Docetaxel plus gemcitabine in recurrent and/or metastatic squamous cell carcinoma of the head and neck: a phase II multicenter study.
OBJECTIVE
This phase II study was conducted to assess the efficacy of docetaxel plus gemcitabine in locally recurrent and/or metastatic squamous cell carcinoma of the head and neck.


METHODS
Forty patients with pharynx or larynx cancer were included and treated with an intravenous infusion of docetaxel 75 mg/m2 on day 8 and gemcitabine 1000 mg/m2 day 1 and day 8 every 3 weeks for 6 cycles.


RESULTS
Among the 40 patients included, 17 had metastatic disease and 18 had received prior chemotherapy. Thirty-two patients were assessable for response. The overall response rate was 20.0% (95% confidence interval [CI], 9.0%-35.7%), with 8 (20.0%) partial responses. Thirteen patients (32.5%) had stable disease, whereas 11 patients (27.5%) had progressive disease. The median response duration was 6.5 months (95% CI, 5.8-7.2). Grade 3 or 4 neutropenia was observed in 18 patients (45.0%). Three treatment-related deaths due to infection were reported.


CONCLUSIONS
The docetaxel and gemcitabine combination is an active treatment of recurrent or metastatic head and neck cancer. However, this regimen is associated with a high hematologic toxicity. A new schedule of administration must be explored.
Labourey
Jean-Luc
JL
CHU Dupuytren, Limoges, France. jeanluc.labourey@freesbee.fr
Cupissol
Didier
D
Calais
Gilles
G
Tourani
Jean-Marc
JM
Kohser
Fréderic
F
Borel
Christian
C
Eymard
Jean-Christophe
JC
Germann
Nathalie
N
Tubiana-Mathieu
Nicole
N
D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000556:secondary; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D007822:Laryngeal Neoplasms / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D010610:Pharyngeal Neoplasms / Q000188:drug therapy; D012008:Recurrence; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D000093542:Gemcitabine
D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine