Dataset related to article "Comparison of Metabolic and Morphological Response Criteria for Early Prediction of Response and Survival in NSCLC Patients Treated With Anti-PD-1/PD-L1"

This record contains raw data related to article "Comparison of Metabolic and Morphological Response Criteria for Early Prediction of Response and Survival in NSCLC Patients Treated With Anti-PD-1/PD-L1"

Abstract

Introduction/Aim: Immunotherapy with immune checkpoint inhibitors (ICIs) has positively changed the history of several malignant tumors. In parallel, new challenges have emerged in the evaluation of treatment response as a result of their peculiar anticancer effect. In the current study, we aimed to compare different response criteria, both morphological and metabolic, for assessing response and outcome in patients with advanced non-small cell lung cancer (NSCLC) treated with ICI. Materials and Methods: Overall, 52 patients with advanced NSCLC candidate to ICI were prospectively evaluated. Inclusion criteria comprised whole-body contrast-enhanced CT and 18F-FDG PET/CT at baseline and at the first response evaluation 3 or 4 cycles after ICI. Response assessment on CT was performed according to RECIST 1.1 and imRECIST criteria, whereas metabolic response on PET was computed by EORTC, PERCIST, imPERCIST, and PERCIMT criteria. The concordance between the different tumor response criteria and the performance of each criterion to predict progression-free survival (PFS) and overall survival (OS) were calculated. Results: Inclusion criteria were fulfilled in 35 out of 52 patients. We observed a low agreement between imRECIST and imPERCIST (κ = 0.143) with discordant response in 20 patients, particularly regarding stable disease and progressive disease groups. Fair agreement between imRECIST and EORTC (κ = 0.340), and PERCIST (κ = 0.342), and moderate for PERCIMT (κ = 0.413) were detected. All criteria were significantly associated with PFS, while only PERCIMT and imPERCIST were associated with OS. Of note, in patients classified as immune stable disease (iSD), imPERCIST, and PERCIMT well-differentiated those with longer PFS (p < 0.001, p = 0.009) and OS (p = 0.001, p = 0.002). In the multivariate analysis, performance status [hazard ratio (HR) = 0.278, p = 0.015], imRECIST (HR = 3.799, p = 0.026), and imPERCIST (HR = 4.064, p = 0.014) were predictive factors for PFS, while only performance status (HR = 0.327, p = 0.035) and imPERCIST (HR = 3.247, p = 0.007) were predictive for OS. Conclusions: At the first evaluation during treatment with ICI, imPERCIST criteria correctly evaluated treatment response and appeared able to predict survival. Moreover, in patients with iSD on CT, imPERCIST were able to discriminate those with longer survival. This advantage might allow for earlier therapy modification based on metabolic response

本数据集包含与论文《抗PD-1/PD-L1治疗非小细胞肺癌（non-small cell lung cancer, NSCLC）患者早期疗效及生存预测的代谢与形态学疗效评价标准比较》相关的原始数据。

摘要

引言/研究目的：免疫检查点抑制剂（immune checkpoint inhibitors, ICIs）免疫治疗已重塑多种恶性肿瘤的诊疗格局。与此同时，由于其独特的抗肿瘤作用机制，治疗疗效评估面临全新挑战。本研究旨在对比多种形态学及代谢性疗效评价标准，以评估接受免疫检查点抑制剂治疗的晚期非小细胞肺癌患者的治疗应答与预后。

材料与方法：前瞻性入组共52例拟接受免疫检查点抑制剂治疗的晚期非小细胞肺癌患者。纳入标准为：治疗基线及免疫检查点抑制剂治疗3~4个周期后首次疗效评估时，均完成全身增强CT及18F-FDG PET/CT检查。CT疗效评估依据实体瘤疗效评价标准1.1版（Response Evaluation Criteria in Solid Tumors 1.1, RECIST 1.1）及免疫相关实体瘤疗效评价标准（immune-related Response Evaluation Criteria in Solid Tumors, imRECIST）进行；PET代谢疗效评估则分别采用欧洲癌症研究与治疗组织（European Organisation for Research and Treatment of Cancer, EORTC）标准、实体瘤代谢疗效评价标准（PET Response Criteria in Solid Tumors, PERCIST）、免疫相关实体瘤代谢疗效评价标准（immune-related PET Response Criteria in Solid Tumors, imPERCIST）及转移性肿瘤代谢成像疗效评价标准（PET Response Criteria in Metastatic Tumors, PERCIMT）。计算不同肿瘤疗效评价标准间的一致性，以及各标准预测无进展生存期（progression-free survival, PFS）与总生存期（overall survival, OS）的效能。

结果：52例患者中共有35例符合纳入标准。研究观察到imRECIST与imPERCIST间一致性较低（κ=0.143），20例患者存在疗效评估结果不一致的情况，尤其在疾病稳定与疾病进展亚组中差异显著。imRECIST与EORTC（κ=0.340）、PERCIST（κ=0.342）间一致性尚可，与PERCIMT间则具有中等程度一致性（κ=0.413）。所有评价标准均与无进展生存期显著相关，而仅PERCIMT与imPERCIST与总生存期相关。值得注意的是，在CT评估为免疫相关性疾病稳定（immune stable disease, iSD）的患者中，imPERCIST与PERCIMT可有效区分无进展生存期更长（p<0.001, p=0.009）及总生存期更长（p=0.001, p=0.002）的亚组。多因素分析显示，体能状态[风险比（hazard ratio, HR）=0.278, p=0.015]、imRECIST（HR=3.799, p=0.026）及imPERCIST（HR=4.064, p=0.014）为无进展生存期的独立预测因素；而仅体能状态（HR=0.327, p=0.035）与imPERCIST（HR=3.247, p=0.007）为总生存期的独立预测因素。

结论：在免疫检查点抑制剂治疗期间的首次疗效评估中，imPERCIST标准可准确评估治疗应答，且能够预测患者生存预后。此外，对于CT评估为iSD的患者，imPERCIST可有效甄别生存时间更长的亚组，这一优势可为基于代谢应答的早期治疗方案调整提供依据。