Bevacizumab Beyond First Progression Is Associated With Prolonged Overall Survival in Metastatic Colorectal Cancer: Results From a Large Observational Cohort Study (BRiTE)
Bevacizumab Beyond First Progression Is Associated With Prolonged Overall Survival in Metastatic Colorectal Cancer: Results From a Large Observational Cohort Study (BRiTE)
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DOI：
10.1200/jco.2008.16.3212
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发表时间：
2008-11-20
影响因子：
45.3
通讯作者：
Kozloff, Mark
中科院分区：
文献类型：
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作者：
Grothey, Axel;Sugrue, Mary M.;Kozloff, Mark
目的：贝伐单抗可提高一线和二线转移性结直肠癌（mCRC）患者的生存期。在一项大型观察性贝伐单抗治疗研究（贝伐单抗方案：治疗效果和安全性调查[BRiTE]）中，mCRC患者的总生存期（OS）超过预期，为25.1个月。研究了各种治疗前和治疗后因素（包括首次进展后使用贝伐单抗[BBP]）与生存之间的关系。患者和方法纳入BRiTE的1953例既往未治疗且经历疾病进展（PD）的mCRC患者中的1445例被分为三组：PD后未治疗（n = 253）， PD后未治疗（n = 531）和BBP （n = 642）。相关的基线和研究变量，包括BBP，用Cox模型分析它们对首次PD后生存的独立影响。结果总体BRiTE人群的中位OS为25.1个月（95% CI, 23.4 - 27.5个月），中位无进展生存期为10.0个月。基线和基线后因素在BBP组和非BBP组之间平衡良好。无pd后治疗组、无BBP组和BBP组的中位OS率分别为12.6、19.9和31.8个月。在多变量分析中，与无BBP相比，BBP与生存率的提高有很强的独立相关性（HR, 0.48; P < 0.001）。在BBP组中，需要用药的高血压是唯一发生频率更高的贝伐单抗相关安全事件（24.6% vs 19.2%）。结论：这些来自一项大型前瞻性观察性研究的结果表明，贝伐单抗在初始PD之后持续抑制血管内皮生长因子可能在提高mCRC患者治疗的总体成功率方面发挥重要作用。
PurposeBevacizumab provides a survival benefit in first- and second-line metastatic colorectal cancer (mCRC). In a large, observational, bevacizumab treatment study (Bevacizumab Regimens: Investigation of Treatment Effects and Safety [BRiTE]) in patients who had mCRC, a longer-than-expected overall survival (OS) of 25.1 months was reported. The association between various pre- and post-treatment factors (including the use of bevacizumab beyond first progression [BBP]) and survival was examined.Patients and MethodsThe 1,445 of 1,953 previously untreated patients with mCRC who were enrolled in BRiTE and who experienced disease progression (PD) were classified into three groups: no post-PD treatment (n = 253), post-PD treatment without bevacizumab (no BBP; n = 531), and BBP (n = 642). Relevant baseline and on-study variables, including BBP, were analyzed with a Cox model with respect to their independent effect on survival beyond first PD.ResultsMedian OS was 25.1 months (95% CI, 23.4 to 27.5 months), and median progression-free survival was 10.0 months in the overall BRiTE population. Baseline and postbaseline factors were well balanced between the BBP and no-BBP groups. Median OS rates were 12.6, 19.9, and 31.8 months in the no post-PD treatment, no-BBP, and BBP groups, respectively. In multivariate analyses, compared with no BBP, BBP was strongly and independently associated with improved survival (HR, 0.48; P < .001). Hypertension that required medication was the only bevacizumab-related safety event that occurred more frequently in the BBP group (24.6% v 19.2%).ConclusionThese results from a large, prospective, observational study suggest that continued vascular endothelial growth factor inhibition with bevacizumab beyond initial PD could play an important role improving the overall success of therapy for patients who have mCRC.