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

-- EORTC 18991 Phase III Study Results Presented At ASCO --

CHICAGO – June 2, 2007 – Long-term treatment with pegylated interferon alfa-2b in stage III melanoma had a significant and sustained impact on relapse-free survival (RFS), according to the results of the largest adjuvant trial ever conducted in patients with stage III melanoma. Results of the Phase III study, led by the European Organisation for the Research and Treatment of Cancer (EORTC) and supported by Schering-Plough, were presented today by Alexander Eggermont, M.D., Ph.D. at the 43rd Annual Meeting of the American Society of Clinical Oncology.

“Advanced stage melanoma remains difficult to treat and a need still exists to find treatment options,” said Alexander Eggermont, M.D., Ph.D., lead investigator and head of the department of surgical oncology, Erasmus University Medical Center, Rotterdam, The Netherlands. “These findings demonstrate the benefit of an increased relapse-free survival (RFS) despite no difference in overall survival.”
Median RFS was 34.8 months in the pegylated interferon alfa-2b arm vs. 25.5 months in the observational arm (p-value 0.01). Median distant metastasis-free survival (DMFS) was 45.6 months in subjects receiving pegylated interferon alfa-2b therapy versus 36.1 months in observational arm (p-value 0.11).


The response to therapy appeared to be most pronounced in a subgroup of subjects with only microscopic nodal involvement (patients with positive sentinel node(s) who experienced both increased relapse-free survival (RFS) (p-value 0.02) and distant metastasis-free survival (DMFS) (p-value 0.03). This group of patients constituted
43 percent of the trial population. At present, because of the increased use of sentinel node staging , this patient population largely constitutes the majority of patients diagnosed with stage III disease.'"/>




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