Comparison of methotrexate and sequential methotrexate-5-fluorouracil for patients with recurrent squamous cell carcinoma of the oral cavity.
Forty-eight fully assessable previously treated patients with biopsy-proven recurrent squamous cell carcinoma of the oral cavity were randomized to receive either methotrexate (MTX), 40 mg/m2 iv push weekly, or sequential MTX and 5-fluorouracil (5-FU) (MTX 150 mg/m2 iv for 1 h; 1 h after the end of MTX, 5-FU 600 mg/m2 iv for 2 h; 24 h later, leucovorin rescue 10 mg/m2 iv and the same dose was given orally every 6 h 4 times; the treatment was repeated every 10 days). There were 1 complete response (CR) and 5 partial responses (PR) in the MTX group; median remission duration = 84 days. There were 3 CR and 11 PR in the MTX-5-FU group (overall response 14/24, 58.3%--p less than 0.05); median remission duration = 125 days. Median survival was 6.2 months in the MTX group and 8.1 months in the MTX-5-FU group. There was no difference in mucositis between the two groups, and a prevalence of leukopenia and moderate gastro-intestinal toxicity in the MTX-5-FU group.
Airoldi
M
M
Clinica Medica II Università di Torino, Italy.
Pedani
F
F
Brando
V
V
Gabriele
P
P
Orecchia
R
R
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000188:drug therapy*; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D011446:Prospective Studies; D011897:Random Allocation
D005472:Fluorouracil; D008727:Methotrexate