title: Phase I/II study of carboplatin and 5-fluorouracil in patients with advanced head and neck carcinoma.
abstract: 59 patients with histological verified squamous cell carcinoma of the head and neck, 39 with primary disease and 20 with relapse were given carboplatin and 5-fluorouracil (5-FU) in escalated carboplatin doses. The starting dose with carboplatin was 200 mg/m2 and the dose was escalated to 300 mg/m2, 350 mg/m2, 400 mg/m2 and thereafter by 20 mg/m2 per step. All patients received a dose of 1000 mg/m2 5-FU as a continuous infusion for 5 days. The myelotoxicity was moderate. No patients had grade 4 haemoglobin toxicity, while 7 patients had grade 3 toxicity. 2 patients had grade 4 leucocyte toxicity and 1 patient had grade 3. 4 patients were observed with a grade 4 platelet toxicity. 2 early deaths occurred at a dose level of 420 mg/m2. 18 out of 39 patients in primary treatment responded while 2 out of 20 patients treated for relapse responded. On the basis of the present study the maximum tolerable dose for carboplatin in combination with 5-FU 1000 mg/m2 is between 350 and 400 mg/m2.
authors.affiliation: Department of Medical Oncology and Radiotherapy, Norwegian Radium Hospital, Oslo.
authors.forename: S
authors.initials: S
authors.lastname: Kaasa
authors.forename: E
authors.initials: E
authors.lastname: Thorud
authors.forename: J
authors.initials: J
authors.lastname: Tausjø
authors.forename: E
authors.initials: E
authors.lastname: Wist
authors.forename: J F
authors.initials: JF
authors.lastname: Evensen
authors.forename: S
authors.initials: S
authors.lastname: Gundersen
authors.forename: H
authors.initials: H
authors.lastname: Høst
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004341:Drug Evaluation; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006287:Health Planning Guidelines; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: D016190:Carboplatin; D005472:Fluorouracil