Comparative Safety Profiles of Lutetium-177 and Enzalutamide: A Pharmacovigilance Study and Disproportionality Analysis Using Real World Data
Document Type
Conference Proceeding
Publication Date
6-1-2025
Publication Title
Journal of Clinical Oncology
Abstract
Background: Lutetium-177 represents a significant advancement in treating metastatic castration-resistant prostate cancer (mCRPC), showing a favorable safety profile characterized primarily by mild to moderate nausea and fatigue. Despite its recent approval and focus on these primary adverse effects, conducting a comprehensive pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) data for Lutetium-177 remains essential. This study aims to compare the safety profiles of Lutetium-177 and another mCRPC treatment, Enzalutamide. Methods: This pharmacovigilance study utilized FAERS data from the database’s inception up to January 2025 to assess the adverse effects (AEs) of Lutetium-177 and Enzalutamide. Descriptive statistics were employed to analyze demographics, AEs, and outcomes, comparing the results for both drugs. A disproportionality analysis was conducted using three complementary signal detection methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Empirical Bayes Geometric Mean (EBGM). To ensure the robustness and clinical relevance of identified safety signals, stringent criteria were implemented: ROR—upper bound of 95% Confidence Interval (CI) < 1; PRR—x2 < 4, PRR < 2, and cases > 3; EBGM—lower bound of 90% CI (EB05) < 1. Results: From inception to January 2025, there were 11,593 reported cases of Lutetium-177 and 51,805 cases of Enzalutamide. After excluding non-specific reactions, the most common adverse effects for both drugs were fatigue and nausea. For fatigue, the ROR was 0.119 (95% CI: 0.125-0.158), the PRR was 0.141, and the EBGM was 0.207. For nausea, the ROR was 0.358 (95% CI: 0.244-0.522), the PRR was 0.373, and the EBGM was 0.363. The table presents the outcomes associated with the use of Lutetium-177. Conclusions: The disproportionality analysis indicated that Lutetium-177 exhibited lower ROR, PRR, and EBGM for fatigue and nausea compared to Enzalutamide, suggesting a potentially lower association of these specific adverse effects with Lutetium-177
Volume
43
Issue
16 Suppl
First Page
e15136
Last Page
e15136
Recommended Citation
Pustake M, Ganiyani MA, Khosla AA, Harisingani AR, Aziz N, Syed S, et al. Comparative safety profiles of lutetium-177 and enzalutamide: a pharmacovigilance study and disproportionality analysis using real world data. J Clin Oncol. 2025 Jun 1;43(16 Suppl):e15136. doi:10.1200/JCO.2025.43.16_suppl.e15136
DOI
10.1200/JCO.2025.43.16_suppl.e15136
Comments
2025 ASCO (American Society of Clinical Oncology) Annual Meeting, May 30 - June 3, 2025, Chicago, IL