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Sorafenib and pegylated interferon-α2b in advanced metastatic melanoma: a multicenter phase II DeCOG trial

Background - The combination of sorafenib, a multikinase inhibitor, and pegylated interferon-α2b (Peg-IFN-α2b) could potentially lead to an improved antitumoral response. Previously, combinations of interferon and sorafenib have been used in renal cell cancer. - Patients and methods - Patients with...

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Main Authors: Egberts, Friederike (Author) , Gutzmer, R. (Author) , Ugurel, S. (Author) , Becker, J. C. (Author) , Trefzer, U. (Author) , Degen, A. (Author) , Schenck, F. (Author) , Frey, L. (Author) , Wilhelm, T. (Author) , Hassel, Jessica C. (Author) , Schadendorf, D. (Author) , Livingstone, E. (Author) , Mauch, C. (Author) , Garbe, C. (Author) , Berking, C. (Author) , Rass, K. (Author) , Mohr, P. (Author) , Kaehler, K. C. (Author) , Weichenthal, M. (Author) , Hauschild, A. (Author)
Format: Article (Journal)
Language:English
Published: 2011
In: Annals of oncology
Year: 2011, Volume: 22, Issue: 7, Pages: 1667-1674
ISSN:1569-8041
DOI:10.1093/annonc/mdq648
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1093/annonc/mdq648
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S0923753419384455
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Author Notes:F. Egberts, R. Gutzmer, S. Ugurel, J.C. Becker, U. Trefzer, A. Degen, F. Schenck, L. Frey, T. Wilhelm, J.C. Hassel, D. Schadendorf, E. Livingstone, C. Mauch, C. Garbe, C. Berking, K. Rass, P. Mohr, K.C. Kaehler, M. Weichenthal & A. Hauschild
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Summary:Background - The combination of sorafenib, a multikinase inhibitor, and pegylated interferon-α2b (Peg-IFN-α2b) could potentially lead to an improved antitumoral response. Previously, combinations of interferon and sorafenib have been used in renal cell cancer. - Patients and methods - Patients with stage IV metastatic melanoma and no previous systemic therapies apart from adjuvant immunotherapy received Peg-IFN-α2b 3 μg/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-α2b 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-α2b showed modest clinical activity and some serious side-effects including fatal bleeding complications.
Item Description:Version of Record 6 January 2020
Gesehen am 06.04.2022
Physical Description:Online Resource
ISSN:1569-8041
DOI:10.1093/annonc/mdq648

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