Comparison of SP263 and 22C3 pharmDx assays to test programmed death ligand‐1 (PD‐L1) expression in surgically resected non‐small cell lung cancer

IF 2.3 3区医学 Q3 ONCOLOGY

Thoracic Cancer Pub Date : 2024-05-03 DOI:10.1111/1759-7714.15319

Naoko Shigeta, Shuji Murakami, Tomoyuki Yokose, Tetsuya Isaka, Kanako Shinada, Takuya Nagashima, Hiroyuki Adachi, Shunsuke Shigefuku, Kotaro Murakami, Jun Miura, Noritake Kikunishi, Kozue Watabe, Haruhiro Saito, Hiroyuki Ito

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引用次数: 0

Abstract

BackgroundAtezolizumab, one of the immune checkpoint inhibitors, has been approved as an adjuvant treatment following resection and platinum‐based chemotherapy in patients with stage II–IIIA non‐small cell lung cancer with 1% or more programmed death ligand‐1 (PD‐L1) expression. The Food and Drug Administration (FDA) has approved SP263 as a companion diagnostic assay for adjuvant treatment with atezolizumab; however, in clinical practice, the 22C3 assay is most commonly used for advanced non‐small cell lung cancer. Therefore, our study aimed to compare two PD‐L1 assays, SP263 and 22C3, to evaluate whether 22C3 could replace SP263 when deciding whether to administer adjuvant atezolizumab.MethodsWe retrospectively and prospectively analyzed 98 patients who underwent surgical resection at Kanagawa Cancer Center (Japan). An immunohistochemistry assay was performed for all the cases with both SP263 and 22C3. We statistically analyzed the concordance of PD‐L1 expression between SP263 and 22C3 assays.ResultsThe concordance between the two assays using Cohen's kappa was κ = 0.670 (95% CI: 0.522–0.818) at the 1% cutoff and κ = 0.796 (95% CI: 0.639–0.954) at the 50% cutoff. The Spearman correlation coefficient of 0.874 (p < 0.01) indicated high concordance. PD‐L1 expression with 22C3 resulted slightly higher than that with SP263.ConclusionsThis study showed a high concordance of PD‐L1 expression with the SP263 and 22C3 assays. Further studies examining the therapeutic effects of adjuvant atezolizumab are required.

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比较 SP263 和 22C3 pharmDx 检测法，以测试手术切除的非小细胞肺癌中程序性死亡配体-1 (PD-L1) 的表达情况

背景阿特珠单抗是免疫检查点抑制剂之一，已被批准用于铂类化疗后的辅助治疗，适用于程序性死亡配体-1（PD-L1）表达率达到或超过1%的II-IIIA期非小细胞肺癌患者。美国食品和药物管理局（FDA）已批准将 SP263 作为阿特珠单抗辅助治疗的辅助诊断测定；但在临床实践中，22C3测定最常用于晚期非小细胞肺癌。因此，我们的研究旨在比较 SP263 和 22C3 这两种 PD-L1 检测方法，以评估在决定是否使用阿特珠单抗辅助治疗时，22C3 是否能取代 SP263。所有病例均使用 SP263 和 22C3 进行了免疫组化检测。我们对 SP263 和 22C3 检测方法之间 PD-L1 表达的一致性进行了统计分析。结果两种检测方法之间的一致性（使用 Cohen's kappa）为：1% 临界值时，κ = 0.670（95% CI：0.522-0.818）；50% 临界值时，κ = 0.796（95% CI：0.639-0.954）。斯皮尔曼相关系数为 0.874 (p < 0.01)，表明两者高度一致。22C3检测的PD-L1表达略高于SP263。需要进一步研究辅助阿特珠单抗的治疗效果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Thoracic Cancer ONCOLOGY-RESPIRATORY SYSTEM

CiteScore

5.20

自引率

3.40%

发文量

439

审稿时长

2 months

期刊介绍： Thoracic Cancer aims to facilitate international collaboration and exchange of comprehensive and cutting-edge information on basic, translational, and applied clinical research in lung cancer, esophageal cancer, mediastinal cancer, breast cancer and other thoracic malignancies. Prevention, treatment and research relevant to Asia-Pacific is a focus area, but submissions from all regions are welcomed. The editors encourage contributions relevant to prevention, general thoracic surgery, medical oncology, radiology, radiation medicine, pathology, basic cancer research, as well as epidemiological and translational studies in thoracic cancer. Thoracic Cancer is the official publication of the Chinese Society of Lung Cancer, International Chinese Society of Thoracic Surgery and is endorsed by the Korean Association for the Study of Lung Cancer and the Hong Kong Cancer Therapy Society. The Journal publishes a range of article types including: Editorials, Invited Reviews, Mini Reviews, Original Articles, Clinical Guidelines, Technological Notes, Imaging in thoracic cancer, Meeting Reports, Case Reports, Letters to the Editor, Commentaries, and Brief Reports.