Hematological toxicities in antibody–drug conjugates related with breast cancer: a pharmacovigilance study using FDA adverse event reporting system database

OBJECTIVE: The trastuzumab emtansine, trastuzumab deruxtecan, and sacituzumab govitecan are antibody-drug conjugates (ADCs) that have demonstrated efficacy in the treatment of breast cancer. Nonetheless, these ADCs can also induce severe toxicities in various organ systems, particularly the hematological system. Therefore, this study evaluated the hematological toxicities associated with ADCs in breast cancer based on real-world data. METHODS: Data were extracted from the FDA Adverse Event Reporting System (FAERS) database, spanning from 2014 Q1 to 2023 Q3. Further analysis was done on the hematological toxicities related with ADCs, including their features, onset time, and fatality proportion. RESULTS: Out of 10,976 adverse event reports, 1895 hematotoxicity reports (17.26%) were analyzed. All ADCs exhibited positive safety signals for hematological toxicities, as indicated by reporting odds ratios and the information component. Unexpected significant adverse events, including splenomegaly, immune thrombocytopenia, hemolytic anemia, and hemolytic anemia, that were discovered in the medication label transpired during our data mining. The median time-to-onset of these toxicities was 13 days (interquartile range [IQR] 7-54.75), and the fatality proportion associated with hematological toxicities and ADCs was 17.41%. CONCLUSION: The study indicated that hematological toxicities caused by ADCs preferentially emerge early and may have catastrophic consequences. Early detection and management of these hematological toxicities associated with ADC is essential.