Phase II trial:: concurrent radio-chemotherapy with weekly docetaxel for advanced squamous cell carcinoma of head and neck

Introduction: Standard fractionation radiation therapy (RT) combined with concomitant chemotherapy (CT) based on cisplatin schemes is actually the standard treatment for locally advanced non-resectable squamous cell carcinoma of head and neck (SCCHN). The appearance of taxoids has introduced a new kind of treatment with high antitumoral power. The aim of this study is to add more information about the role of this new approach. Materials and methods: Twenty-six patients with locally advanced non-resectable SCCHN were recruited at six institutions in Spain, between January 2001 and January 2003. Docetaxel was administered weekly, for 6 weeks, concurrently with RT. Results: The mean total delivered dose of RT was 70'2 Gy ( range 64-74 Gy). The median and mean duration of time were 63 days and 61 days (range 49-103 days) respectively. After a median time control of 19 months (range 3.3-42.2 months), the response rate was 83.4%. The median time to local progression was 16.4 months ( 95% confidence interval [CI]= 4.4-28.4 months). The median survival time was 26.9 months, with one- and two-year overall survival of 66.9% (95% CI= 48.1-85.7%) and 57.5% ( 95% CI= 37.3-77.7%) respectively. The median duration time response was 15.1 months ( 95% CI= 3.7-26.5 months). The median time until treatment failure was 9.4 months ( 95% CI= 4.7-14.1). Incidence of grade III-IV mucositis was 88%, neutropenia 72% and skin toxicity 92% (24% grade III-IV). The incidence of severe late toxicity (grade III and IV) due to RT/CT was 31.4%. Conclusions: Although therapeutics results are equivalent to cisplatin schemes of concurrent CT- RT, mucositis and cutaneous toxicity registered in this trial must be considered as limiting factors to application of this new approach.