Results of a randomised phase II study comparing docetaxel with methotrexate in patients with recurrent head and neck cancer.
Fiche publication
Date publication
septembre 2004
Journal
European journal of cancer (Oxford, England : 1990)
Auteurs
Membres identifiés du Cancéropôle Est :
Dr CHAIGNEAU Loïc, Pr PIVOT Xavier
Tous les auteurs :
Guardiola E, Peyrade F, Chaigneau L, Cupissol D, Tchiknavorian X, Bompas E, Madroszyk A, Ronchin P, Schneider M, Bleuze JP, Blay JY, Pivot X
Lien Pubmed
Résumé
We report the results of a randomised phase II trial of docetaxel tested as a single agent in patients with recurrent head and neck cancer using methotrexate as a control arm to validate the results. Eligibility criteria included: histologically-confirmed squamous cell carcinoma, measurable disease, adequate haematological, renal and hepatic functions, no prior chemotherapy for recurrent cancer, signed informed consent. 40 mg/m2 methotrexate was given as a short weekly bolus i.v. injection, and 40 mg/m2 docetaxel was administered as a one hour weekly infusion. A total of 57 patients were randomised based on a ratio of 2/1:37 and 20 patients received docetaxel and methotrexate, respectively. Patient characteristics included 49 males and 8 females; the median age was 59 years (range: 43-82 years). Twenty-eight patients had a local-regional relapse and 29 had distant metastasis, the median disease-free interval was 7.9 months (range: 0-165 months). For patients treated with docetaxel, the following grade 3-4 toxicities occurred: neutropenia (12.5%) with febrile neutropenia in one patient (1%), anaemia (19%) mucositis (9%) and ungueal toxicity (9%). In the methotrexate arm, the grade 3-4 toxicities were: anaemia (15%) and mucositis (5%). The response rate was significantly higher in the docetaxel arm with 27% (95% confidence interval (CI): 21.7-32.3%) of objective responses versus 15% (95% CI: 11.2-18.8%) in the methotrexate arm. Overall survival and time to progression were super-imposable between the docetaxel and methotrexate treatments. Docetaxel given as a weekly infusion has a high activity in patients with head and neck cancer. A phase III trial is needed to test if this translates into a survival benefit for docetaxel use.
Mots clés
Adult, Aged, Aged, 80 and over, Antimetabolites, Antineoplastic, adverse effects, Antineoplastic Agents, Phytogenic, adverse effects, Carcinoma, Squamous Cell, drug therapy, Female, Head and Neck Neoplasms, drug therapy, Humans, Male, Methotrexate, adverse effects, Middle Aged, Neoplasm Recurrence, Local, drug therapy, Survival Analysis, Taxoids, adverse effects, Treatment Outcome
Référence
Eur. J. Cancer. 2004 Sep;40(14):2071-6