Clinical Studies on the Oral Administration of 5-Fluorouracil with Reference to the Control of Advanced Breast Cancer

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Based upon the encouraging results obtained in our preceding animal experiments, the clinical usefulness of oral administration of 5-fluorouracil was explored among the patients treated at our surgical service. 250 mg of 5-fluorouracil was given daily through oral route to 155 patients with inoperable primary lesions or with recurrent foci after their mastectomies, either as a sole agent or as combined with other carcinostatic agents. The objective tumor regression rate among sixteen patients treated solely with 5-fluorouracil was 44% which is considered to be supportive of oral administration of this particular drug. Among 101 patients treated with the drug combination inclusive of 5-fluorouracil, the tumor regression rate was 53%, whereas the rate of 54 patients treated with the combination of the anticancer agents exclusive of 5-fluorouracil was 39%. The patients well tolerated the oral usage of 5-fluorouracil fairly long period at the abovely mentioned dosage schedule. The mean duration of the medication was 14.3 weeks when given as a sole agent. The dosage form used in this trial was water mixture, and it seems to be satisfactory as to the antitumor efficacies and the tolerability.
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