SURGICAL ADJUVANT THERAPY OF LARGE-BOWEL CARCINOMA - AN EVALUATION OF LEVAMISOLE AND THE COMBINATION OF LEVAMISOLE AND FLUOROURACIL
SURGICAL ADJUVANT THERAPY OF LARGE-BOWEL CARCINOMA - AN EVALUATION OF LEVAMISOLE AND THE COMBINATION OF LEVAMISOLE AND FLUOROURACIL
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DOI：
10.1200/jco.1989.7.10.1447
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发表时间：
1989-10-01
影响因子：
45.3
通讯作者：
BARLOW, JF
中科院分区：
文献类型：
--
作者：
LAURIE, JA;MOERTEL, CG;BARLOW, JF
共401例符合条件的B期和C期结直肠癌切除患者被随机分配至无进一步治疗组或辅助治疗组，分别接受左旋咪唑单药治疗（150 mg/d，每2周一次，持续3天，持续1年）或左旋咪唑联合氟尿嘧啶（5-FU）治疗（450 mg/m2/d，静脉注射（IV），持续5天，从第28天开始），每周450 mg/m2，持续1年。与无辅助治疗相比，左旋咪唑加5-FU和左旋咪唑单独治疗在较小程度上降低了癌症复发。在校正预后变量的不平衡后，这些差异仅提示左旋咪唑单药治疗（P = 0.05），但左旋咪唑联合5-FU治疗非常显著（P = 0.003）。尽管两种治疗方案均与生存期的总体改善相关，但这些改善仅在左旋咪唑联合5-FU治疗的C期患者中达到了临界值（P = .03）。两种方案的治疗在临床上均可耐受，严重毒性并不常见。这些有希望的结果导致了目前正在进行的一项大型国家组间确证性试验。
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.