[Phase II study of UFT for malignant tumors of urinary organs]

Phase II Study of UFT was performed in 59 patients with malignant tumors of urinary organs in 5 Cooperative Study Institutions. Forty-nine patients out of 59 were evaluable for response according to Koyama -Saito's criteria. Complete response (CR) was recorded in 7 patients, partial response (PR) in 3, minor response in 2, no change in 27 and progressive disease in 10, respectively. The overall response rate was 20.4%. The response classified in terms of tumor type was as follows: 4 CR and 2 PR of 23 patients with bladder tumor, response rate of 26.1%; 1 CR and 2 PR of 10 patients with renal tumor, response rate of 30.0%; 1 CR of 12 patients with prostatic tumor, response rate of 8.3%. Side effects occurred in 22 (41.5%) out of 53 patients. The high incidence was mainly concerned with GI toxicity such as anorexia (24.5%), nausea and vomiting (9.4%), general malaise (9.4%), diarrhea (3.8%) and stomatitis (3.8%), respectively. Renal function disorder was not induced, and marrow depression and hepatic function disorder occurred at low frequency (1 case each).