Comparative Pharmacovigilance Analysis of Safety Signals Among Advanced Prostate Cancer Therapies Using FAERS (FDA Adverse Event Reporting System)

Vollständiger Abstract

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Therapeutic options for advanced prostate cancer have expanded in recent years, incorporating multiple-system treatment approaches with differing mechanisms of action. However, comparative real-world safety data following drug approval remain limited. As such, the aim of this study is to characterize adverse events and disproportionate safety signals among advanced prostate cancer therapies using the FDA Adverse Event Reporting System (FAERS). A retrospective pharmacovigilance study of FAERS reports evaluated enzalutamide, darolutamide, apalutamide, abiraterone acetate, relugolix, niraparib/abiraterone, talazoparib, rucaparib, cabazitaxel, sipuleucel-T, and lutetium-177 vipivotide. Adverse events were categorized by System Organ Class and Preferred Terms. Reporting odds ratios (RORs) with 95% confidence intervals identified safety signals. Among 172,440 reports, most involved patients aged 65–85 years. Cabazitaxel had the highest proportion of serious reports (86.6%) and deaths (22%), whereas relugolix had the lowest (23.3% and 4.8%). Nervous system disorders predominated with enzalutamide and darolutamide, gastrointestinal disorders with abiraterone, rucaparib, and niraparib/abiraterone, and hematologic toxicities with cabazitaxel, talazoparib, and lutetium-177 vipivotide. Significant safety signals were identified for abiraterone and cabazitaxel, but not other therapies. The absence of a detected signal should not be interpreted as evidence of safety or equivalence, as reporting volume, detection bias, and statistical power varied across therapies. Overall, the therapies demonstrated distinct toxicity profiles, which may inform treatment selection, toxicity monitoring, and patient counseling.