Randomized, Controlled Study of Continuous 5-FU Infusion Starting Immediately after Curative Surgery for Advanced Colorectal Cancer

Background/Aims: The usefulness of adjuvant chemotherapy started immediately following surgery was evaluated. Methodology: A randomized clinical trial was performed on 133 patients with advanced colorectal cancer using oral anticancer agents with one-week continuous 5-FU infusion starting immediately after curative surgery. In Group A and Group B, 300 mg/day of HCFU was orally administered for two years starting two weeks after surgery, and in addition, 333 mg/m(2)/day of 5-FU was drip infused from the central vein for seven days from the day of surgery in Group B. Results: For 1919 days after surgery, there were no significant intergroup differences in overall survival (OS) and disease-free survival (DFS), but OS and DFS in Group B rectal cancer patients were significantly better when compared to Group A rectal cancer patients. On the other hand, OS tended to be better in Group A colon cancer patients, but no significant intergroup differences were seen, while intergroup differences tended to be smaller when corrected for disease stage. Conclusions: Continuous 5-FU infusion starting immediately after curative surgery for colorectal cancer was safe. While further investigation is necessary to elucidate the degree of improvement in postoperative prognosis, the results of the present study suggest that, continuous 5-FU infusion improves prognosis in advanced rectal cancer.