Hematological toxicity of anti-tumor antibody-drug conjugates: A retrospective pharmacovigilance study using the FDA adverse event reporting system.

ABSTRACT:

Background

Although antibody-drug conjugates (ADCs) have shown significant efficacy in cancer treatment, hematotoxicity remains a serious issue. This study aims to investigate the relationship between ADCs and hematological toxicity.

Methods

Our study was conducted using data extracted from the U.S. Food and Drug Administration Adverse Events Reporting System (FAERS) from the third quarter of 2011 to the second quarter of 2024. We used four disproportionality analysis methods to measure risk signals. In addition, we analyzed the time-to-onset of hematotoxicity adverse events (AEs).

Results

A total of 4,803 cases of hematotoxicity AEs associated with ADCs were identified, the median age of patients was 60 years (IQR: 47-72). Different ADCs have different hematotoxicity

SUBMITTER: Rao M 

PROVIDER: S-EPMC12558476 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature