A group of 496 patients was entered into a randomized trial to study the possible value of fluorouracil in conjunction with surgical resection of carcinoma of the colon. Patients randomized to receive drug were given fluorouracil, 12 mg/kg body weight intravenously, for five successive days beginning 14 days after operation. Those termed clinically "curative" (A) and those termed clinically palliative (C) received a second course of drug six weeks later. Those termed proved palliative (B) continued to receive an intermittent course of fluorouracil. At 4½ years postrandomization, life table survival in group A, "currative resection," is 56% in treated patients and 50% in controls. Survival at 18 months in group B is 30% in treated vs 16% in controls, and group C, 57% in treated vs 31% in controls. While these results are encouraging, sufficient numbers of patients have not been followed up for a long enough period to justify valid evidence of drug benefit.
Higgins GA, Dwight RW, Smith JV, Keehn RJ. Fluorouracil As an Adjuvant to Surgery in Carcinoma of the Colon. Arch Surg. 1971;102(4):339-343. doi:10.1001/archsurg.1971.01350040101020