Purpose: This postmarketing surveillance (PMS) study aimed to evaluate real-world data on the effectiveness and safety of abiraterone acetate plus prednisone (AAP) in patients with metastatic hormone-sensitive prostate cancer (mHSPC).Materials and Methods: This prospective, multicenter observational study was conducted at 27 centers in South Korea between June 2018 and April 2021. Among 117 enrolled patients, 108 were included in the final analysis. Median follow-up period was 40.4 weeks (interquartile range, 22.8–49.2 weeks). Patients aged ≥18 years with mHSPC treated with AAP were included. Effectiveness endpoints included radiographic progression-free survival (rPFS), time to prostate-specific antigen (PSA) progression (TTPP), and PSA response (≥50%, ≥90% reduction). Adverse events (AEs) were assessed and graded based on severity.Results: A total of 108 patients were included in the analysis. Radiographic and PSA progression were observed in 13 (12.0%) and 26 patients (24.1 %), respectively. In the Kaplan-Meier analysis, the median rPFS and TTPP were not reached. The PSA response rates were 85.2% (≥50% reduction) and 75.9% (≥90% reduction) during the study period. AEs were reported in 31 patients (28.7%), with grade 3 or 4 AEs reported in 6 patients (5.6%). The most frequently observed AE was elevated aspartate aminotransferase level (5.6%).Conclusion: This PMS study found that AAP is effective and well-tolerated in the real-world management of mHSPC.
Lee et al. (Wed,) studied this question.