Oral uracil and tegafur plus leucovorin compared with intravenous fluorouracil and leucovorin in stage II and III carcinoma of the colon: Results from National Surgical Adjuvant Breast and Bowel Project protocol C-06
Oral uracil and tegafur plus leucovorin compared with intravenous fluorouracil and leucovorin in stage II and III carcinoma of the colon: Results from National Surgical Adjuvant Breast and Bowel Project protocol C-06
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DOI：
10.1200/jco.2005.04.7498
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发表时间：
2006-05-01
影响因子：
45.3
通讯作者：
Wolmark, N
中科院分区：
文献类型：
--
作者：
Lembersky, BC;Wieand, HS;Wolmark, N
目的本研究的主要目的是比较口服尿嘧啶和替加氟（LIFT）加甲酰四氢叶酸（LV）与每周静脉注射氟尿嘧啶（FU）加LV在延长结肠癌初次手术后无病生存期（DFS）和总生存期（OS）方面的相对疗效。608例II期和III期结肠癌患者被随机分配接受口服UFT+LV或静脉FU+LV。结果在所有患者中，47%的患者患有II期结肠癌，53%患有III期结肠癌。中位随访时间为62.3个月。接受UFT+LV的患者与接受FU+LV的患者的OS估计风险比（HR）为1.014（95% CI，0.825 - 1.246）。DFS的估计HR为1.004（95% CI，0.847 - 1.190）。考克斯比例风险模型分析年龄（≥ 60岁）、分期或受累淋巴结数量（无v 1 - 3 v ≥ 4个淋巴结）与OS或DFS无相互作用。两组的毒性相似。在UFT+LV组中，38.2%的患者发生了任何3级或4级毒性事件，而FU+LV组的患者为37.8%。两种方案的主要生活质量终点无差异，尽管便利性护理分析支持UFT+LV。结论与静脉内、每周一次、推注FU+LV方案相比，UFT+ LV方案的DFS和OS相似。这两种方案毒性相当，一般耐受性良好。
Purpose The primary aim of this study was to compare the relative efficacy of oral uracil and tegafur (LIFT) plus leucovorin (LV) with the efficacy of weekly intravenous fluorouracil (FU) plus LV in prolonging disease-free survival (DFS) and overall survival (OS) after primary surgery for colon carcinoma.Patients and Methods Between February 1997 and March 1999, 1,608 patients with stage II and III carcinoma of the colon were randomly assigned to receive either oral UFT+LV or intravenous FU+LV.Results Of the total patients, 47% had stage II colon cancer, and 53% had stage III colon cancer. Median follow-up time was 62.3 months. The estimated hazard ratio (HR) for OS of patients who received UFT+LV versus that of patients who received FU+LV was 1.014 (95% CI, 0.825 to 1.246). The estimated HR for DFS was 1.004 (95% CI, 0.847 to 1.190). Cox proportional hazards model analyses with regard to age (= 60 years), stage, or number of involved nodes (none v one to three v >= four nodes) revealed no interaction with OS or DFS. Toxicity was similar in the two groups. In the UFT+LV arm, 38.2% of patients experienced any grade 3 or 4 toxic event compared with 37.8% of patients in the FU+LV arm. Primary quality-of-life end points did not differ between the two regimens, although convenience of care analysis favored UFT+LV.Conclusion UFT+LV achieved similar DFS and OS when compared with an intravenous, weekly, bolus FU+LV regimen. The two regimens were equitoxic and generally well tolerated.