[Studies on the new anticancer preparation, 5-fluorouracil-polyglycolic acid-composite and its therapeutic...

The purpose of these studies was to characterize the effect of the new anticancer preparation, 5-fluorouracil-polyglycolic acid-composite (F-PGA needle), on experimental tumors and in patients with solid tumors. The formative composite in a F-PGA needle was found to easily dissociate in physiologic saline resulting in the release of 5-fluorouracil (5-FU). The aspect of 5-FU release was observed to be relative to 5-FU content in the needle, but not to the length of the needle. When a F-PGA needle of 10mm in length and 30% in 5-FU content was subcutaneously or intrahepatically implanted in healthy rats, the release of 5-FU was maintained for 9 days in each case. Pathophysiologic examination of the liver following the implantation of a F-PGA needle revealed an increase in severe necrosis and/or degeneration and infiltration of small-round cells with the increase in release of 5-FU. Implantation of F-PGA needles into tumor mass of AH 130-bearing rats resulted in an increased 5-FU level in tumor tissue reaching the maximum level of 16.00 +/- 1.98 micrograms/g after 24 hours, and in a marked inhibition of the tumor growth indicating 2.4% of T/C (tested/controlled) at 10 days after implantation of the needle. A study of the F-PGA needle was made for 10 patients with terminal carcinomas and in 5 of these were verifiable. Of these 5 patients, shrinkage of tumors or improvement of symptoms was observed in 3 cases. From these results, the F-PGA needle is promising in the treatment of unresectable cancer as a long-acting chemotherapy.