Comparison of three PD-L1 immunohistochemical assays in head and neck squamous cell carcinoma (HNSCC)
Expression of programmed cell death-ligand 1 (PD-L1) is being used as predictive biomarker for immunotherapy in head and neck squamous cell carcinoma (HNSCC). Several antibodies are available for PD-L1 testing and multiple staining and scoring methods are used. This study aimed to compare the perfor...
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Veröffentlicht in: | Modern pathology 2021-06, Vol.34 (6), p.1125-1132 |
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creator | de Ruiter, Emma J. Mulder, Frans J. Koomen, Bregje M. Speel, Ernst-Jan van den Hout, Mari F. C.M. de Roest, Reinout H. Bloemena, Elisabeth Devriese, Lot A. Willems, Stefan M. |
description | Expression of programmed cell death-ligand 1 (PD-L1) is being used as predictive biomarker for immunotherapy in head and neck squamous cell carcinoma (HNSCC). Several antibodies are available for PD-L1 testing and multiple staining and scoring methods are used. This study aimed to compare the performance of two PD-L1 standardized assays (SP263 and 22C3 pharmDx) and one laboratory-developed test (LDT) (22C3) in HNSCC using the tumor proportion score (TPS) and the combined positive score (CPS). Pretreatment biopsies from 147 HNSCC patients were collected in a tissue-microarray (TMA). Serial sections of the TMA were immunohistochemically stained for PD-L1 expression using 22C3 pharmDx on the Dako Link 48 platform, SP263 on the Ventana Benchmark Ultra platform, and 22C3 as an LDT on the Ventana Benchmark Ultra. Stained slides were assessed for TPS and CPS. Cutoffs of ≥1% and ≥50% for TPS and ≥1 and ≥20 for CPS were used. Concordance between the different staining assays was moderate to poor for TPS (intraclass correlation coefficient (ICC) 0.46) as well as for CPS (ICC 0.34). When stratifying patients by clinically relevant cutoffs, considerable differences between the assays were observed: concordance was poor for both TPS and CPS. Generally, SP263 stained a higher percentage of cells than the other assays, especially when using the CPS. Moderate concordance was shown between three different PD-L1 immunohistochemical assays and considerable differences in PD-L1 positivity were observed when using clinically relevant cutoffs. This should be taken into account when using PD-L1 expression to guide clinical practice. |
doi_str_mv | 10.1038/s41379-020-0644-7 |
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C.M. ; de Roest, Reinout H. ; Bloemena, Elisabeth ; Devriese, Lot A. ; Willems, Stefan M.</creator><creatorcontrib>de Ruiter, Emma J. ; Mulder, Frans J. ; Koomen, Bregje M. ; Speel, Ernst-Jan ; van den Hout, Mari F. C.M. ; de Roest, Reinout H. ; Bloemena, Elisabeth ; Devriese, Lot A. ; Willems, Stefan M.</creatorcontrib><description>Expression of programmed cell death-ligand 1 (PD-L1) is being used as predictive biomarker for immunotherapy in head and neck squamous cell carcinoma (HNSCC). Several antibodies are available for PD-L1 testing and multiple staining and scoring methods are used. This study aimed to compare the performance of two PD-L1 standardized assays (SP263 and 22C3 pharmDx) and one laboratory-developed test (LDT) (22C3) in HNSCC using the tumor proportion score (TPS) and the combined positive score (CPS). Pretreatment biopsies from 147 HNSCC patients were collected in a tissue-microarray (TMA). Serial sections of the TMA were immunohistochemically stained for PD-L1 expression using 22C3 pharmDx on the Dako Link 48 platform, SP263 on the Ventana Benchmark Ultra platform, and 22C3 as an LDT on the Ventana Benchmark Ultra. Stained slides were assessed for TPS and CPS. Cutoffs of ≥1% and ≥50% for TPS and ≥1 and ≥20 for CPS were used. Concordance between the different staining assays was moderate to poor for TPS (intraclass correlation coefficient (ICC) 0.46) as well as for CPS (ICC 0.34). When stratifying patients by clinically relevant cutoffs, considerable differences between the assays were observed: concordance was poor for both TPS and CPS. Generally, SP263 stained a higher percentage of cells than the other assays, especially when using the CPS. Moderate concordance was shown between three different PD-L1 immunohistochemical assays and considerable differences in PD-L1 positivity were observed when using clinically relevant cutoffs. This should be taken into account when using PD-L1 expression to guide clinical practice.