Abstract 1071P
Background
Clinical trials have shown promising results for adjuvant immunotherapy in resected stage III-IV melanoma patients, but real-life data are scarce. Data on efficacy and quality of life (QoL) during anti-PD-1 adjuvant therapy from a complete national cohort of melanoma patients may support treatment choices and help patient guidance.
Methods
Patients with stage III-IV resected melanoma have been registered in The Danish Metastatic Melanoma Database (DAMMED) since the introduction of adjuvant immunotherapies in Denmark in Nov 2018. Patient characteristics, treatment, outcome data, and pathology results were included. EORTC QLQ-C30 was submitted to all patients who had not relapsed at the cutoff date 31 Dec 2020, and patients were divided into cohorts based on time elapsed from treatment initiation.
Results
Between Nov 2018 and Jan 2021, 546 patients were treated with adjuvant nivolumab. At baseline, 91.6% of patients had cutaneous melanoma, 86.8% had an ECOG performance score of 0, 82.4% had normal LDH level, 85.0% had stage III resected melanoma, and median age was 62 years (range 16-86). With a median follow-up of 14.2 months (95% CI 12.9-15.3), 25.5% of patients had relapsed and 5.3% had died. 1-year recurrence-free survival (RFS) and overall survival (OS) were 75.5% (71.1-79.3) and 95.1% (92.5-96.9), respectively, and 2-year RFS and OS were 56.0% (47.7-63.1) and 91.4% (87.6-94.1). For 292 patients with a follow-up >12 months, the median number of cycles of nivolumab administered was 11 (range 1-13). A total of 135 patients finalized planned therapy (46%), 80 patients discontinued due to toxicity (27%), 67 patients due to relapse (23%), and 10 patients due to other reasons (4%). 263/405 (64.9%) patients completed the EORTC QLQ-C30 questionnaire. A drop in median global health score was observed in responding patients between 3-6 months after treatment initiation (n=45), compared to patients at 0-3 months (n=26) or >15 months (n=103).
Conclusions
Half of all real-world melanoma patients from an entire national cohort undergoing adjuvant therapy with nivolumab stopped the planned 1-year treatment prematurely due to either toxicity or relapse. A questionnaire revealed a temporary drop in QoL.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
E. Ellebaek: Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Personal, Invited Speaker: Kyowa Kirin; Financial Interests, Personal, Other, Travel/conference expenses: MSD. C.H. Ruhlmann: Financial Interests, Institutional, Principal Investigator, Coordinating PI: Helsinn Healthcare. H. Schmidt: Financial Interests, Personal, Invited Speaker: Pierre Fabre. C.A. Haslund: Financial Interests, Personal, Invited Speaker: MSD. M. Donia: Financial Interests, Personal, Invited Speaker, Teaching: Novartis; Financial Interests, Personal, Invited Speaker, Teaching: Roche; Other, Personal, Principal Investigator, Sub-investigator of clinical trial with connected translational research: Bristol-Myers Squibb. C. Johansen: Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Role: Janssen; Financial Interests, Personal, Stocks/Shares: Novozymes; Financial Interests, Personal, Stocks/Shares: Y-mAbs Therapeutics, Inc . L. Bastholt: Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Merck; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Advisory Board: AstraZeneca; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Eisai. I.M. Svane: Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Advisory Board: BMS; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Advisory Board: Novartis; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Advisory Board: Pierre Fabre; Financial Interests, Personal, Invited Speaker: Pierre Fabre; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Stocks/Shares, Cofounder and Founder warrents: IO Biotech; Non-Financial Interests, Institutional, Research Grant: Adaptimmune; Non-Financial Interests, Institutional, Research Grant: Enara Bio; Non-Financial Interests, Institutional, Funding: Evaxion; Non-Financial Interests, Institutional, Research Grant: Lytix Biopharma; Non-Financial Interests, Institutional, Research Grant: TILT Biotherapeutics; Non-Financial Interests, Institutional, Principal Investigator: BMS; Non-Financial Interests, Institutional, Principal Investigator: Lytix Biopharma; Non-Financial Interests, Institutional, Principal Investigator: Novartis; Non-Financial Interests, Institutional, Principal Investigator: Roche; Non-Financial Interests, Institutional, Principal Investigator: TILT Biotherapeutics. All other authors have declared no conflicts of interest.