Treatment outcomes in patients with advanced mucosal melanoma in Spain: results from the real-world GEM1801 study

Melanoma Research

Clinical Summary

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What was studied

An observational, real‑world analysis from the Spanish GEM1801 study evaluated outcomes of immune checkpoint inhibitors (ICIs) in advanced mucosal melanoma enrolled between August 2018 and January 2024. It reported first‑ and second‑line objective response, progression‑free survival (PFS), and overall survival (OS), and explored prognostic factors using univariate Cox regression.

Key findings

Among 52 mucosal melanoma patients (median age 70), 32 (62%) received ICIs; at a 13.7‑month median follow‑up, first‑line median PFS was 9.4 months (95% CI 6.6–17.0) and OS 25.9 months (95% CI 21–not reached). Second‑line median PFS was 5.1 months (95% CI 1.9–not reached) and OS 21.0 months (95% CI 11.1–not reached).

Study limitations

Small mucosal melanoma cohort (n=52; only 32 treated with ICIs) limits precision. Observational design with only univariate Cox analysis and no randomized comparator may leave confounding unaddressed.

Clinical implications

In routine care, ICIs yield limited but measurable benefit in advanced mucosal melanoma, with first‑line median PFS ~9 months and OS ~26 months. Set expectations and prioritize clinical trial enrollment when feasible.