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.

作者：John A. Laurie, C G Moertel, Thomas R. Fleming, Harry S. Wieand, John E. Leigh, Joseph Rubin, Greg W. McCormack, James B. Gerstner, James Edward Krook, James A. Malliard · 发表于：Journal of Clinical Oncology · 年份：1989 · DOI：10.1200/jco.1989.7.10.1447 · 被引用次数：703 · 研究领域：Colorectal Cancer Treatments and Studies、Gastric Cancer Management and Outcomes、Colorectal Cancer Surgical Treatments

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.