Evaluation of Safety of Elacestrant in Patients with Breast Cancer: Insights from Food and Drug Administration Adverse Event Reporting System Database Analysis.

Abstract

Introduction: This study aims to evaluate the safety profile of elacestrant in real-world settings using data from the FDA adverse event (AE) reporting system (FAERS) database, offering insights to inform clinical use.

Methods: Data are collected from the FAERS database spanning the first quarter of 2023 through the third quarter of 2024. AEs associated with elacestrant are identified using reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multinomial gamma Poisson shrinkageanalyses. The temporal distribution of AEs is assessed using Weibull distribution to evaluate the drug's safety comprehensively.

Results: Reports of 6,476 AEs with elacestrant as the primary suspect drug are identified, spanning 27 organ systems. A total of 53 preferred terms signal are detected across four algorithms, including known adverse reactions such as nausea, vomiting, fatigue, elevated blood cholesterol, and musculoskeletal pain. Potential new AEs, including pathological fractures, gastroesophageal reflux disease, hypokalemia, lymphedema, and dehydration, are also identified. The median onset time for elacestrant-related AEs is 44 days, with most events occurring within the first month of treatment.

Conclusion: This study offers real-world insights into elacestrant usage, confirming known adverse reactions and identifying previously unreported events. These findings provide valuable guidance for clinicians in minimizing drug risks during treatment.