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)

Annals of Oncology : Official Journal of the European Society for Medical Oncology
Konstanze SpiethDirk Schadendorf

Abstract

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-IFNalpha-2b), hypothesizing improved efficacy due to modified pharmacokinetic properties of the novel interferon (IFN) formulation. In all, 124 patients with stage IV melanoma without prior chemotherapy and no cerebral metastases were treated with 100 mug peg-IFNalpha-2b s.c. per week and oral TMZ 200 mg/m(2) (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. 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%. The efficacy of TMZ plus peg-IFNalpha-2b in this large phase II study is moderate and comparable to published results of the combination ...Continue Reading

Citations

Jul 28, 2009·Annals of Oncology : Official Journal of the European Society for Medical Oncology·D SchadendorfP Hersey
Jun 17, 2010·Journal of Immunotherapy·Doru T AlexandrescuConstantin A Dasanu
Aug 27, 2009·Biologics : Targets & Therapy·Reinhard Dummer, Joanna Mangana
Mar 26, 2013·Oncoimmunology·Trine Zeeberg IversenInge Marie Svane
Aug 13, 2009·Advanced Drug Delivery Reviews·Gianfranco Pasut, Francesco M Veronese
Feb 7, 2018·The Cochrane Database of Systematic Reviews·Sandro PasqualiSimone Mocellin
Jul 14, 2010·International Journal of Dermatology·Ettore Minutilli
Mar 14, 2019·International Journal of Oncology·Kotaro MakitaAtsuo Yoshino
Jun 21, 2013·APMIS : Acta Pathologica, Microbiologica, Et Immunologica Scandinavica·Pierre CoursagetAntoine Touzé
Oct 15, 2013·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Ronald S GoJohn M Kirkwood
Nov 17, 2009·Clinics in Plastic Surgery·Jonathan Treisman, Nina Garlie
Nov 3, 2009·Clinics in Dermatology·Melinda JenJane M Grant-Kels

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