[Phase II study of 5-FU tablet in bladder tumor]

A phase II study of 5-FU tablet at a dose of 200 to 300 mg/day (b.i.d. or t.i.d.) for 28 patients with tumor of urinary bladder was undertaken by a cooperative study group consisting of 7 institutions including Okayama University. The clinical response rate in 25 evaluable cases was 20.0 (5/25) (CR: 2 cases, PR: 3 cases, MR: 4 cases, NC: 11 cases and PD: 5 cases). Efficacy rates of 5-FU tablet were higher in patients having smaller lesions or those who received no previous chemotherapy. Some adverse effects were observed in 6 of 27 cases (22.2%), all of which were gastrointestinal symptoms. Abnormal laboratory tests were seen in 18.5%, but all of these abnormalities were mild. 5-FU tablet administered to patients with tumor of urinary bladder was found to be highly distributed in tumor tissue. It is considered from the above results that 5-FU tablet is one of the useful agents for tumor of urinary bladder.