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.

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.

• Authors: 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
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 22 Issue 7 Pg. 1667-1674 (Jul 2011) ISSN: 1569-8041 [Electronic] England
• PMID: 21220519 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Antiviral Agents
• Benzenesulfonates
• Interferon alpha-2
• Interferon-alpha
• Phenylurea Compounds
• Pyridines
• Recombinant Proteins
• Niacinamide
• Polyethylene Glycols
• Sorafenib
• peginterferon alfa-2b

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents (therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols
• Antiviral Agents (therapeutic use)
• Benzenesulfonates (therapeutic use)
• Female
• Follow-Up Studies
• Head and Neck Neoplasms (drug therapy, pathology)
• Humans
• Interferon alpha-2
• Interferon-alpha (therapeutic use)
• Male
• Maximum Tolerated Dose
• Melanoma (drug therapy, secondary)
• Middle Aged
• Neoplasm Staging
• Niacinamide (analogs & derivatives)
• Phenylurea Compounds
• Polyethylene Glycols (therapeutic use)
• Prospective Studies
• Pyridines (therapeutic use)
• Recombinant Proteins
• Sorafenib
• Survival Rate
• Treatment Outcome
• Young Adult