Abstract 863P
Background
Cutaneous melanoma (CM) is suffering an increase in incidence and mortality in recent decades, especially in elderly pts, who experience different biological behavior. Management of CM in elderly pts is conditioned by limited expectations of survival, quality of life and a high incidence of comorbidities. These abstract reviews the treatment elections and the outcomes of elderly pts in the real world setting in Spain, specifically in a prospective manner.
Methods
GEM1801 is a prospective cohort 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 elderly pts diagnosed with advanced CM and the first line (1L) of treatment choice.
Results
357 pts were included since August 2018 to January 2019 from 35 hospitals in Spain, 146 ≥70 y. A survival cutoff was made by March 2022. 57.4% pts were male; median age was 78.3 y (range: 70.2-95.2). 60.1% were cutaneous, 9.5% acral, and 2.7% uveal. 8.1% were unresectable stage IIIB/C/D and 91.9% stage IV (33.8% A, 15.5% B, 27.8% C and 14.9% D). ECOG was 0-1 in 75.6%; LDH levels were normal in 49.3%, elevated in 39.3% (UK: 11.5%). BRAF was mutated in the 34.5% of elderly pts. Median survival follow up was 21.3 months (range: 1.3-46.9) with 36.5% pts alive at time of analysis. Median overall survival was 23.4 m (95% CI: 18.1-30.1) for pts ≥70 y. Table summarizes the 1L options according to BRAF status and age. Table: 863P
| BRAF - | BRAF + | |||
| Treatment type; n (%) | ≥70; N= 95 | All; N= 156 | ≥70; N= 51 | All; N = 170 |
| Immunotherapy (IT) | 77 (90.6) | 148 (94.9) | 9 (18) | 51 (30.0) |
| PD-1 / PD-L1 IT | 68 (80) | 115 (73.7) | 9 (18) | 36 (21.2) |
| Dual IT or other IT | 9 (10.6) | 33 (19.4) | 0 (0) | 15 (8.8) |
| Targeted Therapy (TT) | - | - | 40 (80) | 109 (64.1) |
| Chemotherapy | 1 (1.2) | 1 (0.6) | 0 (0) | 2 (1.2) |
| Other, Clinical trials | 7 (8.2) | 7 (4.5) | 1 (2) | 7 (4.1) |
Conclusions
Survival results of elderly pts are consistent with results of modern clinical trials. Either for the overall population or elderly pts in Spain, TT is the most frequent 1L choice in BRAF + pts. Monotherapy with anti PD-1 is the most frequent IT 1L choice.
Clinical trial identification
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 en Melanoma (GEM).
Funding
Grupo español Multidisciplinar en Melanoma (GEM) / Industry partners Novartis, Pierre Fabre, BMS, Incyte, Roche, MSD.
