Surgical adjuvant therapy of large bowel carcinoma an evaluation of levamisole and the combination of levamisole and fluorouracil
Laurie, J.A.; Moertel, C.G.; Fleming, T.R.; Wieand, H.S.; Leigh, J.E.; Rubin, J.; McCormack, G.W.; Gerstner, J.B.; Krook J.E.; Malliard, J.
Journal of Clinical Oncology 7(10): 1447-1456
A total of 401 eligible patients with resected stages B and C colorectal carcinoma were randomly assigned to no-further therapy or to adjuvant treatment with either levamisole alone, 150 mg/d for 3 days every 2 weeks for 1 years, or levamisole plus fluorouracil (5-FU), 450 mg/m2/d intravenously (IV) for 5 days and beginning at 28 days, 450 mg/m2 weekly for 1 year. Levamisole plus 5-FU, and to a lesser extent levamisole alone, reduced cancer recurrence in comparison with no adjuvant therapy. These differences, after correction for imbalances in prognostic variables, were only suggestive for levamisole alone (P = .05) but quite significant for levamisole plus 5-FU (P = .003). Whereas both treatment regimens were associated with overall improvements in survival, these improvements reached boderline significance only for stage C patients treated with levamisole plus 5-FU (P = .03). Therapy was clinically tolerable with either regimen and severe toxicity was uncommon. These promising results have led to a large national intergroup confirmatory trial currently in progress.