Risk of selected gastrointestinal and hepatic toxicities in cancer patients treated with nintedanib: a meta-analysis.

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.