title: Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer.
abstract: BACKGROUND
  A randomized phase 3 trial of the treatment of squamous-cell carcinoma of the head and neck compared induction chemotherapy with docetaxel plus cisplatin and fluorouracil (TPF) with cisplatin and fluorouracil (PF), followed by chemoradiotherapy.
  
  
  METHODS
  We randomly assigned 501 patients (all of whom had stage III or IV disease with no distant metastases and tumors considered to be unresectable or were candidates for organ preservation) to receive either TPF or PF induction chemotherapy, followed by chemoradiotherapy with weekly carboplatin therapy and radiotherapy for 5 days per week. The primary end point was overall survival.
  
  
  RESULTS
  With a minimum of 2 years of follow-up (> or =3 years for 69% of patients), significantly more patients survived in the TPF group than in the PF group (hazard ratio for death, 0.70; P=0.006). Estimates of overall survival at 3 years were 62% in the TPF group and 48% in the PF group; the median overall survival was 71 months and 30 months, respectively (P=0.006). There was better locoregional control in the TPF group than in the PF group (P=0.04), but the incidence of distant metastases in the two groups did not differ significantly (P=0.14). Rates of neutropenia and febrile neutropenia were higher in the TPF group; chemotherapy was more frequently delayed because of hematologic adverse events in the PF group.
  
  
  CONCLUSIONS
  Patients with squamous-cell carcinoma of the head and neck who received docetaxel plus cisplatin and fluorouracil induction chemotherapy plus chemoradiotherapy had a significantly longer survival than did patients who received cisplatin and fluorouracil induction chemotherapy plus chemoradiotherapy. (ClinicalTrials.gov number, NCT00273546 [ClinicalTrials.gov].).
authors.affiliation: Dana-Farber Cancer Institute, Boston, MA 02115, USA.
authors.forename: Marshall R
authors.initials: MR
authors.lastname: Posner
authors.forename: Diane M
authors.initials: DM
authors.lastname: Hershock
authors.forename: Cesar R
authors.initials: CR
authors.lastname: Blajman
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Mickiewicz
authors.forename: Eric
authors.initials: E
authors.lastname: Winquist
authors.forename: Vera
authors.initials: V
authors.lastname: Gorbounova
authors.forename: Sergei
authors.initials: S
authors.lastname: Tjulandin
authors.forename: Dong M
authors.initials: DM
authors.lastname: Shin
authors.forename: Kevin
authors.initials: K
authors.lastname: Cullen
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Ervin
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Murphy
authors.forename: Luis E
authors.initials: LE
authors.lastname: Raez
authors.forename: Roger B
authors.initials: RB
authors.lastname: Cohen
authors.forename: Monica
authors.initials: M
authors.lastname: Spaulding
authors.forename: Roy B
authors.initials: RB
authors.lastname: Tishler
authors.forename: Berta
authors.initials: B
authors.lastname: Roth
authors.forename: Rosana del Carmen
authors.initials: Rdel C
authors.lastname: Viroglio
authors.forename: Varagur
authors.initials: V
authors.lastname: Venkatesan
authors.forename: Ilya
authors.initials: I
authors.lastname: Romanov
authors.forename: Sanjiv
authors.initials: S
authors.lastname: Agarwala
authors.forename: K William
authors.initials: KW
authors.lastname: Harter
authors.forename: Matthew
authors.initials: M
authors.lastname: Dugan
authors.forename: Anthony
authors.initials: A
authors.lastname: Cmelak
authors.forename: Arnold M
authors.initials: AM
authors.lastname: Markoe
authors.forename: Paul W
authors.initials: PW
authors.lastname: Read
authors.forename: Lynn
authors.initials: L
authors.lastname: Steinbrenner
authors.forename: A Dimitrios
authors.initials: AD
authors.lastname: Colevas
authors.forename: Charles M
authors.initials: CM
authors.lastname: Norris
authors.forename: Robert I
authors.initials: RI
authors.lastname: Haddad
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; D011878:Radiotherapy / Q000009:adverse effects; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil