title: A phase II trial of docetaxel, cisplatin and 5-fluorouracil in patients with recurrent squamous cell carcinoma of the head and neck (SCCHN).
abstract: BACKGROUND
  In this phase II study, for the first time the efficacy and toxicity of triple chemotherapy with docetaxel, cisplatin and 5-fluorouracil (TPF) in patients with recurrent head and neck cancer was evaluated.
  
  
  METHODS
  Twenty-four patients with stage IV (UICC) recurrent squamous cell carcinoma of the head and neck (SCCHN), with different tumor sites, were treated with a polychemotherapy consisting of docetaxel 75 mg/m2 day 1, cisplatin 100 mg/m2 day 1 and 5-fluorouracil (5-FU) 1000 mg/m2 days 1 through 4 (total dose 4000 mg/m2) on days 1, 22 and 43, for a maximum of 3 cycles. The performance status of all patients at the start of the chemotherapy was 0-2, according to the Eastern Cooperative Oncology Group (ECOG).
  
  
  RESULTS
  Sixty-eight cycles were administered to 24 patients. The reversible major acute toxicities were afebrile neutropenia in 6 patients and emesis in 4 patients. One patient died, probably because of myocardial infarction related to treatment. A remission was observed in 10 patients. Six patients showed a complete remission and 4 patients a partial remission. The median time to progression was 10 months (range, 4-42 months), the median overall survival after treatment was 13 months (range, 6-48 months) and the median recurrence-free survival was 12 months (range, 10-18 months).
  
  
  CONCLUSIONS
  In terms of toxicity, TPF seems to be a feasible option for the treatment of recurrent SCCHN in patients with a compromised performance status. These results justify further investigations to evaluate the efficacy of this treatment.
authors.affiliation: Department for ENT-Surgery, University of Frankfurt am Main, Germany.
authors.forename: Mehran
authors.initials: M
authors.lastname: Baghi
authors.forename: Markus
authors.initials: M
authors.lastname: Hambek
authors.forename: Jens
authors.initials: J
authors.lastname: Wagenblast
authors.forename: Angelika
authors.initials: A
authors.lastname: May
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Gstoettner
authors.forename: Rainald
authors.initials: R
authors.lastname: Knecht
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D002945:Cisplatin; D005472:Fluorouracil