title: A phase II study of docetaxel in patients with metastatic squamous cell carcinoma of the head and neck.
abstract: This study was designed to evaluate the activity, safety and tolerance of docetaxel (D) in a selected population with metastatic squamous cell carcinoma of the head and neck (SCCHN). Twenty-four patients with no prior palliative therapy were enrolled and received D 100 mg m(-2) by 1 h of infusion, every 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. Twenty-one patients were assessable for response and 24 for toxicity. One hundred 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 neutropenia. 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%, stomatitis 16.7%, vomiting 8.3% and HSR 8.3%). A mean clearance of 19.6 l h(-1) m(-2) and an area under the curve of 6.00 microg ml(-1) h(-1) was found in the pharmacokinetic analysis. Docetaxel is active in this selected population with metastatic SCCHN, with a good tolerance.
authors.affiliation: Institut Gustave Roussy, Department of Medecine, Villejuif, France.
authors.forename: C
authors.initials: C
authors.lastname: Couteau
authors.forename: N
authors.initials: N
authors.lastname: Chouaki
authors.forename: S
authors.initials: S
authors.lastname: Leyvraz
authors.forename: D
authors.initials: D
authors.lastname: Oulid-Aissa
authors.forename: A
authors.initials: A
authors.lastname: Lebecq
authors.forename: C
authors.initials: C
authors.lastname: Domenge
authors.forename: V
authors.initials: V
authors.lastname: Groult
authors.forename: S
authors.initials: S
authors.lastname: Bordessoule
authors.forename: F
authors.initials: F
authors.lastname: Janot
authors.forename: M
authors.initials: M
authors.lastname: De Forni
authors.forename: J P
authors.initials: JP
authors.lastname: Armand
mesh_terms: D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000493:pharmacokinetics / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000401:mortality / Q000556:secondary* / Q000628:therapy; D003131:Combined Modality Therapy; D000077143:Docetaxel; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000628:therapy; D006801:Humans; D015993:Life Tables; D008297:Male; D008657:Metabolic Clearance Rate; D008875:Middle Aged; D017239:Paclitaxel / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D016019:Survival Analysis; D043823:Taxoids; D014057:Tomography, X-Ray Computed
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel