Tolerability of single agent nivolumab in cancer patients—A meta-analysis.
e15146 Background: Nivolumab, a PD-1 immune checkpoint inhibitor, is being widely utilized in a number of cancers as a single agent. Adverse events, including those that are immune mediated, have been reported that resulted in discontinuation of the drug. We conducted a meta-analysis of published clinical trials to further investigate the tolerability of nivolumab in cancer patients. Methods: Databases, including PubMed and abstracts presented at American Society of Clinical Oncology annual meetings from 2015 to December 2019 were searched to identify relevant studies. This included randomized controlled trials and single arm trials that reported a discontinuation rate due to adverse events. Incidences and relative risks were calculated based on the heterogeneity of included studies. Results: Seventeen studies published between 2015 and 2019 were selected, which included a total of 4216 patients. Overall, the discontinuation rate of nivolumab due to adverse events was 6.7% (95% CI 4.7-9.5%). The rate varied significantly with the type of cancer (p < 0.001). The lowest discontinuation rate was in NSCLC of 2.1% (95% CI 1.3-2.3%), and the highest discontinuation rate was in melanoma of 15.2% (95% CI 6.8-30.6%). In addition, significantly higher intolerability is associated with the fixed dose of nivolumab at 240 mg than 3 mg/kg (P = 0.004). In comparison with chemotherapy controls, the intolerability in the nivolumab group was not significantly different, with a relative risk of 0.97 (95% CI: 0.36-2.6). Conclusions: The intolerability of nivolumab as monotherapy may be similar to chemotherapy, and can be improved with dose adjustment.