A phase II study of docetaxel in patients with metastatic squamous cell carcinoma of the head and neck

This study was designed to evaluate the activity, safety and tolerance of d ocetaxel (D) in a selected population with metastatic squamous cell carcino ma of the head and neck (SCCHN). Twenty-four patients with no prior palliat ive therapy were enrolled and received D 100 mg m(-2) by 1 h of infusion, e very 3 weeks. All but two patients had been evaluated for efficacy on lung metastatic sites. No prophylactic administration of anti-emetics or growth factors was given. A pharmacokinetic study was performed in 22 patients. Tw enty-one patients were assessable for response and 24 for toxicity. One hun dred and four cycles were administered with a median of 4.5 (range 1-9) per patient. The median cumulative dose was 449 mg m-2. Partial responses were achieved in five patients with a median duration of 18.7 weeks (range 13.1 -50.3). The overall response rate was 20.8% with a median duration of 11.0 weeks (range 2.4-52.6). The most frequent side-effect was neutropenia (79.2 % grade IV) but with a short duration (median 4 days) and no febrile neutro penia. The incidence of moderate/severe fluid retention was 29.2% with one treatment discontinuation. Other toxicities (all grades) were common (skin 75%, asthenia 50%, infection 29.2%, nausea 16.7%, diarrhoea 12.5%, stomatit is 16.7%, vomiting 8.3% and HSR 8.3%). A mean clearance of 19.6 1 h(-1) m(- 2) and an area under the curve of 6.00 mu g ml(-1) h(-1) was found in the p harmacokinetic analysis. Docetaxel is active in this selected population wi th metastatic SCCHN, with a good tolerance. (C) 1999 Cancer Research Campai gn.