A Randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer
A Randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer
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DOI：
10.1200/jco.2004.09.046
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发表时间：
2004-01-01
影响因子：
45.3
通讯作者：
Alberts, SR
中科院分区：
文献类型：
--
作者：
Goldberg, RM;Sargent, DJ;Alberts, SR
目的：氟尿嘧啶、伊立替康和奥沙利铂三种作用机制不同的药物可用于治疗晚期结直肠癌。在这项研究中，我们比较了三种不同的两种药物组合的活性和毒性与转移性结直肠癌患者谁没有接受过治疗以前的先进diseases.Patients和MethodsPatients同时随机分配到接受伊立替康和丸氟尿嘧啶加甲酰四氢叶酸（IFL，对照组合），奥沙利铂和输注氟尿嘧啶加甲酰四氢叶酸（FOLFOX），或伊立替康和奥沙利铂（IROX）。主要终点是进展时间，与反应率，生存时间，和toxics.ResultsA的次要终点，共有795例患者被随机分配1999年5月至2001年4月。FOLFOX的中位进展时间为8.7个月，有效率为45%，中位生存时间为19.5个月。这些结果在所有终点均显著上级IFL。（分别为6.9个月、31%和15.0个月）或IROX（分别为6.5个月、35%和17.4个月）。FOLFOX方案的重度恶心、呕吐、腹泻、发热性中性粒细胞减少和脱水的发生率显著较低。结论奥沙利铂联合氟尿嘧啶加亚叶酸钙的FOLFOX方案是一种有效、安全的化疗方案。应考虑将其作为晚期结直肠癌患者的标准治疗。
PurposeThree agents with differing mechanisms of action are available for treatment of advanced colorectal cancer: fluorouracil, irinotecan, and oxaliplatin. In this study, we compared the activity and toxicity of three different two-drug combinations in patients with metastatic colorectal cancer who had not been treated previously for advanced disease.Patients and MethodsPatients were concurrently randomly assigned to receive irinotecan and bolus fluorouracil plus leucovorin (IFL, control combination), oxaliplatin and infused fluorouracil plus leucovorin (FOLFOX), or irinotecan and oxaliplatin (IROX). The primary end point was time to progression, with secondary end points of response rate, survival time, and toxicity.ResultsA total of 795 patients were randomly assigned between May 1999 and April 2001. A median time to progression of 8.7 months, response rate of 45%, and median survival time of 19.5 months were observed for FOLFOX These results were significantly superior to those observed for IFL for all end points (6.9 months, 31%, and 15.0 months, respectively) or for IROX (6,5 months, 35%, and 17.4 months, respectively) for time to progression and response. The FOLFOX regimen had significantly lower rates of severe nausea, vomiting, diarrhea, febrile neutropenia, and dehydration. Sensory neuropathy and neutropenia were more common with the regimens containing oxaliplatin.ConclusionThe FOLFOX regimen of oxaliplatin and infused fluorouracil plus leucovorin was active and comparatively safe. It should be considered as a standard therapy for patients with advanced colorectal cancer.