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

被引：24

作者：

Egberts, F. ^{[1
]}

Gutzmer, R. ^{[2
]}

Ugurel, S. ^{[3
,4
]}

Becker, J. C. ^{[3
,4
]}

Trefzer, U. ^{[5
]}

Degen, A. ^{[2
]}

Schenck, F. ^{[2
]}

Frey, L. ^{[3
]}

Wilhelm, T. ^{[5
]}

Hassel, J. C. ^{[6
]}

Schadendorf, D. ^{[7
]}

Livingstone, E. ^{[1
,7
]}

Mauch, C. ^{[8
]}

Garbe, C. ^{[9
]}

Berking, C. ^{[10
]}

Rass, K. ^{[11
]}

Mohr, P. ^{[12
]}

Kaehler, K. C. ^{[1
]}

Weichenthal, M. ^{[1
]}

Hauschild, A. ^{[1
]}

机构：

[1] Univ Kiel, Dept Dermatol, D-24105 Kiel, Germany

[2] Hannover Med Sch, Dept Dermatol, D-3000 Hannover, Germany

[3] Univ Wurzburg, Dept Dermatol, D-8700 Wurzburg, Germany

[4] Graz Univ, Dept Dermatol, Graz, Austria

[5] Univ Berlin, Dept Dermatol, Berlin, Germany

[6] Univ Heidelberg Mannheim, Dept Dermatol, Heidelberg, Germany

[7] Univ Essen Gesamthsch, Dept Dermatol, Essen, Germany

[8] Univ Cologne, Dept Dermatol, D-5000 Cologne, Germany

[9] Univ Tubingen, Dept Dermatol, Tubingen, Germany

[10] Univ Munich, Dept Dermatol, D-8000 Munich, Germany

[11] Univ Homburg Saar, Dept Dermatol, Homburg, Germany

[12] Dermatol Ctr, Buxtehude, Germany

来源：

ANNALS OF ONCOLOGY | 2011年 / 22卷 / 07期

关键词：

metastatic melanoma; pegylated IFN; sorafenib; ADJUVANT THERAPY; PEGINTERFERON ALPHA-2A; STAGE-III; COMBINATION; CARCINOMA; 1ST-LINE;

D O I：

10.1093/annonc/mdq648

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：1667 / 1674

页数：8

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