Capecitabine as adjuvant treatment for stage III colon cancer
Capecitabine as adjuvant treatment for stage III colon cancer
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DOI：
10.1056/nejmoa043116
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发表时间：
2005-06-30
影响因子：
158.5
通讯作者：
Scheithauer, W
中科院分区：
文献类型：
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作者：
Twelves, C;Wong, A;Scheithauer, W
背景：静脉推注氟尿嘧啶加亚叶酸是结肠癌的标准辅助治疗。口服氟尿嘧啶卡培他滨是一种既定的替代推注氟尿嘧啶加亚叶酸作为一线治疗转移性结直肠癌。我们评估了卡培他滨在辅助setting.METHODS：我们随机分配了1987例切除的III期结肠癌患者接受口服卡培他滨（1004例）或大剂量氟尿嘧啶加亚叶酸（马约诊所方案; 983例）超过24周。主要疗效终点为无病生存率至少相当;主要安全性终点为氟尿嘧啶所致3级或4级毒性反应的发生率。结果：卡培他滨组的无病生存率至少与氟尿嘧啶加亚叶酸组相当（在意向治疗分析中，P
BACKGROUND:Intravenous bolus fluorouracil plus leucovorin is the standard adjuvant treatment for colon cancer. The oral fluoropyrimidine capecitabine is an established alternative to bolus fluorouracil plus leucovorin as first-line treatment for metastatic colorectal cancer. We evaluated capecitabine in the adjuvant setting.METHODS:We randomly assigned a total of 1987 patients with resected stage III colon cancer to receive either oral capecitabine (1004 patients) or bolus fluorouracil plus leucovorin (Mayo Clinic regimen; 983 patients) over a period of 24 weeks. The primary efficacy end point was at least equivalence in disease-free survival; the primary safety end point was the incidence of grade 3 or 4 toxic effects due to fluoropyrimidines.RESULTS:Disease-free survival in the capecitabine group was at least equivalent to that in the fluorouracil-plus-leucovorin group (in the intention-to-treat analysis, P