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Annals of Oncology Advance Access originally published online on January 4, 2008
Annals of Oncology 2008 19(4):801-806; doi:10.1093/annonc/mdm565
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

melanoma

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)

K. Spieth1,*, R. Kaufmann1, R. Dummer2, C. Garbe3, J. C. Becker4, A. Hauschild5, W. Tilgen6, S. Ugurel7, M. Beyeler2, E. B. Bröcker4, K. C. Kaehler5, C. Pföhler6, J. Gille1, U. Leiter3 and D. Schadendorf7

1 Department of Dermatology, Johann Wolfgang Goethe-University, Frankfurt am Main, Germany
2 Department of Dermatology, University of Zürich, Zürich, Switzerland
3 Department of Dermatology, University of Tübingen, Tübingen
4 Department of Dermatology, University of Würzburg, Würzburg
5 Department of Dermatology, University of Schleswig-Holstein Campus Kiel, Kiel
6 Department of Dermatology, Saarland University, Homburg Saar
7 Department of Dermatology, Skin Cancer Unit, German Cancer Research Center, University Hospital Mannheim, Mannheim, Germany

* Correspondence to: Dr K. Spieth, Department of Dermatology, J. W. Goethe-University, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany. Tel: +49-69-630183300; Fax: +49-69-63013804; E-mail: konstanze.spieth{at}kgu.de

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-IFN{alpha}-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-IFN{alpha}-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-IFN{alpha}-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-IFN{alpha}-2b seems to be similar to non-peg-IFN when combined with TMZ.

Key words: metastatic melanoma, pegylated interferon alfa-2b, temozolomide

Received for publication August 2, 2007. Revision received November 11, 2007. Accepted for publication November 13, 2007.


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