Eggermont AMM et al. - In a trial to determine whether pegylated interferon alfa-2b can facilitate prolonged exposure while maintaining tolerability, it was shown that adjuvant pegylated interferon alfa-2b for stage III melanoma has a significant, sustained effect on recurrence-free survival Methods
1256 pts with resected stage III melanoma were randomly assigned to observation (n=629) or pegylated interferon alfa-2b (n=627) 6 μg/kg per week for 8 weeks then 3 μg/kg per week for 5 years
Randomisation was stratified for microscopic (N1) vs macroscopic (N2) nodal involvement, number of positive nodes, ulceration and tumour thickness, sex, and centre
Randomisation was done with a minimisation technique; primary endpoint was recurrence-free survival
Results
All randomised pts were included in the primary efficacy analysis
608 pts in the interferon group and 613 pts in the observation group were included in safety analyses
The median length of treatment with pegylated interferon alfa-2b was 12 months
At 3.8 years median follow-up, 328 recurrence events had occurred in the interferon group vs 368 in the observation group
4-year rate of recurrence-free survival was 45.6% in the interferon group and 38.9% in the observation group
There was no difference in overall survival (OS) between the groups
Grade 3 adverse events occurred in 40% of pts in the interferon group and 10% in the observation group; grade 4 adverse events occurred in 5% of pts in the interferon group and 2% in the observation group
In the interferon group, the most common grade 3 or 4 adverse events were fatigue (16%), hepatotoxicity (11%), and depression (6%)
Treatment with pegylated interferon alfa-2b was discontinued because of toxicity in 31% of pts
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