Post-marketing safety surveillance of ado-trastuzumab emtansine: a real-world data retrospective cohort study using disproportionality analysis.

Chen, Endong; Gan, Yaowei; Chen, Yingying; Chen, Chen; Weng, Yujing; Zhang, Bowen; Cai, Yefeng; Wang, Qingxuan; Li, Quan

Background: Ado-trastuzumab emtansine (T-DM1) is prescribed for HER2-positive, metastatic breast cancer or early breast cancer after neoadjuvant therapy. Although several adverse events (AEs) have been reported, there remains a need for a comprehensive evaluation of its safety profile. Research design and methods: To quantify the signals of ado-trastuzumab emtansine associated AEs, we employed the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the multi-item gamma Poisson shrinker (MGPS) algorithms. Results: Between Q1 2013 and Q4 2022, 3699 patient reports of AEs associated with ado-trastuzumab emtansine were received, including 440 cases of ado-trastuzumab emtansine-induced bleeding events. Of the 3699 patient reports, 142 significant disproportionality preferred terms (PTs) were identified. New AEs have been identified with ado-trastuzumab emtansine administration, including telangiectasia, spider nevus, pericardial effusion, pleural effusion, radiation necrosis, and corneal disorders. The most common bleeding events were observed in the digestive system (27.05%), respiratory system (35.00%), and nervous system (14.55%). Hemorrhagic adverse events exhibited early failure-type characteristics. Conclusion: This analysis offers the most comprehensive overview of ado-trastuzumab emtansine induced hemorrhage to date, shedding new light on this severe complication. Understanding the underlying mechanisms of these positive PTs can provide useful insights for further research.

METASTATIC breast cancer; TRASTUZUMAB; ADVERSE health care events; TELANGIECTASIA; THROMBOCYTOPENIA

Expert Opinion on Drug Safety, 2025, Vol 24, Issue 5, p565

1474-0338

Academic Journal

10.1080/14740338.2024.2438748