Apalutamide

Prostate cancer is the most common malignancy in men and a leading cause of cancer-related death. Progression from non-metastatic castration-resistant prostate cancer (nmCRPC) to metastatic CRPC (mCRPC) significantly worsens health-related quality of life (HRQoL), increases mortality, and raises healthcare costs. This study assessed the impact of avoiding or delaying progression to mCRPC on HRQoL, mortality, and economic outcomes, incorporating patients' lived experiences and unmet needs.

Three complementary studies were conducted. Study 1 was a scoping review of HRQoL and functional outcomes across disease stages, analyzing 56 studies (27 RCTs, 29 observational). Study 2 used a pharmacoeconomic survival-partition model of apalutamide, calibrated for the Portuguese healthcare system, to estimate utility gains, mortality impacts, and healthcare costs associated with delaying progression (excluding drug costs). Study 3 comprised two virtual focus groups (n = 5) exploring patient experiences, including symptom burden, psychological impact, daily life disruption, coping strategies, and care-related unmet needs.

High-risk nmCRPC patients had higher HRQoL and better function than mCRPC patients. Symptomatic mCRPC had the lowest HRQoL (EQ-5D 0.63-0.90 vs 0.85-0.86; FACT-P 93-123 vs 109-121). Delaying progression yielded an estimated utility gain of 0.192, reduced annual mortality (0.1% vs 19.1%), and 4.4-fold lower healthcare costs. Focus groups confirmed greater physical symptoms, emotional distress, and social disruption in mCRPC, while nmCRPC experiences centered on monitoring and uncertainty. Patients identified gaps in supportive care, including psychosocial, sexual, and functional needs.

Delaying progression from nmCRPC to mCRPC confers substantial HRQoL, survival, and economic benefits. Patient perspectives highlight gaps in supportive care and the value of early targeted interventions.

Small qualitative sample, reliance on baseline HRQoL without longitudinal adjustment, heterogeneity across studies, and exclusion of nmCRPC treatment costs may limit generalizability and precision.

Severe cutaneous adverse reactions (SCARs) encompassing Stevens‐Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) are increasingly reported among patients treated with novel antiandrogens, but the signals of disproportionate reporting and clinical features remain inadequately defined. This study was an observational retrospective pharmacovigilance study using the publicly available FAERS/EudraVigilance/JADER databases. To explore the signals of disproportionate reporting, disproportionality analysis was conducted using information component (IC) and reporting odds ratio (ROR) methodologies. Descriptive statistics were calculated for baseline and demographic information, onset time, and reaction outcomes. There was no disproportional signal for SCARs in patients using abiraterone, enzalutamide, and darolutamide. Significant over‐reporting signals for apalutamide were observed in SJS (FAERS, ROR 025  = 4.12, IC 025  = 1.70, N  = 30; EudraVigilance, ROR 025  = 11.54, IC 025  = 2.84, N  = 55; JADER, ROR 025  = 2.90, IC 025  = 1.33, N  = 25), TEN (FAERS, ROR025 = 4.40, IC025 = 1.75, N  = 29, EudraVigilance, ROR 025  = 30.96, IC 025  = 3.74, N  = 58; JADER, ROR 025  = 5.34, IC 025  = 1.85, N  = 25), DRESS (FAERS, ROR025 = 2.68, IC025 = 1.33, N  = 38; EudraVigilance, ROR 025  = 25.06, IC 025  = 3.53, N  = 55; JADER, ROR 025  = 0.62, IC 025  = 0.19, N  = 6) and AGEP (FAERS, ROR025 = 1.16, IC025 = 0.55, N  = 7; EudraVigilance, ROR 025  = 4.18, IC 025  = 1.02, N  = 5; JADER, ROR 025  = 1.05, IC 025  = 0.45, N  = 4). Incorporated data from 3 databases, the lethal rates of apalutamide‐related SCARs were 24.4% for SJS, 51.1% for TEN, and 10.5% for DRESS. The median time to onset was 41 days for SJS, 29 days for TEN, and 40 days for DRESS, respectively. The postmarketing pharmacovigilance study suggested an association between SCARs and apalutamide use, but not for other novel antiandrogens. As apalutamide gains greater clinical use, practitioners must be aware of apalutamide‐SCARs risk.