Survival and toxicity profile of elderly melanoma patients treated with immune checkpoint inhibitors: a retrospective study from a tertiary care center

The use of immune checkpoint inhibitors (ICI) in the elderly population remains challenging because of age-related factors and lack of evidence due to underrepresentation in clinical trials. This retrospective study aimed to assess the efficacy and safety of ICI in elderly melanoma patients compared with younger individuals, to describe their toxicity profile, and to analyze the influence of health status. We included 93 melanoma patients treated with ICI from January 2016 to July 2024 at a single institution. Patients were grouped by age: less than 65, 65-74, and greater than or equal to 75 years. Baseline characteristics, treatment data, progression-free survival (PFS), overall survival (OS), adverse events and geriatric assessments (ECOG Performance Status, Charlson Comorbidity Index and G8 Frailty Scale) were analyzed. Statistical analyses included Kaplan-Meier and regression models. Survival outcomes were comparable across age groups. In advanced disease, patients over 65 showed improved mean PFS [40.2 vs. 17.1 months, P = 0.036; hazard ratio: 0.49, 95% confidence interval (CI): 0.25-0.95]. OS did not differ significantly. Older patients had lower overall toxicity rates (46-50 vs. 74% in <65 years, P = 0.008; odds ratio: 0.31, 95% CI: 0.13-0.75), with fewer grade 3 adverse events. No association was found between comorbidity indices or frailty status and increased toxicity. Adverse events were predominantly mild-to-moderate, mainly skin-related and constitutional; grade 3 adverse events and gastrointestinal symptoms were more frequent in less than 65 years. In conclusion, immunotherapy is effective and well-tolerated in elderly melanoma patients, neither advanced age nor frailty status alone should restrict its use.