Considerable interlaboratory variation in PD‐L1 positivity for head and neck squamous cell carcinoma in the Netherlands— A nationwide evaluation study
Aims Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) are eligible for first‐line immune checkpoint inhibition if their tumour is positive for programmed death ligand 1 (PD‐L1) determined by the combined positive score (CPS). This nationwide study, using real‐world...
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| Veröffentlicht in: | Histopathology 2024-07, Vol.85 (1), p.133-142 |
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| creator | Hempenius, Maaike Anna Koomen, Bregje M Deckers, Ivette A G Oosting, Sjoukje F Willems, Stefan M Vegt, Bert |
| description | Aims
Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) are eligible for first‐line immune checkpoint inhibition if their tumour is positive for programmed death ligand 1 (PD‐L1) determined by the combined positive score (CPS). This nationwide study, using real‐world data, investigated the developing PD‐L1 testing landscape in the first 3 years after introduction of the test in HNSCC and examined interlaboratory variation in PD‐L1 positivity rates.
Methods
Pathology reports of HNSCC patients mentioning PD‐L1 were extracted from the Dutch Pathology Registry (Palga). Tumour and PD‐L1 testing characteristics were analysed per year and interlaboratory variation in PD‐L1 positivity rates was assessed using funnel plots with 95% confidence limits around the overall mean.
Results
A total of 817 PD‐L1 tests were reported in 702 patients among 19 laboratories; 85.2% of the tests on histological material were stated to be positive. The national PD‐L1 positivity rate differed significantly per year during the study period (79.7–89.9%). The use of the recommended 22C3 antibody increased from 59.9 to 74.3%. A total of 673 PD‐L1 tests on histological material from 12 laboratories were analysed to investigate interlaboratory variation. Four (33%) deviated significantly from the national mean of PD‐L1‐positive cases using CPS ≥ 1 cut‐off, while two (17%) deviated significantly for CPS ≥ 20 cut‐off.
Conclusion
In the first 3 years of PD‐L1 assessment in HNSCC, the testing landscape became more uniform. However, interlaboratory variation in PD‐L1 positivity rates between Dutch laboratories was substantial. This implies that there is a need for further test standardisation to reduce this variation.
The first 3 years of PD‐L1 testing in head and neck squamous cell carcinoma were evaluated in this nationwide real‐world data study. Although PD‐L1 assessment methods became more uniform, interlaboratory variation in PD‐L1 positivity rates remained substantial. |
| doi_str_mv | 10.1111/his.15184 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_3038437393</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3038437393</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3484-59c241b885a8301326201d6bc4360053b2c887ae9a04a04f54e3c21548e79c263</originalsourceid><addsrcrecordid>eNp1kU9u1DAUhy0EotPCggsgS2zoIq3_x1lWU6CVRoAErCPHeaNxSeypnUyVXY_Agh0bzsJRehI8TWGBhGX5Lfz5e8_6IfSCkhOa1-nGpRMqqRaP0IJyJQsmZfUYLQgnVUGoKg_QYUpXhNCSM_YUHXCtiKoqtkA_lsEn10I0TQfY-QFiZ5oQzRDihHcmOjO44PMN_nh-d_ttRfE2JDe4nRsmvA7x188NmBYb32IP9itO16Ppw5iwha7D1kTrfOjNXjBsAL-HfOYWvk13t9_xGfb3_ps8Aoad6ca5XRrGdnqGnqxNl-D5Qz1CX96--by8KFYf3l0uz1aF5UKLQlaWCdpoLY3mhHKmGKGtaqzgihDJG2a1Lg1Uhoi811IAt4xKoaHMTxU_Qq9n7zaG6xHSUPcu7cc3HvJPak64FrzkFc_oq3_QqzBGn6fLlJKyJJJVmTqeKRtDShHW9Ta63sSppqTeJ1bnxOr7xDL78sE4Nj20f8k_EWXgdAZuXAfT_031xeWnWfkbuAGjXg</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3065570529</pqid></control><display><type>article</type><title>Considerable interlaboratory variation in PD‐L1 positivity for head and neck squamous cell carcinoma in the Netherlands— A nationwide evaluation study</title><source>Access via Wiley Online Library</source><creator>Hempenius, Maaike Anna ; Koomen, Bregje M ; Deckers, Ivette A G ; Oosting, Sjoukje F ; Willems, Stefan M ; Vegt, Bert</creator><creatorcontrib>Hempenius, Maaike Anna ; Koomen, Bregje M ; Deckers, Ivette A G ; Oosting, Sjoukje F ; Willems, Stefan M ; Vegt, Bert</creatorcontrib><description>Aims
Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) are eligible for first‐line immune checkpoint inhibition if their tumour is positive for programmed death ligand 1 (PD‐L1) determined by the combined positive score (CPS). This nationwide study, using real‐world data, investigated the developing PD‐L1 testing landscape in the first 3 years after introduction of the test in HNSCC and examined interlaboratory variation in PD‐L1 positivity rates.
