A crossover study of oral administration of UFT in chronic liver disease: comparison of continuous and intermittent schedules.
This study was aimed at evaluating the tolerance to an intermittently administered oral UFT for hepatocellular carcinoma (HCC) with chronic liver disease (CLD). Ten patients who had received curative therapy for HCC with CLD (Child's classification A or B) were randomly assigned either an intermittent schedule (IS), oral administration of UFT (130 mg/m2/b.i.d.) with 2 days rest a week, or a continuous schedule (CS), consecutive administration of UFT with the same dose. On day 12, the serum concentration of 5-fluorouracil (5-FU) was measured. After 2 weeks rest, the patients were switched to the other schedule for 10 weeks and the concentration of 5-FU was measured on day 12. The median values of the area under the curve (AUC) and maximum concentration (Cmax) of 5-FU in IS and CS were 187.7 and 263.2 ng/ml/h, 57.1 and 93.0 ng/ml, respectively. Both the AUC and Cmax for IS were significantly lower than those for CS. One IS patient had tolerable diarrhea, while three of the CS patients had intolerable nausea and one had hemorrhagic gastritis. IS seemed to be a suitable measure for CLD.
Yamashita
F
F
Department of Medicine, Saga Social Insurance Hospital, Japan.
Tanaka
M
M
Fukumori
K
K
Ando
E
E
Yano
Y
Y
Kato
O
O
Yamamoto
H
H
Fukuda
H
H
Kusaba
T
T
Tanikawa
K
K
Sata
M
M
D000284:Administration, Oral; D000368:Aged; D019540:Area Under Curve; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy; D002908:Chronic Disease; D018592:Cross-Over Studies; D003967:Diarrhea / Q000139:chemically induced; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005472:Fluorouracil / Q000097:blood; D005756:Gastritis / Q000139:chemically induced; D006471:Gastrointestinal Hemorrhage / Q000139:chemically induced; D006801:Humans; D008107:Liver Diseases / Q000188:drug therapy*; D008113:Liver Neoplasms / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D005641:Tegafur / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use; D016896:Treatment Outcome; D014498:Uracil / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use
D004338:Drug Combinations; C096910:UFT(R) drug; D005641:Tegafur; D014498:Uracil; D005472:Fluorouracil