title: Concomitant chemoradiotherapy using carboplatin, tegafur-uracil and leucovorin for stage III and IV head-and-neck cancer: results of GORTEC Phase II study.
abstract: OBJECTIVE
  Concomitant chemoradiotherapy is the standard treatment of locally advanced, nonresectable, head-and-neck squamous cell carcinoma. However, the optimal chemotherapy regimen is still controversial. The objective of this Phase II study was to evaluate the feasibility and efficacy of a concomitant treatment using tegafur-uracil, leucovorin, carboplatin, and radiotherapy.
  
  
  METHODS
  A total of 77 patients with head-and-neck squamous cell carcinoma Stage III and IVA were enrolled between October 2003 and July 2005. Of the 77 patients, 72 were eligible. They were treated with tegafur-uracil (300 mg/m(2)/d) and leucovorin (75 mg/d) from Days 1 to 19 and from Days 29 to 47 and carboplatin (70 mg/m(2) intravenously for 4 consecutive days), in three cycles every 21 days. Conventional radiotherapy was delivered to a total dose of 70 Gy in 35 fractions.
  
  
  RESULTS
  With a mean follow-up of 22.8 months, the 3-year locoregional control, overall survival and disease-free survival actuarial rate was 33.1%, 41.9%, and 27.2%, respectively. The compliance of the treatment was correct. The main acute toxicity was mucositis, with 62% Grade 3-4. Three patients (4.2%) died of acute toxicity. The incidence and severity of late toxicity was acceptable, with 32% Grade 3 and no Grade 4 toxicity.
  
  
  CONCLUSIONS
  The protocol of concomitant chemoradiotherapy using tegafur-uracil, leucovorin, and carboplatin for locally advanced unresectable head-and-neck squamous cell carcinoma is feasible. The compliance was correct. The incidence and severity of the acute and late toxicities were acceptable, but not improved. The efficacy of this regimen seems equivalent to the main protocols of concurrent chemoradiotherapy. It represents a possible alternative for patients without an intravenous catheter.
authors.affiliation: Department of Radiation Oncology, Henry Kaplan Center, Tours, France.
authors.forename: Melanie
authors.initials: M
authors.lastname: Fesneau
authors.forename: Yoann
authors.initials: Y
authors.lastname: Pointreau
authors.forename: Sophie
authors.initials: S
authors.lastname: Chapet
authors.forename: Laurent
authors.initials: L
authors.lastname: Martin
authors.forename: Pascal
authors.initials: P
authors.lastname: Pommier
authors.forename: Marc
authors.initials: M
authors.lastname: Alfonsi
authors.forename: Brigitte
authors.initials: B
authors.lastname: Laguerre
authors.forename: Nasreddine
authors.initials: N
authors.lastname: Feham
authors.forename: Christine
authors.initials: C
authors.lastname: Berger
authors.forename: Pascal
authors.initials: P
authors.lastname: Garaud
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* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D003131:Combined Modality Therapy / Q000379:methods; D019583:Dose Fractionation, Radiation; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage; D014803:Vitamin B Complex / Q000008:administration & dosage
chemical_list: D014803:Vitamin B Complex; D005641:Tegafur; D016190:Carboplatin; D002955:Leucovorin