Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: Results of a randomized phase III study
Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: Results of a randomized phase III study
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DOI：
10.1200/jco.2001.19.8.2282
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发表时间：
2001-04-15
影响因子：
45.3
通讯作者：
Wong, R
中科院分区：
文献类型：
--
作者：
Hoff, PM;Ansari, R;Wong, R
目的：比较口服卡培他滨与静脉推注（IV）氟尿嘧啶加亚叶酸（5-FU/LV）作为一线治疗转移性结直肠癌患者的反应率、疗效参数和毒性特征。我们前瞻性地将605例患者随机分为两组，一组口服卡培他滨，每3周一次，持续14天，另一组在4- 12个月内每天快速静脉注射5-FU/LV，持续5天。结果：卡培他滨组（24.8%）的总体客观肿瘤缓解率显著高于5-FU/LV组（15.5%; P = 0.005）。在卡培他滨和5-FU/LV组中，至疾病进展的中位时间分别为4.3和4.7个月（对数秩P = 0.72），至治疗失败的中位时间分别为4.1和3.1个月（P = 0.19），中位总生存时间分别为12.5和13.3个月（P = 0.974）。卡培他滨与5-FU/LV静脉推注治疗相比，
Purpose: To compare the response rate, efficacy parameters, and toxicity profile of oral capecitabine with bolus intravenous (IV) fluorouracil plus leucovorin (5-FU/LV) as first-line treatment in patients with metastatic colorectal cancer.Patients and Methods: We prospectively randomized 605 patients to treatment with oral capecitabine for 14 days every 3 weeks or 5-FU/LV by rapid IV injection daily for 5 days in 4-week cycles.Results: The overall objective tumor response rate among all randomized patients was significantly higher in the capecitabine group (24.8%) than in the 5-FU/LV group (15.5%; P =.005). In the capecitabine and 5-FU/LV groups, median times to disease progression were 4.3 and 4.7 months (log-rank P =.72), median times to treatment failure were 4.1 and 3.1 months (P =.19), and median overall survival times were 12.5 and 13.3 months (P =.974), respectively. Capecitabine, compared with bolus 5-FU/LV treatment, produced a significantly lower incidence (P