Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, 2-17-77 Higashi, Naniwa-cho, Amagasaki, Hyogo, 660-8550, Japan.
Department of Internal Medicine, Japan Community Healthcare Organization, Osaka Hospital, Osaka, Japan.
Cancer Chemother Pharmacol. 2018 Feb;81(2):333-337. doi: 10.1007/s00280-017-3498-z. Epub 2017 Dec 11.
The immune-related response criteria (irRC) were proposed to incorporate pseudo-progression. However, the association between the irRC and overall survival (OS) has yet to be evaluated in non-small cell lung cancer (NSCLC). Therefore, the purpose of this study is to evaluate the concordance between the response evaluation criteria in solid tumors (RECIST) version 1.1 and the irRC in patients with NSCLC treated with nivolumab, as well as, to determine the relationship between these two response criteria and OS.
We conducted a retrospective cohort study of 143 patients at three tertiary care hospitals in Japan between January and December 2016 (UMIN000022014).
The weighted kappa statistic for the two response criteria was 0.72 (95% confidence interval (CI) 0.66-0.76). The Harrell's C-index was 0.74 (95% CI 0.68-0.80) for the RECIST and 0.74 (95% CI 0.68-0.80) for the irRC, respectively. The difference between the two criteria was - 0.002 (95% CI - 0.05 to 0.04). The Moreau, O'Quigley, and Lellouch statistic was 0.03 for the RECIST and 0.17 for the irRC, respectively.
We demonstrated a good concordance between the RECIST and the irRC for predicting OS in patients with NSCLC treated with nivolumab.
免疫相关缓解标准（irRC）的提出是为了纳入假性进展。然而，irRC 与非小细胞肺癌（NSCLC）患者的总生存期（OS）之间的关联尚未得到评估。因此，本研究旨在评估nivolumab 治疗 NSCLC 患者中实体瘤反应评估标准（RECIST）1.1 版和 irRC 之间的一致性，并确定这两种反应标准与 OS 之间的关系。
我们对 2016 年 1 月至 12 月在日本三家三级保健医院的 143 名患者进行了回顾性队列研究（UMIN000022014）。
两种反应标准的加权 Kappa 统计量为 0.72（95%置信区间（CI）0.66-0.76）。RECIST 的 Harrell's C 指数为 0.74（95%CI 0.68-0.80），irRC 为 0.74（95%CI 0.68-0.80）。两种标准之间的差异为-0.002（95%CI-0.05 至 0.04）。RECIST 的 Moreau、O'Quigley 和 Lellouch 统计量为 0.03，irRC 为 0.17。
我们证明了 RECIST 和 irRC 在预测 nivolumab 治疗 NSCLC 患者 OS 方面具有良好的一致性。
