title: Randomized trial of induction chemotherapy with cisplatin and 5-fluorouracil with or without docetaxel for larynx preservation.
abstract: BACKGROUND
  Chemotherapy with cisplatin (P) and 5-fluorouracil (F) followed by radiotherapy in patients who respond to chemotherapy is an alternative to total laryngectomy for patients with locally advanced larynx and hypopharynx cancer. Data suggest that docetaxel (T) may add to the efficacy of PF. The objective of this trial was to determine whether adding T to PF could increase the larynx preservation rate.
  
  
  METHODS
  Patients who had larynx and hypopharynx cancer that required total laryngectomy were randomly assigned to receive three cycles of TPF or PF. Patients who responded to chemotherapy received radiotherapy with or without additional chemotherapy. Patients who did not respond to chemotherapy underwent total laryngectomy followed by radiotherapy with or without additional chemotherapy. The primary endpoint was 3-year larynx preservation rate. Secondary endpoints included acute toxicities and overall response. All statistical tests were two-sided.
  
  
  RESULTS
  Baseline patient and tumor characteristics were well balanced between the TPF (n = 110) and PF (n = 103) groups. With a median follow-up of 36 months, the 3-year actuarial larynx preservation rate was 70.3% with TPF vs 57.5% with PF (difference = 12.8%; P = .03). Patients in the TPF group had more grade 2 alopecia, grade 4 neutropenia, and febrile neutropenia, whereas patients in the PF group had more grade 3 and 4 stomatitis, thrombocytopenia, and grade 4 creatinine elevation. The overall response was 80.0% in the TPF group vs 59.2% in the PF group (difference = 20.8%; P = .002).
  
  
  CONCLUSIONS
  In patients with advanced larynx and hypopharynx carcinomas, TPF induction chemotherapy was superior to the PF regimen in terms of overall response rate. These results suggest that larynx preservation could be achieved for a higher proportion of patients.
authors.affiliation: Centre Hospitalier Régional et Universitaire, Henry Kaplan Center, Clinique d'Oncologie et de Radiothérapie, Tours, France.
authors.forename: Yoann
authors.initials: Y
authors.lastname: Pointreau
authors.forename: Pascal
authors.initials: P
authors.lastname: Garaud
authors.forename: Sophie
authors.initials: S
authors.lastname: Chapet
authors.forename: Christian
authors.initials: C
authors.lastname: Sire
authors.forename: Claude
authors.initials: C
authors.lastname: Tuchais
authors.forename: Jacques
authors.initials: J
authors.lastname: Tortochaux
authors.forename: Sandrine
authors.initials: S
authors.lastname: Faivre
authors.forename: Stephane
authors.initials: S
authors.lastname: Guerrif
authors.forename: Marc
authors.initials: M
authors.lastname: Alfonsi
authors.forename: Gilles
authors.initials: G
authors.lastname: Calais