Comparative analysis of cdki-related adverse events in older patients: a real-world data from the FDA adverse event reporting system database.

Abstract

Background: Cyclin-dependent kinase 4 and 6 inhibitors(CDKIs) are effective and safe against advanced and metastatic breast cancer;however, limited information is available for older patients. We conducted ananalysis of real-world data pertaining to the safety of older patients usingthe Adverse Event Reporting System (FAERS) database of the FDA.

Researchdesign and methods: We performed adisproportionality analysis to evaluate CDKI-related adverse events (AEs) inolder adults administered abemaciclib, palbociclib, and ribociclib.

Results: Data were from 2132, 36916, and 4328 casereports on abemaciclib, palbociclib, and ribociclib in older patients,respectively. Disproportionality analysis revealed 242, 295, and 439 drug-AEsignals. The numbers of system organ classes (SOC) for abemaciclib,palbociclib, and ribociclib were 25, 27, and 26, respectively. We found several expected AE signals consistent with thosein the drug instructions, such as nausea, neutropenia, and fatigue, for allCDKIs. Interstitial lung disease, thromboembolicevents, and cardiac toxicity were also noteworthy. Unexpected AE signals, suchas acute kidney injury, atrial fibrillation, and memory impairment associatedwith abemaciclib, ribociclib, and palbociclib, respectively, were identified.

Conclusion: Our results aligned with clinicalobservations, emphasizing possible CDKI-related AEs. Conducting future clinicalresearch is essential to confirm AE-related differences among CDKIs in olderindividuals.