Abstract 1174P
Background
The incidence of melanoma is increasing in patients (pts) of both sexes, with female pts generally living longer than their male counterparts. This study assessed the sex-based difference in survival of pts with melanoma and the relationship of this difference with pathological features and response to different treatment options in Spain.
Methods
GEM1801 is a prospective observational study that analyzes the clinical and pathological disease presentation patterns, the different lines of treatment choices and the health outcomes derived from treatments. Here we focus on the sex of pts diagnosed with locally advanced unresectable or metastatic melanoma and their first line (1L) treatment assigned.
Results
From Aug 2018 to Dec 2022, 712 evaluable pts were enrolled, 430 males (60.4%) and 282 (39.6%) females. Median age was 67 years (range: 22-95). Most were superficial spreading (42.6% vs 30.5%; p<0.001), being more frequent than other types in females. Primary tumors were more frequently located in the trunk and head in males and in extremities in females (p<0.001). Chronic sun exposure was more frequent among males (12.3% vs 4.6%; p=0.002). Sex led to no statistically significant differences in therapeutic assignment. At data cutoff, the median follow-up was 14.4 m (95% CI: 13.3-16.2). Efficacy is shown in the table. Table: 1174P
N, (%) | Median PFS (95% CI), months | p-value Cox | Median OS (95% CI), months | p-value Cox | |
BRAF + IT Male | 61 (58.7) | 20.6 (7.9-NR) | 0.381 | 35.8 (24.1-NR) | 0.766 |
BRAF + IT Female | 43 (41.3) | 15.3 (6.5-NR) | NR (22.9-NR) | ||
BRAF + TT Male | 109 (57.4) | 9.7 (7.5-12.2) | 0.001 | 13.9 (11.7-26.2) | 0.026 |
BRAF + TT Female | 81 (42.6) | 16.8 (10.2-27.5) | 26.1 (21.1-NR) | ||
BRAF - IT Male | 158 (64.6) | 9.6 (6.6-24.9) | 0.827 | 29.6 (17.9-47.9) | 0.865 |
BRAF - IT Female | 89 (35.4) | 8.8 (6.5-16.8) | 23 (18.4-NR) |
IT = Immunotherapy; TT = Targeted therapy.
Conclusions
Melanoma in Spain showed sex-based differences in prevalence, histology type, primary location and risk factors exposure. Therapies are not assigned based on sex. TT in 1L showed significantly better outcomes in females, which may suggest a potential prognostic role of sex useful for therapeutic assignment.
Clinical trial identification
NCT03605771.
Editorial acknowledgement
We acknowledge MFAR Clinical Research staff for their assistance in the development of this abstract.
Legal entity responsible for the study
Grupo Español Multidisciplinar de Melanoma (GEM).
Funding
Grupo Español Multidisciplinar de Melanoma (GEM).
Disclosure
E. Muñoz Couselo: Financial Interests, Personal, Speaker, Consultant, Advisor: BMS, MSD, Novartis, Pierre Fabre, Sanofi, Roche; Financial Interests, Personal, Advisory Board: Amgen, BMS, MSD, Roche, Sanofi, Novartis, Pierre Fabre; Financial Interests, Personal, Principal Investigator, Clinical trial participation: Amgen, BMS, GSK, MSD, Pierre Fabre, Roche, Sanofi, Novartis; Financial Interests, Personal, Other, Honoraria: Amgen, BMS, Pierre Fabre, MSD, Novartis, Roche. M. Berciano-Guerrero: Financial Interests, Personal, Speaker, Consultant, Advisor: BMS, MSD, Eisai, Pierre Fabre, Roche, Novartis; Financial Interests, Personal and Institutional, Research Grant, Research project. Recipient: My Institution: Novartis. T. Puértolas: Financial Interests, Personal, Advisory Role: Bristol Myers Squibb, Immunocore, Novartis, Seagen; Financial Interests, Personal, Other, Travel, Accommodation, Expenses: Novartis, MSD, Pierre Fabre. E. Espinosa: Financial Interests, Personal, Invited Speaker: BMS, Novartis, Pierre Fabre; Financial Interests, Personal, Advisory Board: MSD; Non-Financial Interests, Personal, Leadership Role, Grupo Español Multidisciplinario de Melanoma (GEM): Vice president: GEM. L.A. Fernández-Morales: Financial Interests, Personal, Speaker, Consultant, Advisor, Speak at sponsored meeting: BMS, MSD, Pierre Fabre, Roche, Novartis, Pfizer; Financial Interests, Personal, Advisory Role: Novartis, Pfizer. J. Medina: Financial Interests, Personal, Speaker, Consultant, Advisor: Novartis, Roche, Pierre Fabre, BSM, MSD, Sanofi. I. Márquez-Rodas: Financial Interests, Personal, Advisory Board: BMS, MSD, Novartis, Pierre Fabre, Roche, GSK, AstraZeneca, Celgene, Regeneron, Sanofi, Merck Serono, Highlight Therapeutics, Bioline Rx, Sun Pharma, Immunocore; Financial Interests, Personal and Institutional, Coordinating PI, GEM1802 clinical trial: Pierre Fabre; Financial Interests, Institutional, Coordinating PI, GEM1801 Clinical Study: Novartis, BSM, Roche, Pierre Fabre, Incyte, MSD; Financial Interests, Institutional, Coordinating PI, National coordinator of Spotlight 203 clinical trial: Highlight Therapeutics; Non-Financial Interests, Member of Board of Directors: Spanish Melanoma Group. All other authors have declared no conflicts of interest.
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