Methotrexate: an active drug in bladder cancer.

Forty-nine patients with transitional urothelial tract tumors received methotrexate: 0.5-1.0 mg/kg I.V. Q W (40 patients) or 250 mg/M2 in a 2-hour infusion with citrovorum factor rescue 24 hours later (nine patients). Eleven (26%, 95% confidence limits 13-39%) of 42 patients with bidimensionally measurable metastases achieved partial remission. Most responses occurred within 2-3 weeks and persisted for a median duration of six months (range, 2-20). Response rates were increased to 38% (6/16 patients, 95% confidence limits 18-65%) in patients who had no prior chemotherapy, and a 90-100% performance status (50, 5/10 patients, 95% confidence limits 22-78%) compared with 19% (5/26, 95% confidence limits 8-37%) in patients who had prior chemotherapy and a less than or equal to 80% performance status (19%, 6/32 cases, 95% confidence limits 9-32%). Toxicity included mucositis and myelosuppression. A review of the literature coupled with the present data suggest that methotrexate is as active as cisplatin in the treatment of patients with advanced urinary bladder cancer.