1090P - Outcome impact of time from complete resection to start of adjuvant immunotherapy in stage III-IV melanoma patients

Background

Adjuvant therapy with immune checkpoint inhibitors improves outcomes in patients with resected melanoma. However, clinical trials included patients that started treatment within a maximum of three months after complete resection. The objective of this study is to analyze whether starting adjuvant therapy beyond 3 months after surgery could impact on efficacy.

Methods

This is a multicenter retrospective study of patients with completely surgically resected stage III to IV melanoma that have been treated with PD-1 inhibitors (either alone or in combination). We compared efficacy and pattern of recurrence according to the period of time from last resection to the start of immunotherapy (more -group A- or less -group B- than three months).

Results

We included 214 patients, group A included 31 (14%) patients and group B 183 (86%) patients; baseline characteristics were similar between both groups. With a median follow up of 20 months, 22 (71%) patients in group A and 76 (42%) patients in group B have recurred; the median disease free survival (DFS) was 8,4 months (95% CI 2-14,8) in group A and 43,4 months (95%CI 26-60,7) in group B (log rank p=0,002). After multivariate analysis Hazard Ratio (HR) was 3,8 (95% CI 2,1-6,8, p<0,001). Patients in group A presented higher rate of distant recurrence (86% vs 73%) and visceral non-pulmonary recurrence (18% vs 8%) than group B, without differences in central nervous system (CNS) recurrence (18% vs 15%). For patients with distant recurrence that received systemic therapy (18 in group A and 51 in group B), both groups showed similar overall response rate (40% vs 42%) and DFS (median 6,6 vs 8,9 months, p>0,05). Group A showed a trend to shorter overall survival (OS) than group B (median OS NR in both groups; OS at 18 and 24 months were 81% and 69% in group A vs 91% and 87% in group B, respectively).

Conclusions

Starting adjuvant PD-1 inhibitors after more than 3 months from last resection surgery negatively impacts in DFS in patients with resected melanoma, with a higher proportion of distant recurrence.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Hospital de la Santa Creu i Sant Pau.

Funding

Has not received any funding.

Disclosure

S. Martinez Recio: Financial Interests, Personal, Invited Speaker: Pierre Fabre, Sanofi; Other, Other, Travel fees, meeting registration expenses: Merck; Other, Other, Accommodation expenses: Sanofi; Other, Other, Travel fees: Lilly. E. Muñoz Couselo: Financial Interests, Personal, Advisory Role: BMS, MSD, Pierre Fabre, Sanofi, Roche, Immunocore; Financial Interests, Personal, Invited Speaker: Novartis, BMS, MSD, Pierre Fabre, Sanofi; Financial Interests, Personal, Other, Travels, accommodations, expenses: MSD; Financial Interests, Personal, Other, Travels, accommodations, Expenses: BMS. J. Martin-Liberal: Financial Interests, Personal, Invited Speaker: Astellas, Bristol Myers Squibb, MSD, Novartis, Pierre Fabre, Pfizer, Roche, Sanofi; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb, Novartis, Pierre Fabre, Roche, Sanofi, Highlight Therapeutics; Financial Interests, Personal, Other, Travel grant: Bristol Myers Squibb, MSD, Novartis, Pierre Fabre, Pfizer, Roche, Ipsen. A.M. Arance Fernandez: Financial Interests, Personal, Advisory Board, Consultant /Advisory/Speaker/Travel, Accommodations, Expenses: Pierre Fabre, Novartis, Roche, BMS, MSD, Merck, Sanofi; Financial Interests, Institutional, Other, Research Funding: Pierre Fabre, Novartis, MSD, BMS, Merck, Roche, Sanofi, Amgen. F. Aya Moreno: Financial Interests, Personal, Invited Speaker: MSD, Novartis; Financial Interests, Personal, Other, Scientific Coordinator and Communication Officer: GETICA; Non-Financial Interests, Other, ASEICA Young committee member: ASEICA. L.A. Fernández-Morales: Financial Interests, Personal, Invited Speaker: BMS, MSD, Pierre Fabre, Roche, Novartis, Pfizer; Financial Interests, Personal, Advisory Role: Novartis, Pfizer. M. Quindos Varela: Financial Interests, Personal, Speaker, Consultant, Advisor: BMS, Novartis; Financial Interests, Personal, Speaker’s Bureau: Pierre Fabre, MSD, Sanofi. R. Lesta: Financial Interests, Personal, Invited Speaker: Rovi, Sanofi; Financial Interests, Personal, Other, Travel, accommodation, expenses: Roche, GSK, AstraZeneca, MSD, Pierre Fabre. A. Barba Joaquín: Financial Interests, Personal, Invited Speaker: Pfizer, MSD, Sanofi, BMS, Novartis, Roche, AstraZeneca, Pierre Fabre; Financial Interests, Personal, Advisory Board: BMS, Sanofi; Non-Financial Interests, Principal Investigator, PI - Clinical Trial C4221016: Pfizer. I.G. Sullivan: Financial Interests, Personal, Advisory Board: Roche, Novartis, Boehringer Ingelheim, Takeda, Sanofi, Bristol Myers Squibb; Financial Interests, Personal, Invited Speaker: Roche, AstraZeneca, Takeda, Pfizer, Merck Sharp & Dohme; Financial Interests, Personal, Other, Travel grant: Roche, Takeda, Lilly, AstraZeneca. M. Majem: Financial Interests, Personal, Advisory Board: Amgen, Roche, AstraZeneca, Takeda, Janssen, Casen Recordati, BMS; Financial Interests, Personal, Invited Speaker: Amgen, Roche, AstraZeneca, Pfizer, Takeda, Helsinn; Financial Interests, Institutional, Funding: BMS, AstraZeneca, Roche. All other authors have declared no conflicts of interest.