Methods
Pathology reports of HNSCC patients mentioning PD‐L1 were extracted from the Dutch Pathology Registry (Palga). Tumour and PD‐L1 testing characteristics were analysed per year and interlaboratory variation in PD‐L1 positivity rates was assessed using funnel plots with 95% confidence limits around the overall mean.
Results
A total of 817 PD‐L1 tests were reported in 702 patients among 19 laboratories; 85.2% of the tests on histological material were stated to be positive. The national PD‐L1 positivity rate differed significantly per year during the study period (79.7–89.9%). The use of the recommended 22C3 antibody increased from 59.9 to 74.3%. A total of 673 PD‐L1 tests on histological material from 12 laboratories were analysed to investigate interlaboratory variation. Four (33%) deviated significantly from the national mean of PD‐L1‐positive cases using CPS ≥ 1 cut‐off, while two (17%) deviated significantly for CPS ≥ 20 cut‐off.
Conclusion
In the first 3 years of PD‐L1 assessment in HNSCC, the testing landscape became more uniform. However, interlaboratory variation in PD‐L1 positivity rates between Dutch laboratories was substantial. This implies that there is a need for further test standardisation to reduce this variation.
The first 3 years of PD‐L1 testing in head and neck squamous cell carcinoma were evaluated in this nationwide real‐world data study. Although PD‐L1 assessment methods became more uniform, interlaboratory variation in PD‐L1 positivity rates remained substantial.</description><identifier>ISSN: 0309-0167</identifier><identifier>ISSN: 1365-2559</identifier><identifier>EISSN: 1365-2559</identifier><identifier>DOI: 10.1111/his.15184</identifier><identifier>PMID: 38606992</identifier><language>eng</language><publisher>England: Wiley Subscription Services, Inc</publisher><subject>Apoptosis ; Head and neck carcinoma ; head and neck squamous cell carcinoma ; Immune checkpoint inhibitors ; immunohistochemistry ; interlaboratory variation ; Laboratories ; Metastases ; Pathology ; PD-L1 protein ; pembrolizumab ; programmed cell death‐ligand 1 ; Squamous cell carcinoma ; Tumors ; Variation</subject><ispartof>Histopathology, 2024-07, Vol.85 (1), p.133-142</ispartof><rights>2024 The Authors. published by John Wiley & Sons Ltd.</rights><rights>2024 The Authors. Histopathology published by John Wiley & Sons Ltd.</rights><rights>2024. This article is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3484-59c241b885a8301326201d6bc4360053b2c887ae9a04a04f54e3c21548e79c263</cites><orcidid>0000-0002-2613-1506 ; 0000-0002-1083-6130 ; 0000-0002-3106-5734</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fhis.15184$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fhis.15184$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38606992$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hempenius, Maaike Anna</creatorcontrib><creatorcontrib>Koomen, Bregje M</creatorcontrib><creatorcontrib>Deckers, Ivette A G</creatorcontrib><creatorcontrib>Oosting, Sjoukje F</creatorcontrib><creatorcontrib>Willems, Stefan M</creatorcontrib><creatorcontrib>Vegt, Bert</creatorcontrib><title>Considerable interlaboratory variation in PD‐L1 positivity for head and neck squamous cell carcinoma in the Netherlands— A nationwide evaluation study</title><title>Histopathology</title><addtitle>Histopathology</addtitle><description>Aims
Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) are eligible for first‐line immune checkpoint inhibition if their tumour is positive for programmed death ligand 1 (PD‐L1) determined by the combined positive score (CPS). This nationwide study, using real‐world data, investigated the developing PD‐L1 testing landscape in the first 3 years after introduction of the test in HNSCC and examined interlaboratory variation in PD‐L1 positivity rates.
