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Poster session 13

1174P - Sex differences in advanced melanoma in Spain: Results from the prospective real-world study GEM 1801

Date

21 Oct 2023

Session

Poster session 13

Topics

Clinical Research

Tumour Site

Melanoma

Presenters

Eva Muñoz Couselo

Citation

Annals of Oncology (2023) 34 (suppl_2): S651-S700. 10.1016/S0923-7534(23)01941-5

Authors

E. Muñoz Couselo1, M. Berciano-Guerrero2, J.L. Manzano3, A. Soria Rivas4, P. Cerezuela-Fuentes5, G. Crespo6, M. Antoñanzas7, T. Puértolas8, A. García Castaño9, L. Gutiérrez Sanz10, E. Espinosa11, P. Ayala de Miguel12, M. Majem13, R. López Castro14, L.A. Fernández-Morales15, B. Rivas16, J. Medina17, A. Berrocal18, S. Martín Algarra19, I. Márquez-Rodas20

Author affiliations

  • 1 Medical Oncology Department, Hospital Universitari Vall d’Hebron y Vall D'hebron Institute of Oncology (VHIO), 08035 - Barcelona/ES
  • 2 Unidad Intercentros De Oncología, Hospitales Universitarios Regional y Virgen de la Victoria (HURyVV). Instituto de Investigaciones Biomédicas de Málaga (IBIMA), Malaga/ES
  • 3 Medical Oncology Department, Instituto Catalán de Oncología, ICO-Badalona, H. Germans Trias i Pujol, Badalona/ES
  • 4 Medical Oncology Department, Hospital Universitario Ramón y Cajal, Madrid/ES
  • 5 Medical Oncology Department, Hospital Clínico Universitario Virgen de la Arrixaca, Ciudad de Murcia/ES
  • 6 Medical Oncology Department, Hospital Universitario de Burgos, Burgos/ES
  • 7 Medical Oncology Department, Hospital Universitario Clínico San Carlos, Madrid/ES
  • 8 Medical Oncology Department, Hospital Universitario Miguel Servet, Zaragoza/ES
  • 9 Medical Oncology Department, Hospital Universitario Marqués de Valdecilla, 39008 - Santander/ES
  • 10 Medical Oncology Department, Hospital Universitario Puerta de Hierro, Madrid/ES
  • 11 Medical Oncology Department, Hospital Universitario La Paz, CIBERONC, Madrid/ES
  • 12 Medical Oncology Department, Hospital Universitario San Pedro de Alcántara, Cáceres/ES
  • 13 Medical Oncology Department, Hospital de la Santa Creu i Sant Pau, Barcelona/ES
  • 14 Medical Oncology Department, Hospital Clínico Universitario de Valladolid, Valladolid/ES
  • 15 Medical Oncology Department, Hospital Universitari Parc Taulí, Sabadell/ES
  • 16 Medical Oncology Department, Complejo Asistencial Universitario de Salamanca, Salamanca/ES
  • 17 Medical Oncology Department, Hospital Universitario Toledo, Toledo/ES
  • 18 Medical Oncology Department, Hospital General Universitario Valencia, Valencia/ES
  • 19 Medical Oncology Department, Clínica Universidad de Navarra, Pamplona/ES
  • 20 Medical Oncology Department, Hospital General Universitario Gregorio Marañón, Madrid/ES

Resources

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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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