</description><identifier>ISSN: 0893-3952</identifier><identifier>EISSN: 1530-0285</identifier><identifier>DOI: 10.1038/s41379-020-0644-7</identifier><identifier>PMID: 32759978</identifier><language>eng</language><publisher>New York: Elsevier Inc</publisher><subject>13/1 ; 13/51 ; 631/67/1536 ; 692/53/2423 ; Adult ; Aged ; Antibodies ; Apoptosis ; Automation ; B7-H1 Antigen - analysis ; Biomarkers ; Biomarkers, Tumor - analysis ; Biopsy ; Cancer ; Cell death ; Clinical trials ; Cohort Studies ; FDA approval ; Female ; Head & neck cancer ; Humans ; Immunohistochemistry - methods ; Immunotherapy ; Laboratories ; Laboratory Medicine ; Ligands ; Male ; Medicine ; Medicine & Public Health ; Metastasis ; Middle Aged ; Pathology ; Patients ; PD-L1 protein ; Retrospective Studies ; Squamous cell carcinoma ; Squamous Cell Carcinoma of Head and Neck - metabolism ; Squamous Cell Carcinoma of Head and Neck - pathology</subject><ispartof>Modern pathology, 2021-06, Vol.34 (6), p.1125-1132</ispartof><rights>2020 United States & Canadian Academy of Pathology</rights><rights>The Author(s), under exclusive licence to United States & Canadian Academy of Pathology 2020</rights><rights>The Author(s), under exclusive licence to United States & Canadian Academy of Pathology 2020.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c515t-d4e226b645ba53faad9e794a6c3e311a91d12cfad5145cf7befaef139abfac73</citedby><cites>FETCH-LOGICAL-c515t-d4e226b645ba53faad9e794a6c3e311a91d12cfad5145cf7befaef139abfac73</cites><orcidid>0000-0002-3106-5734 ; 0000-0002-0221-9538</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2530775917?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,776,780,27903,27904,64362,64364,64366,72216</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32759978$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>de Ruiter, Emma J.</creatorcontrib><creatorcontrib>Mulder, Frans J.</creatorcontrib><creatorcontrib>Koomen, Bregje M.</creatorcontrib><creatorcontrib>Speel, Ernst-Jan</creatorcontrib><creatorcontrib>van den Hout, Mari F. C.M.</creatorcontrib><creatorcontrib>de Roest, Reinout H.</creatorcontrib><creatorcontrib>Bloemena, Elisabeth</creatorcontrib><creatorcontrib>Devriese, Lot A.</creatorcontrib><creatorcontrib>Willems, Stefan M.</creatorcontrib><title>Comparison of three PD-L1 immunohistochemical assays in head and neck squamous cell carcinoma (HNSCC)</title><title>Modern pathology</title><addtitle>Mod Pathol</addtitle><addtitle>Mod Pathol</addtitle><description>Expression of programmed cell death-ligand 1 (PD-L1) is being used as predictive biomarker for immunotherapy in head and neck squamous cell carcinoma (HNSCC). Several antibodies are available for PD-L1 testing and multiple staining and scoring methods are used. This study aimed to compare the performance of two PD-L1 standardized assays (SP263 and 22C3 pharmDx) and one laboratory-developed test (LDT) (22C3) in HNSCC using the tumor proportion score (TPS) and the combined positive score (CPS). Pretreatment biopsies from 147 HNSCC patients were collected in a tissue-microarray (TMA). Serial sections of the TMA were immunohistochemically stained for PD-L1 expression using 22C3 pharmDx on the Dako Link 48 platform, SP263 on the Ventana Benchmark Ultra platform, and 22C3 as an LDT on the Ventana Benchmark Ultra. Stained slides were assessed for TPS and CPS. Cutoffs of ≥1% and ≥50% for TPS and ≥1 and ≥20 for CPS were used. Concordance between the different staining assays was moderate to poor for TPS (intraclass correlation coefficient (ICC) 0.46) as well as for CPS (ICC 0.34). When stratifying patients by clinically relevant cutoffs, considerable differences between the assays were observed: concordance was poor for both TPS and CPS. Generally, SP263 stained a higher percentage of cells than the other assays, especially when using the CPS. Moderate concordance was shown between three different PD-L1 immunohistochemical assays and considerable differences in PD-L1 positivity were observed when using clinically relevant cutoffs. This should be taken into account when using PD-L1 expression to guide clinical practice.