Risk of gastrointestinal complications in cancer patients treated with immune checkpoint inhibitors: a meta-analysis

Immunotherapy. 2015;7(11):1213-27. doi: 10.2217/imt.15.87. Epub 2015 Oct 29.

Abstract

Aim: We performed a meta-analysis of the risk of selected gastrointestinal toxicities associated with immune checkpoint inhibitors.

Patients & methods: Eligible studies included randomized trials of patients with solid tumors on ipilimumab, nivolumab, pembrolizumab, tremelimumab, pidilizumab and atezolizumab, describing events of diarrhea, vomiting or colitis.

Results: After exclusion of ineligible studies, a total of ten clinical trials were considered eligible for the meta-analysis. The relative risk of all-grade diarrhea, vomiting and colitis was 1.64 (95% CI: 1.19-2.26; p = 0.002), 0.72 (95% CI: 0.49-1.07; p = 0.1), 10.35 (95% CI: 5.78-18.53; p < 0.00001), respectively.

Conclusion: Our meta-analysis has demonstrated that immune checkpoint inhibitors are associated with a significantly increased risk of all grade and high-grade colitis.

Keywords: colitis; diarrhea; ipilimumab; nivolumab.

Publication types

  • Meta-Analysis

MeSH terms

  • Antibodies, Blocking / adverse effects
  • Antibodies, Blocking / therapeutic use*
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • CTLA-4 Antigen / antagonists & inhibitors
  • Colitis / etiology
  • Colitis / immunology
  • Colitis / prevention & control*
  • Gastrointestinal Tract / drug effects*
  • Gastrointestinal Tract / immunology
  • Humans
  • Immunotherapy*
  • Neoplasms / complications
  • Neoplasms / immunology
  • Neoplasms / therapy*
  • Programmed Cell Death 1 Receptor / antagonists & inhibitors
  • Randomized Controlled Trials as Topic

Substances

  • Antibodies, Blocking
  • Antineoplastic Agents
  • CTLA-4 Antigen
  • Programmed Cell Death 1 Receptor