Toxicities associated with sacituzumab govitecan: Data from clinical trials and real-word pharmacovigilance database.

Abstract

e24093 Background: This study aimed to analyze the adverse effect of sacituzumab govitecan (SG) with multiple source data, to provide reference for clinical medication safety management. Methods: Clinical trials of SG with available safety data were searched and included in the pooled analysis (up to January 5th, 2023). The adverse drug reaction (ADR) signals of SG were collected from the FDA Adverse Event Reporting System (FAERS) database up to January 1st, 2023. The ADR signals were presented and sorted by incidence frequency and reporting odds ratio (ROR) strength, respectively. We also searched and summarized drug interactions with SG in DDInter database. Results: A total of 6 clinical trials enrolled 1737 patients were included in pooled analysis, the most common adverse events of ≥3 grade were neutropenia (51.55%), leukopenia (14.50%), anemia (10.69%), diarrhea (7.30%), fatigue and asthenia (4.23%). In pharmacovigilance study, 1024 AE reports were extracted, the most common toxicities of SG are hematologic and gastrointestinal. AEs not included in the instructions also showed high signals, such as meningitis, colitis and lymphedema. A total of 40 drugs identified can induce drug-drug interaction when concomitant administration with SG. Conclusions: This study provides a comprehensive profile of SG based on clinical trial, FRAES and DDInter database, attention should be paid not only to the common ADRs, but also to the ADRs not reported in the drug instructions and potential drugs that induce drug-drug interactions. [Table: see text]