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比较纳武利尤单抗治疗晚期肺癌患者时 RECIST 和 iRECIST 标准。

Comparison of RECIST and iRECIST criteria in patients with advanced lung cancer treated with nivolumab.

机构信息

Department of Radiology, Rajiv Gandhi Cancer Institute and Research Centre, Delhi, India.

School of Engineering and Computer Sciences, Jawaharlal Nehru University, Delhi, India.

出版信息

J Cancer Res Ther. 2023 Jul-Sep;19(5):1212-1218. doi: 10.4103/jcrt.jcrt_1456_21.

DOI:10.4103/jcrt.jcrt_1456_21
PMID:37787285
Abstract

BACKGROUND

Systemic therapy in lung cancer is mainstay of treatment as most patients present in advanced stages, with rising importance of new immunotherapy agents.

PURPOSE

To compare the RECIST 1.1 and the immunotherapy Response Evaluation Criteria in Solid Tumors (iRECISTs) criteria for response assessment in lung cancer patients on immunotherapy. To find the incidence of pseudoprogression and associated imaging patterns.

MATERIAL AND METHODS

Retrospective study in 28 patients treated with immunotherapy for advanced metastatic NSCLC. End points were progression-free survival (PFS) and overall survival (OS). Response assessments were separately tabulated according to RECIST 1.1 and iRECIST and classified into dichotomous groups of responders and nonresponders. Agreement in assessments between RECIST 1.0 and iRECIST examined using Cohen kappa (κ) coefficient with 95% confidence intervals. Kaplan-Meier survival analysis was done for PFS and OS. Differences between RECIST 1.1 and iRECIST for both responder and nonresponder were evaluated by the log rank test, Breslow (Generalized Wilcoxon) test, and Tarone-Ware test.

RESULTS

Incidence of pseudoprogression was 7% (2/28). The RECIST1.1 and iRECIST were in disagreement in two patients. The agreement between RECIST and iRECIST was almost perfect. The PFS and the OS are significantly longer in duration for responders in comparison to nonresponders for both RECIST and iRECIST and the difference between two assessment criteria is not significant.

CONCLUSION

Although iRECIST aims to monitor treatment more precisely than conventional response criteria, this must be weighed against how infrequent pseudoprogression is and the cost of this therapy, both financially and in the potential delay in changing to a more effective treatment.

摘要

背景

由于大多数肺癌患者处于晚期,因此系统治疗是治疗的主要手段,新型免疫治疗药物的重要性日益增加。

目的

比较 RECIST 1.1 和免疫治疗实体瘤反应评估标准(iRECISTs)在评估肺癌患者免疫治疗反应中的应用。寻找假性进展的发生率和相关的影像学模式。

材料和方法

回顾性研究了 28 例接受免疫治疗的晚期转移性 NSCLC 患者。终点是无进展生存期(PFS)和总生存期(OS)。根据 RECIST 1.1 和 iRECIST 分别单独列出反应评估,并分为应答者和无应答者的二分类组。使用 Cohen kappa(κ)系数(95%置信区间)检查 RECIST 1.0 和 iRECIST 之间评估的一致性。进行 Kaplan-Meier 生存分析以评估 PFS 和 OS。通过对数秩检验、Breslow(广义Wilcoxon)检验和 Tarone-Ware 检验评估 RECIST 1.1 和 iRECIST 对应答者和无应答者的差异。

结果

假性进展的发生率为 7%(2/28)。在 2 名患者中,RECIST1.1 和 iRECIST 存在分歧。RECIST 和 iRECIST 之间的一致性几乎是完美的。与无应答者相比,应答者的 PFS 和 OS 持续时间明显更长,无论是 RECIST 还是 iRECIST 评估标准,两者之间的差异均无统计学意义。

结论

尽管 iRECIST 旨在比传统的反应标准更精确地监测治疗,但必须权衡假性进展的罕见性以及这种治疗的成本,包括经济成本和潜在的治疗效果延迟。

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