Originally published as JCO Early Release 10.1200/JCO.2008.21.3892 on May 11 2009

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Prospective Randomized Multicenter Adjuvant Dermatologic Cooperative Oncology Group Trial of Low-Dose Interferon Alfa-2b With or Without a Modified High-Dose Interferon Alfa-2b Induction Phase in Patients With Lymph Node–Negative Melanoma

From the Departments of Dermatology at University of Kiel, Kiel; University of Homburg/Saar, Homburg; Helios Klinikum Erfurt, Erfurt; University of Magdeburg, Magdeburg; Johannes Wesling Hospital Minden, Minden; University of Munich, Ludwig-Maximilians-Universität, Munich; University of Mainz, Mainz; University of Essen, Essen; University of Dresden, Dresden; University of Mannheim, Mannheim; University of Bochum, Bochum; University of Regensburg, Regensburg; Municipal Hospital Kassel, Kassel; University of Frankfurt/Main, Frankfurt; University of Jena, Jena; University of Heidelberg, Heidelberg; Elbeklinikum Buxtehude, Buxtehude; University of Tübingen, Tübingen, Germany.

Corresponding author: Axel Hauschild, MD, Department of Dermatology, University Hospital of Schleswig-Holstein, Campus Kiel, Schittenhelmstr 7, D-24105 Kiel, Germany; e-mail: ahauschild{at}dermatology.uni-kiel.de.

Purpose Interferon alfa (IFN-) has shown clinical efficacy in the adjuvant treatment of patients with high-risk melanoma in several clinical trials, but optimal dosing and duration of treatment are still under discussion. It has been argued that in high-dose IFN- (HDI), the intravenous (IV) induction phase might be critical for the clinical benefit of the regimen.

Patients and Methods In an attempt to investigate the potential role of a modified high-dose induction phase, lymph node–negative patients with resected primary malignant melanoma of more than 1.5-mm tumor thickness were included in this prospective randomized multicenter Dermatologic Cooperative Oncology Group trial. Six hundred seventy-four patients were randomly assigned to receive 4 weeks of a modified HDI scheme. This schedule consisted of 5 times weekly 10 MU/m² IFN--2b IV for 2 weeks and 5 times weekly 10 MU/m² IFN--2b administered subcutaneously (SC) for another 2 weeks followed by 23 months of low-dose IFN--2b (LDI) 3 MU SC three times a week (arm A). LDI 3 MU three times a week was given for 24 months in arm B.

Results Of 650 assessable patients, there were 92 relapses among the 321 patients receiving high-dose induction as compared with 95 relapses among the 329 patients receiving LDI only. Five-year relapse-free survival rates were 68.0% (arm A) and 67.1% (arm B), respectively. Likewise, melanoma-related fatalities were similar between both groups, resulting in 5-year overall survival rates of 80.2% (arm A) and 82.9% (arm B).

Conclusion The addition of a 4-week modified HDI induction phase to a 2-year low-dose adjuvant IFN--2b treatment schedule did not improve the clinical outcome.

Supported by grants from Schering-Plough.

Presented in part at the 38th Annual Meeting of the American Society of Clinical Oncology, May 18-21, 2002, Orlando, FL (abstract 1373).

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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