Efficacy and safety of nivolumab plus ipilimumab versus nivolumab alone in patients with advanced melanoma: a systematic review and meta-analysis.

ABSTRACT

BACKGROUND: Annual melanoma incidence in the US is escalating. OBJECTIVE: Comprehensive evaluation of nivolumab alone or with ipilimumab for advanced melanoma treatment. RESEARCH DESIGN AND METHODS: A systematic search was conducted across PubMed, Embase, Web of Science, and Cochrane databases, extending until August 2023. A range of outcomes were evaluated, encompassing overall survival (OS), recurrence-free survival (RFS), progression-free survival (PFS), disease-free survival (DFS), adverse events (both any and serious), complete response rate, mortality rate, and recurrence rate in patients with advanced melanoma. RESULTS: This analysis was conducted on seven relevant studies, involving 2,885 patients. The baseline characteristics of both groups were found to be comparable across all outcomes, with the exception of tumor size. The pooled analysis did not reveal any significant disparities, except for PFS, where the nivolumab-ipilimumab treatment group demonstrated a significantly longer PFS compared to the nivolumab group. However, there was a notable discrepancy in any adverse events (Odds Ratio (OR) 2.69; 95% Confidence Interval (CI) 1.96, 3.69; p < 0.00001) and serious adverse events (OR 3.59; 95% CI 2.88, 4.49, p < 0.00001) between the two groups, suggesting that the safety profile of nivolumab combined with ipilimumab was inferior. CONCLUSIONS: Given diversity and potential biases, oncologists should base immunotherapy decisions on professional expertise and patient characteristics. REGISTRATION PROSPERO registration number CRD42023453484.