title: Final report of RTOG 9610, a multi-institutional trial of reirradiation and chemotherapy for unresectable recurrent squamous cell carcinoma of the head and neck.
abstract: BACKGROUND
  Our objectives were to determine the incidence of acute and late toxicities and to estimate the 2-year overall survival for patients treated with reirradiation and chemotherapy for unresectable squamous cell carcinoma of the head and neck (SCCHN).
  
  
  METHODS
  Patients with recurrent squamous cell carcinoma or a second primary arising in a previously irradiated field were eligible. Four weekly cycles of 5-fluorouracil 300 mg/m2 IV bolus and hydroxyurea 1.5 g by mouth were used with 60 Gy at 1.5 Gy twice-daily fractions. Toxicity was scored according to Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) criteria.
  
  
  RESULTS
  Seventy-nine of the 86 patients enrolled were analyzable. The worst acute toxicity was grade 4 in 17.7% and grade 5 in 7.6%. Grade 3 and 4 late toxicities were found in 19.4% and 3.0%, respectively. The estimated cumulative incidence of grade 3 to 4 late effects occurring at >1 year was 9.4% (95% confidence interval [CI]: 0, 19.7) at 2 and 5 years. The 2- and 5-year cumulative incidence for grade 4 toxicity was 3.1% (95% CI: 0, 9.3). The estimated 2- and 5-year survival rates were 15.2% (95% CI: 7.3, 23.1) and 3.8% (95% CI: 0.8, 8.0), respectively. Patients who entered the study at >1 year from initial radiotherapy (RT) had better survival than did those who were <1 year from prior RT (median survival, 9.8 months vs 5.8 months; p = .036). No correlation was detected between dose received and overall survival. Three patients were alive at 5 years.
  
  
  CONCLUSIONS
  This is the first prospective multi-institutional trial testing reirradiation plus chemotherapy for recurrent or second SCCHN. The approach is feasible with acceptable acute and late effects. The results serve as a benchmark for ongoing RTOG trials.
authors.affiliation: Department of Radiation Oncology, University of Alabama at Birmingham, Birmingham, Alabama, USA. sspencer@uabmc.edu
authors.forename: Sharon A
authors.initials: SA
authors.lastname: Spencer
authors.forename: Jonathan
authors.initials: J
authors.lastname: Harris
authors.forename: Richard H
authors.initials: RH
authors.lastname: Wheeler
authors.forename: Mitchell
authors.initials: M
authors.lastname: Machtay
authors.forename: Christopher
authors.initials: C
authors.lastname: Schultz
authors.forename: William
authors.initials: W
authors.lastname: Spanos
authors.forename: Marvin
authors.initials: M
authors.lastname: Rotman
authors.forename: Ruby
authors.initials: R
authors.lastname: Meredith
authors.forename: Kie-Kian
authors.initials: KK
authors.lastname: Ang
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000628:therapy*; D019583:Dose Fractionation, Radiation; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000628:therapy*; D006801:Humans; D006918:Hydroxyurea / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000628:therapy*; D016609:Neoplasms, Second Primary / Q000401:mortality / Q000628:therapy*; D011446:Prospective Studies; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects / Q000379:methods; D019233:Retreatment; D015996:Survival Rate
chemical_list: D005472:Fluorouracil; D006918:Hydroxyurea