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Adjuvant therapy with pegylated interferon alfa-2b versus observation alone in resected stage III melanoma: final results of EORTC 18991, a randomised phase III trial

Alexander MM Eggermont, Stefan Suciu, Mario Santinami, Alessandro Testori, Wim HJ Kruit, Jeremy Marsden, Cornelis JA Punt, François Salès, Martin Gore, Rona MacKie, Zvonko Kusic, Reinhard Dummer, Axel Hauschild, Elena Musat, Alain Spatz, Ulrich Keilholz

The Lancet, Volume 372, Issue 9633, Pages 117 - 126, 12 July 2008

Findings

All randomised patients were included in the primary efficacy analysis. 608 patients in the interferon group and 613 patients in the observation group were included in safety analyses. The median length of treatment with pegylated interferon alfa-2b was 12 (IQR 3·8–33·4) months. At 3·8 (3·2–4·2) years median follow-up, 328 recurrence events had occurred in the interferon group compared with 368 in the observation group (hazard ratio 0·82, 95% CI 0·71–0·96; p=0·01); the 4-year rate of recurrence-free survival was 45·6% (SE 2·2) in the interferon group and 38·9% (2·2) in the observation group. There was no difference in overall survival between the groups. Grade 3 adverse events occurred in 246 (40%) patients in the interferon group and 60 (10%) in the observation group; grade 4 adverse events occurred in 32 (5%) patients in the interferon group and 14 (2%) in the observation group. In the interferon group, the most common grade 3 or 4 adverse events were fatigue (97 patients, 16%), hepatotoxicity (66, 11%), and depression (39, 6%). Treatment with pegylated interferon alfa-2b was discontinued because of toxicity in 191 (31%) patients.