Seven patients with advanced
cancer of the uterine cervix were treated by anal submucosal injection of
methotrexate. Each course consists of five
injections, one every 5 days; each injection contains 100 mg of
methotrexate. The course was repeated at 3-week intervals and was given on an outpatient basis. Investigations were performed before, during, and
after treatment.
Methotrexate blood level was measured 4 and 24 hours after administration. Complete response occurred in all seven patients. Relapse occurred in four but could be controlled by further
methotrexate administration. Average duration of survival is 46 1/2 months. No side effects were encountered as a result of a low
methotrexate serum level that was recorded 4 hours after administration, 0.82 mumol after anal injection compared with 2.8 mumol for the intravenous route. The beneficial effect seems to be the result of the high
methotrexate concentration in uterine and
tumor tissue. The route adopted by the
drug to reach the uterus from the anal submucosa is through the hemorrhoidogenital communicating veins. This preliminary study demonstrates that anal injection of
methotrexate is effective in the treatment of advanced
cancer. It is safe, well tolerated, and can be used as an outpatient treatment.