Diamminedichloride platinum II and cyclophosphamide in the treatment of advanced urothelial cancer

Diamminedichloride platinum II (DDP), 1.6 mg/kg and cyclophosphamide, 250–1000 mg/m2, were administered intravenously every 3–4 weeks to 36 patients with advanced, measurable urothelial cancer. Partial remissions were achieved in 15/32 (47%) adequately treated patients and 2 (6%) additional patients obtained minor remissions. The median duration of response was 7 months with responders surviving 11 months (range 2-15+) vs. 4 months (range 1-9) for nonresponders (p < 0.01). Most patients refused or delayed further therapy because of intense vomiting and persistent nausea and unmaintained remissions persisted for 1-9 months, median 2.0 months. There was no statistical difference between responders and nonresponders when examined for age, sex, tumor grade, prior therapy and site of metastasis. Serum carcinoembryonic antigen which was elevated (>5 ng%) in 70% of patients and correlated with response or progression of disease should be used as a biologic marker in Phase II trials in bladder cancer. Computerized transaxial tomograms also were useful in corroborating intraabdominal and pelvic responses and should be followed sequentially when pelvic lesions are used as response parameters. Although there was a slight prolongation in the duration of response of 2 months (5 vs. 7 months) when the results obtained with DDP used singly are compared with the combination of DDP and cyclophosphamide in the schedule and dosage employed in this protocol, there was no increase in the number of remissions or in survival. In essence, this study confirms the anti-tumor activity of DDP in the treatment of urothelial cancers.