Real-world data analysis of topotecan in combination with Bevacizumab or CycloPhosphamide in the FDA adverse event reporting system (FAERS) database.

Background: The main purpose of this study is to observe and detect adverse reactions to the combination of topotecan, bevacizumab and cyclophosphamide, to learn more about possible adverse drug reactions (ADRs) and to help doctors make the right medication decisions and treatment plans.

Research design and methods: Adverse event signals were detected and quantified using data from the U.S. Food and Drug Administration's Adverse Event Reporting System using reporting ratios, proportions of reports (PRR), Bayesian Confidence Propagation Neural Networks (BCPN), and empirical Bayesian Geometric Mean (EBGM). Subgroup analyses were performed to compare adverse events associated with topotecan alone.

Results: The analysis of FAERS data revealed a total of 1,789 primary suspected adverse events (PS AEs) linked to topotecan. The Weibull shape parameter (β) for females was lower than for males across all age groups, indicating a potentially higher susceptibility to the adverse effects of topotecan in female patients.

Conclusions: This study proved several expected and new adverse drug reactions associated with the combination of topotecan, bevacizumab, and cyclophosphamide. While some ADRs, such as neutropenia and anemia, align with the known adverse profile of topotecan, the detection of novel signals, including potential gender-based differences in drug response, warrants further investigation.