Disclosure
E. Muñoz Couselo: Financial Interests, Personal, Other, Speaker, consultancy or advisory role or similar activity: BRIstoL Myers Squib, Novartis, Pierre Fabre, MSD, Sanofi, Amgen, Roche. A. Soria: Financial Interests, Institutional, Invited Speaker: Merck Sharp & Dhome, Bristol Myers Squibb, Novartis Pharma, Merck Serono, Sanofi Aventis; Financial Interests, Institutional, Expert Testimony: Merck Sharp & Dhome, Bristol Myers Squibb, Novartis Pharma, Merck Serono, Sanofi Aventis; Financial Interests, Institutional, Advisory Board: Merck Sharp & Dhome, Bristol Myers Squibb, Novartis Pharma, Merck Serono, Sanofi Aventis; Financial Interests, Institutional, Writing Engagements: Bristol Myers Squibb; Financial Interests, Institutional, Research Grant: Sanofi Aventis. P. Cerezuela-Fuentes: Financial Interests, Personal, Other, Consultancy. Conferences. Attendance/infrastructure for congresses: BMS, MSD, Pierre Fabre, Roche, Sanofi, SunPharma. G. Crespo: Financial Interests, Personal, Other, speaker, consultancy or advisory role: BMS, Novartis, Ipsen, Janssen, Sanofi, Eusa Pharma, Pierre Fabre, MSD, Eisai, Bayer. T. Puértolas: Financial Interests, Personal, Other, Speaker and advisory role: BMS, Novartis, Pierre-Fabre; Financial Interests, Personal, Invited Speaker: Roche, MSD, Sun-Pharma; Financial Interests, Personal, Advisory Role: Sanofi; Financial Interests, Institutional, Other, Clinical trial: Roche, BMS, Apexigen Inc, Aduro Biotech, Alkermes Inc; Non-Financial Interests, Institutional, Other, congresses inscriptions: Lilly, Sun-Pharma, Novartis, Roche, MSD; Non-Financial Interests, Institutional, Leadership Role, Vocal: GEM (Grupo Español Multidisciplinar de Melanoma); Non-Financial Interests, Institutional, Affiliate: SEOM (Sociedad Española de Oncología Médica), GEM (Grupo Español Multidisciplinar de Melanoma). A. García Castaño: Non-Financial Interests, Advisory Role: Bristol, MSD, Novartis. E. Espinosa: Financial Interests, Personal, Advisory Role, Advisory: BMS, MSD; Financial Interests, Personal, Other, Advisory, educational activities: Novartis, Pierre Fabre; Financial Interests, Personal, Other, Funding for translational investigation: Roche; Non-Financial Interests, Member, Vicepresident: Grupo Español Multidisciplinario de Melanoma: Grupo Español Multidisciplinario de Melanoma. R. López Castro: Financial Interests, Personal, Other, Advisory, speaker: Takeda, Novartis, Roche, BMS; Financial Interests, Personal, Other, Advisory: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: MSD. P. Ayala de Miguel: Financial Interests, Personal, Invited Speaker, Public speaking: Novartis, Merck Sharp & Dohme, Sanofi, Pierre Fabre. J. Medina Martínez: Financial Interests, Personal, Other, speaker, consultancy or advisory role: Novartis, Roche, Pierre Fabre, BMS, MSD, Sanofi. L.A. Fernández-Morales: Financial Interests, Personal, Invited Speaker, Speak at sponsored meetings: BMS, MSD, Pierre Fabre, Roche; Financial Interests, Personal, Invited Speaker, Speak at sponsored meetings and advisory role: Novartis. S. Martín Algarra: Financial Interests, Personal, Advisory Board: MSD, Sanofi/Regeneron; Financial Interests, Personal, Invited Speaker: MSD, Sanofi/Regeneron, BMS, Novartis, Roche, Sanofi-Genzyme; Financial Interests, Personal, Other, Travel Accommodation to Oncology meeting: Pierre-Fabre; Financial Interests, Personal, Other, Travel Accommodation to Oncology meeting Virtual Access to Oncology meeting: MSD; Financial Interests, Personal, Advisory Board, A member of my household: AstraZeneca; Financial Interests, Personal, Invited Speaker, A member of my household: AstraZeneca, Roche; Financial Interests, Personal, Other, Travel Expenses to Medical meetings: Roche; Non-Financial Interests, Invited Speaker: Grupo Español Multidisciplinar de Melanoma (GEM); Non-Financial Interests, Invited Speaker, A member of my household: Sociedad Española de Citología. 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; Financial Interests, Personal and Institutional, Invited Speaker, GEM1801 clinical study: Pierre Fabre; Financial Interests, Institutional, Invited Speaker, GEM1801 clinical study: Novartis, BMS, Roche, Pierre Fabre, Incyte, MSD; Financial Interests, Institutional, Invited Speaker, National coordinator of Spotlight 203 clinical trial: Highlight Therapeutics; Non-Financial Interests, Invited Speaker: Spanish Melanoma Group. All other authors have declared no conflicts of interest.