Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Egberts, F; Gutzmer, R; Ugurel, S; Becker, JC; Trefzer, U; Degen, A; Schenck, F; Frey, L; Wilhelm, T; Hassel, JC; Schadendorf, D; Livingstone, E; Mauch, C; Garbe, C; Berking, C; Rass, K; Mohr, P; Kaehler, KC; Weichenthal, M; Hauschild, A.
Sorafenib and pegylated interferon-α2b in advanced metastatic melanoma: a multicenter phase II DeCOG trial.
Ann Oncol. 2011; 22(7):1667-1674
Doi: 10.1093/annonc/mdq648
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- Co-authors Med Uni Graz
- Becker Jürgen Christian
- Ugurel-Becker Selma
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- Abstract:
- Patients and methods: Patients with stage IV metastatic melanoma and no previous systemic therapies apart from adjuvant immunotherapy received Peg-IFN-alpha 2b 3 mu g/kg once per week, and sorafenib 400-mg b.i.d. for a minimum of 8 weeks. The primary study end point was disease control rate (DCR). Results: Between February 2008 and February 2009, 55 patients were enrolled with a median age of 64 years (20-85). At 8 weeks, 2 patients (3.6%) had a partial response (PR) and 14 patients a stable disease (25.5%), for a DCR of 29.1% in the intention-to-treat (ITT) population. The median progression-free survival in the ITT population was 2.47 months (95% confidence interval 1.22-3.72 months). The toxicity of sorafenib and Peg-IFN-alpha 2b combination was characterized by mainly hematological side-effects, including one treatment-related bleeding complication with a fatal outcome. Other grade 3/4 toxic effects were fatigue and flu-like symptoms. Conclusion: The combination of sorafenib and Peg-IFN-alpha 2b showed modest clinical activity and some serious side-effects including fatal bleeding complications.
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