Cancer Diagnosis and Treatment

BACKGROUND AND OBJECTIVE: ), particularly in BRCA1/2. METHODS: Patients were prospectively screened for HRR alterations and randomized 1:1 to niraparib + AAP (n = 212) or placebo + AAP (n = 211). We report results from the prespecified, event-driven, final analysis of secondary efficacy endpoints. KEY FINDINGS AND LIMITATIONS: population (HR 0.688, 95% CI 0.499-0.950; p = 0.022) and the BRCA1/2 subgroup (HR 0.598, 95% CI 0.387-0.924; nominal p = 0.019) in comparison to placebo + AAP. The niraparib + AAP safety profile remains unchanged at longer follow-up; adverse events were primarily hematologic and manageable. CONCLUSIONS AND CLINICAL IMPLICATIONS: mCRPC, including those with the approved indication of BRCA-altered mCRPC, generally continue to benefit from first-line treatment with niraparib + AAP in comparison to placebo + AAP.