title: Docetaxel plus gemcitabine in recurrent and/or metastatic squamous cell carcinoma of the head and neck: a phase II multicenter study.
abstract: 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.
authors.affiliation: CHU Dupuytren, Limoges, France. jeanluc.labourey@freesbee.fr
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Labourey
authors.forename: Didier
authors.initials: D
authors.lastname: Cupissol
authors.forename: Gilles
authors.initials: G
authors.lastname: Calais
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Tourani
authors.forename: Fréderic
authors.initials: F
authors.lastname: Kohser
authors.forename: Christian
authors.initials: C
authors.lastname: Borel
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Eymard
authors.forename: Nathalie
authors.initials: N
authors.lastname: Germann
authors.forename: Nicole
authors.initials: N
authors.lastname: Tubiana-Mathieu
mesh_terms: 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
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine