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Long-Term Pegylated Interferon Alfa-2b Therapy in Stage III Melanoma Demonstrated Significant and Sustained Impact on Relapse-Free Survival
Date:7/11/2008

de 4 events occurred in 5 percent (32 patients) in the pegylated interferon alfa-2b arm versus 2 percent (14 patients) in the observational arm. A total of 31 percent (191 patients) in the pegylated interferon alfa-2b arm discontinued treatment due to toxicity. In the peginterferon alfa-2b group, the most common Grade 3 or 4 adverse events were fatigue (97 patients, 16 percent), liver toxicity (66 patients, 11 percent), and depression (39 patients, 6 percent).

In the malignant melanoma trial and other clinical studies, patients receiving peginterferon alfa-2b experienced mild-to-moderate or severe/life- threatening side effects. The most common side effects of peginterferon alfa- 2b are: flu-like symptoms, including headache, fatigue, aches and pains, fevers and chills; depression, nausea, loss of appetite and diarrhea; insomnia; alopecia (hair loss); a reaction at the site of injection; changes in blood liver function tests and in blood cell counts, including leukopenia (low white blood cell count), thrombocytopenia (low platelet count) and neutropenia (low neutrophil count); thyroiditis (inflammation of the thyroid gland); and autoimmunity (production of antibodies against the body's own tissues).

About Peg-IFN

Interferon is a protein produced naturally by white blood cells to help the immune system fight viral infections and certain cancer growths. Pegylated interferon alfa-2b is a longer-acting form of interferon made by attaching an inert molecule called polyethylene glycol, or PEG, to the alpha interferon molecule. This modification increases the size of the interferon molecule and results in slower elimination from the body, allowing for less frequent dosing than required for standard interferon.

Peginterferon alfa-2b is not approved for treatment of melanoma in either the US or EU. Peginterferon alfa-2b is marketed as PEGINTRON(TM) for other indications in the US and EU. Full prescribing information in the US may be found at '/>"/>

SOURCE Schering-Plough
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