Methods
Pathology reports of HNSCC patients mentioning PD‐L1 were extracted from the Dutch Pathology Registry (Palga). Tumour and PD‐L1 testing characteristics were analysed per year and interlaboratory variation in PD‐L1 positivity rates was assessed using funnel plots with 95% confidence limits around the overall mean.
Results
A total of 817 PD‐L1 tests were reported in 702 patients among 19 laboratories; 85.2% of the tests on histological material were stated to be positive. The national PD‐L1 positivity rate differed significantly per year during the study period (79.7–89.9%). The use of the recommended 22C3 antibody increased from 59.9 to 74.3%. A total of 673 PD‐L1 tests on histological material from 12 laboratories were analysed to investigate interlaboratory variation. Four (33%) deviated significantly from the national mean of PD‐L1‐positive cases using CPS ≥ 1 cut‐off, while two (17%) deviated significantly for CPS ≥ 20 cut‐off.
Conclusion
In the first 3 years of PD‐L1 assessment in HNSCC, the testing landscape became more uniform. However, interlaboratory variation in PD‐L1 positivity rates between Dutch laboratories was substantial. This implies that there is a need for further test standardisation to reduce this variation.
The first 3 years of PD‐L1 testing in head and neck squamous cell carcinoma were evaluated in this nationwide real‐world data study. Although PD‐L1 assessment methods became more uniform, interlaboratory variation in PD‐L1 positivity rates remained substantial.</description><subject>Apoptosis</subject><subject>Head and neck carcinoma</subject><subject>head and neck squamous cell carcinoma</subject><subject>Immune checkpoint inhibitors</subject><subject>immunohistochemistry</subject><subject>interlaboratory variation</subject><subject>Laboratories</subject><subject>Metastases</subject><subject>Pathology</subject><subject>PD-L1 protein</subject><subject>pembrolizumab</subject><subject>programmed cell death‐ligand 1</subject><subject>Squamous cell carcinoma</subject><subject>Tumors</subject><subject>Variation</subject><issn>0309-0167</issn><issn>1365-2559</issn><issn>1365-2559</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><recordid>eNp1kU9u1DAUhy0EotPCggsgS2zoIq3_x1lWU6CVRoAErCPHeaNxSeypnUyVXY_Agh0bzsJRehI8TWGBhGX5Lfz5e8_6IfSCkhOa1-nGpRMqqRaP0IJyJQsmZfUYLQgnVUGoKg_QYUpXhNCSM_YUHXCtiKoqtkA_lsEn10I0TQfY-QFiZ5oQzRDihHcmOjO44PMN_nh-d_ttRfE2JDe4nRsmvA7x188NmBYb32IP9itO16Ppw5iwha7D1kTrfOjNXjBsAL-HfOYWvk13t9_xGfb3_ps8Aoad6ca5XRrGdnqGnqxNl-D5Qz1CX96--by8KFYf3l0uz1aF5UKLQlaWCdpoLY3mhHKmGKGtaqzgihDJG2a1Lg1Uhoi811IAt4xKoaHMTxU_Qq9n7zaG6xHSUPcu7cc3HvJPak64FrzkFc_oq3_QqzBGn6fLlJKyJJJVmTqeKRtDShHW9Ta63sSppqTeJ1bnxOr7xDL78sE4Nj20f8k_EWXgdAZuXAfT_031xeWnWfkbuAGjXg</recordid><startdate>202407</startdate><enddate>202407</enddate><creator>Hempenius, Maaike Anna</creator><creator>Koomen, Bregje M</creator><creator>Deckers, Ivette A G</creator><creator>Oosting, Sjoukje F</creator><creator>Willems, Stefan M</creator><creator>Vegt, Bert</creator><general>Wiley Subscription Services, Inc</general><scope>24P</scope><scope>WIN</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QP</scope><scope>7QR</scope><scope>7T5</scope><scope>7TK</scope><scope>7TM</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope><scope>RC3</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-2613-1506</orcidid><orcidid>https://orcid.org/0000-0002-1083-6130</orcidid><orcidid>https://orcid.org/0000-0002-3106-5734</orcidid></search><sort><creationdate>202407</creationdate><title>Considerable interlaboratory variation in PD‐L1 positivity for head and neck squamous cell carcinoma in the Netherlands— A nationwide evaluation study</title><author>Hempenius, Maaike Anna ; Koomen, Bregje M ; Deckers, Ivette A G ; Oosting, Sjoukje F ; Willems, Stefan M ; Vegt, Bert</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3484-59c241b885a8301326201d6bc4360053b2c887ae9a04a04f54e3c21548e79c263</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Apoptosis</topic><topic>Head and neck carcinoma</topic><topic>head and neck squamous cell carcinoma</topic><topic>Immune checkpoint inhibitors</topic><topic>immunohistochemistry</topic><topic>interlaboratory variation</topic><topic>Laboratories</topic><topic>Metastases</topic><topic>Pathology</topic><topic>PD-L1 