Results of Medical Research Council Phase II Study of Low Dose Cisplatin and Methotrexate in the Primary Treatment of Locally Advanced (T3 and T4) Transitional Cell Carcinoma of the Bladder

Abstract

A series of 49 previously untreated patients with category T3 or T4 bladder cancer underwent treatment with low dose methotrexate and cisplatin; 44 patients were eligible for assessment of response. Complete response (CR) was seen in 5 patients (11%) and partial response in 15 (34%) (overall response rate 45%). Treatment was reasonably well tolerated with no major morbidity and no treatment-related deaths. After a median follow-up of 3.5 years, the 1-year and 2-year survival rates were 70 and 30% respectively. Ten patients remain recurrence-free without having received "definitive local therapy" (cystectomy and/or radiotherapy) at follow-up extending from 20 to 50 months.