Risk of Selected Gastrointestinal and Hepatic Toxicities in Cancer Patients Treated with Nintedanib: A Meta-Analysis

ABSTRACT

Background: A meta-analysis of the risk of selected gastrointestinal and hepatic toxicities associated with nintedanib has been conducted. Methods: Randomized Phase II/III trials of cancer patients on nintedanib; describing events of diarrhea, vomiting, elevated ALT and elevated AST constituted the eligible studies. Results: The odds ratio for high-grade diarrhea was 3.76 (95% CI: 1.42–9.96; p = 0.008); high-grade vomiting: 1.38 (95% CI: 0.76–2.51; p = 0.28); high-grade elevated ALT: 4.36 (95% CI: 2.14–8.85; p < 0.0001); high-grade elevated AST: 6.96 (95% CI: 4.09–11.85; p < 0.00001). Conclusion: Nintedanib-based regimens are associated with a higher risk of high-grade diarrhea, elevated ALT and elevated AST. Moreover, there is a proportional relationship between nintedanib dose and the risk of elevated transaminases.

KEYWORDS:

• ALT
• AST
• diarrhea
• nintedanib
• vomiting

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.