title: French multicenter phase III randomized study testing concurrent twice-a-day radiotherapy and cisplatin/5-fluorouracil chemotherapy (BiRCF) in unresectable pharyngeal carcinoma: Results at 2 years (FNCLCC-GORTEC).
abstract: BACKGROUND
  Unresectable carcinomas of the oropharynx and hypopharynx still have a poor long-term prognosis. Following a previous phase II study, this phase III multicenter trial was conducted between November 1997 and March 2002.
  
  
  METHODS
  Nontreated, strictly unresectable cases were eligible. Twice-daily radiation: two fractions of 1.2 Gy/day, 5 days per week, with no split (D1-->D46). Total tumor doses: 80.4 Gy/46 day (oropharynx), 75.6 Gy/44 day (hypopharynx). Chemotherapy (arm B): Cisplatin 100 mg/m2 (D1, D22, D43); 5FU, continuous infusion (D1-->D5), 750 mg/m2/day cycle 1; 430 mg/m2/day cycles 2 and 3.
  
  
  RESULTS
  A total of 163 evaluable patients. Grade 3-4 acute mucositis 82.6% arm B/69.5% arm A (NS); Grade 3-4 neutropenia 33.3% arm B/2.4% arm A (p < 0.05). Enteral nutrition through gastrostomy tube was more frequent in arm B before treatment and at 6 months (p < 0.01). At 24 months, overall survival (OS), disease-free survival (DFS), and specific survival (SS) were significantly better in arm B. OS: 37.8% arm B vs. 20.1% arm A (p = 0.038); DFS: 48.2% vs. 25.2% (p = 0.002); SS: 44.5% vs. 30.2% (p = 0.021). No significant difference between the two arms in the amount of side effects at 1 and 2 years.
  
  
  CONCLUSIONS
  For these unresectable cases, chemoradiation provides better outcome than radiation alone, even with an "aggressive" dose-intensity radiotherapy schedule.
authors.affiliation: Department of Radiation Oncology, Centre Antoine Lacassagne, Nice, France. rene-jean.bensadoun@nice.fnclcc.fr
authors.forename: René-Jean
authors.initials: RJ
authors.lastname: Bensadoun
authors.forename: Karen
authors.initials: K
authors.lastname: Bénézery
authors.forename: Olivier
authors.initials: O
authors.lastname: Dassonville
authors.forename: Nicolas
authors.initials: N
authors.lastname: Magné
authors.forename: Gilles
authors.initials: G
authors.lastname: Poissonnet
authors.forename: Alain
authors.initials: A
authors.lastname: Ramaïoli
authors.forename: Claire
authors.initials: C
authors.lastname: Lemanski
authors.forename: Sylvain
authors.initials: S
authors.lastname: Bourdin
authors.forename: Jacques
authors.initials: J
authors.lastname: Tortochaux
authors.forename: Frédéric
authors.initials: F
authors.lastname: Peyrade
authors.forename: Pierre-Yves
authors.initials: PY
authors.lastname: Marcy
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Chamorey
authors.forename: Jacques
authors.initials: J
authors.lastname: Vallicioni
authors.forename: Hang
authors.initials: H
authors.lastname: Seng
authors.forename: Claude
authors.initials: C
authors.lastname: Alzieu
authors.forename: Bernard
authors.initials: B
authors.lastname: Géry
authors.forename: Pierre
authors.initials: P
authors.lastname: Chauvel
authors.forename: Maurice
authors.initials: M
authors.lastname: Schneider
authors.forename: José
authors.initials: J
authors.lastname: Santini
authors.forename: François
authors.initials: F
authors.lastname: Demard
authors.forename: Gilles
authors.initials: G
authors.lastname: Calais
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* / Q000556:secondary / Q000601:surgery; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy / Q000009:adverse effects / Q000379:methods; D019583:Dose Fractionation, Radiation; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005602:France; D006801:Humans; D007012:Hypopharyngeal Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery; D008297:Male; D008875:Middle Aged; D037981:Neck Dissection; D009364:Neoplasm Recurrence, Local; D009959:Oropharyngeal Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery; D010610:Pharyngeal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D011446:Prospective Studies; D016019:Survival Analysis
chemical_list: D002945:Cisplatin; D005472:Fluorouracil