[Clinical results of UFT fine granule therapy by cooperative study. Osaka UFT Granulation Study Group]

We carried out a Phase II study by single oral administration of the antineoplastic agent UFT fine granule containing 1-(2-tetrahydrofuryl)-5-fluorouracil (FT-207) and uracil in a molar ratio of 1 : 4. Of 20 cases entered into the study, 18 were evaluable, among which four (22.2%) achieved PR. It took an average of forty days until these four PR cases were evaluable, and the duration of efficacy was 89 days. We observed an efficacy lasting over 150 days in a case of lung cancer. Side-effects were observed in 62.2% of cases. Only one case of thrombocytopenia and one case of hepatic malfunction occurred. Both of these two patients recovered two weeks after this study. Among the major symptoms were gastrointestinal disorders such as subjective and objective anorexia, nausea and vomiting. In one patient, treatment was discontinued, but other patients were able to continue following a decrease or withdrawal of the agent. The same trend was observed in a study of UFT capsule.