评估改良RECIST 1.1在晚期非小细胞肺癌中的肿瘤反应评估：来自EAST-LC试验的1147例患者分析
Evaluating the tumor response assessment of modified-RECIST 1.1 in advance non-small cell lung cancer: a analysis of 1,147 patients from the EAST-LC trial.
作者信息
Chen Qun, Huang Wenwen, Chen Gang, Zhou Huaqiang, Luo Jing, Zhao Yuanyuan, Huang Yan, Yang Yunpeng, Fang Wenfeng, Zhou Ting, Ma Yuxiang, Zhang Li, Zhao Hongyun
机构信息
Department of Clinical Research, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.
Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, China.
出版信息
Transl Lung Cancer Res. 2025 May 30;14(5):1688-1698. doi: 10.21037/tlcr-24-809. Epub 2025 May 23.
BACKGROUND
Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) provides conventional response evaluation in solid tumors. However, RECIST 1.1 measures up to two lesions per organ, which can be time-consuming and less-reliable in terms of reproducibility. This study sought to compare response assessment using RECIST 1.1 and modified RECIST 1.1 (mRECIST 1.1, measuring the single largest lesion per organ) in advanced non-small cell lung cancer (NSCLC).
METHODS
This study analyzed the medical files of 1,147 advanced NSCLC patients from the East Asia S-1 Trial in Lung Cancer (EAST-LC) clinical trial. The tumor responses were compared using the RECIST 1.1 and the mRECIST 1.1 by the kappa statistics. And a κ value of >0.75 indicated strong concordance. Concordance index (C-index), which ranges from 0-1, was calculated to evaluate prognostic accuracy of radiologic response according to the two criteria. The Kaplan-Meier method and log-rank test were conducted for survival. Statistical analyses were tested at a two-sided significance level of 0.05.
RESULTS
The amount of target lesions was lower by mRECIST 1.1 than RECIST 1.1. The best tumor responses revealed a great concordance between two criteria (κ=0.989). The C-index by the two criteria was similar for overall survival (OS) (0.709 versus 0.708) and responders had significantly longer progression-free survival (PFS) and OS versus non-responders (P<0.001) by the RECIST 1.1 and mRECIST 1.1. The median OS using the original RECIST 1.1 criteria was 33.6 months in the complete response (CR) and partial response (PR) arm, 18.6 months in the stable disease (SD) arm, and 7.3 months in the progressive disease (PD) arm. When the mRECIST 1.1 criteria were applied, the median OS of the above three groups was 30.9, 18.3 and 7.3 months, respectively. Patients were also stratified into four groups using quartiles of the absolute PFS value according to the two criteria. In comparison with RECIST 1.1, the median OS were 5.8 versus 6.0 months, 8.3 versus 8.4 months, 14.5 versus 14.6 months, and 25.6 versus 25.6 months in the lowest quartile, 2 quartile, 3 quartile, and 4 quartile groups, respectively.
CONCLUSIONS
mRECIST 1.1 was comparable to RECIST 1.1 and might be preferable owing to its convenience in the assessment of tumor response in advanced NSCLC.
背景
实体瘤疗效评价标准1.1版（RECIST 1.1）为实体瘤提供了传统的疗效评价方法。然而，RECIST 1.1每个器官最多测量两个病灶，这可能耗时且在可重复性方面可靠性较低。本研究旨在比较在晚期非小细胞肺癌（NSCLC）中使用RECIST 1.1和改良RECIST 1.1（mRECIST 1.1，每个器官测量单个最大病灶）进行疗效评估的情况。
方法
本研究分析了东亚肺癌S-1试验（EAST-LC）临床试验中1147例晚期NSCLC患者的病历。通过kappa统计量比较使用RECIST 1.1和mRECIST 1.1的肿瘤反应。κ值>0.75表示高度一致性。计算范围为0至1的一致性指数（C-index），以评估根据这两个标准的放射学反应的预后准确性。采用Kaplan-Meier法和对数秩检验进行生存分析。统计分析在双侧显著性水平0.05下进行检验。
结果
mRECIST 1.1的靶病灶数量低于RECIST 1.1。最佳肿瘤反应显示两个标准之间具有高度一致性（κ=0.989）。两个标准的C-index在总生存期（OS）方面相似（0.709对0.708），并且根据RECIST 1.1和mRECIST 1.1，反应者的无进展生存期（PFS）和OS明显长于无反应者（P<0.001）。使用原始RECIST 1.1标准时，完全缓解（CR）和部分缓解（PR）组的中位OS为33.6个月，疾病稳定（SD）组为18.6个月，疾病进展（PD）组为7.3个月。应用mRECIST 1.1标准时，上述三组的中位OS分别为30.9、18.3和7.3个月。根据这两个标准，还使用绝对PFS值的四分位数将患者分为四组。与RECIST 1.1相比，最低四分位数、第二四分位数、第三四分位数和第四四分位数组的中位OS分别为5.8对6.0个月、8.3对8.4个月、14.5对14.6个月和25.6对25.6个月。
结论
mRECIST 1.1与RECIST 1.1相当，由于其在晚期NSCLC肿瘤反应评估中的便利性，可能更具优势。
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