Concurrent chemoradiotherapy with cisplatin and docetaxel for advanced head and neck cancer. A phase I study.

BACKGROUND This phase I study of weekly low-dose administration of cisplatin (CDDP) and docetaxel (DOC) combined with concurrent conventionally fractionated radiotherapy was designed for locoregionally advanced head and neck cancer. PATIENTS AND METHODS Twelve patients were treated at varying levels of DOC (level 1: 5 mg/m2/week, level 2: 7.5 mg/m2/week, level 3: 10 mg/m2/week) with CDDP constant at 20 mg/m2/week in four cohorts of three patients. Radiation was given at 1.8-2.0 Gy/fraction to a total dose of 60-70.2 Gy. RESULTS Hematological toxicities, except lymphocytopenia, were minimal. Mucosal toxicities, especially grade 3 mucositis, were common. Dose-limiting toxicity was grade 3 pain, although level 3 did not reach a maximum tolerated dose. No grade 4 toxicities were observed. Complete response rate ranged from 33% to 67% in the various dose levels. CONCLUSION This concurrent chemoradiotherapy seems to be a promising treatment modality, in which level 3 is the recommended dose for a phase II study.