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贝伐珠单抗用于一线治疗进展后的转移性结直肠癌可延长总生存期:一项大型观察性队列研究(BRiTE)的结果

Bevacizumab beyond first progression is associated with prolonged overall survival in metastatic colorectal cancer: results from a large observational cohort study (BRiTE).

作者信息

Grothey Axel, Sugrue Mary M, Purdie David M, Dong Wei, Sargent Daniel, Hedrick Eric, Kozloff Mark

机构信息

Division of Medical Oncology, Mayo Clinic, Rochester, MN 55905, USA.

出版信息

J Clin Oncol. 2008 Nov 20;26(33):5326-34. doi: 10.1200/JCO.2008.16.3212. Epub 2008 Oct 14.

Abstract

PURPOSE

Bevacizumab 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 METHODS

The 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.

RESULTS

Median 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%).

CONCLUSION

These 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.

摘要

目的

贝伐单抗在一线和二线转移性结直肠癌(mCRC)治疗中可带来生存获益。在一项针对mCRC患者的大型观察性贝伐单抗治疗研究(贝伐单抗治疗方案:治疗效果和安全性调查[BRiTE])中,报告了长达25.1个月的总生存期(OS),这一生存期长于预期。本研究考察了各种治疗前和治疗后因素(包括一线进展后使用贝伐单抗[BBP])与生存之间的关联。

患者和方法

在BRiTE研究中入组的1953例既往未治疗的mCRC患者中,1445例出现疾病进展(PD)的患者被分为三组:PD后未接受治疗(n = 253)、PD后接受不含贝伐单抗的治疗(无BBP;n = 531)和BBP组(n = 642)。采用Cox模型分析包括BBP在内的相关基线和研究期间变量对首次PD后生存的独立影响。

结果

在整个BRiTE研究人群中,中位OS为25.1个月(95%CI,23.4至27.5个月),中位无进展生存期为10.0个月。BBP组和无BBP组之间的基线和基线后因素平衡良好。PD后未治疗组、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与生存改善密切且独立相关(HR,0.48;P <.001)。需要药物治疗的高血压是唯一在BBP组中更频繁发生的与贝伐单抗相关的安全事件(24.6%对19.2%)。

结论

这项大型前瞻性观察性研究的结果表明,在初始PD后继续使用贝伐单抗抑制血管内皮生长因子,可能对提高mCRC患者的总体治疗成功率起到重要作用。

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