Methotrexate as salvage or adjunctive therapy for primary invasive carcinoma of the bladder

A phase II study of methotrexate (MTX) treatment of recurrent primary invasive tumors of the bladder is reported. The incidence of measurable response is lower than that seen when the drug is used to treat patients with metastatic disease. However, the overall response achieved when durable symptomatic responses are included, and the absence of major side effects, establishes this drug as a good palliative treatment. Results from a pilot study giving MTX prior to radiotherapy demonstrate that it is possible to combine the two treatments without increasing toxicity. The early results from this study were better than a previously treated historical control series and justify evaluation of adjuvant chemotherapy with MTX in a prospectively randomized trial.