title: Phase II study of carboplatin and continuous infusion bleomycin followed by cisplatin and 5-fluorouracil in recurrent head and neck cancer.
abstract: BACKGROUND
  Recurrent squamous cell carcinoma of the head and neck is poorly responsive to most chemotherapy regimens. Carboplatin and bleomycin are effective single agents with non-overlapping toxicity; therefore, we sought to explore the efficacy of this regimen in a phase II study. In the second stage of the study, patients who did not respond to carboplatin and bleomycin were given treatment with cisplatin and 5-fluorouracil (5-FU).
  
  
  METHODS
  Patients with recurrent squamous cell carcinoma of the head and neck were treated with carboplatin 400 mg/m2 followed by bleomycin 15 units intravenously as a continuous infusion for 4 days. Patients with no tumor response after 3 cycles of carboplatin and bleomycin were crossed-over to receive cisplatin 100 mg/m2 and 5-FU 1000 mg/m2/day continuous infusion for 5 days.
  
  
  RESULTS
  Among the 20 carboplatin-bleomycin patients evaluable for toxicity, no cases of grade 4 granulocytopenia were reported and grade 3 or 4 thrombocytopenia developed in only three patients. Three partial responses occurred among the 19 patients (16%) [95% C.I. 0% to 32%] evaluable for response to carboplatin-bleomycin. None of the 11 patients crossed-over to cisplatin and 5-FU had a major response.
  
  
  CONCLUSIONS
  The combination of carboplatin and bleomycin is well tolerated in patients with recurrent head and neck cancer, but the activity does not appear to be superior to the activity of either agent alone. Patients who did not respond to carboplatin and bleomycin were also resistant to the cisplatin and 5-FU regimen.
authors.affiliation: University of Texas, M. D. Anderson Cancer Center, Department of Thoracic/Head and Neck Medical Oncology, Houston, USA.
authors.forename: M H
authors.initials: MH
authors.lastname: Huber
authors.forename: S M
authors.initials: SM
authors.lastname: Lippman
authors.forename: S E
authors.initials: SE
authors.lastname: Benner
authors.forename: M
authors.initials: M
authors.lastname: Shirinian
authors.forename: I W
authors.initials: IW
authors.lastname: Dimery
authors.forename: C L
authors.initials: CL
authors.lastname: Earley
authors.forename: R J
authors.initials: RJ
authors.lastname: Winn
authors.forename: J
authors.initials: J
authors.lastname: Brooks
authors.forename: L
authors.initials: L
authors.lastname: Baez
authors.forename: W K
authors.initials: WK
authors.lastname: Hong
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage; D016190:Carboplatin / Q000008:administration & dosage; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D015996:Survival Rate
chemical_list: D001761:Bleomycin; D016190:Carboplatin; D002945:Cisplatin; D005472:Fluorouracil