Outcome of adjuvant immunotherapy in a real-world nation-wide cohort of patients with melanoma

• Published in: European journal of cancer (1990) 2024-05, Vol.202, p.114023-114023, Article 114023
• Main Authors: Holmstroem, Rikke B., Pedersen, Sidsel, Jurlander, Rebecca, Madsen, Kasper, Donia, Marco, Ruhlmann, Christina H., Schmidt, Henrik, Haslund, Charlotte A., Bastholt, Lars, Svane, Inge Marie, Ellebaek, Eva
• Format: Article
• Language: English
• Subjects: Adjuvant immunotherapy; Adjuvants, Immunologic - therapeutic use; Anti-PD-1; Humans; Immunotherapy - methods; Ipilimumab - adverse effects; Melanoma; Melanoma - drug therapy; Melanoma recurrence; Nivolumab; Nivolumab - adverse effects; Pembrolizumab; Skin Neoplasms - chemically induced; Skin Neoplasms - drug therapy
• ISSN: 0959-8049; 1879-0852
• DOI: 10.1016/j.ejca.2024.114023

Clinical trials have demonstrated promising outcomes for adjuvant immunotherapy in patients with resected melanoma. Real-life data provide valuable insights to support patient guidance and treatment decisions. Observational population-based study examining a national cohort of patients with resected stage III-IV melanoma referred for adjuvant therapy. Data were extracted from the Danish Metastatic Melanoma Database (DAMMED). Between November 2018 and January 2022, 785 patients received adjuvant anti-PD-1. The majority had stage III resected melanoma (87%), normal LDH levels (80%), and performance score 0 (87%). Patients were followed for a median of 25.6 months (95%CI 24−28). The median recurrence-free survival (RFS) and melanoma-specific survival (MSS) were not reached. The RFS was 78% (95%CI 75−81), 66% (63−70), and 59% (55−63); MSS was 97% (95−98), 93% (91−95), and 87% (84−90) at 1-, 2-, and 3-year; respectively. Less than half (42%) of the patients finalized planned therapy, 32% discontinued due to toxicity, and 19% due to melanoma recurrence. Patients discontinuing adjuvant treatment prematurely, without recurrence, had similar outcomes as patients finalizing therapy. In a multivariable analysis, ipilimumab plus nivolumab did not improve outcomes compared to ipilimumab monotherapy as a first-line metastatic treatment after adjuvant anti-PD-1. Survival outcomes in real-world patients with melanoma treated with adjuvant anti-PD-1 align with results from the randomized controlled trials. Patients discontinuing therapy prematurely, for other reasons than recurrence, had similar outcomes as patients finalizing planned treatment. First-line metastatic treatment with ipilimumab and nivolumab post-adjuvant anti-PD-1 did not show improved outcomes compared to ipilimumab/anti-PD-1 monotherapy. •Similar outcome in adjuvant anti-PD-1 melanoma in real-world and clinical trials.•Outcomes were not affected by early discontinuation of adjuvant anti-PD-1 therapy.•Combination immunotherapy was not superior to monotherapy in melanoma recurrence.