Abstract 802P
Background
Approximately one-third of patients (pts) with stage III nodal disease will eventually develop metastatic disease and 17% will develop local unresectable relapse. The use of lymphadenectomy and adjuvant treatment (AT) for local disease is controversial.
Methods
Here we present the demographic characteristics and clinical outcomes of those pts receiving AT other than interferon, included in the prospective observational study GEM 1801.
Results
From 2018 to 2019, 400 locally advanced / metastatic melanoma pts were included, 54 pts (13.5%) received AT. Pts receiving AT were stage IIIA-B (18.5%), IIIC (42.6%), IIID-IV (38.9%) at inclusion according to AJCC 8th ed. Median age was 51.6 y (range: 23.3-86.6), 59.3% were male, and 57.4% BRAF mutated. Resection of the sentinel lymph node (LN) was performed in 72.2%. The median of resected LN was 2 (range: 1-5), of which a median of 1 LN (range: 1-2) was positive. Lymphadenectomy was performed in 55.6% pts, with a median of 14 LN (range: 2-40) resected, of which a median of 0 LN (range: 0-42) was positive. Immunotherapy (IT) was the prefered AT in 44 (81.5%) pts, targeted therapy (TT) in 10 (18.5%). With median follow-up of 36.1 m (95% CI: 29.9-39.2), 24 pts (44.4,%) continued without evidence of disease and 25 pts (46.3%) relapsed (29.6% intra-AT, 16.7% post-AT), 9.3% Not Evaluable. The median relapse-free survival (RFS) was 36.6 m (95% CI: 28.9-44.3).After relapse 19 (76%) pts received subsequent systemic treatments, 9 (36%) pts IT, 8 (32%) TT, and 2 (8%) other. The 24-m OS rate was 85.7% (95% CI: 76.5-96.1). Stratified analysis of RFS and OS is depicted in the table. Table: 802P
| 24-m RFS; % (95%CI) | 24-m OS; % (95%CI) | ||
| Stage at diagnosis | IIIA-B | 87.5 (67.3-100) | 87.5 (67.3-100) |
| IIIC | 68.4 (50.4-92.9) | 94.7 (85.2-100) | |
| IIID - IV | 36.4 (20.9-63.2) | 77.3 (61.6-96.9) | |
| Lymphadenectomy | Yes | 51.9 (36.1-74.6) | 85.2 (72.8-99.7) |
| No | 70 (52.5-93.3) | 90 (77.8-100) |
Conclusions
Our data, as previously reported, suggest that lymphadenectomy previous to AT would have no impact on both RFS and OS in our population.
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) as Sponsor. / Industry partners NOVARTIS, Pierre Fabre, BMS, Incyte, Roche and MSD.
Disclosure
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: Pierre-Fabre; Financial Interests, Personal, Other, Travel Accommodation to Oncology meeting: MSD; Financial Interests, Personal, Advisory Board, Travel Accommodation to Oncology meeting: AstraZeneca; Financial Interests, Personal, Invited Speaker, A member of my household: AstraZeneca, Roche; Financial Interests, Personal, Other, A member of my household: Roche; Non-Financial Interests, Invited Speaker: Grupo Español Multidisciplinar de Melanoma (GEM); Non-Financial Interests, Invited Speaker, A Member of my household Travel Expenses to Medical meeting: Sociedad Española de Citología. A. Piñero Madrona: Non-Financial Interests, Leadership Role, President of the Spanish Society of Senology (SESPM): SESPM; Non-Financial Interests, Leadership Role, Member of the Scientific Committee of the Murcian Institute for Biomedical Research (IMIB-Arrixaca): IMIB-Arrixaca; Non-Financial Interests, Member, Member of Spanish Group for Research in Breast Cancer (GEICAM): GEICAM; Non-Financial Interests, Member, Member of the Spanish Society of Surgical Oncology (SEOQ): SEOQ; Non-Financial Interests, Member, Member of the European Society of Surgical Oncology (ESSO): ESSO. M. Berciano-Guerrero: Financial Interests, Personal, Speaker’s Bureau: Bristol Myers Squibb, MSD Oncology, Eisai, Pierre Fabre, Roche, Novartis; Financial Interests, Personal, Advisory Role, Consulting or advisory role: Bristol Myers Squibb, MSD Oncology, EISAI, Pierre Fabre, Roche, Novartis; Financial Interests, Personal, Project Lead, Research Project. Recipient: My Institution: Novartis. 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, Personal, Invited Speaker: Bristol Myers Squibb, Merck Serono, Merck Sharp & Dhome, Novartis Pharma, Pierre Fabre, Sanofi Aventis; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Merck Serono, Merck Sharp & Dhome, Novartis Pharma, Pierre Fabre, Sanofi Aventis. G. Crespo: Financial Interests, Personal, Other, speaker, consultancy and advisory role: BMS, Novartis, Ipsen, Janssen, Sanofi, Evsa Pharma, Pierre Fabre, MSD, Eisai, Bayer. T. Puértolas: Financial Interests, Personal, Invited Speaker: BMS, Roche, MSD, Novartis, Pierre-Fabre, Sun-Pharma; Financial Interests, Personal, Advisory Role: BMS, Novartis, Pierre-Fabre, Sanofi; Financial Interests, Institutional, Other, Clinical Trial: Roche, BMS, Apexigen Inc, Aduro Biotech, Alkermes Inc; Non-Financial Interests, Other, Congresses inscriptions: Lilly, Sun-Pharma, Novartis, Roche, MSD; Non-Financial Interests, Leadership Role, Vocal: GEM (Grupo Español Multidisciplinar de Melanoma); Non-Financial Interests, Affiliate: GEM (Grupo Español Multidisciplinar de Melanoma), SEOM (Sociedad Española de Oncología Médica). A. García Castaño: Financial Interests, Personal, Advisory Role: Bristol, MSD, Novartis. E. Espinosa: Financial Interests, Personal, Other, Advisory: BMS, MSD; Financial Interests, Personal, Other, Advisory, educational activities: Novartis, Pierre Fabre; Financial Interests, Personal, Project Lead, Funding for translational investigation: Roche; Non-Financial Interests, Institutional, Member, Vice president: Grupo Español Multidisciplinario de Melanoma. R. López Castro: Financial Interests, Personal, Invited Speaker, Speaker: Takeda, Novartis, Roche, BMS, MSD; Financial Interests, Personal, Advisory Role, Advisory: Takeda, Novartis, Roche, Boehringer Ingelheim, BMS. P. Ayala de Miguel: Financial Interests, Personal, Invited Speaker, Public speaking: Novartis, Merck Sharp & Dhome, Sanofi, Pierre-Fabré. J. Medina Martínez: Financial Interests, Personal, Other, speaker, consultancy or advisory role or similar activity: 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, Other, Speak at sponsored meetings and advisory role: Novartis. P. Cerezuela-Fuentes: Financial Interests, Personal, Other, Consulting. Conferences. Attendance/infrastructure for congresses: BMS, MSD, Pierre Fabre, Roche, Sanofi, SunPharma. 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, GEM1802 clinical trial: 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.