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贝伐单抗在非小细胞肺癌患者疾病进展后使用的有效性:ARIES观察性队列研究分析

Effectiveness of bevacizumab exposure beyond disease progression in patients with non-small-cell lung cancer: analyses of the ARIES observational cohort study.

作者信息

Leon Larry, Kosty Michael, Jahanzeb Mohammad, Spigel David, Wozniak Antoinette J, Brahmer Julie, Fish Susan, Flick E Dawn, Hazard Sebastien J, Lynch Thomas J

机构信息

Department of US Medical Affairs, Genentech, Inc., South San Francisco, CA, USA.

Department of Oncology, Scripps Clinic, La Jolla, CA, USA.

出版信息

Pharmacoepidemiol Drug Saf. 2016 May;25(5):569-77. doi: 10.1002/pds.3948. Epub 2016 Jan 8.

DOI:10.1002/pds.3948
PMID:26748833
Abstract

PURPOSE

Bevacizumab used in combination with first-line chemotherapy confers an overall survival (OS) benefit for patients with non-squamous non-small-cell lung cancer (NSCLC). This analysis from the ARIES observational cohort study (OCS) was initiated to evaluate the effect of bevacizumab use beyond disease progression (BBP) on clinical outcomes in patients with NSCLC receiving first-line treatment with bevacizumab and chemotherapy.

METHODS

The ARIES OCS prospectively enrolled patients from 2006 to 2009 in the United States who had advanced non-squamous NSCLC, received bevacizumab with chemotherapy in the first-line setting, and survived progressive disease (PD). A dichotomous landmark analysis examined post-PD OS (ppOS) in patients who received BBP versus no BBP within 30 days post PD. A time-dependent Cox model assessed the effect of cumulative BBP exposure on ppOS.

RESULTS

The ARIES OCS enrolled 1967 patients with first-line NSCLC; 1358 patients had first PD and were alive at the 30-day landmark (351 patients with BBP and 1007 patients with no BBP). The landmark analysis showed that BBP was associated with a lower risk of death (BBP versus No-BBP); hazard ratio [HR], 0.75; 95% confidence interval 0.65-0.86. In the cumulative exposure analysis of 1461 patients who had PD, HRs for ppOS decreased by approximately 4% for each additional 21-day interval of bevacizumab received. Protocol-specified bevacizumab-select adverse events occurred in 14% of BBP patients.

CONCLUSIONS

BBP was associated with a lower risk of death in patients with NSCLC treated with first-line bevacizumab and chemotherapy. Copyright © 2016 John Wiley & Sons, Ltd.

摘要

目的

贝伐单抗联合一线化疗可使非鳞状非小细胞肺癌(NSCLC)患者的总生存期(OS)获益。开展这项来自ARIES观察性队列研究(OCS)的分析,以评估在接受贝伐单抗和化疗一线治疗的NSCLC患者中,疾病进展后使用贝伐单抗(BBP)对临床结局的影响。

方法

ARIES OCS于2006年至2009年在美国前瞻性纳入了患有晚期非鳞状NSCLC、在一线治疗中接受贝伐单抗联合化疗且疾病进展(PD)后仍存活的患者。一项二分法标志性分析检查了PD后30天内接受BBP与未接受BBP的患者的PD后OS(ppOS)。一个时间依赖性Cox模型评估了累积BBP暴露对ppOS的影响。

结果

ARIES OCS纳入了1967例一线NSCLC患者;1358例患者首次发生PD且在30天标志性时间点仍存活(351例接受BBP,1007例未接受BBP)。标志性分析表明,BBP与较低的死亡风险相关(BBP与未接受BBP相比);风险比[HR]为0.75;95%置信区间为0.65 - 0.86。在对1461例发生PD的患者进行的累积暴露分析中,每多接受一个21天周期的贝伐单抗,ppOS的HR下降约4%。14%接受BBP的患者发生了方案规定的贝伐单抗特异性不良事件。

结论

在接受一线贝伐单抗和化疗治疗的NSCLC患者中,BBP与较低的死亡风险相关。版权所有© 2016约翰威立父子有限公司。

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