Randomized controlled trial of reduced-dose bolus fluorouracil plus leucovorin and irinotecan or infused fluorouracil plus leucovorin and oxaliplatin in patients with previously untreated metastatic colorectal cancer: A North American intergroup trial
Randomized controlled trial of reduced-dose bolus fluorouracil plus leucovorin and irinotecan or infused fluorouracil plus leucovorin and oxaliplatin in patients with previously untreated metastatic colorectal cancer: A North American intergroup trial
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DOI：
10.1200/jco.2006.06.1317
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发表时间：
2006-07-20
影响因子：
45.3
通讯作者：
Alberts, Steven
中科院分区：
文献类型：
--
作者：
Goldberg, Richard M.;Sargent, Daniel J.;Alberts, Steven
目的之前，我们报告了组间 N9741 的结果，该结果比较了标准推注氟尿嘧啶 (FU)、亚叶酸加伊立替康 (IFL) 与输注 FU、亚叶酸加奥沙利铂 (FOLFOX4) 和伊立替康加奥沙利铂治疗未经治疗的转移性结直肠癌患者的情况。升学率高！ IFL 的 3 毒性（导致一些死亡）导致我们将伊立替康和 FU 的起始剂量减少 20% (rIFL)。本文比较了 rIFL 与 FOLFOX4。患者和方法主要比较是进展时间，次要终点是缓解率 (RR)、总生存期和毒性。结果 305 名患者被随机分配。当结果超出预定的停止边界时，中北癌症治疗组数据安全监测委员会在计划的中期分析中中断了招募。与 rIFL 相比，FOLFOX4 的进展时间明显优于 rIFL（分别为 9.7 个月和 5.5 个月；P
PurposePreviously, we reported results of Intergroup N9741, which compared standard bolus fluorouracil (FU), leucovorin, plus irinotecan (IFL) with infused FU, leucovorin, plus oxaliplatin (FOLFOX4) and irinotecan plus oxaliplatin in patients with untreated metastatic colorectal cancer. High rates of grade ! 3 toxicity on IFL (resulting in some deaths) led us to reduce the starting doses of both irinotecan and FU by 20% (rIFL). This article compares rIFL with FOLFOX4.Patients and MethodsThe primary comparison was time to progression, with secondary end points of response rate (RR), overall survival, and toxicity.ResultsThree hundred five patients were randomly assigned. The North Central Cancer Treatment Group Data Safety Monitoring Committee interrupted enrollment at a planned interim analysis when outcomes crossed predetermined stopping boundaries. The results were significantly superior for FOLFOX4 compared with rIFL for time to progression (9.7 v 5.5 months, respectively; P