Challenges facing pathologists evaluating PD‐L1 in head & neck squamous cell carcinoma
dc.contributor.author | Girolami, Ilaria | |
dc.contributor.author | Pantanowitz, Liron | |
dc.contributor.author | Barberis, Massimo | |
dc.contributor.author | Paolino, Gaetano | |
dc.contributor.author | Brunelli, Matteo | |
dc.contributor.author | Vigliar, Elena | |
dc.contributor.author | Munari, Enrico | |
dc.contributor.author | Satturwar, Swati | |
dc.contributor.author | Troncone, Giancarlo | |
dc.contributor.author | Eccher, Albino | |
dc.date.accessioned | 2021-11-02T00:47:20Z | |
dc.date.available | 2022-11-01 20:47:19 | en |
dc.date.available | 2021-11-02T00:47:20Z | |
dc.date.issued | 2021-10 | |
dc.identifier.citation | Girolami, Ilaria; Pantanowitz, Liron; Barberis, Massimo; Paolino, Gaetano; Brunelli, Matteo; Vigliar, Elena; Munari, Enrico; Satturwar, Swati; Troncone, Giancarlo; Eccher, Albino (2021). "Challenges facing pathologists evaluating PD‐L1 in head & neck squamous cell carcinoma." Journal of Oral Pathology & Medicine (9): 864-873. | |
dc.identifier.issn | 0904-2512 | |
dc.identifier.issn | 1600-0714 | |
dc.identifier.uri | https://hdl.handle.net/2027.42/170876 | |
dc.description.abstract | BackgroundProgrammed death‐ligand 1 (PD‐L1) expression with combined positive score (CPS) ≥1 is required for administration of checkpoint inhibitor therapy in recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). The 22C3 pharmDx Dako immunohistochemical assay is the one approved as companion diagnostic for pembrolizumab, but many laboratories work on other platforms and/or with other clones, and studies exploring the potential interchangeability of assays have appeared.Evidence from the literatureAfter review of the literature, it emerges that the concordance among assays ranges from fair to moderate, with a tendence of assay SP263 to yield a higher quota of positivity and of assay SP142 to stain better immune cells. Moreover, pathologists achieve very good concordance in assessing PD‐L1 CPS, particularly with SP263.ConclusionsDifferences in terms of platforms, procedures, and study design still preclude a quantitative synthesis of evidence and clearly further work is needed to draw stronger conclusions on the interchangeability of PD‐L1 assays in HNSCC. | |
dc.publisher | Wiley Periodicals, Inc. | |
dc.subject.other | programmed death‐ligand 1 | |
dc.subject.other | review | |
dc.subject.other | head and neck squamous cell carcinoma | |
dc.subject.other | immunohistochemical assay | |
dc.subject.other | combined positive score | |
dc.title | Challenges facing pathologists evaluating PD‐L1 in head & neck squamous cell carcinoma | |
dc.type | Article | |
dc.rights.robots | IndexNoFollow | |
dc.subject.hlbsecondlevel | Dentistry | |
dc.subject.hlbtoplevel | Health Sciences | |
dc.description.peerreviewed | Peer Reviewed | |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/170876/1/jop13220_am.pdf | |
dc.description.bitstreamurl | http://deepblue.lib.umich.edu/bitstream/2027.42/170876/2/jop13220.pdf | |
dc.identifier.doi | 10.1111/jop.13220 | |
dc.identifier.source | Journal of Oral Pathology & Medicine | |
dc.identifier.citedreference | Hirsch FR, McElhinny A, Stanforth D, et al. PD‐L1 Immunohistochemistry assays for lung cancer: results from phase 1 of the blueprint PD‐L1 IHC assay comparison project. J Thorac Oncol. 2017; 12: 208 ‐ 222. https://doi.org/10.1016/j.jtho.2016.11.2228 | |
dc.identifier.citedreference | Cramer JD, Burtness B, Ferris RL. Immunotherapy for head and neck cancer: recent advances and future directions. Oral Oncol. 2019; 99: 104460 ‐ https://doi.org/10.1016/j.oraloncology.2019.104460 | |
dc.identifier.citedreference | Emancipator K, Huang L, Aurora‐Garg D, et al. Comparing programmed death ligand 1 scores for predicting pembrolizumab efficacy in head and neck cancer. Mod Pathol. 2021; 34: 532 ‐ 541. https://doi.org/10.1038/s41379‐020‐00710‐9 | |
dc.identifier.citedreference | Concha‐Benavente F, Srivastava RM, Trivedi S, et al. Identification of the cell‐intrinsic and ‐extrinsic pathways downstream of EGFR and IFNγ that induce PD‐L1 expression in head and neck cancer. Cancer Res. 2016; 76: 1031 ‐ 1043. https://doi.org/10.1158/0008‐5472.CAN‐15‐2001 | |
