Fluorouracil As an Adjuvant to Surgery in Carcinoma of the Colon

George A. Higgins, MD; Richard W. Dwight, MD; John V. Smith, MD; Robert J. Keehn
Arch Surg. 1971;102(4):339-343. doi:10.1001/archsurg.1971.01350040101020.
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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.


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