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| |  Pegylated Interferon Alfa-2b Improves Recurrence-Free Survival in Patients With Melanoma NEW YORK -- July 10, 2008 -- Pegylated interferon alfa-2b improves recurrence-free survival (RFS) in melanoma patients compared with observation alone, according to a study published in this week's edition of The Lancet. In this randomised, phase 3 study, Alexander Eggermont, Erasmus University Medical Center, Rotterdam, Netherlands, and colleagues from the European Organisation for Research and Treatment of Cancer (EORTC) Melanoma Group aimed to determine whether pegylated interferon alfa-2b (PEG-IFN alfa-2b) could facilitate prolonged exposure while maintaining tolerability. The trial looked at 1,256 patients with post-surgery stage III melanoma. Of the patients, 629 were assigned to observation and 627 to PEG-IFN alfa-2b at 6 mcg/kg body weight for 8 weeks, then 3 mcg/kg for an intended duration of 5 years. The final analysis included 613 observation patients and 608 PEG-IFN alfa-2b patients. The median length of treatment with PEG-IFN alfa-2b was 1 year, with a median-follow up of just over 3.5 years. During this time, 328 recurrence events occurred in the PEG-IFN alfa-2b group and 368 in the observation group. PEG-IFN alfa-2b reduced the risk of recurrence by 18%, which became 15% after 4 years. There was no difference in overall survival between both groups. Grade 3 adverse events occurred in 246 (40%) of PEG-IFN alfa-2b patients and in 60 (10%) observation patients, while grade 4 serious adverse events occurred in 32 (5%) of PEG-IFN alfa-2b patients and 14 (2%) observation patients. In the PEG-IFN alfa-2b group, the most common grade 3 or 4 adverse events were fatigue (16%), liver toxicity (11%), and depression (6%). Treatment with PEG-IFN alfa-2b was discontinued in 191 patients because of toxicity. "The results of this large phase 3 study of adjuvant therapy in patients with stage III melanoma suggest that prolonged treatment with pegylated interferon alfa-2b significantly improves recurrence-free survival compared with observation alone," the authors said. In an accompanying comment, Vernon Sondak, MD, H. Lee Moffitt Cancer Center and the University of South Florida College of Medicine, Tampa, Florida, and Lawrence Flaherty, MD, Karmanos Institute and Wayne State University School of Medicine, Detroit, Michigan, say RFS is an appropriate endpoint as many patients with melanoma are willing to accept significant toxicity in exchange for modest improvements in RFS, even in the absence of an overall survival effect. "For the large group of patients with melanoma found in their sentinel node, we believe this regimen will be an attractive alternative to high-dose interferon," they said. "Some patients with macroscopic nodal disease who would not tolerate or accept high-dose interferon will also want to consider this approach."
SOURCE: The Lancet
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