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Clinical Trial
. 1989 Oct;7(10):1447-56.
doi: 10.1200/JCO.1989.7.10.1447.

Surgical adjuvant therapy of large-bowel carcinoma: an evaluation of levamisole and the combination of levamisole and fluorouracil. The North Central Cancer Treatment Group and the Mayo Clinic

J A Laurie  1 , C G Moertel, T R Fleming, H S Wieand, J E Leigh, J Rubin, G W McCormack, J B Gerstner, J E Krook, J Malliard, et al.
Affiliations
Clinical Trial

Surgical adjuvant therapy of large-bowel carcinoma: an evaluation of levamisole and the combination of levamisole and fluorouracil. The North Central Cancer Treatment Group and the Mayo Clinic

J A Laurie et al. J Clin Oncol. 1989 Oct.

Abstract

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 year, 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 borderline 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.

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Comment in

  • Levamisole toxicity.
    DeLorenzo L, Stewart JA. DeLorenzo L, et al. J Clin Oncol. 1990 Feb;8(2):365. doi: 10.1200/JCO.1990.8.2.365. J Clin Oncol. 1990. PMID: 2299376 No abstract available.

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