Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: Results from NSABP C-07
Oxaliplatin combined with weekly bolus fluorouracil and leucovorin as surgical adjuvant chemotherapy for stage II and III colon cancer: Results from NSABP C-07
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DOI：
10.1200/jco.2006.08.2974
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发表时间：
2007-06-01
影响因子：
45.3
通讯作者：
Wolmark, Norman
中科院分区：
文献类型：
--
作者：
Kuebler, J. Philip;Wieand, H. Samuel;Wolmark, Norman
目的本III期临床试验评价了奥沙利铂加氟尿嘧啶（FU）联合甲酰四氢叶酸作为II期和III期结肠癌的手术辅助治疗对无病生存期的影响。患者和方法接受了潜在治愈性切除术的患者随机分为FU 500 mg/m（2）静脉（IV）推注每周6周加甲酰四氢叶酸500 mg/m（2）（2）静脉（IV）推注每周6周。2）在每8周的周期中每周静脉注射6周，共3个周期（FULV），或在每8周的周期中第1、3、5周静脉注射奥沙利铂85 mg/m2，共3个周期（FLOX）。结果在随机分配的2,492例患者中，共有2,407例（96.6%）符合条件。存活患者的中位随访时间为42.5个月。风险比（FLOX v FULV）为0.80（95%CI，0.69 - 0.93），FLOX组风险降低20%（P
PurposeThis phase III clinical trial evaluated the impact on disease-free survival QFS) of adding oxaliplatin to bolus weekly fluorouracil (FU) combined with leucovorin as surgical adjuvant therapy for stage II and III colon cancer.Patients and MethodsPatients who had undergone a potentially curative resection were randomly assigned to either FU 500 mg/m(2) intravenous (IV) bolus weekly for 6 weeks plus leucovorin 500 mg/m(2) IV weekly for 6 weeks during each 8-week cycle for three cycles (FULV), or the same FULV regimen with oxaliplatin 85 mg/m(2) IV administered on weeks 1, 3, and 5 of each 8-week cycle for three cycles (FLOX).ResultsA total of 2,407 patients (96.6%) of the 2,492 patients randomly assigned were eligible. Median follow-up for patients still alive is 42.5 months. The hazard ratio (FLOX v FULV) is 0.80 (95% Cl, 0.69 to 0.93), a 20% risk reduction in favor of FLOX (P