title: A phase I/II trial of twice daily irradiation and concurrent chemotherapy for locally advanced squamous cell carcinoma of the head and neck.
abstract: OBJECTIVE
  This study was designed to test the toxicity and efficacy of a regimen of twice daily irradiation and concurrent multiagent chemotherapy for patients with locally advanced squamous cell carcinoma of the head and neck.
  
  
  METHODS
  This was a prospective Phase I/II trial. Patients received 125 cGy b.i.d. to 7000 cGy with a 6 hr interfraction interval. Chemotherapy was given during weeks 1 and 6 of irradiation and consisted of a 5 day infusion of 5-fluorouracil at 600 mg/M2/day and 5 daily injections of cisplatin at 12 mg/M2/day. Two additional cycles of chemotherapy were given after the completion of radiotherapy.
  
  
  RESULTS
  Forty-six patients were evaluable: 28 had technically unresectable disease and 18 had resectable tumors. All had Stage III or IV disease: 84% had T3 or T4 primaries while 53% had > or = N2 neck disease. The primary acute toxicity, confluent mucositis, was seen in 74% of patients. Late side effects occurred in four patients. Median follow-up is 36 months (range 25-44 months). Kaplan-Meier estimates of 2-year disease-free survival and overall survival are 65% and 73%, respectively, while 2-year local regional control and distant disease-free survival are 72% and 88%, respectively. Multivariate analysis revealed that resectability and receiving > 2 cycles of chemotherapy significantly influenced local regional control while age < 60 significantly influenced disease-free survival.
  
  
  CONCLUSIONS
  This form of treatment can be delivered safely. The encouraging results have led to the initiation of a Phase III trial comparing this regimen with b.i.d. radiation alone.
authors.affiliation: Duke University Comprehensive Cancer Center, Durham, NC 27710.
authors.forename: D M
authors.initials: DM
authors.lastname: Brizel
authors.forename: K A
authors.initials: KA
authors.lastname: Leopold
authors.forename: S R
authors.initials: SR
authors.lastname: Fisher
authors.forename: T J
authors.initials: TJ
authors.lastname: Panella
authors.forename: R L
authors.initials: RL
authors.lastname: Fine
authors.forename: C L
authors.initials: CL
authors.lastname: Bedrosian
authors.forename: P D
authors.initials: PD
authors.lastname: Kenan
authors.forename: A
authors.initials: A
authors.lastname: Huang
authors.forename: T
authors.initials: T
authors.lastname: Womack
authors.forename: T
authors.initials: T
authors.lastname: Bjurstrom
mesh_terms: D000818:Animals; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003131:Combined Modality Therapy; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D009092:Mucous Membrane / Q000187:drug effects / Q000528:radiation effects; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D016019:Survival Analysis
chemical_list: D002945:Cisplatin; D005472:Fluorouracil