Originally published as JCO Early Release 10.1200/JCO.2008.16.3121 on January 12 2009

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Randomized Phase III Study of 1 Month Versus 1 Year of Adjuvant High-Dose Interferon Alfa-2b in Patients With Resected High-Risk Melanoma

Dimitrios Pectasides, Urania Dafni, Dimitrios Bafaloukos, Dimosthenis Skarlos, Aristidis Polyzos, Dimosthenis Tsoutsos, Haralambos Kalofonos, George Fountzilas, Petros Panagiotou, George Kokkalis, Othon Papadopoulos, Ourania Castana, Stefanos Papadopoulos, Elias Stavrinidis, Georgia Vourli, John Ioannovich, Helen Gogas

From the Second Department of Internal Medicine-Propaedeutic, Oncology Section, University General Hospital Attikon; Laboratory of Biostatistics, University of Athens School of Nursing; Second Department of Medical Oncology, "Henry Dunant" Hospital; First Department of Medicine, University of Athens Medical School, Laiko Hospital; Department of Plastic Surgery and Microsurgery, G. Gennimatas General Hospital of Athens; Department of Plastic Surgery, St Savas, Anticancer Hospital; Department of Dermatology, University of Athens, Andreas Syggros Hospital; Department of Plastic Surgery, Evagelismos Hospital; First Department of Medical Oncology, St Savas, Anticancer Hospital; Hellenic Cooperative Oncology Group, Data Office, Athens; Oncology Department, Metropolitan Hospital, Faliro; Division of Oncology, Department of Medicine, University Hospital, Patras Medical School, Patras; Department of Medical Oncology, Papageorgiou Hospital, Aristotle University of Thessaloniki, School of Medicine, Thessaloniki, Greece.

Corresponding author: Helen Gogas, MD, PO 14120, 11510 Athens, Greece; e-mail: hgogas{at}hol.gr.

Purpose A high-dose interferon alfa (IFN-) regimen as reported in E1684 was unique for the incorporation of an induction phase of maximally tolerated dosages of intravenous (IV) therapy for the initial 4 weeks. This is the only trial that has shown prolongation of overall survival and relapse-free survival (RFS) in comparison with observation. Analysis of the hazard curves for RFS and overall survival (OS) in E1684 revealed separation of the high-dose and observation arms, suggesting that the induction phase may represent a critical component of this regimen, although this has not been tested prospectively.

Patients and Methods We conducted a prospective randomized study of IV induction therapy versus a full year of high-dose IFN, with primary end points of RFS and OS for patients with stage IIB, IIC, and III melanoma, within 56 days of curative surgery. Patients were randomly assigned to receive IFN--2b 15 x 10⁶ U/m² IV x 5/7 days weekly x 4 weeks (arm A) versus the same regimen followed by IFN--2b 10 x 10⁶ U (flat dose) administered subcutaneously three times a week for 48 weeks (arm B).

Results Between 1998 and 2004, 364 patients were enrolled (353 eligible: arm A, n = 177; arm B, n = 176). At a median follow-up of 63 months (95% CI, 58.1 to 67.7), the median RFS was 24.1 months versus 27.9 months (P = .9) and the median OS was 64.4 months versus 65.3 months (P = .49). Patients in arm B had more grade 1 to 2 hepatotoxicity, nausea/vomiting, alopecia, and neurologic toxicity.

Conclusion There were no significant differences in OS and RFS between the regimens of 1 month and 1 year of treatment.

Deceased.

Supported by the Hellenic Cooperative Oncology Group.

Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL.

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

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