Adverse Reactions of First-Line Tyrosine Kinase Inhibitors in Advanced Hepatocellular Carcinoma Treatment: A Descriptive Analysis From WHO-VigiAccess

Abstract

Aims: To determine the safety of first-line tyrosine kinase inhibitors (TKIs) in advanced hepatocellular carcinoma (HCC) treatment by assessing the adverse drug reactions (ADRs) as reported in the World Health Organization (WHO)–VigiAccess database. Methods: We compiled ADR reports for two first-line TKIs from WHO-VigiAccess with retrospective descriptive analysis, gathering data on the disease systems and symptoms associated with ADRs, as well as population and geographic characteristics of advanced HCC patients. Results: A total of 63,375 ADR reports were analyzed for two first-line TKIs used in advanced HCC treatment: lenvatinib (N = 28,419) and sorafenib (N = 34,956). Gender distribution revealed male predominance for sorafenib (67.62%), whereas lenvatinib had more female reporters (53.40%). Among the 27 system organ classes, gastrointestinal disorders had the highest number of ADR reports for lenvatinib (15,683, 55.18%) and sorafenib (21,423, 61.29%). Based on gastrointestinal disorders, lenvatinib and sorafenib had similar reporting odds ratio (ROR) of 0.94 (0.96–0.92) and 0.96 (0.98–0.94) and proportional reporting ratio (PRR) of 0.95 (0.97–0.94) and 0.97 (0.98–0.95). The highest proportions of adverse reactions of diarrhea reported for the two drugs were 12% for lenvatinib and 15.74% for sorafenib. Conclusion: While gastrointestinal toxicities were class-wide concerns, agent-specific risks necessitate tailored monitoring. These findings emphasized the need for vigilant monitoring and personalized management in clinical practice.