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Clinical Conference Randomized phase III study of 1 month versus 1 year of adjuvant high-dose interferon alfa-2b in patients with resected high-risk melanoma. 2009
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, Athens, Greece. · J Clin Oncol. · Pubmed #19139440 No free full text.
Abstract: 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/m2 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.
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Retraction Melanoma of the head and neck: a review. 2007
Korkolis D, Liapakis IE, Gherardini G, Kokkalis G, Vassilopoulos P. · 1st Department of General Surgery, Hellenic Anticancer Institute, Saint Savvas Hospital, Athens, Greece. · J BUON. · Pubmed #17918285 No free full text.
Abstract: Melanoma of the head and neck and its treatment are complex issues. The behavior of head and neck melanoma is aggressive, and it has an overall poorer prognosis than that of other skin sites. Current understanding of the behavior of head and neck melanoma is reviewed and treatment strategies are presented. Controversies in treatment include the role of lymphoscintigraphy with sentinel node biopsy, nodal dissection, margin size, role of radiation therapy, and reconstruction. The therapeutic goal is to treat melanoma aggressively while minimizing the effects of treatment on patient's quality of life. Due to its biological behavior, head and neck melanoma should be treated in an aggressive manner when morbidity is not significantly increased. Patient's specific treatment is imperative.
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