New CT response criteria in non-small cell lung cancer: Proposal and application in EGFR tyrosine kinase inhibitor therapy
New CT response criteria in non-small cell lung cancer: Proposal and application in EGFR tyrosine kinase inhibitor therapy
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DOI：
10.1016/j.lungcan.2010.10.019
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发表时间：
2011-07-01
期刊：
影响因子：
5.3
通讯作者：
Chung, Myung Jin
中科院分区：
文献类型：
--
作者：
Lee, Ho Yun;Lee, Kyung Soo;Chung, Myung Jin
我们的目标是在非小细胞肺癌(NSCLC)患者中设计新的CT反应标准(New Response Criteria，NRC)，并与传统的基于大小的标准RECIST版本1.1相比，评估该标准在分层患者反应和预测患者生存方面的有效性。我们的机构审查委员会在放弃知情同意的情况下批准了这项研究。我们招募了80例非小细胞肺癌患者作为实验组，并用表皮生长因子受体酪氨酸激酶抑制剂(EGFR TKIs)治疗。两名失明的独立放射科医生使用NRC评估了CT图像的肿瘤反应，并在另一组患者(75名非小细胞肺癌患者)中进行了验证。比较RECIST 1.1和新标准对肿瘤疗效的影响，并与患者生存期进行相关性分析。统计分析采用Kaplan-Meier法和Kappa统计法。在实验ARM(n=80)中，观察者间关于评估患者反应的协议对于RECIST和NRC来说都是极好的。根据NRC的说法，16名RECIST无反应的患者达到了部分缓解的指定标准。在验证组(n=75)中，采用新标准的最佳反应(部分反应)患者的中位总生存期为18.4个月，而反应较差的患者为8.5个月(P=0.04)。然而，RECIST未能显示两个反应组之间的生存差异。在接受EGFR-TKIs治疗的非小细胞肺癌患者中，反映靶病变额外形态特征的新CT标准是可重复性的，并与总体存活率有统计学意义的相关性。(C)2010爱思唯尔爱尔兰有限公司。保留所有权利。
We aimed to devise new CT response criteria (new response criteria, NRC) in patients with non-small cell lung cancer (NSCLC) and to evaluate the efficacy of the criteria for stratifying patient responses and predicting patient survival compared to that of the traditional size-based criteria RECIST version 1.1. Our institutional review board approved this study with a waiver of informed consent. We enrolled 80 NSCLC patients as an experimental arm and treated them with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs). Two blinded, independent radiologists assessed CT images for tumor response using the NRC, which were also validated in a separate arm (75 NSCLC patients). Tumor responses evaluated by RECIST 1.1 and the new criteria were compared from each other and correlated with patient survival. For statistical analyses, Kaplan-Meier method and kappa statistics were used. In the experimental arm (n = 80), interobserver agreements for the assessment of patient response were excellent for both RECIST and NRC. Sixteen RECIST nonresponding patients achieved a designation of partial response according to NRC. In the validation arm (n = 75), patients of optimal response (partial response) with the new criteria had median overall survival of 18.4 months compared with 8.5 months in patients with poor response (P = .04). However, RECIST failed to show survival difference between the two response groups. In NSCLC patients treated with EGFR-TKIs, new CT criteria reflecting additional morphological characteristics of target lesions are reproducible and have statistically significant association with overall survival. (C) 2010 Elsevier Ireland Ltd. All rights reserved.