title: Randomized clinical trial of post-operative radiotherapy versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement.
abstract: OBJECTIVE
  Post-operative radiotherapy is indicated for the treatment of head and neck cancers. In vitro, chemotherapy potentiates the cytotoxic effects of radiation. We report the results of a randomized trial testing post-operative radiotherapy alone versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement.
  
  
  METHODS
  The study involved patients undergoing curative-intent surgery for head and neck cancers with histological evidence of lymph node involvement. Patients were randomly assigned to receive radiotherapy alone (54-72Gy, 30-40 fractions, 6-8 weeks) or identical treatment plus concomitant Carboplatin (50mg/m(2) administered by IV infusion twice weekly).
  
  
  RESULTS
  Between February 1994 and June 2002, 144 patients were included. With a median follow-up of 106 months (95% confidence interval (CI) [92-119]), the 2-year rate of loco-regional control was 73% (95% CI: 0.61-0.84) in the combined treatment group and 68% (95% CI: 0.57-0.80) in the radiotherapy group (p=0.26). Overall survival did not differ significantly between groups (hazard ratio for death, 1.05; 95% CI: 0.69-1.60; p=0.81).
  
  
  CONCLUSIONS
  Twice-weekly administration of carboplatin concomitant to post-operative radiotherapy did not improve local control or overall survival rates in this population of patients with node-positive head and neck cancers.
authors.affiliation: Centre Léon Bérard, Department of Radiation Oncology, Lyon, France. racadot@lyon.fnclcc.fr
authors.forename: Séverine
authors.initials: S
authors.lastname: Racadot
authors.forename: Mariette
authors.initials: M
authors.lastname: Mercier
authors.forename: Sophie
authors.initials: S
authors.lastname: Dussart
authors.forename: Bernadette
authors.initials: B
authors.lastname: Dessard-Diana
authors.forename: René-Jean
authors.initials: RJ
authors.lastname: Bensadoun
authors.forename: Michel
authors.initials: M
authors.lastname: Martin
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Malaurie
authors.forename: Véronique
authors.initials: V
authors.lastname: Favrel
authors.forename: Martin
authors.initials: M
authors.lastname: Housset
authors.forename: Catherine
authors.initials: C
authors.lastname: Durdux
authors.forename: Catherine
authors.initials: C
authors.lastname: Journel
authors.forename: Gilles
authors.initials: G
authors.lastname: Calais
authors.forename: Jocelyne
authors.initials: J
authors.lastname: Huet
authors.forename: Gérard
authors.initials: G
authors.lastname: Pillet
authors.forename: Christophe
authors.initials: C
authors.lastname: Hennequin
authors.forename: Elias
authors.initials: E
authors.lastname: Haddad
authors.forename: Christian
authors.initials: C
authors.lastname: Diana
authors.forename: Brigitte
authors.initials: B
authors.lastname: Blaska-Jaulerry
authors.forename: Michel
authors.initials: M
authors.lastname: Henry-Amar
authors.forename: Pierre
authors.initials: P
authors.lastname: Géhanno
authors.forename: François
authors.initials: F
authors.lastname: Baillet
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Mazeron
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D016190:Carboplatin / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D007822:Laryngeal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009959:Oropharyngeal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D016016:Proportional Hazards Models; D011879:Radiotherapy Dosage; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D016190:Carboplatin