Cardiovascular adverse events in patients with HER2-positive breast cancer treated with trastuzumab-drug conjugates : a Bayesian disproportional real world study for signal detection leveraging the FDA Adverse Event Reporting System (FAERS)

BACKGROUND: The cardiovascular risk profiles of trastuzumab drug conjugates (T-DCs) in the treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-positive breast cancer are uncertain. This study analyzed real-world adverse events data from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to investigate the association between T-DCs and major adverse cardiovascular events (MACE). METHODS: We searched the FAERS database for reports of cardiovascular adverse events in patients with HER2-positive breast cancer receiving trastuzumab, ado-trastuzumab emtansine (T-DM1), and trastuzumab deruxtecan (T-Dxd). The primary endpoint was MACE and the secondary endpoint was other cardiovascular events. Proportionate analysis showed age and weight were the two key factors contributing to the occurrence of T-DCs induced MACE. CONCLUSION: HER2-positive breast cancer patients receiving T-DCs require additional cardiac monitoring, particularly for stroke in younger patients.