ONE MONTH OF HIGH DOSE INTERFERON IS ENOUGH

J Clin Oncol. 2009 Jan 12. [Epub ahead of print]

Related Articles, LinkOut

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

Pectasides D, Dafni U, Bafaloukos D, Skarlos D, Polyzos A, Tsoutsos D, Kalofonos H, Fountzilas G, Panagiotou P, Kokkalis G, Papadopoulos O, Castana O, Papadopoulos S, Stavrinidis E, Vourli G, Ioannovich J, Gogas H.

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.

PURPOSE: A high-dose interferon alfa (IFN-alpha) 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-alpha-2b 15 x 10(6) U/m(2) IV x 5/7 days weekly x 4 weeks (arm A) versus the same regimen followed by IFN-alpha-2b 10 x 10(6) 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.