title: Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer.
abstract: BACKGROUND
  Phase 2 studies suggest that the standard regimen of cisplatin and fluorouracil (PF) plus docetaxel (TPF) improves outcomes in squamous-cell carcinoma of the head and neck. We compared TPF with PF as induction chemotherapy in patients with locoregionally advanced, unresectable disease.
  
  
  METHODS
  We randomly assigned eligible patients between the ages of 18 and 70 years who had stage III or stage IV disease and no distant metastases to receive either TPF (docetaxel and cisplatin, day 1; fluorouracil by continuous infusion, days 1 to 5) or PF every 3 weeks for four cycles. Patients without progression of disease received radiotherapy within 4 to 7 weeks after completing chemotherapy. The primary end point was progression-free survival.
  
  
  RESULTS
  A total of 358 patients underwent randomization, with 177 assigned to the TPF group and 181 to the PF group. At a median follow-up of 32.5 months, the median progression-free survival was 11.0 months in the TPF group and 8.2 months in the PF group (hazard ratio for disease progression or death in the TPF group, 0.72; P=0.007). Treatment with TPF resulted in a reduction in the risk of death of 27% (P=0.02), with a median overall survival of 18.8 months, as compared with 14.5 months in the PF group. There were more grade 3 or 4 events of leukopenia and neutropenia in the TPF group and more grade 3 or 4 events of thrombocytopenia, nausea, vomiting, stomatitis, and hearing loss in the PF group. The rates of death from toxic effects were 2.3% in the TPF group and 5.5% in the PF group.
  
  
  CONCLUSIONS
  As compared with the standard regimen of cisplatin and fluorouracil, induction chemotherapy with the addition of docetaxel significantly improved progression-free and overall survival in patients with unresectable squamous-cell carcinoma of the head and neck. (ClinicalTrials.gov number, NCT00003888 [ClinicalTrials.gov].).
authors.affiliation: Department of Medical Oncology, Universitair Ziekenhuis Antwerpen, Edegem, Belgium. jan.b.vermorken@uza.be
authors.forename: Jan B
authors.initials: JB
authors.lastname: Vermorken
authors.forename: Eva
authors.initials: E
authors.lastname: Remenar
authors.forename: Carla
authors.initials: C
authors.lastname: van Herpen
authors.forename: Thierry
authors.initials: T
authors.lastname: Gorlia
authors.forename: Ricard
authors.initials: R
authors.lastname: Mesia
authors.forename: Marian
authors.initials: M
authors.lastname: Degardin
authors.forename: John S
authors.initials: JS
authors.lastname: Stewart
authors.forename: Svetislav
authors.initials: S
authors.lastname: Jelic
authors.forename: Jan
authors.initials: J
authors.lastname: Betka
authors.forename: Joachim H
authors.initials: JH
authors.lastname: Preiss
authors.forename: Danielle
authors.initials: D
authors.lastname: van den Weyngaert
authors.forename: Ahmad
authors.initials: A
authors.lastname: Awada
authors.forename: Didier
authors.initials: D
authors.lastname: Cupissol
authors.forename: Heinz R
authors.initials: HR
authors.lastname: Kienzer
authors.forename: Augustin
authors.initials: A
authors.lastname: Rey
authors.forename: Isabelle
authors.initials: I
authors.lastname: Desaunois
authors.forename: Jacques
authors.initials: J
authors.lastname: Bernier
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Lefebvre
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D002945:Cisplatin / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011878:Radiotherapy / Q000009:adverse effects; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage*
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil