Anal submucosal injection: a new route for drug administration in pelvic malignancies: II Methotrexate anal injection in the treatment of advanced bladder cancer

ABSTRACT

The clinical efficacy of submucosal anal injection of methotrexate [MXT] in advanced bladder cancer is investigated. In experimental study, done on 20 mice have shown that MXT injected in the anal submucosa has no clinicopathologic effect on the anorectum. The clinical study comprised 18 patients with advanced bladder cancer- [13T [3] and 5 T [4]] as a test group and 8 patients [6 T[3] and 2 T.[4]] as controls. Methotrexate was given intravenously in the control group and injected in the anal submucosa in the test group. The dose in either group was 50 mg every 5 days for 5 consecutive times. The course was repeated at 3-weekly intervals. Most patients received MXT as outpatients. MXT blood level was measured 4 and 24 hours after administration in both the control and test groups. In the test group, 10 of the 18 patients showed complete tumor regression and are still alive 21 to 50 months from the start of treatments. Partial regression was observed in 8 patients. Hematologic reserve remained unchanged. Mild toxicity occurred in 3 patients. Of the 8 control patients; the tumour showed partial regression in 1 patient, was stable in 3 and progressed in 4. In 5 patients side effects were severe. The present results show that MXT anal injection is highly effective in treatment of advanced bladder cancer. It is safe, well tolerated and can be used on an outpatient basis