Phase II study of co-administration of uracil and tegafur (UFT) in hepatocellular carcinoma. Tokyo Liver Cancer Chemotherapy Study Group.

A Phase II study of co-administration of uracil and tegafur (UFT) was performed in 32 patients with unresectable hepatocellular carcinoma. A dose of 400 mg/m2/day of UFT was administered orally, three times a day, for more than 4 weeks. Of 26 patients evaluable for response, one (3.8%) showed a partial response of 9 months' duration. There were no complete responders. A dose-limiting toxicity was gastrointestinal tract disturbance. Six patients (18.8%) had to discontinue UFT treatment because of gastrointestinal toxicity. The clinical advantage of tegafur in the treatment of hepatocellular carcinoma was not enhanced by co-administration of uracil.