Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer
Prospectively randomized trial of postoperative adjuvant chemotherapy in patients with high-risk colon cancer
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DOI：
10.1200/jco.1998.16.1.295
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发表时间：
1998-01-01
影响因子：
45.3
通讯作者：
Figueredo, A
中科院分区：
文献类型：
--
作者：
O'Connell, MJ;Laurie, JA;Figueredo, A
目的：本研究有两个主要目标：(1)评价氟尿嘧啶(5-FU)+左旋咪唑+亚叶酸钙方案作为高危结肠癌患者术后手术辅助治疗的有效性；(2)评价6个月与12个月化疗方案的疗效。患者和方法：将预后不良的II或III期结肠癌患者随机分为强化疗程5-FU、左旋咪唑联合左旋咪唑方案或标准方案。结果：915例患者中有891例(97.4%)符合条件。仍活着的患者的中位随访期为5.1年。在患者存活率方面，四个治疗组之间存在差异，并且观察到不同方案的持续时间有显著的交互作用。化疗6个月时，标准5-FU联合左旋咪唑的疗效低于5-FU+亚叶酸钙+左旋咪唑(5年生存率分别为60%和70%；P<；0.01)。结论：化疗12个月与6个月相比，患者的生存期无明显改善。当化疗持续6个月时，与强化疗程的5-FU+左旋咪唑+左旋咪唑相比，标准5-FU+左旋咪唑的患者存活率较低。提示5-FU联合左旋咪唑6个月不宜用于临床，而5-FU+亚叶酸钙+左旋咪唑治疗6个月是有效的。(C)1998年由美国临床肿瘤学会主办。
Purpose: This study had two major goals: (1) to asses the effectiveness of a regimen of fluorouracil (5-FU) plus levamisole plus leucovorin as postoperative surgical adjuvant therapy for patients with high-risk colon cancer, and (2) to evaluate 6 months versus 12 months of chemotherapy.Patients and Methods: Patients with poor-prognosis stage II or III colon cancer were randomly assigned to receive adjuvant chemotherapy with either intensive-course 5-FU and levcovorin combined with levamisole, or a standard regimen of 5-FU plus levamisole. Patients were also randomly assigned to receive either 12 months or 6 months of chemotherapy, which resulted in four treatment groups.Results: Eight hundred ninety-one of 915 patients entered (97.4%) were eligible. The median follow-up duration is 5.1 years for patients still alive. There was a difference among the four treatment groups with respect to patient survival, and a significant duration-by-regimen interaction was observed. Specifically, standard 5-FU plus levamisole was inferior to 5-FU plus leucovorin plus levamisole when treatment was given for 6 months (5-year survival rate, 60% v 70%; P < .01).Conclusion: There was no significant improvement in patient survival when chemotherapy was given for 12 months compared with 6 months. When chemotherapy was given for 6 months, standard 5-FU plus levamisole was associated with inferior patient survival compared with intensive-course 5-FU plus levcovorin plus levamisole. These data suggest that 5-FU plus levamisole for 6 months should not be used in clinical practice, whereas 6 months of treatment with 5-FU plus leucovorin plus levamisole is effective. (C) 1998 by American Society of Clinical Oncology.