Analysis of cyclin-dependent kinase 4 and 6 inhibitor adverse events in
both younger and older adults using the FDA Adverse Event Reporting
System database
Abstract
Abstract Aim The U.S. Food and Drug Administration (FDA) has granted
approval for the use of cyclin-dependent kinase 4 and 6 inhibitors
(CDKIs) in the management of advanced and metastatic breast cancer. We
evaluated the real-world data associated with safety in younger and
older adults base on Adverse Event Reporting System (FAERS) database of
the FDA. Methods We conducted disproportionality analysis to detect and
compare CDKI-related adverse events (AEs) among the younger and older
adults. Results The data used were from 3,851, 64,731, and 8,420 case
reports on abemaciclib, palbociclib, and ribociclib, respectively
Disproportionality analysis revealed 170, 397, and 626 AEs of
abemaciclib, palbociclib, and ribociclib, respectively, in younger
adults, and 113, 475, and 557 in older adults. The numbers of system
organ classes for abemaciclib, palbociclib, and ribociclib were 27 each
among younger adults, and 25, 27, and 27 among older adults. We found
several expected AE signals same with drug instructions, such as
diarrhea, neutropenia, and thromboembolic events. Furthermore,
unexpected AE signals, such as campylobacter sepsis, enterococcal
endocarditis, and atrioventricular block were identified. Conclusion Our
results align with clinical observations, emphasizing possible AEs
associated with CDKIs. It is essential to conduct future clinical
research to confirm differences in CDKIs among younger and older
individuals.