Abstract
Based upon our preceeding studies which indicated the usefulness of oral administration of 5-fluorouracil, we studied on the anticancer efficacy and the toxicity of this particular usage, especially in the situation of long-term daily-dose schdule. This study is consisted of the animal experiments and the clinical trial for advanced breast cancer.
In the animal experiment, DMBA induced mammary tumor bearing S-D rats were used to assess the anti-tumor efficacy. The drug administration was made either through gastric catheter or through caudal vein. The obtained results were as follows:
1. Young S-D rats well tolerated daily oral dose 20mg/kg/day of 5-fluorouracil longer than 400 days. The body weight growth curve of this group of rat was not so much suppressed, comparing with that of control group.Among the rats which were given same dosage through intravenous route, marked growth suppression was observed.
2. The size of DMBA mammary tumors showed significant range of shrinkage, after 30 days of oral administration of 20mg/kg/day of 5-fluorouracil, comparing with that of non-treated group of DMBA tumor bearing rat.
3. There were no differences of drug distributions to the DMBA tumors between oral administration group and intravenous administration group.
4. The response rate (UICC, 1971) among the patients with advanced breast 38%. As to the side-effects in this schedule, nausea and anorexia were the common limiting factors, but the majority of the patients well tolerated more than 6 months of medication. Myelosuppression encountered during this trial were easily controlable. Neither hepatic nor renal impairment was experienced.
