[Cooperative research of UFT E phase II study. Cooperative Study Group of UFT E in Tohoku Area]

Phase II clinical research of UFT E granules (enteric coated) was carried out in 18 institutes (21 clinical dept.) by Study Group of UFT E in Tohoku Area, to investigate its effect and safety on cancer of the digestive organs. Of all the registered 26 cases, 21 cases were available for evaluation (perfect cases: 17 and imperfect cases: 4). Patients were administered UFT E 600 mg/body/day in principle. The response rate of the overall 26 cases was 14.3% and that of perfect 17 cases was 17.6%. PR was seen in 2 cases with far advanced gastric cancer and in 1 case with sigmoid colon cancer metastasized to lung, NC in 8 cases and PD in 6 cases. Side effects more than Grade II were seen in 4 cases (19%), of which 1 case caused diarrhea with leucopenia, 1 case caused diarrhea with anorexia, fever, pigmentation, stomatitis and general tiredness, 1 case caused anorexia and the other 1 case caused paresthesia on both legs with diarrhea and anorexia. Side effects in upper digestive tract were slight, making it possible to continue administration. But 1 case, which caused simultaneously Grade II anorexia, Grade II diarrhea and Grade III paresthesia on both legs, refused administration and dropped out. He recovered from those symptoms 5 days after discontinuance of administration. UFT E is able to administer for a long term because of its slight side effects on the upper digestive tract.