Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial
Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial
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DOI：
10.1016/s0140-6736(00)02034-1
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发表时间：
2000-03-25
期刊：
影响因子：
168.9
通讯作者：
Rougier, P
中科院分区：
文献类型：
--
作者：
Douillard, JY;Cunningham, D;Rougier, P
背景：伊立替康对氟尿嘧啶难治性结直肠癌患者有效。方法将387例未经化疗（辅助化疗除外）的晚期结直肠癌患者随机分为两组，伊立替康组（n=199）和非伊立替康组（n=188）。输注时间表为每周一次或每2周一次，由各中心选择。我们评估了反应率和进展时间，以及反应持续时间，生存期和生活质量。结果：伊立替康组患者的应答率显著高于非伊立替康组（49 vs 31%，p
Background Irinotecan is active against colorectal cancer in patients whose disease is refractory to fluorouracil. We investigated the efficacy of these two agents combined for first-line treatment of metastatic colorectal cancer.Methods 387 patients previously untreated with chemotherapy (other than adjuvant) for advanced colorectal cancer were randomly assigned open-label irinotecan plus fluorouracil and calcium folinate (irinotecan group, n=199) or fluorouracil and calcium folinate alone (no-irinotecan group, n=188). Infusion schedules were once weekly or every 2 weeks, and were chosen by each centre. We assessed response rates and time to progression, and also response duration, survival, and quality of life. Analyses were done on the intention-to-treat population and on evaluable patients.Findings The response rate was significantly higher in patients in the irinotecan group than in those in the no-irinotecan group (49 vs 31%, p