Anal submucosal injection: a new route for drug administration in pelvic malignancies. V. Advanced prostatic cancer: results of methotrexate treatment using the anal route--preliminary study.

The present study compares the effectiveness of methotrexate injected per anum (group 1, 19 patients) versus that administered intravenously (group 2, 17 patients) in the treatment of advanced metastasizing prostatic carcinoma. The dose in both groups was 50 mg every 5 days for 5 consecutive doses. The course was repeated at 3-week intervals. Patients received treatment as outpatients. In group 1, 5 of the 19 patients showed complete tumor regression and were alive 14-39 months after the start of treatment. Fourteen patients showed partial response. Hematologic reserve remained unchanged. Three patients had mild toxicity. The 17 patients of group 2 showed partial response in 6 and progression in 11. Eleven patients had severe toxic manifestations and 9 of them received blood transfusions due to myelosuppression. These results demonstrate the effectiveness of submucosal anal injection of methotrexate in the treatment of advanced metastasizing prostatic carcinoma. It is safe, well tolerated and can be used on an outpatient basis.