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Hyperfractionated Accelerated Chemoradiation With Concurrent Fluorouracil-Mitomycin Is More Effective Than Dose-Escalated Hyperfractionated Accelerated Radiation Therapy Alone in Locally Advanced Head and Neck Cancer: Final Results of the Radiotherapy Cooperative Clinical Trials Group of the German Cancer Society 95-06 Prospective Randomized Trial

From the Department of Radiation Oncology, Campus Benjamin Franklin; Department of Radiation Oncology, Campus Mitte; Department of Radiation Oncology, Campus Wedding; Department of Head and Neck Surgery; and Institute for Medical Biometry, University Hospitals Charité, Berlin; Departments of Radiation Oncology and Head and Neck Surgery, University Hospitals of Essen, Essen; Department of Radiation Oncology, University Hospitals of Tuebingen, Tuebingen; Department of Radiation Oncology, University Hospitals of Dresden, Dresden; and Department of Radiation Oncology, University Hospitals of Erlangen, Erlangen, Germany

Address reprint requests to Volker Budach, MD, Strahlenklinik, Universitaetsklinikum Charité, Campus Mitte, 10098 Berlin, Germany; e-mail: volker.budach{at}charite.de

PURPOSE: To report the results and corresponding acute and late reactions of a prospective, randomized, clinical study in locally advanced head and neck cancer comparing concurrent fluorouracil (FU) and mitomycin (MMC) chemotherapy and hyperfractionated accelerated radiation therapy (C-HART; 70.6 Gy) to hyperfractionated accelerated radiation therapy alone (HART; 77.6 Gy).

PATIENTS AND METHODS: Three hundred eighty-four stage III (6%) and IV (94%) oropharyngeal (59.4%), hypopharyngeal (32.3%), and oral cavity (8.3%) cancer patients were randomly assigned to receive either 30 Gy (2 Gy every day) followed by 1.4 Gy bid to a total of 70.6 Gy concurrently with FU (600 mg/m², 120 hours continuous infusion) days 1 through 5 and MMC (10 mg/m²) on days 5 and 36 (C-HART) or 14 Gy (2 Gy every day) followed by 1.4 Gy bid to a total dose of 77.6 Gy (HART). The data were analyzed on an intent-to-treat basis.

RESULTS: At 5 years, the locoregional control and overall survival rates were 49.9% and 28.6% for C-HART versus 37.4% and 23.7% for HART, respectively (P = .001 and P = .023, respectively). Progression-free and freedom from metastases rates were 29.3% and 51.9% for C-HART versus 26.6% and 54.7% for HART, respectively (P = .009 and P = .575, respectively). For C-HART, maximum acute reactions of mucositis, moist desquamation, and erythema were lower than with HART, whereas no differences in late reactions and overall rates of secondary neoplasms were observed.

CONCLUSION: C-HART (70.6 Gy) is superior to dose-escalated HART (77.6 Gy) with comparable or less acute reactions and equivalent late reactions, indicating an improvement of the therapeutic ratio.

Supported by grant No. 70-1693 of the Deutsche Krebshilfe e.V.

Presented in part at the 19th Annual Meeting of the European Society for Therapeutic Radiology and Oncology ESTRO, Istanbul, Turkey, September 19-23, 2000; 37th Annual Meeting of the American Society of Clinical Oncology, San Francisco, CA, May 12-15, 2001; 43rd Annual Meeting of the American Society of Therapeutic Radiology and Oncology, San Francisco, CA, November 4-8, 2001; and 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, June 5-8, 2004.

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

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