[Phase II study of sustained released granules of tegafur (SF-SP) on inoperable or recurrent gastric cancer].

Twenty-eight patients with inoperable or recurrent gastric cancer were entered for a phase II study of SF-SP. Of these, 24 were evaluable for response. The SF-SP was given orally at a dose of 800 to 1,200 mg/body b.i.d. daily. Six at the evaluable 24 patients showed PR, 16 NC and 2 PD. Three of the 6 PR patients were administered 1000 mg/body/day of SF-SP and the other 3, 1200 mg/body/day. The hematological toxicities were anemia (5 cases), leukopenia (3 cases) and thrombocytopenia (3 cases). The other side effects were gastrointestinal complaints, such as anorexia (5 cases), nausea (5 cases) and stomatitis (5 cases), and a further toxic effect of pigmentation (4 cases). These side effects tended to develop dose-dependently and disappeared after the SF-SP was discontinued. It was concluded that SF-SP was beneficial for the treatment of advanced gastric cancer, and that its optimal dose was 1000 mg/body/day.