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.
Resources from the same session
1149P - Prognosis for patients with metastatic Merkel cell carcinoma with a complete response on avelumab treatment
Presenter: Lisanne Zijlker
Session: Poster session 13
1150P - Transforming growth factor-beta-1 and soluble co-inhibitory immune checkpoints as putative drivers of immune suppression in advanced basal cell carcinoma
Presenter: Bernardo Rapoport
Session: Poster session 13
1151P - Characteristics and treatment outcomes in cutaneous adnexal carcinomas
Presenter: Adam Rock
Session: Poster session 13
1152P - Association of immune-related adverse events (irAE) requiring glucocorticoids (GCs) with outcome and biomarkers in advanced cutaneous malignant melanoma (CMM) treated with immune checkpoint inhibitors (ICI)
Presenter: Fernanda Costa Svedman
Session: Poster session 13
1153P - Incidence and characteristics of immunotherapy related adrenal insufficiency in a monocenter, pan-cancer cohort of 4314 patients
Presenter: Minke Lucas
Session: Poster session 13
1154P - Thromboembolic events in patients with melanoma receiving immune checkpoint inhibitors: Incidence and risk factors
Presenter: Daan van Dorst
Session: Poster session 13
1155P - Application of novel machine learning to predict immunotherapy related toxicities for metastatic melanoma patients from baseline 18F-FDG PET/CT scans
Presenter: Roslyn Francis
Session: Poster session 13
1156P - Immune-related adverse events in a nationwide cohort of melanoma patients treated with adjuvant anti-PD1: Seasonal variation and association with outcome
Presenter: Eva Ellebæk
Session: Poster session 13
1157P - Corticosteroids and second-line immunosuppressants for immune-related adverse events and melanoma survival
Presenter: Rik Verheijden
Session: Poster session 13
1158P - Association of corticosteroid (CS) exposure with treatment failure in patients (pts) with advanced melanoma treated with immune checkpoint inhibitors (ICIs)
Presenter: Ha Mo Linh Le
Session: Poster session 13