Adjuvant therapy with pegylated interferon alfa-2a (PEG-IFN) versus low-dose interferon alfa-2a (IFN) in patients with malignant melanoma in stages IIa(T3a): IIIb (AJCC 2002)—Decog-trial.

9071 Background: Adjuvant treatment with IFN improved disease free survival (DFS) and showed a trend for improving overall survival (OS). PEG-IFN has a prolonged half life time and is just given once weekly. This trial was designed to examine if PEG-IFN is superior to IFN in regard to distant metastasis free survival (DMFS), DFS and OS. Methods: In this multicenter, open-label, prospective randomized phase III trial, patients (pts) with resected cutaneous melanoma stage IIA(T3a)-IIIB (AJCC 2002) were randomized to receive IFN (3 MU subcutaneously [sc] 3x/week; 24 months) or to PEG-IFN (180 mcg sc 1x/week; 24 months). Randomization was stratified for tumor stage, number of metastatic nodes, patient’s age and previous interferon treatment. Primary endpoint was DMFS, secondary endpoints were OS, DFS, quality of life and tolerability. Sample size (880 pts) was calculated on an expected difference of 55% vs 45% in the 5 years DMFS rate and assuming 80% power (2-sided, significance level 5%). Non-parametric sur...