Abstract

Nivolumab and ipilimumab combination immunotherapy has become a standard treatment option for certain cancers. However, the benefits of combination therapy compared to nivolumab monotherapy in lung cancer patients are not entirely clear. We aimed to evaluate whether nivolumab plus ipilimumab improves clinical outcomes in lung cancer patients compared to nivolumab monotherapy. A literature search was performed on PubMed, Web of Science, and Scopus from inception until November 2024 to identify relevant randomized controlled trials. The Cochrane risk of bias tool was used to assess the risk of bias, the hazard ratio (HR) was calculated for survival, risk ratios (RRs) were calculated for response rate and safety outcomes, and a random effects model meta-analysis was performed to estimate the safety and efficacy of the treatments. Seven trials comprising 2134 patients were included. Compared with patients receiving nivolumab monotherapy, non-small cell lung cancer patients who received combination therapy had better progression-free survival (HR = 0.82, 95% CI 0.71; 0.93, P < 0.01, low certainty), and there were no significant differences in overall survival (HR = 0.95, 95% CI 0.86; 1.0, P = 0.31, moderate certainty), or objective response rate (RR = 1.36, 95% CI 0.91; 2.02, P = 0.14 very low certainty). The combination group had a significantly greater risk of grade 3-4 adverse events (RR = 2.77, 95% CI 1.38; 5.56, P < 0.01, low certainty). Although combination treatment significantly improved progression-free survival in NSCLC patients, it was also associated with a greater risk of adverse events and treatment-related mortality than nivolumab monotherapy. The current evidence is insufficient for choosing combination treatment over nivolumab monotherapy.

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