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Temozolomide plus pegylated interferon alfa-2b as first-line treatment for stage IV melanoma: a multicenter phase II trial of the Dermatologic Cooperative Oncology Group (DeCOG)

Spieth, K. ; Kaufmann, R. ; Dummer, R. ; Garbe, C. ; Becker, J. C. ; Hauschild, A. ; Tilgen, W. ; Ugurel, S. ; Beyeler, M. ; Bröcker, E. B. ; Kaehler, K. C. ; Pföhler, C. ; Gille, J. ; Leiter, U. ; Schadendorf, D.

In: Annals of Oncology, 2008, vol. 19, no. 4, p. 801-806

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    Titel
    • Temozolomide plus pegylated interferon alfa-2b as first-line treatment for stage IV melanoma: a multicenter phase II trial of the Dermatologic Cooperative Oncology Group (DeCOG)
    Autor
    • Spieth, K.. Department of Dermatology, Johann Wolfgang Goethe-University, Frankfurt am Main, Germany
    • Kaufmann, R.. Department of Dermatology, Johann Wolfgang Goethe-University, Frankfurt am Main, Germany
    • Dummer, R.. Department of Dermatology, University of Zürich, Zürich, Switzerland
    • Garbe, C.. Department of Dermatology, University of Tübingen, Tübingen
    • Becker, J. C.. Department of Dermatology, University of Würzburg, Würzburg
    • Hauschild, A.. Department of Dermatology, University of Schleswig-Holstein Campus Kiel, Kiel
    • Tilgen, W.. Department of Dermatology, Saarland University, Homburg Saar
    • Ugurel, S.. Department of Dermatology, Skin Cancer Unit, German Cancer Research Center, University Hospital Mannheim, Mannheim, Germany
    • Beyeler, M.. Department of Dermatology, University of Zürich, Zürich, Switzerland
    • Bröcker, E. B.. Department of Dermatology, University of Würzburg, Würzburg
    • Kaehler, K. C.. Department of Dermatology, University of Schleswig-Holstein Campus Kiel, Kiel
    • Pföhler, C.. Department of Dermatology, Saarland University, Homburg Saar
    • Gille, J.. Department of Dermatology, Johann Wolfgang Goethe-University, Frankfurt am Main, Germany
    • Leiter, U.. Department of Dermatology, University of Tübingen, Tübingen
    • Schadendorf, D.. Department of Dermatology, Skin Cancer Unit, German Cancer Research Center, University Hospital Mannheim, Mannheim, Germany
    Dokumententyp
    • Postprint
    Sprache
    • Englisch
    Veröffentlicht in
    • Annals of Oncology, 2008, vol. 19, no. 4, p. 801-806. Oxford University Press
    Andere elektronische Ausgabe
    OAI-PMH-ID
    • oai:doc.rero.ch:296231
    Summary
    Background: Combination of temozolomide (TMZ) with nonpegylated interferon alfa is associated with increased efficacy in terms of response rates compared with monotherapy. A multicenter phase II study was carried out to assess the activity and toxicity of TMZ plus pegylated interferon alfa-2b (peg-IFNα-2b), hypothesizing improved efficacy due to modified pharmacokinetic properties of the novel interferon (IFN) formulation. Patients and methods: In all, 124 patients with stage IV melanoma without prior chemotherapy and no cerebral metastases were treated with 100 μg peg-IFNα-2b s.c. per week and oral TMZ 200 mg/m2 (days 1-5, every 28 days). Primary study end point was objective response, and secondary end points were overall and progression-free survival (PFS) and safety. Results: In all, 116 patients were assessable for response: 2 (1.7%) had a complete response and 19 (16.4%) a partial response (overall response rate 18.1%). Of total, 25.0% achieved disease stabilization and 56.9% progressed. Overall survival was 9.4 months; PFS was 2.8 months. Grade 3/4 thrombocytopenia occurred in 20.7% and grade 3/4 leukopenia in 23.3%. Conclusions: The efficacy of TMZ plus peg-IFNα-2b in this large phase II study is moderate and comparable to published results of the combination of TMZ with non-peg-IFN. Likewise, the safety profile of peg-IFNα-2b seems to be similar to non-peg-IFN when combined with TMZ