Further Clinical Studies With 5-Fluorouracil23

Abstract

Carcinoma of the breast, ovary, large bowel and rectum, and hepatoma appeared sensitive to 5-fluorouracil. While several favorable responses were seen with 5-fluorouracil in carcinoma of the cervix, anaplastic carcinoma (primary unknown), transitional cell carcinoma of the nasopharynx, reticulum-cell sarcoma, and synoviosarcoma, further clinical trial is needed to evaluate effectiveness in these lesions. There was strong evidence that 5-fluorouracil had no value in carcinoma of the lung, hypernephroma, carcinoma of the stomach and the pancreas, and malignant melanoma. In our opinion, the dosage schedule influenced the clinical response of the lesion to this agent. The most promising dosage regimen was the administration of 15 mg. per kg. per day for 5 days, followed by half doses given on alternate days until the appearance of early toxicity. So-called maintenance dosage schedule was not only ineffective, but may have been deleterious to the patient. It was necessary to repeat courses of treatment at approximately monthly intervals. The same dosage schedule of 5-fluorouracil could not be repeated, as a rule, for more than several months, and perhaps the dose should have been slightly reduced. 5-Fluorouracil is a toxic drug and should be given with extreme caution. No patient has been cured by this drug.