title: Final results of the 94-01 French Head and Neck Oncology and Radiotherapy Group randomized trial comparing radiotherapy alone with concomitant radiochemotherapy in advanced-stage oropharynx carcinoma.
abstract: OBJECTIVE
  We report the 5-year survival and late toxicity results of a randomized clinical trial, which showed a 3-year improvement in overall survival and locoregional control of stage III or IV oropharynx carcinoma, using concomitant radiochemotherapy (arm B), compared with standard radiotherapy (arm A).
  
  
  METHODS
  A total of 226 patients were entered onto a phase III multicenter randomized trial comparing radiotherapy alone (70 Gy in 35 fractions; arm A) with concomitant radiochemotherapy (70 Gy in 35 fractions with three cycles of a 4-day regimen comprising carboplatin and fluorouracil; arm B). Prognostic factors were evaluated by univariate and multivariate analysis. Five-year late toxicity was evaluated using National Cancer Institute Common Toxicity Criteria for neurological toxicity, hearing, taste, mandibula, and teeth damage, and Radiation Therapy Oncology Group toxicity criteria for skin, salivary gland, and mucosa.
  
  
  RESULTS
  Five-year overall survival, specific disease-free survival, and locoregional control rates were 22% and 16% (log-rank P =.05), 27% and 15% (P =.01), and 48% and 25% (P =.002), in arm B and arm A, respectively. Stage IV, hemoglobin level lower than 125 g/L, and standard treatment were independent prognostic factors of short survival and locoregional failure by univariate and multivariate analysis. One or more grade 3 to 4 complications occurred in 56% of the patients in arm B, compared with 30% in arm A (P was not significant).
  
  
  CONCLUSIONS
  Concomitant radiochemotherapy improved overall survival and locoregional control rates and does not statistically increase severe late morbidity. Anemia was the most important prognostic factor for survival in both arms.
authors.affiliation: Clinique d'Oncologie et Radiothérapie, Hôpital Bretonneau, 2 Blvd Tonnelé, 37044 Tours, France. fcdenis@club-internet.fr
authors.forename: Fabrice
authors.initials: F
authors.lastname: Denis
authors.forename: Pascal
authors.initials: P
authors.lastname: Garaud
authors.forename: Etienne
authors.initials: E
authors.lastname: Bardet
authors.forename: Marc
authors.initials: M
authors.lastname: Alfonsi
authors.forename: Christian
authors.initials: C
authors.lastname: Sire
authors.forename: Thierry
authors.initials: T
authors.lastname: Germain
authors.forename: Philippe
authors.initials: P
authors.lastname: Bergerot
authors.forename: Beatrix
authors.initials: B
authors.lastname: Rhein
authors.forename: Jacques
authors.initials: J
authors.lastname: Tortochaux
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*; D016190:Carboplatin / Q000008:administration & dosage; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009959:Oropharyngeal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D011379:Prognosis
chemical_list: D016190:Carboplatin; D005472:Fluorouracil