Department of Radiology and Center for Imaging Science, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul 135-710, Republic of Korea.
Lung Cancer. 2011 Jul;73(1):63-9. doi: 10.1016/j.lungcan.2010.10.019. Epub 2010 Nov 18.
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.
我们旨在为非小细胞肺癌（NSCLC）患者制定新的 CT 反应标准（新反应标准，NRC），并评估与传统基于大小的 RECIST 1.1 标准相比，这些标准在分层患者反应和预测患者生存方面的疗效。我们的机构审查委员会批准了这项研究，并豁免了知情同意。我们招募了 80 名作为实验组的 NSCLC 患者，并使用表皮生长因子受体酪氨酸激酶抑制剂（EGFR TKIs）对其进行治疗。两名盲法、独立的放射科医生使用 NRC 评估 CT 图像的肿瘤反应，这些反应也在独立的实验组（75 名 NSCLC 患者）中进行了验证。比较了 RECIST 1.1 和新标准评估的肿瘤反应，并与患者生存相关。统计分析采用 Kaplan-Meier 方法和 Kappa 统计。在实验组（n=80）中，RECIST 和 NRC 对患者反应的评估具有良好的观察者间一致性。根据 NRC，16 名 RECIST 无反应的患者被诊断为部分缓解。在验证组（n=75）中，新标准下最佳反应（部分缓解）的患者中位总生存期为 18.4 个月，而不良反应患者为 8.5 个月（P=.04）。然而，RECIST 未能显示两组患者的生存差异。在接受 EGFR-TKIs 治疗的 NSCLC 患者中，反映靶病变额外形态特征的新 CT 标准具有可重复性，与总生存期具有统计学显著相关性。
