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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.

Volker Budach·Martin Stuschke·Wilfried Budach·Michael Baumann·Dirk Geismar·Gerhard Grabenbauer·Ingrid Lammert·Klaus Jahnke·Georg Stueben·Thomas Herrmann·Michael Bamberg·Peter Wust·Wolfgang Hinkelbein·Klaus-Dieter Wernecke
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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/m(2), 120 hours continuous infusion) days 1 through 5 and MMC (10 mg/m(2)) 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.

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Actuarial AnalysisAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinomaCombined Modality TherapyDose Fractionation, RadiationFemaleFluorouracilGermanyHead and Neck NeoplasmsHumansMaleMiddle AgedMitomycinNeoplasm MetastasisNeoplasm Recurrence, LocalPatient ComplianceProspective StudiesRadiotherapyRadiotherapy DosageSurvival AnalysisSurvival RateClinical TrialComparative StudyJournal ArticleRandomized Controlled TrialResearch Support, Non-U.S. Gov't

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Volker Budach, Martin Stuschke, Wilfried Budach, Michael Baumann, Dirk Geismar, Gerhard Grabenbauer, Ingrid Lammert, Klaus Jahnke, Georg Stueben, Thomas Herrmann, Michael Bamberg, Peter Wust, Wolfgang Hinkelbein, Klaus-Dieter Wernecke. 2005-02-20. 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.. https://doi.org/10.1200/jco.2005.07.010

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