protein</topic><topic>pembrolizumab</topic><topic>programmed cell death‐ligand 1</topic><topic>Squamous cell carcinoma</topic><topic>Tumors</topic><topic>Variation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hempenius, Maaike Anna</creatorcontrib><creatorcontrib>Koomen, Bregje M</creatorcontrib><creatorcontrib>Deckers, Ivette A G</creatorcontrib><creatorcontrib>Oosting, Sjoukje F</creatorcontrib><creatorcontrib>Willems, Stefan M</creatorcontrib><creatorcontrib>Vegt, Bert</creatorcontrib><collection>Wiley-Blackwell Open Access Titles</collection><collection>Wiley Online Library Free Content</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Chemoreception Abstracts</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Histopathology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hempenius, Maaike Anna</au><au>Koomen, Bregje M</au><au>Deckers, Ivette A G</au><au>Oosting, Sjoukje F</au><au>Willems, Stefan M</au><au>Vegt, Bert</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Considerable interlaboratory variation in PD‐L1 positivity for head and neck squamous cell carcinoma in the Netherlands— A nationwide evaluation study</atitle><jtitle>Histopathology</jtitle><addtitle>Histopathology</addtitle><date>2024-07</date><risdate>2024</risdate><volume>85</volume><issue>1</issue><spage>133</spage><epage>142</epage><pages>133-142</pages><issn>0309-0167</issn><issn>1365-2559</issn><eissn>1365-2559</eissn><abstract>Aims
Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) are eligible for first‐line immune checkpoint inhibition if their tumour is positive for programmed death ligand 1 (PD‐L1) determined by the combined positive score (CPS). This nationwide study, using real‐world data, investigated the developing PD‐L1 testing landscape in the first 3 years after introduction of the test in HNSCC and examined interlaboratory variation in PD‐L1 positivity rates.
Methods
Pathology reports of HNSCC patients mentioning PD‐L1 were extracted from the Dutch Pathology Registry (Palga). Tumour and PD‐L1 testing characteristics were analysed per year and interlaboratory variation in PD‐L1 positivity rates was assessed using funnel plots with 95% confidence limits around the overall mean.
Results
A total of 817 PD‐L1 tests were reported in 702 patients among 19 laboratories; 85.2% of the tests on histological material were stated to be positive. The national PD‐L1 positivity rate differed significantly per year during the study period (79.7–89.9%). The use of the recommended 22C3 antibody increased from 59.9 to 74.3%. A total of 673 PD‐L1 tests on histological material from 12 laboratories were analysed to investigate interlaboratory variation. Four (33%) deviated significantly from the national mean of PD‐L1‐positive cases using CPS ≥ 1 cut‐off, while two (17%) deviated significantly for CPS ≥ 20 cut‐off.
Conclusion
In the first 3 years of PD‐L1 assessment in HNSCC, the testing landscape became more uniform. However, interlaboratory variation in PD‐L1 positivity rates between Dutch laboratories was substantial. This implies that there is a need for further test standardisation to reduce this variation.
The first 3 years of PD‐L1 testing in head and neck squamous cell carcinoma were evaluated in this nationwide real‐world data study. Although PD‐L1 assessment methods became more uniform, interlaboratory variation in PD‐L1 positivity rates remained substantial.</abstract><cop>England</cop><pub>Wiley Subscription Services, Inc</pub><pmid>38606992</pmid><doi>10.1111/his.15184</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-2613-1506</orcidid><orcidid>https://orcid.org/0000-0002-1083-6130</orcidid><orcidid>https://orcid.org/0000-0002-3106-5734</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Apoptosis Head and neck carcinoma head and neck squamous cell carcinoma Immune checkpoint inhibitors immunohistochemistry interlaboratory variation Laboratories Metastases Pathology PD-L1 protein pembrolizumab programmed cell death‐ligand 1 Squamous cell carcinoma Tumors Variation |
| title | Considerable interlaboratory variation in PD‐L1 positivity for head and neck squamous cell carcinoma in the Netherlands— A nationwide evaluation study |
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