5-FU+甲酰四氢叶酸、奥沙利铂治疗转移性结直肠癌的随机研究
发布于 2003-12-30 · 浏览 615 · IP 辽宁辽宁
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文题：A Randomized Controlled Trial of Fluorouracil Plus Leucovorin, Irinotecan, and Oxaliplatin Combinations in Patients With Previously Untreated Metastatic Colorectal Cancer
作者：Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts SR
杂志全名： Journal of Clinical Oncology
年份，卷（期）: 起止页码：Vol 22, No 1 (January 1), 2004: pp. 23-30
PMID： 14665611
英文摘要：PURPOSE: Three 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 METHODS: Patients 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. RESULTS: A 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. CONCLUSION: The 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.
5-FU+甲酰四氢叶酸、依立替康、奥沙利铂治疗未经治转移性结直肠癌的随机研究
中文译文：在1999年5月－2001年4月，共795例未经治转移性结直肠癌患者入组，随机分为3组分别接受5-FU+甲酰四氢叶酸+依立替康(IFL)、5-FU+甲酰四氢叶酸+奥沙利铂(FOLFOX)及依立替康+奥沙利铂(IROX)3种方案治疗。结果发现，FOLFOX组患者中位肿瘤进展时间为8.7个月,有效率为45%,中位生存期为19.5个月；IFL组，中位肿瘤进展时间为6.9个月,有效率为31%,中位生存期为15.0个月；IROX组，中位肿瘤进展时间为6.5个月,有效率为35%,中位生存期为17.4个月。FOLFOX组显著优于其他两组。同时研究还发现，FOLFOX组患者的严重恶心、呕吐、腹泻、血细胞减少性发热、脱水症状发生率较低；含有奥沙利铂方案组患者的神经毒性和血液学毒性较常见。
本研究结果显示，5-FU+甲酰四氢叶酸+奥沙利铂方案是一个高效低毒方案，应推荐为晚期转移性结直肠癌患者的标准方案。
版权声明：本译文文字内容版权归丁香园网站（ http://www.dxy.cn ）所有，未经本网站书面许可，请勿转载或摘编。
作者：Goldberg RM, Sargent DJ, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Alberts SR
杂志全名： Journal of Clinical Oncology
年份，卷（期）: 起止页码：Vol 22, No 1 (January 1), 2004: pp. 23-30
PMID： 14665611
英文摘要：PURPOSE: Three 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 METHODS: Patients 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. RESULTS: A 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. CONCLUSION: The 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.
5-FU+甲酰四氢叶酸、依立替康、奥沙利铂治疗未经治转移性结直肠癌的随机研究
中文译文：在1999年5月－2001年4月，共795例未经治转移性结直肠癌患者入组，随机分为3组分别接受5-FU+甲酰四氢叶酸+依立替康(IFL)、5-FU+甲酰四氢叶酸+奥沙利铂(FOLFOX)及依立替康+奥沙利铂(IROX)3种方案治疗。结果发现，FOLFOX组患者中位肿瘤进展时间为8.7个月,有效率为45%,中位生存期为19.5个月；IFL组，中位肿瘤进展时间为6.9个月,有效率为31%,中位生存期为15.0个月；IROX组，中位肿瘤进展时间为6.5个月,有效率为35%,中位生存期为17.4个月。FOLFOX组显著优于其他两组。同时研究还发现，FOLFOX组患者的严重恶心、呕吐、腹泻、血细胞减少性发热、脱水症状发生率较低；含有奥沙利铂方案组患者的神经毒性和血液学毒性较常见。
本研究结果显示，5-FU+甲酰四氢叶酸+奥沙利铂方案是一个高效低毒方案，应推荐为晚期转移性结直肠癌患者的标准方案。
版权声明：本译文文字内容版权归丁香园网站（ http://www.dxy.cn ）所有，未经本网站书面许可，请勿转载或摘编。
最后编辑于 2022-10-09 · 浏览 615
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