F. Yamashita et al., A CROSSOVER STUDY OF ORAL-ADMINISTRATION OF UFT IN CHRONIC LIVER-DISEASE - COMPARISON OF CONTINUOUS AND INTERMITTENT SCHEDULES, Anti-cancer drugs, 9(5), 1998, pp. 399-404
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 fo
r HCC with CLD (Child's classification A or B) were randomly assigned
either an intermittent schedule (IS), oral administration of UFT (130
mg/m(2)/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 we
eks rest, the patients were switched to the other schedule for 10 week
s and the concentration of 5-FU was measured on day 12. The median val
ues of the area under the curve (AUC) and maximum concentration (C-max
) 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 C-max for IS were significantly low
er than those for CS. One IS patient had tolerable diarrhea, while thr
ee of the CS patients had intolerable nausea and one had hemorrhagic g
astritis. IS seemed to be a suitable measure for CLD. [(C) 1998 Lippic
ott-Raven Publishers.].