Performance Analysis of Leica Biosystems Monoclonal Antibody Programmed Cell Death Ligand 1 Clone 73-10 on Breast, Colorectal, and Hepatocellular Carcinomas.

IF 1.3 4区 医学 Q3 ANATOMY & MORPHOLOGY
Konstantin Shilo, Tiansheng Shen, Scott Hammond, Anil V Parwani, Zaibo Li, Shubham Dayal, Joseph Chiweshe, Fangru Lian
{"title":"Performance Analysis of Leica Biosystems Monoclonal Antibody Programmed Cell Death Ligand 1 Clone 73-10 on Breast, Colorectal, and Hepatocellular Carcinomas.","authors":"Konstantin Shilo, Tiansheng Shen, Scott Hammond, Anil V Parwani, Zaibo Li, Shubham Dayal, Joseph Chiweshe, Fangru Lian","doi":"10.1097/PAI.0000000000001202","DOIUrl":null,"url":null,"abstract":"<p><p>Programmed cell death receptor 1/Programmed cell death ligand 1 (PD-L1) checkpoint pathway is responsible for the control of immune cell responses. Immunotherapy using checkpoint inhibitors, such as anti-PD-L1 therapy, aids disease management and potentiates clinical outcomes. This study aimed to analyze the performance of the Leica Biosystems (LBS) USA FDA class I in vitro diagnostic monoclonal antibody (clone 73-10) to detect PD-L1 expression in breast, colorectal, and hepatocellular carcinomas compared with the class III FDA-approved PD-L1 detecting antibodies [SP263 (Ventana), 22C3 (Dako), and 28-8 (Dako)] using 208 unique tissue microarray-based cases for each tumor type. The interassay concordances between LBS 73-10 clone and other PD-L1 antibodies ranged from 0.59 to 0.95 Cohen kappa coefficient (K) and from 0.66 to 0.90 (K) for cutoff values of 1% and 50% tumor proportion score (TPS), respectively. The 73-10 clones showed inter-pathologist agreements ranging from 0.53 to 1.0 (K) and 0.34 to 0.94 (K) for cutoff values of 1% and 50% TPS, respectively. For the immune cell proportion score (IPS) using a cutoff of 1%, the Kappa coefficient of interassay concordances and inter-pathologist agreements ranged from 0.34 to 0.94. The 73-10 clone assay's sensitivity ranged from 78.3% to 100% (TPS ≥1%), 100% (TPS ≥50%), and 77.4% to 93.5% (IPS ≥1%), while its specificity was 97.9% to 100% (TPS ≥1%), 99.5% to 99.8% (TPS ≥50%), and 97.9% to 100% (IPS ≥1%). This exploratory evaluation of LBS 73-10 monoclonal antibody on a large set of breast, colorectal, and hepatocellular carcinomas showed the assay's technical performance is comparable to the FDA-approved companion/complementary diagnostics PD-L1 detection assays.</p>","PeriodicalId":48952,"journal":{"name":"Applied Immunohistochemistry & Molecular Morphology","volume":null,"pages":null},"PeriodicalIF":1.3000,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11227302/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Applied Immunohistochemistry & Molecular Morphology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/PAI.0000000000001202","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/5/10 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"ANATOMY & MORPHOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Programmed cell death receptor 1/Programmed cell death ligand 1 (PD-L1) checkpoint pathway is responsible for the control of immune cell responses. Immunotherapy using checkpoint inhibitors, such as anti-PD-L1 therapy, aids disease management and potentiates clinical outcomes. This study aimed to analyze the performance of the Leica Biosystems (LBS) USA FDA class I in vitro diagnostic monoclonal antibody (clone 73-10) to detect PD-L1 expression in breast, colorectal, and hepatocellular carcinomas compared with the class III FDA-approved PD-L1 detecting antibodies [SP263 (Ventana), 22C3 (Dako), and 28-8 (Dako)] using 208 unique tissue microarray-based cases for each tumor type. The interassay concordances between LBS 73-10 clone and other PD-L1 antibodies ranged from 0.59 to 0.95 Cohen kappa coefficient (K) and from 0.66 to 0.90 (K) for cutoff values of 1% and 50% tumor proportion score (TPS), respectively. The 73-10 clones showed inter-pathologist agreements ranging from 0.53 to 1.0 (K) and 0.34 to 0.94 (K) for cutoff values of 1% and 50% TPS, respectively. For the immune cell proportion score (IPS) using a cutoff of 1%, the Kappa coefficient of interassay concordances and inter-pathologist agreements ranged from 0.34 to 0.94. The 73-10 clone assay's sensitivity ranged from 78.3% to 100% (TPS ≥1%), 100% (TPS ≥50%), and 77.4% to 93.5% (IPS ≥1%), while its specificity was 97.9% to 100% (TPS ≥1%), 99.5% to 99.8% (TPS ≥50%), and 97.9% to 100% (IPS ≥1%). This exploratory evaluation of LBS 73-10 monoclonal antibody on a large set of breast, colorectal, and hepatocellular carcinomas showed the assay's technical performance is comparable to the FDA-approved companion/complementary diagnostics PD-L1 detection assays.

Leica Biosystems 单克隆抗体程序性细胞死亡配体 1 克隆 73-10 在乳腺癌、结直肠癌和肝细胞癌上的性能分析。
程序性细胞死亡受体1/程序性细胞死亡配体1(PD-L1)检查点通路负责控制免疫细胞反应。使用检查点抑制剂(如抗PD-L1疗法)的免疫疗法有助于疾病管理和提高临床疗效。本研究旨在分析徕卡生物系统公司(LBS)的美国 FDA I 类体外诊断单克隆抗体(克隆 73-10)与 FDA 批准的 III 类 PD-L1 检测抗体[SP263(Ventana)、22C3(Dako)和 28-8(Dako)]在检测乳腺癌、结直肠癌和肝细胞癌中的 PD-L1 表达方面的性能比较。LBS 73-10 克隆与其他 PD-L1 抗体的测定间一致性为 0.59 至 0.95 Cohen kappa coefficient (K),截断值为 1%和 50%的肿瘤比例评分(TPS)分别为 0.66 至 0.90 (K)。73-10克隆的病理学家之间的一致性在1%和50% TPS的临界值上分别为0.53至1.0(K)和0.34至0.94(K)。免疫细胞比例评分(IPS)的临界值为 1%,测定间一致性和病理学家间一致性的 Kappa 系数范围为 0.34 至 0.94。73-10 克隆测定的灵敏度为 78.3%至 100%(TPS ≥1%)、100%(TPS ≥50%)和 77.4%至 93.5%(IPS ≥1%),特异性为 97.9%至 100%(TPS ≥1%)、99.5%至 99.8%(TPS ≥50%)和 97.9%至 100%(IPS ≥1%)。LBS 73-10单克隆抗体对大量乳腺癌、结直肠癌和肝细胞癌的探索性评估表明,该检测方法的技术性能与FDA批准的辅助/补充诊断PD-L1检测方法相当。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Applied Immunohistochemistry & Molecular Morphology
Applied Immunohistochemistry & Molecular Morphology ANATOMY & MORPHOLOGY-MEDICAL LABORATORY TECHNOLOGY
CiteScore
3.20
自引率
0.00%
发文量
153
期刊介绍: ​Applied Immunohistochemistry & Molecular Morphology covers newly developed identification and detection technologies, and their applications in research and diagnosis for the applied immunohistochemist & molecular Morphologist. Official Journal of the International Society for Immunohistochemisty and Molecular Morphology​.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信