Chemotherapy as an adjuvant to surgery for colorectal cancer. A follow-up report.

An adjuvant program of fluorouracil for patients undergoing "curative" resection for adenocarcinoma of the colon and rectum was initiated as a randomized clinical trial in January 1968. Patients were randomly assigned to an intraluminal fluorouracil or intraluminal control (saline) group and were so treated at the time of surgical resection if findings at operation indicated that all gross neoplastic disease could be resected. Those patients receiving intraluminal fluorouracil (30 mg/kg) received intravenous fluorouracil (10 mg/kg) on each of the first two postoperative days and five subsequent postoperative courses of oral fluorouracil (90 mg/kg) in each 18-day course over a one-year period. By July 1, 1975, there were 203 patients undergoing curative resection entered into the study. Survival and disease-free data, as of Dec 31, 1976, revealed no benefit from this adjuvant course of fluorouracil. These data support the need for continued randomized clinical trials of new and innovative adjuvant therapy compared with an untreated control group.