ArticleTranslational gastroenterology and hepatology2026
Adverse reactions of second-line tyrosine kinase inhibitors in advanced hepatocellular carcinoma treatment: a descriptive analysis from WHO-VigiAccess.
Article in Translational gastroenterology and hepatology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Given the increasing use of targeted therapies in clinical practice, we aimed to determine the clinically actionable safety profiles of second-line tyrosine kinase inhibitors (TKIs) in advanced hepatocellular carcinoma (HCC) by analysing adverse drug reactions (ADRs) reported in the WHO-VigiAccess database. Methods: Retrospective descriptive analysis of ADR reports for cabozantinib and regorafenib in advanced HCC after first-line failure. Data included patient demographics, geographic distribution, system organ classes (SOCs) and preferred terms (PTs) (MedDRA v24.0). Chi-squared tests were used to compare patient characteristics; head-to-head disproportionality analysis [reporting odds ratio (ROR)] was performed for gastrointestinal (GI) disorders. Results: A total of 51,404 reports were analysed (cabozantinib: 33,846; regorafenib: 17,558). Cabozantinib exhibited a significantly higher proportion of GI disorders (87.2% Conclusions: Cabozantinib carries a disproportionately higher risk of severe GI toxicity compared with regorafenib. Clinicians should consider prophylactic anti-diarrhoeal therapy, routine liver-function monitoring, and early dose modifications when initiating cabozantinib, especially in male patients aged 45-64 years. These data supported personalized second-line TKI selection after first-line failure.
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