Fluorouracil plus leucovorin as effective adjuvant chemotherapy in curatively resected stage III colon cancer:: Results of the trial adjCCA-01
Fluorouracil plus leucovorin as effective adjuvant chemotherapy in curatively resected stage III colon cancer:: Results of the trial adjCCA-01
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DOI：
10.1200/jco.2001.19.6.1787
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发表时间：
2001-03-15
影响因子：
45.3
通讯作者：
Strohmeyer, G
中科院分区：
文献类型：
--
作者：
Porschen, R;Bermann, A;Strohmeyer, G
目的：在根治性切除的III期结肠癌患者术后辅以氟尿嘧啶(5-FU)和左旋咪唑治疗，可显著降低肿瘤复发风险，提高生存率。5-FU与亚叶酸钙的生化调节导致转移性结直肠癌缓解率增加，从而反映了肿瘤细胞杀伤率的增加。在前瞻性多中心试验ADJCCA-01中，对比分析5-FU加左旋咪唑与5-FU加左旋咪唑对生存率和肿瘤复发的影响。患者和方法：国际抗癌联盟根据T、N、G分类进行分层，随机分配两种辅助治疗方案之一：5-FU 400 mg/m(2)静脉滴注体表面积，然后450 mg/m(2)×5天；12周期联合亚叶酸钙100 mg/m(2)(A组)或5-FU+左旋咪唑(Moertel方案；B组)。结果：702例患者中有680例(96.9%)符合条件。中位随访时间为46.5个月后，与5-FU+左旋咪唑相比，5-FU+亚叶酸钙联合用药显著提高了无病存活率(P=.037)，显著降低了总死亡率(P=.0089)。在多变量比例风险模型中，辅助化疗成为生存(P=.0059)和无病生存(P=.03)的重要预后因素。5-FU联合左旋咪唑和5-FU联合左旋咪唑辅助治疗的耐受性良好，仅有少数患者出现3级和4级毒性反应。结论：晚期结肠癌根治术后，5-FU联合亚叶酸钙辅助治疗的耐受性良好，在减少肿瘤复发和提高生存率方面明显优于5-FU+左旋咪唑。(C)2001年，由美国临床肿瘤学会主办。
Purpose: Adjuvant postoperative treatment with fluorouracil (5-FU) and levamisole in curatively resected stage III colon cancer significantly reduces the risk of cancer recurrence and improves survival. Biochemical modulation of 5-FU with leucovorin has resulted in increased remission rates in metastatic colorectal cancer, thus reflecting an increased tumor-cell kill. The impact of 5-FU plus leucovorin on survival and tumor recurrence was analyzed in comparison with the effects of 5-FU plus levamisole in the prospective multicentric trial adjCCA-01.Patients and Methods: Patients with a curatively resected International Union Against Cancer stage ill colon cancer were stratified according to T, N, and G category and randomly assigned to receive one of the two adjuvant treatment schemes: 5-FU 400 mg/m(2) body-surface area inf intravenously in the first chemotherapy course, then 450 mg/m(2) x 5 days; 12 cycles, plus leucovorin 100 mg/m(2) (arm A), or 5-FU plus levamisole (Moertel scheme; arm B).Results: Six hundred eighty (96.9%) of 702 patients enrolled onto this study were eligible. After a median follow-up time of 46.5 months, the 5-FU plus leucovorin combination significantly improved disease-free survival (P = .037) and significantly decreased overall mortality (P = .0089) in comparison with 5-FU plus levamisole. In a multivariate proportional hazards model, adjuvant chemotherapy emerged as a significant prognostic factor for survival (P = .0059) and disease-free survival (P = .03). Adjuvant treatment with 5-FU plus levamisole as well as with 5-FU plus leucovorin was generally well tolerated; only a minority of patients experienced grade 3 and 4 toxicities.Conclusion: After a curative resect ion of a stage ill colon cancer, adjuvant treatment with 5-FU plus leucovorin is generally well tolerated and significantly more effective than 5-FU plus levamisole in reducing tumor relapse and improving survival. (C) 2001 by American Society of Clinical Oncology.