[Joint clinical Phase II study of SF-SP]

A clinical Phase II study on a new type of anti-malignant tumor agent 1-(2-tetrahydrofuryl) 5-fluorouracil (SF-SP) encapsulated with slow releasing granules has been performed by the Tokyo cancer chemotherapy joint study group. Sixty-five patients out of 81 were evaluable for response by criteria of Saito and Koyama 's clinical evaluation. The partial response rate was obtained in 21.5% of evaluable patients and better than that of FT-207 observed by the same group. More effective rates in colon and breast cancer were obtained by SF-SP as compared with FT-207. The optimal dosage was considered to be between 17 mg/kg and 24 mg/kg. The side effects of this therapy were encountered in 33.3% (27 of 81 cases) of patients and were less gastrointestinal disturbance and bone marrow depression than in FT-207 treatment. The effective responses were demonstrated even in patients with previous therapy by 5-FU, FT-207, or HCFU.