Neoadjuvant medium-dose methotrexate, cisplatin in category T3b-T4a (N0M0) bladder cancer.

Between July 1985 and December 1988, 31 consecutive patients with category T3b-T4a (NOMO) urothelial cancer of the urinary bladder were entered into a phase II study of neoadjuvant chemotherapy with medium-dose methotrexate (300 mg/m2 followed by folinic acid rescue), cisplatin (100 mg/m2 continuous i.v. infusion) every 4 weeks for a total of 4 courses. Six patients did not respond to the first two courses of neoadjuvant chemotherapy and another 3 were considered non-responders after 4 courses. Three of these 9 patients progressed and could not undergo salvage cystectomy. Only 4 patients (13%) entered complete remission, and one of them refused surgery. All the 18 (58%) partial responders underwent radical cystectomy. The overall 2-year disease-free survival is 72%: it is 100% for the 4 complete responders, 76% for the 18 partial responders and 56% for the 9 nonresponders. A longer follow-up is necessary to evaluate the impact of the neoadjuvant chemotherapy on survival of category T3b-T4a (NOMO) bladder cancer.