title: Favorable survival observed after carboplatin, paclitaxel, and concurrent accelerated hyperfractionated radiotherapy for treatment of locally advanced head and neck carcinoma.
abstract: OBJECTIVE
  Several trials have demonstrated the superiority of simultaneous chemoradiotherapy compared with radiation alone for patients with locally advanced head and neck cancers. However, the optimal regimen remains to be defined. This study assessed the safety and activity of combined carboplatin (C), paclitaxel (P), and twice-daily radiotherapy (RT) in a community based, multicenter, phase II trial.
  
  
  METHODS
  Eligible patients (N = 52) had ECOG PS 0-2 and previously untreated, stage III or IV (M0), unresectable, squamous cell cancers of the head and neck. Treatment consisted of 6 weekly courses of C (AUC = 1), P (40 mg/m(2)/1-h) and twice-daily radiation (120 cGy BID; total dose of 6,960 cGy). Subsequently, patients with N2/N3 disease were permitted neck dissection.
  
  
  RESULTS
  Median follow-up was 61 months. Sixty-seven percent (67%) of patients had stage IV (M0) disease at baseline. Fifty-five percent (55%) of treated patients experienced NCI Grade 3-4 dysphagia, stomatitis, or mucositis; 80% had > or = Grade 3 toxicity of any organ system. Median weight loss was 7.1 lbs; 35% of patients experienced 10% or more weight loss. Of 43 patients evaluable for response, responses were: 29 CR (67%), 7 PR (16%), 1 MR (2%), 4 SD (9%), and 2 PD (5%); the overall response rate (CR+PR) was 84%. For the entire cohort of 52 patients, the estimated overall survival at 36 months was 60%; progression-free survival was 50%.
  
  
  CONCLUSIONS
  We conclude that weekly C + P and concurrent twice-daily hyperfractionated radiotherapy is tolerated and highly active in patients with unresectable, locally advanced squamous cell carcinoma of the head and neck.
authors.affiliation: US Oncology Research, Inc., Houston, TX, USA. Dennis.Carter@usoncology.com
authors.forename: Dennis L
authors.initials: DL
authors.lastname: Carter
authors.forename: Lina
authors.initials: L
authors.lastname: Asmar
authors.forename: David
authors.initials: D
authors.lastname: Barrera
authors.forename: John
authors.initials: J
authors.lastname: Caracandas
authors.forename: J Shaker
authors.initials: JS
authors.lastname: Dakhil
authors.forename: Dean
authors.initials: D
authors.lastname: McCracken
authors.forename: Mark A
authors.initials: MA
authors.lastname: O'Rourke
authors.forename: Richard K
authors.initials: RK
authors.lastname: Rosenberg
authors.forename: Kristi A
authors.initials: KA
authors.lastname: Boehm
authors.forename: Des
authors.initials: D
authors.lastname: Ilegbodu
authors.forename: Robert L
authors.initials: RL
authors.lastname: Reid
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D004334:Drug Administration Schedule; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011879:Radiotherapy Dosage; D016019:Survival Analysis
chemical_list: D016190:Carboplatin; D017239:Paclitaxel