</description><subject>13/1</subject><subject>13/51</subject><subject>631/67/1536</subject><subject>692/53/2423</subject><subject>Adult</subject><subject>Aged</subject><subject>Antibodies</subject><subject>Apoptosis</subject><subject>Automation</subject><subject>B7-H1 Antigen - analysis</subject><subject>Biomarkers</subject><subject>Biomarkers, Tumor - analysis</subject><subject>Biopsy</subject><subject>Cancer</subject><subject>Cell death</subject><subject>Clinical trials</subject><subject>Cohort Studies</subject><subject>FDA approval</subject><subject>Female</subject><subject>Head & neck cancer</subject><subject>Humans</subject><subject>Immunohistochemistry - methods</subject><subject>Immunotherapy</subject><subject>Laboratories</subject><subject>Laboratory Medicine</subject><subject>Ligands</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Metastasis</subject><subject>Middle Aged</subject><subject>Pathology</subject><subject>Patients</subject><subject>PD-L1 protein</subject><subject>Retrospective Studies</subject><subject>Squamous cell carcinoma</subject><subject>Squamous Cell Carcinoma of Head and Neck - metabolism</subject><subject>Squamous Cell Carcinoma of Head and Neck - pathology</subject><issn>0893-3952</issn><issn>1530-0285</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp9UU1v1DAUtBCILoUfwAVZ4lIOof6IN4k4ofBRpBVFonfrxXlmXdb21k4q9d_jKIVKHHqynjwzb94MIa85e8-ZbM9zzWXTVUywim3rumqekA1XskyiVU_JhrWdrGSnxAl5kfM1Y7xWrXhOTqRoVNc17YZgH_0Rkssx0GjptE-I9Menasep834Oce_yFM0evTNwoJAz3GXqAt0jjBTCSAOa3zTfzODjnKnBw4EaSMaF6IGeXXz_2ffvXpJnFg4ZX92_p-Tqy-er_qLaXX791n_cVUZxNVVjjUJsh22tBlDSAowdNl0NWyNRcg4dH7kwFkZVDjG2GdACWi47GCyYRp6Ss1X2mOLNjHnS3uXFEQQs5rSoJW85U21doG__g17HOYViTouSYFPy4YsgX1EmxZwTWn1MzkO605zppQK9VqBLBXqpQC-cN_fK8-Bx_Mf4m3kBiBWQy1f4helh9WOqH1YSlvhuXSFl4zAYHF1CM-kxukfYfwANnKSH</recordid><startdate>20210601</startdate><enddate>20210601</enddate><creator>de Ruiter, Emma J.</creator><creator>Mulder, Frans J.</creator><creator>Koomen, Bregje M.</creator><creator>Speel, Ernst-Jan</creator><creator>van den Hout, Mari F. 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C.M.</au><au>de Roest, Reinout H.</au><au>Bloemena, Elisabeth</au><au>Devriese, Lot A.</au><au>Willems, Stefan M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparison of three PD-L1 immunohistochemical assays in head and neck squamous cell carcinoma (HNSCC)</atitle><jtitle>Modern pathology</jtitle><stitle>Mod Pathol</stitle><addtitle>Mod Pathol</addtitle><date>2021-06-01</date><risdate>2021</risdate><volume>34</volume><issue>6</issue><spage>1125</spage><epage>1132</epage><pages>1125-1132</pages><issn>0893-3952</issn><eissn>1530-0285</eissn><abstract>Expression of programmed cell death-ligand 1 (PD-L1) is being used as predictive biomarker for immunotherapy in head and neck squamous cell carcinoma (HNSCC). Several antibodies are available for PD-L1 testing and multiple staining and scoring methods are used. This study aimed to compare the performance of two PD-L1 standardized assays (SP263 and 22C3 pharmDx) and one laboratory-developed test (LDT) (22C3) in HNSCC using the tumor proportion score (TPS) and the combined positive score (CPS). Pretreatment biopsies from 147 HNSCC patients were collected in a tissue-microarray (TMA). Serial sections of the TMA were immunohistochemically stained for PD-L1 expression using 22C3 pharmDx on the Dako Link 48 platform, SP263 on the Ventana Benchmark Ultra platform, and 22C3 as an LDT on the Ventana Benchmark Ultra. Stained slides were assessed for TPS and CPS. Cutoffs of ≥1% and ≥50% for TPS and ≥1 and ≥20 for CPS were used. Concordance between the different staining assays was moderate to poor for TPS (intraclass correlation coefficient (ICC) 0.46) as well as for CPS (ICC 0.34). When stratifying patients by clinically relevant cutoffs, considerable differences between the assays were observed: concordance was poor for both TPS and CPS. Generally, SP263 stained a higher percentage of cells than the other assays, especially when using the CPS. Moderate concordance was shown between three different PD-L1 immunohistochemical assays and considerable differences in PD-L1 positivity were observed when using clinically relevant cutoffs. This should be taken into account when using PD-L1 expression to guide clinical practice.</abstract><cop>New York</cop><pub>Elsevier Inc</pub><pmid>32759978</pmid><doi>10.1038/s41379-020-0644-7</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-3106-5734</orcidid><orcidid>https://orcid.org/0000-0002-0221-9538</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | 13/1 13/51 631/67/1536 692/53/2423 Adult Aged Antibodies Apoptosis Automation B7-H1 Antigen - analysis Biomarkers Biomarkers, Tumor - analysis Biopsy Cancer Cell death Clinical trials Cohort Studies FDA approval Female Head & neck cancer Humans Immunohistochemistry - methods Immunotherapy Laboratories Laboratory Medicine Ligands Male Medicine Medicine & Public Health Metastasis Middle Aged Pathology Patients PD-L1 protein Retrospective Studies Squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck - metabolism Squamous Cell Carcinoma of Head and Neck - pathology |
title | Comparison of three PD-L1 immunohistochemical assays in head and neck squamous cell carcinoma (HNSCC) |
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