Skip Navigation


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
This Article
Right arrow Full Text Freely available
Right arrow FREE Full Text (PDF) Freely available
Right arrow All Versions of this Article:
19/4/801    most recent
mdm565v1
Right arrow E-letters: Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when E-letters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Search for citing articles in:
ISI Web of Science (2)
Right arrowRequest Permissions
Right arrow Disclaimer
Google Scholar
Right arrow Articles by Spieth, K.
Right arrow Articles by Schadendorf, D.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Spieth, K.
Right arrow Articles by Schadendorf, D.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

© 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.


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?


This article has been cited by other articles:


Home page
 Ann OncolHome page
D. Schadendorf, S. M. Algarra, L. Bastholt, G. Cinat, B. Dreno, A. M. M. Eggermont, E. Espinosa, J. Guo, A. Hauschild, T. Petrella, et al.
Immunotherapy of distant metastatic disease
Ann. Onc., August 1, 2009; 20(suppl_6): vi41 - vi50.
[Abstract] [Full Text] [PDF]


Disclaimer: Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.