Background: Sorafenib, an oral multikinase inhibitor, was the first systemic therapy to demonstrate an overall survival benefit in advanced hepatocellular carcinoma (HCC). Gastrointestinal (GI) adverse events (AE), particularly diarrhea, nausea, and abdominal pain, are commonly reported toxicities and often drive dose modifications. Objectives: To map the prevalence of GI AE in patients with HCC receiving sorafenib. Design: Systematic review and meta-analysis conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Data sources and methods: Clinical trials and relevant observational studies from PubMed reporting on GI side effects with sorafenib were included. Exclusion criteria were studies not involving Sorafenib, studies not involving HCC, previous meta-analyses or systematic reviews, and inaccessible publications. Prevalence of reported GI complications, including diarrhea, nausea, GI toxicity, weight loss/anorexia, constipation, and abdominal pain, were extracted from the included studies and analyzed using GraphPad Prism. Results: The analysis included 136 studies (178 study divisions; total 14,416 patients). Diarrhea was reported in 132 studies, with a mean prevalence of 40.44% (95% CI: 37.31–43.58) and a weighted prevalence of 42.21%. Nausea was reported in 92 studies (mean 24.75%, 95% CI: 21.19–28.28; weighted 20.35%). Abdominal pain was reported in 62 studies (mean 25.85%, 95% CI: 21.52–30.18; weighted 22.30%). GI toxicity was reported in 69 studies (mean 16.96%, 95% CI: 13.07–20.85; weighted 16.11%). Weight loss and anorexia was reported in 66 studies (mean 24.79%, 95% CI: 20.58–29.00; weighted 22.67%). Constipation was reported in 33 studies (mean 16.93%, 95% CI: 13.97–19.89; weighted 14.13%). Conclusion: This meta-analysis synthesizes current evidence on GI AEs with sorafenib in HCC, highlighting diarrhea as the most frequent toxicity and underscoring the need for standardized AE reporting and proactive management strategies to maintain adherence and outcomes.
Arendt et al. (Fri,) studied this question.