医学
贝伐单抗
内科学
荟萃分析
随机对照试验
胶质母细胞瘤
置信区间
无进展生存期
肿瘤科
临床试验
临床研究阶段
外科
总体生存率
化疗
癌症研究
作者
Eric T. Wong,Shiva Gautam,Christopher Malchow,Melody P. Lun,Edward Pan,Steven Brem
出处
期刊:Journal of The National Comprehensive Cancer Network
日期:2011-04-01
卷期号:9 (4): 403-407
被引量:133
标识
DOI:10.6004/jnccn.2011.0037
摘要
The FDA's approval of bevacizumab for recurrent glioblastoma on May 9, 2009, was based on the significant response rate and clinical benefits seen from randomized phase II studies. Large-scale phase III data are unavailable. In an effort to determine benchmark efficacy parameters for bevacizumab and analyze its dose–response effect, the authors performed a meta-analysis of 15 studies published from 2005 to 2009, involving 548 patients with a median age of 53 years (range, 5–74 years), that used bevacizumab to treat recurrent glioblastoma. Median overall survival was 9.3 months (95% CI, 7.9–10.6 months). The respective 6-month progression-free and 6-month overall survival rates were 45% (95% CI, 34%–57%) and 76% (95% CI, 69%–84%), respectively. Median time to tumor progression was 6.1 months (95% CI, 4.2–8.1 months). The response analysis yielded a 6% complete response (95% CI, 2%–9%), 49% partial response (95% CI, 37%–61%), and 29% stable disease (95% CI, 20%–38%). No difference was seen in bevacizumab dose–response benefit between 5 mg/kg and 10 to 15 mg/kg. The efficacy benchmarks from this meta-analysis did not differ from those of the recently published randomized phase II studies. The lack of a dose–response effect would require confirmation in a prospectively conducted clinical trial.
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