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Long-Term Pegylated Interferon Alfa-2b Therapy in Stage III,Melanoma Demonstrated Significant and Sustained Impact on,Relapse-Free Survival

r /> In the study, participants reached a median 88 percent and 83 percent relative dose intensity, or percent of planned dose intensity, during the induction and maintenance phases, respectively. Forty percent (251 subjects) ceased pegylated interferon alfa-2b therapy due to toxicity or patient’s withdrawal of consent, while approximately 23 percent of subjects continued into year 4 and 5 of treatment. Grade 3 or 4 toxicities, mostly grade 3 in severity, were reported in 45 percent of subjects in the pegylated interferon alfa-2b arm versus
12 percent in the observational arm. These events included primarily Grade 3 fatigue, hepatotoxicity and depression. An ECOG 0-1 Performance Status was maintained in 83 percent of patients during the maintenance phase. These data represent the planned final analysis with a median follow-up of 3.8 years; study participants will be followed for survival for a total of 10 years.

About the Study
This study was designed to assess the efficacy and safety of long-term pegylated interferon alfa-2b vs. observation. Researchers enrolled 1,256 subjects with stage III melanoma. Participants were given pegylated interferon alfa-2b at a dose of 6 ?g/kg/week for an eight week induction phase followed by 3 ?g/kg/wk (maintenance phase), for total treatment duration of 5 years.
“We are pleased with the results of this important study,” said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. “Patient follow-up will continue to assess long-term treatment with pegylated interferon alfa-2b and overall survival.”

About Peg Interferon
Pegylated interferon alfa-2b is not approved in the United States for treatment of melanoma. In the United States, pegylated interferon alfa-2b is indicated for use alone or with ribavirin for the treatment of chronic hepatitis C in patients with compensated liver disease who have not b
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