Moertel C G, Fleming T R, Macdonald J S, Haller D G, Laurie J A, Goodman P J, Ungerleider J S, Emerson W A, Tormey D C, Glick J H
Mayo Clinic, Rochester, MN 55905.
N Engl J Med. 1990 Feb 8;322(6):352-8. doi: 10.1056/NEJM199002083220602.
Twelve hundred ninety-six patients with resected colon cancer that either was locally invasive (Stage B2) or had regional nodal involvement (Stage C) were randomly assigned to observation or to treatment for one year with levamisole combined with fluorouracil. Patients with Stage C disease could also be randomly assigned to treatment with levamisole alone. The median follow-up time at this writing is 3 years (range, 2 to 5 1/2). Among the patients with Stage C disease, therapy with levamisole plus fluorouracil reduced the risk of cancer recurrence by 41 percent (P less than 0.0001). The overall death rate was reduced by 33 percent (P approximately 0.006). Treatment with levamisole alone had no detectable effect. The results in the patients with Stage B2 disease were equivocal and too preliminary to allow firm conclusions. Toxic effects of levamisole alone were infrequent, usually consisting of mild nausea with occasional dermatitis or leukopenia, and those of levamisole plus fluorouracil were essentially the same as those of fluorouracil alone--i.e., nausea, vomiting, stomatitis, diarrhea, dermatitis, and leukopenia. These reactions were usually not severe and did not greatly impede patients' compliance with their regimen. We conclude that adjuvant therapy with levamisole and fluorouracil should be standard treatment for Stage C colon carcinoma. Since most patients in our study were treated by community oncologists, this approach should be readily adaptable to conventional medical practice.
1296例已切除结肠癌患者，这些患者要么是局部浸润性（B2期），要么有区域淋巴结受累（C期），被随机分配至观察组，或接受左旋咪唑联合氟尿嘧啶治疗1年。C期患者也可随机分配至单独接受左旋咪唑治疗组。撰写本文时的中位随访时间为3年（范围2至5.5年）。在C期患者中，左旋咪唑加氟尿嘧啶治疗使癌症复发风险降低了41%（P<0.0001）。总死亡率降低了33%（P约为0.006）。单独使用左旋咪唑治疗未发现有明显效果。B2期患者的结果不明确且过于初步，无法得出确切结论。单独使用左旋咪唑的毒性作用不常见，通常为轻度恶心，偶尔伴有皮炎或白细胞减少，而左旋咪唑加氟尿嘧啶的毒性作用与单独使用氟尿嘧啶基本相同，即恶心、呕吐、口腔炎、腹泻、皮炎和白细胞减少。这些反应通常不严重，也没有严重妨碍患者坚持治疗方案。我们得出结论，左旋咪唑和氟尿嘧啶辅助治疗应成为C期结肠癌的标准治疗方法。由于我们研究中的大多数患者是由社区肿瘤学家治疗的，这种方法应该很容易应用于传统医疗实践。
