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

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Serval ID
serval:BIB_554804F9BCA7
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
A phase II study of docetaxel in patients with metastatic squamous cell carcinoma of the head and neck.
Journal
British Journal of Cancer
Author(s)
Couteau C., Chouaki N., Leyvraz S., Oulid-Aissa D., Lebecq A., Domenge C., Groult V., Bordessoule S., Janot F., De Forni M., Armand J.P.
ISSN
0007-0920 (Print)
ISSN-L
0007-0920
Publication state
Published
Issued date
1999
Volume
81
Number
3
Pages
457-462
Language
english
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.
Keywords
Aged, Antineoplastic Agents, Phytogenic/pharmacokinetics, Antineoplastic Agents, Phytogenic/therapeutic use, Carcinoma, Squamous Cell/drug therapy, Carcinoma, Squamous Cell/mortality, Combined Modality Therapy, Female, Head and Neck Neoplasms/drug therapy, Head and Neck Neoplasms/mortality, Humans, Life Tables, Male, Metabolic Clearance Rate, Middle Aged, Paclitaxel/analogs & derivatives, Paclitaxel/pharmacokinetics, Survival Analysis, Taxoids, Tomography, X-Ray Computed
Pubmed
Web of science
Open Access
Yes
Create date
28/01/2008 8:31
Last modification date
20/08/2019 14:09
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