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The practical usefulness of oral administration of 5-fluorouracil has been shown in our previous reports, in terms of organ-distribution, anti-tumor efficacies and toxicities, experimentally as well as clinically, in comparing with its parenteral usage. However, these results have urged us to study further on the ideal dosage schedules of this particular mode of administration of this agent. Seeking the most appropriate dosage to be given at each administration and the most reasonable medication interval, we made some experimental study using transplantable animal tumor. Following the results obtained in this fundamental study, we engaged in clinical trials to confirm the antitumor effects and toxicities of several dosage schedules of oral administration of 5-fluorouracil, on the patients in advanced stage of breast cancer. The results obtained in these experimental and clinical studies are asfollows: 1. Animal experiments Using Walker-carcinosarcoma 256 implanted to SD-JCL female rats, Yoshidasarcoma (solid) implanted to Donryu male rats and Sarcoma 180 implanted to dd male mice, the tumor shrinkage effects of orally administered 5-fluorouracil were evaluated according to specially designed many dosage schedules. Regarding the drug dosage given at each administration, those transplantable animal tumors required different amounts of the drug respectively, as minimum threshold level of dosage, to achievesignificant tumor shrinkage. However, the dosage above these threshold levels could not produce any better responses. As to the administration interval, even when large amounts of the agent were given, the cyclic administration within 2 day period was required to produce significant tumor regressions. Concerning the administration routes of 5-fluorouracil, both oral and intraperitoneal administration showed almost identical tumor regressions, at each dosage schedule. 2. Clinical trials During ten year period from 1970 to 1979, at the Breast Service Unit of National Nagoya Hospital, 106 patients with measurable lesions of advanced breast cancer were treated with oral administration of 5-fluorouracil, either as a sole anti-cancer agent or combined together with other agents. The standard dosage schedule was 250 mg/body/day, given as a water mixture at 3 o'clock p.m. every day. This schedule rarely invited severe toxicities, accordingly majority of the patients tolerated the long-term continuous chemotherapy. The response rate according to UICC criteria was 29% (6/21) among the patients treated wih 5-fluorouracil solely, and was 48% (15/31) among the patients given 5-fluorouracil together with cyclophosphamide.
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