title: A randomized study of methotrexate, bleomycin, hydroxyurea with versus without cisplatin in patients with previously untreated and recurrent squamous cell carcinoma of the head and neck.
abstract: The value of a combination of methotrexate, bleomycin and hydroxyurea with vs. without cisplatin was randomly examined in 62 evaluable patients with previously untreated (44 patients) and recurrent (18 patients) squamous cell carcinoma of the head and neck. Methotrexate (30 mg/m2) and bleomycin (15 mg) were given intravenously weekly, hydroxyurea (1000 mg/m2) per os 3 times per week for 4 weeks. Cisplatin (60 mg/m2) was added on Day 1 every month. A higher overall response rate was observed with the cisplatin-containing regimen (66%, included 17% complete) as compared with 27% (3% complete) with the 3-drug combination (P value 0.0025). The cisplatin-containing regimen was more active in both previously untreated patient group and in the group recurrent patients. Toxicity was more pronounced in the cisplatin regimen and necessitated frequently reduced drug dosages. No survival difference was observed between the treatment groups. Median survival in previously untreated patients was 16.2 months and 7.2 months in patients who failed conventional local treatment. It is concluded that a cisplatin-containing regimen is more effective in advanced head and neck carcinoma than the same combination without cisplatin.
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D006918:Hydroxyurea / Q000008:administration & dosage; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D011897:Random Allocation
chemical_list: D001761:Bleomycin; D002945:Cisplatin; D006918:Hydroxyurea; D008727:Methotrexate