| Purpose: The aim of this study was to evaluate the risk of immune-related adverse events(irAEs)among cancer patients receiving nivolumab-plus-ipilimumab therapy and nivolumab monotherapy.Patients and methods: PubMed and Web of Science were searched for related studies from inception to June 2018.Eligible studies included randomized controlled trials comparing nivolumab-plusipilimumab with nivolumab alone in cancer patients reporting on all-grade(grade 1–4)and highgrade(grade 3/4)irAEs.Paired reviewers selected studies for inclusion and extracted data.The odds risk and 95% CI were calculated.Results: A total of 2,946 patients from four studies were included in the meta-analysis.The underlying malignancies included lung cancer(two trials)and melanoma(two trials).Compared with nivolumab monotherapy,the nivolumab-plus-ipilimumab therapy was associated with a significantly higher risk of all-and high-grade irAEs such as pruritus,rash,diarrhea,colitis,alanine aminotransferase elevation,and pneumonitis.Conclusion: The combination therapy of nivolumab and ipilimumab increased the incidence of irAEs in patients with advanced cancer. |