Respiratory Oncology Unit, Otto-Wagner Hospital, Vienna.
Department of Internal Medicine I & CCC, Medical University of Vienna, Vienna, Austria.
Clin Nucl Med. 2019 Jul;44(7):535-543. doi: 10.1097/RLU.0000000000002603.
The aim of this study was to compare the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, the immune RECIST (iRECIST) criteria, and the Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) 1.0 in patients with advanced non-small cell lung cancer treated with programmed cell death protein 1 (PD-1)/programmed cell death protein 1 ligand (PD-L1) inhibitors.
This prospective study of 42 patients treated with a PD-1/PD-L1 inhibitor was approved by our institutional review board, and all patients gave written, informed consent. Tumor burden dynamics were assessed on F-FDG PET/CT before and after treatment initiation. Immunotherapeutic responses were evaluated according to RECIST 1.1, iRECIST, and PERCIST 1.0 for the dichotomous groups, responders versus nonresponders. Cohen κ and Wilcoxon signed rank tests were used to evaluate concordance among these criteria. We assessed progression-free survival and overall survival using the Kaplan-Meier estimator.
The RECIST 1.1 and PERCIST 1.0 response classifications were discordant in 6 patients (14.2%; κ = 0.581). RECIST 1.1 and iRECIST were discordant in 2 patients, who evidenced pseudoprogression after treatment initiation. Median progression-free survival, as well as overall survival, was significantly longer for responders compared with nonresponders for all criteria (P < 0.001), with no significant difference between the 3 criteria (P > 0.05).
RECIST 1.1 and PERCIST 1.0 show only moderate agreement, but both can predict treatment response to PD-1/PD-L1 inhibitor therapy. In case of pseudoprogression, metabolic tumor activity may help to correctly classify treatment response.
本研究旨在比较晚期非小细胞肺癌患者接受程序性死亡蛋白 1（PD-1）/程序性死亡蛋白 1 配体（PD-L1）抑制剂治疗时，实体瘤反应评估标准 1.1（RECIST 1.1）、免疫 RECIST（iRECIST）标准和实体瘤正电子发射断层扫描反应标准 1.0（PERCIST 1.0）的疗效。
本前瞻性研究纳入了 42 例接受 PD-1/PD-L1 抑制剂治疗的患者，该研究已获得我院伦理审查委员会批准，所有患者均签署了书面知情同意书。在治疗开始前后，通过 F-FDG PET/CT 评估肿瘤负荷的动态变化。根据 RECIST 1.1、iRECIST 和 PERCIST 1.0 对二分类组（应答者与无应答者）进行免疫治疗反应评估。采用 Cohen κ 和 Wilcoxon 符号秩检验评估这些标准之间的一致性。采用 Kaplan-Meier 估计法评估无进展生存期和总生存期。
在 6 例患者（14.2%）中，RECIST 1.1 和 PERCIST 1.0 的反应分类不一致（κ=0.581）。2 例患者在治疗开始后出现假性进展，其 RECIST 1.1 和 iRECIST 分类不一致。对于所有标准，与无应答者相比，应答者的无进展生存期和总生存期均显著延长（均 P<0.001），但 3 种标准之间无显著差异（均 P>0.05）。
RECIST 1.1 和 PERCIST 1.0 仅具有中等一致性，但均能预测 PD-1/PD-L1 抑制剂治疗的反应。在出现假性进展的情况下，代谢肿瘤活性可能有助于正确分类治疗反应。
