Phase I and II trial of five-day infused 5-fluorouracil and radiation in advanced cancer of the head and neck.

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Abstract
Eighteen patients with advanced epithelial cancers of the head and neck region were studied for their tolerance and response to combined cycles of 120-h infused 5-fluorouracil (5-FU) and external-beam radiation therapy. 5-FU infusions were given under conditions where radiosensitization would be expected at the higher infusion doses. Coincident radiation treatments were given as 4 sequential daily fractions of 250 rad each administered during days 1 through 4 of each 5 day infusion cycle. The patients were rested for at least 9 days after each cycle or longer until toxicity was resolved. The regimen was then repeated in each patient for a total of 5 treatment cycles. Thereafter therapy was consolidated usually by boast radiation without drug. In sequential patient subsets the infusion load was progressively escalated in a phase I format. The complete response rate for stage IV patients was 75% with survival benefit compared to prior results. 5-FU dose-dependent combined modality loco-regional toxicity was demonstrated without significant enhancement of systemic toxicity of any form; 5-FU dose-dependent enhanced responsiveness and survival benefit is also suggested. Further scheduling and response studies of 5-FU under radiosensitizing conditions appear warranted.