Toxicity profiles of cyclin-dependent kinase 4/6 inhibitors: safety analysis from clinical trials and the FDA adverse event reporting system.

ABSTRACT:

Aims

This study aimed to evaluate the comprehensive safety profile of CDK4/6 inhibitors in breast cancer treatment by analyzing real-world adverse event (AE) data and systematically reviewing clinical trial findings to provide evidence-based safety guidance.

Methods

A disproportionality analysis based on real-world data from the FDA adverse event reporting system (FAERS) was combined with a systematic review to evaluate adverse events (AEs) associated with CDK4/6 inhibitors. A total of 16 studies involving 6,722 patients with advanced breast cancer were included to analyze the toxicity risks of CDK4/6 inhibitor combination therapies. Temporal patterns of AEs were assessed using FAERS data, and signal strengths were determined using the reporting odds ratio (ROR).

Results<

SUBMITTER: Zhou J 

PROVIDER: S-EPMC12738172 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature