Patients with resected melanoma ?1.5 mm thick and without clinically detectable node metastases were randomised 1:1 to treatment with IFN 3 MU subcutaneously (SC) three times weekly for 18 months or Peg-IFN 100 ¦Ìg SC once weekly for 36 months. Sentinel lymph node dissection (SLND) was optional. The primary endpoint was disease-free survival (DFS). Secondary endpoints included distant metastasis-free survival (DMFS), overall survival (OS) and adverse events (AEs) grade 3-4.
Of 898 patients enrolled, 896 (443 Peg-IFN, 453 IFN) were eligible for evaluation (median follow-up 4.7 years). SLND was performed in 68.2 % of patients. There were no statistical differences between the two arms for the primary outcome of DFS (hazard ratio [HR] 0.91, 95 % confidence interval [CI] 0.73-1.15) or the secondary outcomes of DMFS (HR 1.02, 95 % CI 0.80-1.32) and OS (HR 1.09, 95 % CI 0.82-1.45). Peg-IFN was associated with higher rates of grade 3-4 AEs (47.3 % versus 25.2 % ; p < 0.0001) and discontinuations (54.3 % versus 30.4 % ) compared with IFN.
This trial did not show superiority for adjuvant Peg-IFN over conventional low-dose IFN in melanoma patients without clinically detectable nodes. ClinicalTrials.gov identifier: .