Performance of Ventana <scp>SP263 PD‐L1</scp> assay in endobronchial ultrasound <scp>guided‐fine</scp>‐needle aspiration derived <scp>non‐small</scp>‐cell lung carcinoma samples

Chauhan, Aastha; Siegel, Lianne; Freese, Rebecca; Racila, Emilian; Stewart, Jimmie; Amin, Khalid

doi:10.1002/dc.24654

Cited by 8 publications

(12 citation statements)

References 34 publications

(52 reference statements)

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“…Recent studies evaluated PD-L1 expression in cell blocks and compared it with expression in paired biopsy or resection specimens. Using a three-tiered PD-L1 TPS categorization, the overall concordance rate between paired cytology and histology specimens was approximately 67-91.2% (25)(26)(27)(28)(29)(30)(31). Our study provides some insights into PD-L1 testing of paired biopsy and cytology specimens.…”

Section: Discussionmentioning

confidence: 73%

PD-L1 expression in non-small cell lung cancer: heterogeneity by pathologic types, tissue sampling and metastasis

Wang¹,

Jin²,

Zheng³

et al. 2021

J Thorac Dis

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Background: Programmed cell death ligand-1 (PD-L1) is a predictive marker of anti-PD-1/PD-L1 therapy response. Intra-tumour heterogeneity of PD-L1 expression has been reported in non-small cell lung cancer (NSCLC), but comprehensive studies regarding the determination of PD-L1 expression in different materials are still lacking. Therefore, we aimed to compare PD-L1 expression in paired tumour samples and in different specimen types. Methods: A total of 1,002 resected NSCLC specimens, 35 biopsy specimens and 54 endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) samples were performed PD-L1 immunohistochemistry (IHC) testing using the 22C3 assay. PD-L1 expression was evaluated using the tumour proportion score (TPS) and categorized into three levels: negative (TPS <1%), low expression (TPS 1-49%) and high expression (TPS ≥50%). Results: A total of 1,002 resected NSCLC specimens, including 852 adenocarcinomas (ADCs) and 150 squamous cell carcinomas (SCCs); 35 paired biopsy and resected samples; 54 paired cell block and biopsy samples; 53 paired blocks from the same resected tissue and 49 paired primary and metastatic lesion samples were included in this study. Interestingly, high PD-L1 expression was significantly more frequent in poorly differentiated subtypes than in well-differentiated subtypes in the ADC subgroup (P<0.001). In the SCC subgroup, high PD-L1 expression was significantly more associated with the nonkeratinizing type than the keratinizing type (P=0.001). PD-L1 expression differed between cell blocks and matched biopsy specimens (discordance rate =11.1%, 6/54) and between biopsy and matched resected specimens (discordance rate =31.4%, 11/35). PD-L1 expression differed between different paraffin blocks from the same resected specimen (discordance rate =35.8%, 19/53), and the discordance rate of PD-L1 expression between primary tumours and matched lymph node metastases was 28.6% (14/49). Conclusions: Discordant PD-L1 expression is not uncommon in NSCLC and warrants additional studies and serious consideration when interpreting PD-L1 test results. Initial negative test results may lead to repeat PD-L1 testing in additional samples or the use of a different clone if necessary.

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Section: Discussionmentioning

confidence: 73%

PD-L1 expression in non-small cell lung cancer: heterogeneity by pathologic types, tissue sampling and metastasis

Wang¹,

Jin²,

Zheng³

et al. 2021

J Thorac Dis

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“…Wang et al 66 determined that de‐stained Papanicolaou smears were inferior to cell blocks in detecting PD‐L1 due to reduced sensitivity. Methanol based fixatives used in liquid‐based preparations appeared to have high rates of false negatives and low‐intensity staining 54 . Similarly, Diff‐Quik and other Romanosky stained air dried preparations were shown to have high rates of false negatives 20,54 .…”

Section: Resultsmentioning

confidence: 94%

“…These studies have been associated with kappas ranging from 0.31, 34 0.38, 35 and 0.39 36 consistent with fair agreement to 0.68, 37 0.91, 38 0.82, 39 and 0.73 40 associated with substantial agreement. Many studies have not published formal kappa statistics for agreement but have published percentage agreements varying from 74.1% to 97.3% 13,18–20,24,41–56 . The concordance rates appear to be impacted by precise specimen type and antibody clone used.…”

Section: Resultsmentioning

confidence: 99%

PD‐L1 immunohistochemical testing: A review with reference to cytology specimens

Layfield

Zhang²,

Esebua

2022

Diagnostic Cytopathology

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Background: Immunotherapy based on disruption of the PD-1/PD-L1 axis is standard of care for many high stage malignancies including melanomas, non-small cell carcinomas of the lung, triple negative breast carcinomas, and squamous cell carcinomas of the head and neck. Eligibility for immunotherapy requires immunohistochemical assessment of PD-L1 expression. Currently, many high stage malignancies are diagnosed by cytology and cytologic material is the only specimen available for ancillary testing. Formal guidelines do not currently exist defining the optimal specimen type, antibody to be used or the best scoring system for cytologic material. Significant information has been published for PD-L1 testing of pulmonary specimens but much less data exists for the reproducibility, accuracy and best practices for material obtained from other body sites and types of malignancy. Methods:We searched the PubMed data base for manuscripts relating to PD-L1 testing of cytologic specimens. The search period was between 2016 and 2022. The search terms used were PD-L1, cytology, FNA, immunotherapy, immunohistochemistry, immunocytochemistry, cytology-histology correlation. Cross referencing techniques were used to screen for the most relevant manuscripts. The abstracts of these were then reviewed for final data collection and analysis.Results: A total of 86 studies were identified conforming to study relevancy. These were reviewed in their entirety by two authors (LJL, TZ) for extraction of data. The majority of studies involved pulmonary specimens (79) with three relating to PD-L1 testing of head and neck cytologic specimens and one each for PD-L1 testing of cytology specimens from melanomas, pancreas, pleural fluids, and triple negative breast carcinomas. While smears could be used, most studies found cell blocks optimal for testing.Summary: Currently, four drugs are approved for immunotherapy based on PD-L1 status. These drugs require specific antibody clones as well as scoring systems. Scoring systems and cut points vary with the type of neoplasm being treated. Cytology specimens from the lung, head and neck and melanomas can all be used for PD-L1 testing with good agreement with corresponding histology specimens.

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“…Studies analyzing PD‐L1 testing on lung carcinoma cytology specimens originated mostly from the USA, followed by publications arising from Italy, Canada, United Kingdom, China, Germany, Japan, India, Turkey and other countries. The Dako clone 22C3 was the most common clone analyzed on cytology specimens, followed by the Ventana SP263 clone 17–67 . The data collected included the clone type used in each study.…”

Section: Resultsmentioning

confidence: 99%

Program death ligand‐1 immunocytochemistry in lung cancer cytological samples: A systematic review

Satturwar

Girolami

Munari

et al. 2022

Diagnostic Cytopathology

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In this era of personalized medicine, targeted immunotherapies like immune checkpoint inhibitors (ICI) blocking the programmed death-1 (PD-1)/program death ligand-1 (PD-L1) axis have become an integral part of treating advanced stage non-small cell lung carcinoma (NSCLC) and many other cancer types. Multiple monoclonal antibodies are available commercially to detect PD-L1 expression in tumor cells by immunohistochemistry (IHC). As most clinical trials initially required tumor biopsy for PD-L1 detection by IHC, many of the currently available PD-1/PD-L1 assays have been developed and validated on formalin fixed tissue specimens. The majority (>50%) of lung cancer cases do not have a surgical biopsy or resection specimen available for ancillary testing and instead must rely primarily on fine needle aspiration biopsy specimens for diagnosis, staging and ancillary tests. Review of the literature shows multiple studies exploring the feasibility of PD-L1 IHC on cytological samples. In addition, there are studies addressing various aspects of IHC validation on cytology preparations including pre-analytical (e.g., different fixatives), analytical (e.g., antibody clone, staining platforms, inter and intra-observer agreement, cytology-histology concordance) and post-analytical (e.g., clinical outcome) issues. Although promising results in this field have emerged utilizing cytology samples, many important questions still need to be addressed. This review summarizes the literature of PD-L1 IHC in lung cytology specimens and provides practical tips for optimizing analysis.

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Performance of Ventana SP263 PD‐L1 assay in endobronchial ultrasound guided‐fine‐needle aspiration derived non‐small‐cell lung carcinoma samples

Cited by 8 publications

References 34 publications

PD-L1 expression in non-small cell lung cancer: heterogeneity by pathologic types, tissue sampling and metastasis

PD-L1 expression in non-small cell lung cancer: heterogeneity by pathologic types, tissue sampling and metastasis

PD‐L1 immunohistochemical testing: A review with reference to cytology specimens

Program death ligand‐1 immunocytochemistry in lung cancer cytological samples: A systematic review

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