LEVAMISOLE AND FLUOROURACIL FOR ADJUVANT THERAPY OF RESECTED COLON-CARCINOMA
LEVAMISOLE AND FLUOROURACIL FOR ADJUVANT THERAPY OF RESECTED COLON-CARCINOMA
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DOI：
10.1056/nejm199002083220602
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发表时间：
1990-02-08
影响因子：
158.5
通讯作者：
MAILLIARD, JA
中科院分区：
文献类型：
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作者：
MOERTEL, CG;FLEMING, TR;MAILLIARD, JA
1296例局部浸润（B2期）或局部淋巴结受累（C期）的切除结肠癌患者被随机分配到观察组或左旋咪唑联合氟尿嘧啶治疗组，为期一年。C期疾病患者也可以随机分配到左旋咪唑单独治疗。在撰写本文时，中位随访时间为3年（范围2至5年半）。在C期疾病患者中，左旋咪唑加氟尿嘧啶治疗可降低41%的癌症复发风险（P < 0.0001）。总死亡率降低了33% (P .simeq。0.006)。单用左旋咪唑治疗无明显效果。B2期疾病患者的结果是模棱两可的，而且过于初步，无法得出确切的结论。左旋咪唑单独使用的毒性作用并不常见，通常包括轻度恶心，偶尔出现皮炎或白细胞减少，而左旋咪唑加氟尿嘧啶的毒性作用与单独使用氟尿嘧啶的毒性作用基本相同，即恶心、呕吐、口炎、腹泻、皮炎和白细胞减少。这些反应通常不严重，也不会严重影响患者对治疗方案的依从性。我们得出结论，左旋咪唑和氟尿嘧啶的辅助治疗应该是C期结肠癌的标准治疗。由于我们研究中的大多数患者是由社区肿瘤学家治疗的，因此这种方法应该很容易适应传统的医疗实践。
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 < 0.0001). The overall death rate was reduced by 33 percent (P .simeq. 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, ususally 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.