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).


CONCLUSIONS
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.
Clinical Oncology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Omar
O
Abdel-Rahman
Clinical Oncology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Nermean
N
Bahie Eldin
Clinical Oncology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
Hesham
H
ElHalawani
D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D005767:Gastrointestinal Diseases / Q000175:diagnosis / Q000453:epidemiology* / Q000209:etiology*; D006801:Humans; D015994:Incidence; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects*; D008107:Liver Diseases / Q000175:diagnosis / Q000453:epidemiology* / Q000209:etiology*; D009369:Neoplasms / Q000150:complications* / Q000188:drug therapy / Q000453:epidemiology*; D016017:Odds Ratio; D011159:Population Surveillance; D012306:Risk; D012720:Severity of Illness Index
D000970:Antineoplastic Agents; D007211:Indoles; C530716:nintedanib
ALT; AST; diarrhea; nintedanib; vomiting