title: Sorafenib and pegylated interferon-α2b in advanced metastatic melanoma: a multicenter phase II DeCOG trial.
abstract: 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.
  
  
  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.
  
  
  CONCLUSIONS
  The combination of sorafenib and Peg-IFN-α2b showed modest clinical activity and some serious side-effects including fatal bleeding complications.
authors.affiliation: Department of Dermatology, University of Kiel, Kiel.
authors.forename: F
authors.initials: F
authors.lastname: Egberts
authors.affiliation: Department of Dermatology, Hannover Medical School, Hannover.
authors.forename: R
authors.initials: R
authors.lastname: Gutzmer
authors.affiliation: Department of Dermatology, University of Würzburg, Würzburg, Germany; Department of Dermatology, University of Graz, Graz, Austria.
authors.forename: S
authors.initials: S
authors.lastname: Ugurel
authors.affiliation: Department of Dermatology, University of Würzburg, Würzburg, Germany; Department of Dermatology, University of Graz, Graz, Austria.
authors.forename: J C
authors.initials: JC
authors.lastname: Becker
authors.affiliation: Department of Dermatology, University of Berlin, Berlin.
authors.forename: U
authors.initials: U
authors.lastname: Trefzer
authors.affiliation: Department of Dermatology, Hannover Medical School, Hannover.
authors.forename: A
authors.initials: A
authors.lastname: Degen
authors.affiliation: Department of Dermatology, Hannover Medical School, Hannover.
authors.forename: F
authors.initials: F
authors.lastname: Schenck
authors.affiliation: Department of Dermatology, University of Würzburg, Würzburg, Germany.
authors.forename: L
authors.initials: L
authors.lastname: Frey
authors.affiliation: Department of Dermatology, University of Berlin, Berlin.
authors.forename: T
authors.initials: T
authors.lastname: Wilhelm
authors.affiliation: Department of Dermatology, University of Heidelberg-Mannheim, Heidelberg.
authors.forename: J C
authors.initials: JC
authors.lastname: Hassel
authors.affiliation: Department of Dermatology, University of Essen, Essen.
authors.forename: D
authors.initials: D
authors.lastname: Schadendorf
authors.affiliation: Department of Dermatology, University of Kiel, Kiel; Department of Dermatology, University of Essen, Essen.
authors.forename: E
authors.initials: E
authors.lastname: Livingstone
authors.affiliation: Department of Dermatology, University of Köln, Köln.
authors.forename: C
authors.initials: C
authors.lastname: Mauch
authors.affiliation: Department of Dermatology, University of Tübingen, Tübingen.
authors.forename: C
authors.initials: C
authors.lastname: Garbe
authors.affiliation: Department of Dermatology, University of Munich, Munich.
authors.forename: C
authors.initials: C
authors.lastname: Berking
authors.affiliation: Department of Dermatology, University of Homburg/Saar, Homburg/Saar.
authors.forename: K
authors.initials: K
authors.lastname: Rass
authors.affiliation: Dermatological Center, Buxtehude, Buxtehude, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Mohr
authors.affiliation: Department of Dermatology, University of Kiel, Kiel.
authors.forename: K C
authors.initials: KC
authors.lastname: Kaehler
authors.affiliation: Department of Dermatology, University of Kiel, Kiel.
authors.forename: M
authors.initials: M
authors.lastname: Weichenthal
authors.affiliation: Department of Dermatology, University of Kiel, Kiel. Electronic address: ahauschild@dermatology.uni-kiel.de.
authors.forename: A
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authors.lastname: Hauschild
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols; D000998:Antiviral Agents / Q000627:therapeutic use*; D001557:Benzenesulfonates / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D020714:Maximum Tolerated Dose; D008545:Melanoma / Q000188:drug therapy* / Q000556:secondary; D008875:Middle Aged; D009367:Neoplasm Staging; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011446:Prospective Studies; D011725:Pyridines / Q000627:therapeutic use*; D011994:Recombinant Proteins; D000077157:Sorafenib; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D000998:Antiviral Agents; D001557:Benzenesulfonates; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D010671:Phenylurea Compounds; D011725:Pyridines; D011994:Recombinant Proteins; D009536:Niacinamide; D011092:Polyethylene Glycols; D000077157:Sorafenib; C417083:peginterferon alfa-2b