title: Long-term Results of a Multicenter Randomized Phase III Trial of Induction Chemotherapy With Cisplatin, 5-fluorouracil, ± Docetaxel for Larynx Preservation.
abstract: BACKGROUND
  The purpose of GORTEC 2000-01 was to compare the long-term efficacy and safety of induction chemotherapy with cisplatin (P) and 5-fluorouracil (F) with or without docetaxel (T) for larynx preservation.
  
  
  METHODS
  Operable patients with untreated stage III or IV larynx or hypopharynx invasive squamous cell carcinoma who required total laryngectomy were randomly assigned to three cycles of induction chemotherapy with either TPF or PF, followed by radiation therapy for responders. The primary endpoint was three-year larynx preservation rate. Secondary endpoints included larynx dysfunction-free survival (LDFFS), overall survival (OS), disease-free survival (DFS), loco-regional control rate (LCR), cause of death, and later toxicity rates. Survival and other data were analyzed by Kaplan-Meier methods. All statistical tests were two-sided.
  
  
  RESULTS
  Two hundred thirteen patients were treated with median follow-up of 105 months. The five- and 10-year larynx preservation rates were 74.0% (95% CI = 0.64 to 0.82) vs 58.1% (95% CI = 0.47 to 0.68) and 70.3% (95% CI = 0.58 to 0.8) vs 46.5% (95% CI = 0.31 to 0.63, P = .01) in the TPF vs PF arm, respectively. The five- and 10-year LDFFS rates were 67.2% (95% CI = 0.57 to 0.76) vs 46.5% (95% CI = 0.36 to 0.57) and 63.7% (95% CI = 0.52 to 0.74) vs 37.2% (95% CI = 0.24 to 0.52, P = .001), respectively. OS, DFS, and LCR were not statistically improved in the TPF vs the PF arm. Statistically fewer grade 3-4 late toxicities of the larynx occurred with the TPF regimen compared with the PF arm (9.3% vs 17.1%, G-test, P = .038).
  
  
  CONCLUSIONS
  Long-term follow-up confirms that induction chemotherapy with TPF increased larynx preservation and larynx dysfunction-free survival. In this larynx preservation approach using induction chemotherapy, TPF should be recommended, followed by radiation therapy.
authors.affiliation: Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique d'Oncologie et de Radiothérapie, Tours, France (GJ, YP, PG, SC, GC); Université François Rabelais de Tours, France (GJ, GC); Clinique Sainte Catherine, Avignon, France (MA); Centre Hospitalier de Lorient, Lorient, France (CS); Centre Paul Papin, Angers, France (EJ). guillaume.janoray@yahoo.fr.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Janoray
authors.affiliation: Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique d'Oncologie et de Radiothérapie, Tours, France (GJ, YP, PG, SC, GC); Université François Rabelais de Tours, France (GJ, GC); Clinique Sainte Catherine, Avignon, France (MA); Centre Hospitalier de Lorient, Lorient, France (CS); Centre Paul Papin, Angers, France (EJ).
authors.forename: Yoann
authors.initials: Y
authors.lastname: Pointreau
authors.affiliation: Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique d'Oncologie et de Radiothérapie, Tours, France (GJ, YP, PG, SC, GC); Université François Rabelais de Tours, France (GJ, GC); Clinique Sainte Catherine, Avignon, France (MA); Centre Hospitalier de Lorient, Lorient, France (CS); Centre Paul Papin, Angers, France (EJ).
authors.forename: Pascal
authors.initials: P
authors.lastname: Garaud
authors.affiliation: Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique d'Oncologie et de Radiothérapie, Tours, France (GJ, YP, PG, SC, GC); Université François Rabelais de Tours, France (GJ, GC); Clinique Sainte Catherine, Avignon, France (MA); Centre Hospitalier de Lorient, Lorient, France (CS); Centre Paul Papin, Angers, France (EJ).
authors.forename: Sophie
authors.initials: S
authors.lastname: Chapet
authors.affiliation: Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique d'Oncologie et de Radiothérapie, Tours, France (GJ, YP, PG, SC, GC); Université François Rabelais de Tours, France (GJ, GC); Clinique Sainte Catherine, Avignon, France (MA); Centre Hospitalier de Lorient, Lorient, France (CS); Centre Paul Papin, Angers, France (EJ).
authors.forename: Marc
authors.initials: M
authors.lastname: Alfonsi
authors.affiliation: Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique d'Oncologie et de Radiothérapie, Tours, France (GJ, YP, PG, SC, GC); Université François Rabelais de Tours, France (GJ, GC); Clinique Sainte Catherine, Avignon, France (MA); Centre Hospitalier de Lorient, Lorient, France (CS); Centre Paul Papin, Angers, France (EJ).
authors.forename: Christian
authors.initials: C
authors.lastname: Sire
authors.affiliation: Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique d'Oncologie et de Radiothérapie, Tours, France (GJ, YP, PG, SC, GC); Université François Rabelais de Tours, France (GJ, GC); Clinique Sainte Catherine, Avignon, France (MA); Centre Hospitalier de Lorient, Lorient, France (CS); Centre Paul Papin, Angers, France (EJ).
authors.forename: Eric
authors.initials: E
authors.lastname: Jadaud
authors.affiliation: Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique d'Oncologie et de Radiothérapie, Tours, France (GJ, YP, PG, SC, GC); Université François Rabelais de Tours, France (GJ, GC); Clinique Sainte Catherine, Avignon, France (MA); Centre Hospitalier de Lorient, Lorient, France (CS); Centre Paul Papin, Angers, France (EJ).
authors.forename: Gilles
authors.initials: G
authors.lastname: Calais
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000556:secondary / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000556:secondary / Q000601:surgery; D006801:Humans; D007012:Hypopharyngeal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D060828:Induction Chemotherapy / Q000379:methods*; D053208:Kaplan-Meier Estimate; D007822:Laryngeal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D007825:Laryngectomy / Q000379:methods; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D059351:Organ Sparing Treatments; D000077195:Squamous Cell Carcinoma of Head and Neck; D043823:Taxoids / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil