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使用22C3抗程序性死亡配体1(PD-L1)抗体在多个自动化免疫组织化学平台上检测PD-L1表达。

Use of the 22C3 anti-PD-L1 antibody to determine PD-L1 expression in multiple automated immunohistochemistry platforms.

作者信息

Ilie Marius, Khambata-Ford Shirin, Copie-Bergman Christiane, Huang Lingkang, Juco Jonathan, Hofman Veronique, Hofman Paul

机构信息

Université Côte d'Azur, University Hospital Federation OncoAge, Laboratory of Clinical and Experimental Pathology, Hôpital Pasteur, Nice, France.

Université Côte d'Azur, University Hospital Federation OncoAge, Hospital-Related Biobank, Hôpital Pasteur, Nice, France.

出版信息

PLoS One. 2017 Aug 10;12(8):e0183023. doi: 10.1371/journal.pone.0183023. eCollection 2017.

DOI:10.1371/journal.pone.0183023
PMID:28797130
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5552229/
Abstract

BACKGROUND

For non-small cell lung cancer (NSCLC), treatment with pembrolizumab is limited to patients with tumours expressing PD-L1 assessed by immunohistochemistry (IHC) using the PD-L1 IHC 22C3 pharmDx (Dako, Inc.) companion diagnostic test, on the Dako Autostainer Link 48 (ASL48) platform. Optimised protocols are urgently needed for use of the 22C3 antibody concentrate to test PD-L1 expression on more widely available IHC autostainers.

METHODS

We evaluated PD-L1 expression using the 22C3 antibody concentrate in the three main commercially available autostainers Dako ASL48, BenchMark ULTRA (Ventana Medical Systems, Inc.), and Bond-III (Leica Biosystems) and compared the staining results with the PD-L1 IHC 22C3 pharmDx kit on the Dako ASL48 platform. Several technical conditions for laboratory-developed tests (LDTs) were evaluated in tonsil specimens and a training set of three NSCLC samples. Optimised protocols were then validated in 120 NSCLC specimens.

RESULTS

Optimised protocols were obtained on both the VENTANA BenchMark ULTRA and Dako ASL48 platforms. Significant expression of PD-L1 was obtained on tissue controls with the Leica Bond-III autostainer when high concentrations of the 22C3 antibody were used. It therefore was not tested on the 120 NSCLC specimens. An almost 100% concordance rate for dichotomized tumour proportion score (TPS) results was observed between TPS ratings using the 22C3 antibody concentrate on the Dako ASL48 and VENTANA BenchMark ULTRA platforms relative to the PD-L1 IHC 22C3 pharmDx kit on the Dako ASL48 platform. Interpathologist agreement was high on both LDTs and the PD-L1 IHC 22C3 pharmDx kit on the Dako ASL48 platform.

CONCLUSION

Availability of standardized protocols for determining PD-L1 expression using the 22C3 antibody concentrate on the widely available Dako ASL48 and VENTANA BenchMark ULTRA IHC platforms will expand the number of laboratories able to determine eligibility of patients with NSCLC for treatment with pembrolizumab in a reliable and concordant manner.

摘要

背景

对于非小细胞肺癌(NSCLC),帕博利珠单抗的治疗仅限于那些通过使用PD-L1 IHC 22C3 pharmDx(达科公司)配套诊断检测,在达科自动染色仪Link 48(ASL48)平台上经免疫组织化学(IHC)评估肿瘤表达PD-L1的患者。迫切需要优化方案,以便使用22C3抗体浓缩液在更广泛使用的免疫组化自动染色仪上检测PD-L1表达。

方法

我们使用22C3抗体浓缩液在三种主要的商用自动染色仪——达科ASL48、BenchMark ULTRA(文塔纳医疗系统公司)和Bond-III(徕卡生物系统公司)上评估了PD-L1表达,并将染色结果与达科ASL48平台上的PD-L1 IHC 22C3 pharmDx试剂盒进行了比较。在扁桃体标本和一组包含三个NSCLC样本的训练集中评估了实验室开发检测(LDT)的几个技术条件。然后在120例NSCLC标本中验证了优化方案。

结果

在VENTANA BenchMark ULTRA和达科ASL48平台上均获得了优化方案。当使用高浓度的22C3抗体时,使用徕卡Bond-III自动染色仪在组织对照上获得了显著的PD-L1表达。因此未在120例NSCLC标本上进行检测。相对于达科ASL48平台上的PD-L1 IHC 22C3 pharmDx试剂盒,在达科ASL48和VENTANA BenchMark ULTRA平台上使用22C3抗体浓缩液进行二分法肿瘤比例评分(TPS)结果的一致性率接近100%。在LDT和达科ASL48平台上的PD-L1 IHC 22C3 pharmDx试剂盒上,病理医生之间的一致性都很高。

结论

在广泛使用的达科ASL48和VENTANA BenchMark ULTRA免疫组化平台上,使用22C3抗体浓缩液测定PD-L1表达的标准化方案的可用性,将使能够以可靠且一致的方式确定NSCLC患者是否适合接受帕博利珠单抗治疗的实验室数量增加。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2b8/5552229/4a8bdc0198c3/pone.0183023.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2b8/5552229/19b8500a5bae/pone.0183023.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2b8/5552229/4582ded58d83/pone.0183023.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2b8/5552229/4a8bdc0198c3/pone.0183023.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2b8/5552229/19b8500a5bae/pone.0183023.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2b8/5552229/4582ded58d83/pone.0183023.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d2b8/5552229/4a8bdc0198c3/pone.0183023.g003.jpg

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