FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer
FOLFIRINOX versus Gemcitabine for Metastatic Pancreatic Cancer
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DOI：
10.1056/nejmoa1011923
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发表时间：
2011-05-12
影响因子：
158.5
通讯作者：
Ducreux, Michel
中科院分区：
文献类型：
--
作者：
Conroy, Thierry;Desseigne, Francoise;Ducreux, Michel
研究背景缺乏关于奥沙利铂、伊立替康、氟尿嘧啶和亚叶酸组成的联合化疗方案的疗效和安全性的数据方法：我们将342名东部肿瘤协作组体力状态评分为0或1的患者随机分组，（评分为0 - 5分，评分越高表明疾病严重程度越高）接受FOLFIRINOX（奥沙利铂，85 mg/m2体表面积;伊立替康，180 mg/m2;甲酰四氢叶酸，400 mg/m2;和氟尿嘧啶，400 mg/m2作为推注给药，然后2400 mg/m2作为46小时连续输注给药，每2周一次）或吉西他滨，1000 mg/m2每周一次，持续7/8周，然后每周一次，持续3/4周。两组有反应的患者均建议接受6个月的化疗。FOLFIRINOX组的中位总生存期为11.1个月，而吉西他滨组为6.8个月（死亡风险比为0.57; 95%可信区间[CI]为0.45 - 0.73; P
BACKGROUNDData are lacking on the efficacy and safety of a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) as compared with gemcitabine as first-line therapy in patients with metastatic pancreatic cancer.METHODSWe randomly assigned 342 patients with an Eastern Cooperative Oncology Group performance status score of 0 or 1 (on a scale of 0 to 5, with higher scores indicating a greater severity of illness) to receive FOLFIRINOX (oxaliplatin, 85 mg per square meter of body-surface area; irinotecan, 180 mg per square meter; leucovorin, 400 mg per square meter; and fluorouracil, 400 mg per square meter given as a bolus followed by 2400 mg per square meter given as a 46-hour continuous infusion, every 2 weeks) or gemcitabine at a dose of 1000 mg per square meter weekly for 7 of 8 weeks and then weekly for 3 of 4 weeks. Six months of chemotherapy were recommended in both groups in patients who had a response. The primary end point was overall survival.RESULTSThe median overall survival was 11.1 months in the FOLFIRINOX group as compared with 6.8 months in the gemcitabine group (hazard ratio for death, 0.57; 95% confidence interval [CI], 0.45 to 0.73; P