title: Supradose intra-arterial cisplatin and concurrent radiation therapy for the treatment of stage IV head and neck squamous cell carcinoma is feasible and efficacious in a multi-institutional setting: results of Radiation Therapy Oncology Group Trial 9615.
abstract: OBJECTIVE
  To determine the feasibility of high-dose intra-arterial (IA) cisplatin and concurrent radiation therapy (RT) for head and neck squamous cell carcinoma in the multi-institutional setting (Multi-RADPLAT).
  
  
  METHODS
  Eligibility included T4 squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Patients received cisplatin (150 mg/m(2) IA with sodium thiosulfate 9 g/m(2) intravenous [IV], followed by 12 g/m(2) IV over 6 hours, weekly for 4 weeks) and concurrent RT (70 Gy, 2.0 Gy/fraction, daily for 5 days over 7 weeks). Between May 1997 and December 1999, 67 patients from three experienced and eight inexperienced centers were enrolled, of whom 61 were eligible for analysis.
  
  
  RESULTS
  Multi-RADPLAT was feasible (ie, three or four infusions of IA cisplatin and full dose of RT) in 53 patients (87%). The complete response (CR) rate was 85% at the primary site and 88% at nodal regions, and the overall CR rate was 80%. At a median follow-up of 3.9 years for alive patients (range, 0.9 to 6.1 years), the estimated 1-year and 2-year locoregional tumor control rates are 66% and 57%, respectively. The estimated 1-year and 2-year survival rates are 72% and 63%, respectively. The estimated 1-year and 2-year disease-free survival rates are 62% and 46%, respectively. The rates of grade 4 and 5 toxicities at the experienced and the inexperienced institutions were 14% and 0% v 47% and 4%, respectively.
  
  
  CONCLUSIONS
  This intensive treatment regimen for head and neck cancer is feasible and effective in a multi-institutional setting.
authors.affiliation: Southern Illinois University School of Medicine, Division of Otolaryngology Head and Neck Surgery, PO Box 19662, Springfield, IL 62794-9662, USA. trobbins@siumed.edu
authors.forename: K Thomas
authors.initials: KT
authors.lastname: Robbins
authors.forename: Parvesh
authors.initials: P
authors.lastname: Kumar
authors.forename: Jonathan
authors.initials: J
authors.lastname: Harris
authors.forename: Timothy
authors.initials: T
authors.lastname: McCulloch
authors.forename: Anthony
authors.initials: A
authors.lastname: Cmelak
authors.forename: Robert
authors.initials: R
authors.lastname: Sofferman
authors.forename: Paul
authors.initials: P
authors.lastname: Levine
authors.forename: Robert
authors.initials: R
authors.lastname: Weisman
authors.forename: William
authors.initials: W
authors.lastname: Wilson
authors.forename: Ernest
authors.initials: E
authors.lastname: Weymuller
authors.forename: Karen
authors.initials: K
authors.lastname: Fu
mesh_terms: D000328:Adult; D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage*; D003131:Combined Modality Therapy; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D006801:Humans; D007269:Injections, Intra-Arterial; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D002945:Cisplatin