Background For Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST1.1), measuring up to two target lesions per organ is an arbitrary criterion. Objectives We sought to compare response assessment using RECIST1.1 and modified RECIST1.1 (mRECIST1.1, measuring the single largest lesion per organ) in advanced non-small cell lung cancer (aNSCLC) patients undergoing anti-PD-1/PD-L1 monotherapy. Methods Concordance of radiologic response categorization between RECIST1.1 and mRECIST1.1 was compared using the Kappa statistics. C-index was calculated to evaluate prognostic accuracy of radiologic response by the two criteria. The Kaplan-Meier method and Cox regression analysis were conducted for progression-free survival (PFS) and overall survival (OS). Results Eighty-seven patients who had at least two target lesions in any organ per the RECIST1.1 were eligible for comparison analysis. Tumor response showed excellent concordance when measured using the RECIST1.1 and mRECIST1.1 (Kappa = 0.961). C-index by these two criteria was similar for PFS (0.784 versus 0.785) and OS (0.649 versus 0.652). Responders had significantly longer PFS and OS versus non-responders (p < 0.05), whichever criterion adopted. Radiologic response remained a significant predictor of PFS and OS in multivariate analysis (p < 0.05). Conclusion The mRECIST1.1 was comparable to RECIST1.1 in response assessment among aNSCLC patients who received single-agent PD-1/PD-L1 inhibitor. The mRECIST1.1, with reduced number of lesions to be measured, may be sufficient and more convenient to assess antitumor activity in clinical practice.

中文翻译：

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通过测量接受 PD-1/PD-L1 抑制剂治疗的晚期非小细胞肺癌患者每个器官的单个最大病变来评估肿瘤反应。

背景 对于实体​​瘤 1.1 版 (RECIST1.1) 中的疗效评估标准，每个器官最多测量两个目标病灶是一个任意标准。目的 我们试图比较使用 RECIST1.1 和改良 RECIST1.1（mRECIST1.1，测量每个器官的单一最大病变）对接受抗 PD-1/PD-治疗的晚期非小细胞肺癌 (aNSCLC) 患者的疗效评估。 L1单一疗法。方法使用 Kappa 统计数据比较 RECIST1.1 和 mRECIST1.1 之间放射学反应分类的一致性。计算 C 指数以评估这两个标准的放射学反应的预后准确性。对无进展生存期（PFS）和总生存期（OS）进行Kaplan-Meier法和Cox回归分析。结果 根据 RECIST1.1，任何器官至少有两个目标病变的 87 名患者有资格进行比较分析。使用 RECIST1.1 和 mRECIST1.1 测量时，肿瘤反应显示出极好的一致性（Kappa = 0.961）。根据这两个标准，PFS（0.784 与 0.785）和 OS（0.649 与 0.652）的 C 指数相似。无论采用哪种标准，响应者的 PFS 和 OS 均明显长于无响应者 (p < 0.05)。在多变量分析中，放射学反应仍然是 PFS 和 OS 的重要预测因素 (p < 0.05)。结论 mRECIST1.1 在接受单药 PD-1/PD-L1 抑制剂治疗的 aNSCLC 患者中的疗效评估与 RECIST1.1 相当。mRECIST1.1减少了待测量的病灶数量，可能足以且更方便地评估临床实践中的抗肿瘤活性。