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

Author:

Budach Volker1,Stuschke Martin1,Budach Wilfried1,Baumann Michael1,Geismar Dirk1,Grabenbauer Gerhard1,Lammert Ingrid1,Jahnke Klaus1,Stueben Georg1,Herrmann Thomas1,Bamberg Michael1,Wust Peter1,Hinkelbein Wolfgang1,Wernecke Klaus-Dieter1

Affiliation:

1. 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...

Abstract

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.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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