dc.identifier.citedreference | Ancevski Hunter K, Socinski MA, Villaruz LC. PD‐L1 testing in guiding patient selection for pd‐1/pd‐l1 inhibitor therapy in lung cancer. Mol Diagn Ther. 2018; 22: 1 ‐ 10. https://doi.org/10.1007/s40291‐017‐0308‐6 | |
dc.identifier.citedreference | Food and Drug Administration. PD‐L1 IHC 22C3 pharmDx interpretation manual – Head and Neck Squamous Cell Carcinoma (HNSCC). https://www.agilent.com/cs/library/usermanuals/public/29314_22c3_pharmDx_hnscc_interpretation_manual_us.pdf. Accessed March 24, 2021. | |
dc.identifier.citedreference | Food and Drug Administration. PD‐L1 IHC 28‐8 pharmDx interpretation manual – Head and Neck Squamous Cell Carcinoma (HNSCC). https://www.agilent.com/cs/library/usermanuals/public/29186_pd‐l1‐ihc‐28‐8‐interpretation‐manual‐scchn.pdf. Accessed March 24, 2021. | |
dc.identifier.citedreference | Ionescu DN, Downes MR, Christofides A, Tsao MS. Harmonization of PD‐L1 testing in oncology: a Canadian pathology perspective. Curr Oncol. 2018; 25: e209 ‐ e216. https://doi.org/10.3747/co.25.4031 | |
dc.identifier.citedreference | de Ruiter EJ, Mulder FJ, Koomen BM,, et al. Comparison of three PD‐L1 immunohistochemical assays in head and neck squamous cell carcinoma (HNSCC). Mod Pathol. 2021; 34: 1125 ‐ 1132. https://doi.org/10.1038/s41379‐020‐0644‐7 | |
dc.identifier.citedreference | Crosta S, Boldorini R, Bono F, et al. PD‐L1 testing and squamous cell carcinoma of the head and neck: a multicenter study on the diagnostic reproducibility of different protocols. Cancers (Basel). 2021; 13: 292. https://doi.org/10.3390/cancers13020292 | |
dc.identifier.citedreference | Ramos M, Baldion A, Suarez D, et al. Immunohistochemistry analysis of PD‐L1 expression in head and neck cancer. Virchows Arch. 2019; 475 ( S1 ): 1 ‐ 436. https://doi.org/10.1007/s00428‐019‐02631‐8 | |
dc.identifier.citedreference | Al‐Masri H, Ratcliffe M, Sharpe A, et al. Concordance of tumour and immune cell staining with Ventana SP142, Ventana SP263, Dako 22C3 and Dako 28–8 PD‐L1 tests across different cancer types. Virchows Arch. 2017; 471 ( S1 ): 1 ‐ 352. https://doi.org/10.1007/s00428‐017‐2205‐0 | |
dc.identifier.citedreference | Downes MR, Slodkowska E, Katabi N, Jungbluth AA, Xu B. Inter‐ and intraobserver agreement of programmed death ligand 1 scoring in head and neck squamous cell carcinoma, urothelial carcinoma and breast carcinoma. Histopathology. 2020; 76: 191 ‐ 200. https://doi.org/10.1111/his.13946 | |
dc.identifier.citedreference | Hodgson A, Slodkowska E, Jungbluth A, et al. PD‐L1 immunohistochemistry assay concordance in urothelial carcinoma of the bladder and hypopharyngeal squamous cell carcinoma. Am J Surg Pathol. 2018; 42: 1059 ‐ 1066. https://doi.org/10.1097/PAS.0000000000001084 | |
dc.identifier.citedreference | Wang C, Hahn E, Slodkowska E, et al. Reproducibility of PD‐L1 immunohistochemistry interpretation across various types of genitourinary and head/neck carcinomas, antibody clones, and tissue types. Hum Pathol. 2018; 82: 131 ‐ 139. https://doi.org/10.1016/j.humpath.2018.07.024 | |
dc.identifier.citedreference | De Meulenaere A, Vermassen T, Aspeslagh S, et al. Tumor PD‐L1 status and CD8(+) tumor‐infiltrating T cells: markers of improved prognosis in oropharyngeal cancer. Oncotarget. 2017; 8: 80443 ‐ 80452. https://doi.org/10.18632/oncotarget.19045 | |
dc.identifier.citedreference | De Meulenaere A, Vermassen T, Creytens D, et al. Importance of choice of materials and methods in PD‐L1 and TIL assessment in oropharyngeal squamous cell carcinoma. Histopathology. 2018; 73: 500 ‐ 509. https://doi.org/10.1111/his.13650 | |
dc.identifier.citedreference | Gatalica Z, Vanderwalde AM, Rose I, et al. Distribution of PD‐L1 expression in diverse cancer types: experience with over 10,000 cases. J Clin Oncol. 2016; 34 ( 15_suppl ): 11548. https://doi.org/10.1200/JCO.2016.34.15_suppl.11548 | |
