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美国食品药品监督管理局批准替莫唑胺联合放疗和贝伐单抗后胶质母细胞瘤患者的生存获益:一项基于人群的研究。

Survival benefit of glioblastoma patients after FDA approval of temozolomide concomitant with radiation and bevacizumab: A population-based study.

作者信息

Zhu Ping, Du Xianglin L, Lu Guangrong, Zhu Jay-Jiguang

机构信息

Department of Epidemiology, Human Genetics, and Environmental Sciences, The University of Texas Health Science Center at Houston (UTHealth), School of Public Health, Houston, TX 77030, USA.

The Vivian L. Smith Department of Neurosurgery, The University of Texas Health Science Center at Houston (UTHealth), McGovern Medical School, and Memorial Hermann at Texas Medical Center, Houston, TX 77030, USA.

出版信息

Oncotarget. 2017 Jul 4;8(27):44015-44031. doi: 10.18632/oncotarget.17054.

Abstract

Few population-based analyses have investigated survival change in glioblastoma multiforme (GBM) patients treated with concomitant radiotherapy-temozolomide (RT-TMZ) and adjuvant temozolomide (TMZ) and then bevacizumab (BEV) after Food and Drug Administration (FDA) approval, respectively. We aimed to explore the effects on survival with RT-TMZ, adjuvant TMZ and BEV in general GBM population based on the Surveillance, Epidemiology, and End Results (SEER) and Texas Cancer Registry (TCR) databases. A total of 28933 GBM patients from SEER (N = 24578) and TCR (N = 4355) between January 2000 and December 2013 were included. Patients were grouped into three calendar periods based on date of diagnosis: pre-RT-TMZ and pre-BEV (1/2000-2/2005, P1), post-RT-TMZ and pre-BEV (3/2005-4/2009, P2), and post-RT-TMZ and post-BEV (5/2009-12/2013, P3). The association between calendar period of diagnosis and survival was analyzed in SEER and TCR, separately, by the Kaplan-Meier method and Cox proportional hazards model. We found a significant increase in median overall survival (OS) across the three periods in both populations. In multivariate models, the risk of death was significantly reduced during P2 and further decreased in P3, which remained unchanged after stratification. Comparison and validation analysis were performed in the combined dataset, and consistent results were observed. We conclude that the OS of GBM patients in a "real-world" setting has been steadily improved from January 2000 to December 2013, which likely resulted from the administrations of TMZ concomitant with RT and adjuvant TMZ for newly diagnosed GBM and then BEV for recurrent GBM after respective FDA approval.

摘要

很少有基于人群的分析研究过接受同步放化疗(RT-TMZ)和辅助替莫唑胺(TMZ)治疗,随后在分别获得美国食品药品监督管理局(FDA)批准后使用贝伐单抗(BEV)的多形性胶质母细胞瘤(GBM)患者的生存变化。我们旨在基于监测、流行病学和最终结果(SEER)以及德克萨斯癌症登记处(TCR)数据库,探讨RT-TMZ、辅助TMZ和BEV对一般GBM人群生存的影响。纳入了2000年1月至2013年12月期间来自SEER(n = 24578)和TCR(n = 4355)的总共28933例GBM患者。根据诊断日期将患者分为三个日历时间段:RT-TMZ之前和BEV之前(2000年1月 - 2005年2月,P1)、RT-TMZ之后和BEV之前(2005年3月 - 2009年4月,P2)以及RT-TMZ之后和BEV之后(2009年5月 - 2013年12月,P3)。通过Kaplan-Meier方法和Cox比例风险模型分别在SEER和TCR中分析诊断的日历时间段与生存之间的关联。我们发现两个人群在这三个时间段的中位总生存期(OS)均有显著增加。在多变量模型中,P2期间死亡风险显著降低,P3期间进一步降低,分层后保持不变。在合并数据集中进行了比较和验证分析,并观察到一致的结果。我们得出结论,从2000年1月到2013年12月,“真实世界”环境中GBM患者的OS稳步改善,这可能是由于新诊断GBM时使用TMZ同步放疗和辅助TMZ,以及在FDA各自批准后对复发性GBM使用BEV所致。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9a4e/5546458/073e52afae9c/oncotarget-08-44015-g001.jpg

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