Bevacizurnab in combination with fluorouracil and leucovorin: An active regimen for first-line metastatic colorectal cancer
Bevacizurnab in combination with fluorouracil and leucovorin: An active regimen for first-line metastatic colorectal cancer
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DOI：
10.1200/jco.2005.10.017
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发表时间：
2005-05-20
影响因子：
45.3
通讯作者：
Kabbinavar, F
中科院分区：
文献类型：
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作者：
Hurwitz, HI;Fehrenbacher, L;Kabbinavar, F
目的在一项III期试验中，在转移性结直肠癌(CRC)的一线治疗中，贝伐单抗(BV)与伊立替康、氟尿嘧啶(FU)和亚叶酸钙(LV；IFL)联合使用，与单独使用IFL相比，可提高生存率。IFL/BV与IFL/安慰剂的父母研究结果在其他地方报道。在这里，我们描述了试验中第三组患者的疗效和安全性，他们接受了BV和FU/LV的联合治疗，并与同时接受IFL的患者的结果进行了比较。方法将923例患者随机分配到接受IFL/安慰剂(对照组)、IFL/BV或FU/LV/BV的患者。贝伐单抗(阿瓦斯丁；Genentech Inc.，加利福尼亚州旧金山南部)每2周静脉注射5 mg/kg。在中期分析确认IFL/BV可接受的安全性之前，313名患者同时随机分配到这三个组，在此分析之后，FU/LV/BV组停止使用。结果FU/LV/BV组(n=110)和IFL/安慰剂组(n=100)的中位总生存期分别为18.3和15.1个月。中位无进展生存期分别为8.8个月和6.8个月。总有效率分别为40.0%和37.0%，中位有效时间分别为8.5个月和7.2个月。不良反应与以FU/亚叶酸钙或IFL为基础的方案一致，高血压和贝伐单抗的出血也有轻微增加，通常很容易控制。结论FU/LV/BV方案似乎与IFL方案一样有效，且具有可接受的安全性。FU/LU/BV是治疗未经治疗的转移性结直肠癌的一种有效的替代治疗方案。2005年由美国临床肿瘤学会主办。
Purpose In a phase III trial, combining bevacizumab (BV)-a recombinant, humanized, monoclonal antibody targeting vascular endothelial growth factor-with irinotecan, bolus fluorouracil (FU), and leucovorin (LV; IFL) increased survival compared with IFL alone in first-line treatment of patients with metastatic colorectal cancer (CRC). Results for the parent study of IFL/BV versus IFL/placebo are reported elsewhere. Here, we describe efficacy and safety results for the third patient cohort in this trial, who received BV combined with FU/LV, and compare them with results for concurrently enrolled patients who received IFL.Methods Patients (N = 923) were randomly assigned to receive IFL/placebo (control), IFL/BV, or FU/LV/BV. Bevacizumab (Avastin; Genentech Inc, South San Francisco, CA) 5 mg/kg was administered intravenously every 2 weeks. Before an interim analysis confirmed acceptable safety for IFL/BV, 313 patients were concurrently randomly assigned to these three arms, after this analysis, the FU/LV/BV arm was discontinued.Results Median overall survivals were 18.3 and 15.1 months with FU/LV/BV (n = 110) and IFL/placebo (n = 100), respectively. Median progression-free survivals were 8.8 and 6.8 months, respectively. Overall response rates were 40.0% and 37.0%, and median response durations were 8.5 and 7.2 months, respectively. Adverse events consistent with those expected from FU/leucovorin- or IFL-based regimens were seen, as were modest increases in hypertension and bleeding in the bevacizumab arm, which were generally easily managed.Conclusion The FU/LV/BV regimen seems as effective as IFL and has an acceptable safety profile. FU/LU/BV is an active alternative treatment regimen for patients with previously untreated metastatic CRC. 2005 by American Society of Clinical Oncology.