title: Concurrent radiation therapy and chemotherapy for locally unresectable squamous cell head and neck cancer: an Eastern Cooperative Oncology Group pilot study.
abstract: OBJECTIVE
  The feasibility and success of an intensive chemoradiotherapeutic protocol for patients with locally advanced, unresectable squamous cell head and neck cancer was tested in this limited-institution, Eastern Cooperative Oncology Group phase II pilot study.
  
  
  METHODS
  Between December 1987 and September 1989, 57 patients were entered onto this trial. The treatment protocol consisted of three courses of a 4-day continuous fluorouracil infusion, a single cisplatin bolus injection, and concurrent split-course radiotherapy. After 30 Gy of radiation and two chemotherapy courses, patients were evaluated for response and for the possibility of surgical resection.
  
  
  RESULTS
  Fifty-five of 57 registered patients are assessable for toxicity and 52 are assessable for response and survival. Toxicity was significant, but tolerable, although there were three toxic deaths. A complete response to this treatment was ultimately achieved by 77% of patients. Twenty-four patients remain relapse-free. The projected Kaplan-Meier 4-year relapse-free survival rate is 45% and the overall survival rate is 49%. Median relapse-free and overall survival durations are 26 and 37 months, respectively. Of the 28 treatment failures, 79% were locoregional. Fourteen patients underwent surgery. Six remain relapse-free.
  
  
  CONCLUSIONS
  This aggressive concurrent chemoradiotherapy protocol appears feasible within a cooperative group. Treatment results are promising and appear durable. A randomized phase III clinical trial is currently underway.
authors.affiliation: Case Western Reserve University, Cleveland, OH.
authors.forename: D J
authors.initials: DJ
authors.lastname: Adelstein
authors.forename: L A
authors.initials: LA
authors.lastname: Kalish
authors.forename: G L
authors.initials: GL
authors.lastname: Adams
authors.forename: H
authors.initials: H
authors.lastname: Wagner
authors.forename: M M
authors.initials: MM
authors.lastname: Oken
authors.forename: S C
authors.initials: SC
authors.lastname: Remick
authors.forename: E G
authors.initials: EG
authors.lastname: Mansour
authors.forename: R E
authors.initials: RE
authors.lastname: Haselow
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012044:Regression Analysis; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D002945:Cisplatin; D005472:Fluorouracil