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

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