RT Journal Article SR Electronic T1 Levamisole and 5-fluorouracil therapy for resected colon cancer: a new indication JF Canadian Medical Association Journal JO CMAJ FD Canadian Medical Association SP 297 OP 301 VO 144 IS 3 A1 Skillings, J. R. A1 Levine, M. A1 Rayner, H. L. A1 Eisenhauer, E. A1 Erlichman, C. A1 Germond, C. A1 Kerr, I. A1 Lofters, W. A1 Maroun, J. A1 Yoshida, S. YR 1991 UL http://www.cmaj.ca/content/144/3/297.abstract AB OBJECTIVE: To evaluate the benefits and risks of postoperative treatment with levamisole plus 5-fluorouracil (5-FU) in patients with colon cancer. DESIGN: Computerized searches of MEDLINE and CANCERLIT were performed, and the reference list of each retrieved article was checked. Only randomized trials of therapy with levamisole alone or combined with 5-FU for colon cancer without distant metastases were included. The studies were then evaluated with the use of four criteria. RESULTS: We reviewed six randomized trials, of which three satisfied our criteria. Two studies demonstrated a significant improvement in the survival rate with levamisole plus 5-FU among patients with colon cancer and pathologically confirmed metastases to adjacent lymph nodes (Dukes' stage C). A subgroup analysis in another study demonstrated a similar benefit. The toxic effects of the drugs were generally mild. The three other studies showed no difference in survival rates between the treatment groups; however, the samples were too small to detect a clinically or statistically important difference. CONCLUSIONS: Because many patients with colon cancer will suffer a relapse we recommend that they be offered the opportunity to participate in clinical trials of adjuvant therapy. For those with stage C disease not entering a clinical trial levamisole plus 5-FU is appropriate adjuvant therapy.