Sex-specific survival in advanced metastatic melanoma – a DeCOG study on 2032 patients of the multicenter prospective skin cancer registry ADOREG

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BACKGROUND: Females and males differ in their innate and acquired immune responses. Thus, it is hypothesized that the efficacy of anti-tumor immunotherapies may differ by sex. This study aimed to investigate sex-specific survival differences upon different therapy types in metastatic melanoma. PATIENTS AND METHODS: Patients with unresectable metastatic melanoma (stage IV, AJCCv8) of the skin or unknown primary, who had received first-line PD-1-based immune checkpoint inhibition (ICI) or BRAF/MEK-directed targeted therapy (TT) were identified from the prospective multicenter DeCOG skin cancer registry ADOREG. Study endpoints were progression-free survival (PFS) and overall survival (OS). RESULTS: A total of 2032 patients, 1274 males (62.7 %) and 758 females (37.3 %), received ICI (n = 1484) or TT (n = 548) between May 2010 and December 2020. At median follow-up of 28.6 months, no significant sex-specific differences in survival could be detected, neither in the total cohort nor by treatment type: PFS (total, p = 0.86; ICI, p = 0.46; TT, p = 0.21), OS (total, p = 0.60; ICI, p = 0.20; TT, p = 0.30). Multivariable Cox regression analyses also did not show a relevant prognostic influence by sex. Subgroup analyses were performed according to ICI therapy type. In n = 872 patients treated with PD-1 monotherapy, a survival advantage (PFS, p = 0.041; OS, p = 0.07) could be detected for males by univariable and multivariable analyses, whereas no sex-specific survival differences were found for n = 456 patients who received combination immunotherapy. CONCLUSION: No overall sex-specific survival differences were detected for metastatic melanoma patients in the first-line therapy setting. According to subgroup analyses males show a trend towards a survival advantage over females.

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