Efficacy and safety of nivolumab in metastatic melanoma: real-world practice.

ABSTRACT

BACKGROUND: Anti-PD1 antibodies have revolutionized the management of patients with advanced melanoma. In clinical trials, the efficacy of nivolumab is being tested in selected populations of patients. OBJECTIVES: The aim of this study was to analyse the efficacy and safety of nivolumab in patients with advanced melanoma under real-life conditions. MATERIALS AND METHODS: A retrospective, observational study was conducted in patients treated with nivolumab for advanced melanoma included in the RIC-Mel network. Overall survival and progression-free survival (PFS) were assessed using the Kaplan-Meier method. RESULTS: Eighty-seven patients were included with a median follow-up of 31 months. The median PFS was 13 months (95% CI 7-28). Objective response rate was 33.3%. Among patients achieving a complete response, the response was maintained after treatment discontinuation in 80.7% of patients for a median duration of 21.7 months. Multivariate analysis showed that an increased lactate dehydrogenase level (p = 0.03; HR 1.21; 95% CI 1.02-1.45) and brain metastases (p = 0.024; HR 2.78; 95% CI 1.14-6.77) were correlated with a decrease in PFS. Grade 3 or 4 adverse events were found in 10.3% of patients. CONCLUSION: Based on our study, the efficacy and safety of nivolumab in patients with advanced melanoma are consistent with previously published data.