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IL-6 as a prognostic and predictive biomarker in patients with malignant melanoma Background The incidence of melanoma is rapidly increasing worldwide. In Denmark, 1427 new cases of melanoma was diagnosed in 2006. Interleukin (IL)-6 is an immunomodulatory cytokine produced by different immune cells, but also by cancer cells. The serum level of IL-6 is elevated in a number of patients with different types of solid tumors, and is an independent prognostic biomarker for survival in head and neck and prostate cancer. Materials and Methods The project is divided into 2 sub-studies. 1. 850 patients with malignant melanoma stage IIB-III (local and loco regional disease) were randomized to observation without treatment or treatment with adjuvant interferon s.c. for respectively 1 or 2 years. Serum samples have been collected during treatment and follow up until recurrence or maximum five years observation time. These serum samples and the primary biopsies will be analyzed for IL-6 concentration and expression, respectively. 2. 350 patients with malignant melanoma stage IV (metastatic disease) were treated with interferon and IL-2. Tumor biopsies were obtained before initiation of treatment. Serum samples were collected before, during and after treatment until progression. These serum samples and the biopsies will be analysed for IL-6 concentration and expression, respectively. The expression of IL-6 in primary biopsies will be analysed using immunohistochemistry, and the serum concentration of IL-6 by ELISA. Aims of PhD. project • To investigate the robustness of IL-6 as a new independent prognostic biomarker in patients with malignant melanoma for disease free survival and overall survival • To investigate the robustness of IL-6 as a predictive biomarker for the effect of adjuvant interferon and for the effect of interferon combined with IL-2, in patients with malignant melanoma. Perspectives If IL-6 is a prognostic and predictive biomarker in patients with malignant melanoma, the study can potentially lead to a better selection of patients, who will have the best effect of treatment.