dc.identifier.citedreference | Krigsfeld GS, Prince EA, Pratt J, et al. Analysis of real‐world PD‐L1 IHC 28–8 and 22C3 pharmDx assay utilisation, turnaround times and analytical concordance across multiple tumour types. J Clin Pathol. 2020; 73: 656 ‐ 664. https://doi.org/10.1136/jclinpath‐2020‐206466 | |
dc.identifier.citedreference | Ratcliffe M, Sharpe A, Rebelatto M, et al. A comparative study of PD‐L1 diagnostic assays in squamous cell carcinoma of the head and neck (SCCHN). Ann Oncol. 2016; 27: vi328 ‐ vi350. https://doi.org/10.1093/annonc/mdw376.7 | |
dc.identifier.citedreference | Scott M, Wildsmith S, Ratcliffe M, et al. Comparison of patient populations identified by different PD‐L1 assays in head and neck squamous cell carcinoma (HNSCC). Ann Oncol. 2018; 29: 375. | |
dc.identifier.citedreference | Koppel C, Schwellenbach H, Zielinski D, et al. Optimization and validation of PD‐L1 immunohistochemistry staining protocols using the antibody clone 28‐8 on different staining platforms. Mod Pathol. 2018; 31: 1630 ‐ 1644. https://doi.org/10.1038/s41379‐018‐0071‐1 | |
dc.identifier.citedreference | Eccher A, Fontanini G, Fusco N, et al. Digital slides as an effective tool for programmed death ligand 1 combined positive score assessment and training: Lessons learned from the “Programmed death ligand 1 key learning program in Head‐and‐Neck squamous cell carcinoma”. J Pathol Inform. 2021; 12: 1. https://doi.org/10.4103/jpi.jpi_63_20 | |
dc.identifier.citedreference | Jamshidi P, Kaur A, Liu L, Sullivan M, Watkin W, Paintal A. Inter‐Rater Reliability (IRR) in a Consensus PD‐L1 Immunohistochemistry (IHC) service in an academic multi‐hospital health system. Mod Pathol. 2020; 33 ( suppl 2 ): 1863. | |
dc.identifier.citedreference | Nielsen A, Manriquez G, Hayden D, et al. Precision and repeatability of the VENTANA PD‐L1 (SP263) assay across six different tumor types. Mod Pathol. 2020; 33 ( suppl 2 ): 830. | |
dc.identifier.citedreference | Rebelatto MC, Midha A, Mistry A, et al. Development of a programmed cell death ligand‐1 immunohistochemical assay validated for analysis of non‐small cell lung cancer and head and neck squamous cell carcinoma. Diagn Pathol. 2016; 11: 95. https://doi.org/10.1186/s13000‐016‐0545‐8 | |
dc.identifier.citedreference | Mahoney KM, Sun H, Liao X, et al. PD‐L1 antibodies to its cytoplasmic domain most clearly delineate cell membranes in immunohistochemical staining of tumor cells. Cancer Immunol Res. 2015; 3: 1308 ‐ 1315. https://doi.org/10.1158/2326‐6066.CIR‐15‐0116 | |
dc.identifier.citedreference | Inge LJ, Dennis E. Development and applications of computer image analysis algorithms for scoring of PD‐L1 immunohistochemistry. Immuno‐Oncology Technol. 2020; 6: 2 ‐ 8. https://doi.org/10.1016/j.iotech.2020.04.001 | |
dc.identifier.citedreference | Kim H‐N, Jang J, Heo YJ, et al. PD‐L1 expression in gastric cancer determined by digital image analyses: pitfalls and correlation with pathologist interpretation. Virchows Arch. 2020; 476: 243 ‐ 250. https://doi.org/10.1007/s00428‐019‐02653‐2 | |
dc.identifier.citedreference | Barnes M, Srinivas C, Bai I, et al. Whole tumor section quantitative image analysis maximizes between‐pathologists’ reproducibility for clinical immunohistochemistry‐based biomarkers. Lab Investig. 2017; 97: 1508 ‐ 1515. https://doi.org/10.1038/labinvest.2017.82 | |
dc.identifier.citedreference | Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021; 71: 209 ‐ 249. https://doi.org/10.3322/caac.21660 | |
dc.identifier.citedreference | Pulte D, Brenner H. Changes in survival in head and neck cancers in the late 20th and early 21st century: a period analysis. Oncologist. 2010; 15: 994 ‐ 1001. https://doi.org/10.1634/theoncologist.2009‐0289 | |
dc.identifier.citedreference | Johnson DE, Burtness B, Leemans CR, Lui VWY, Bauman JE, Grandis JR. Head and neck squamous cell carcinoma. Nat Rev Dis Prim. 2020; 6: 92. https://doi.org/10.1038/s41572‐020‐00224‐3 | |
dc.identifier.citedreference | Cohen EEW, Soulières D, Le Tourneau C, et al. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head‐and‐neck squamous cell carcinoma (KEYNOTE‐040): a randomised, open‐label, phase 3 study. Lancet. 2019; 393: 156 ‐ 167. https://doi.org/10.1016/S0140‐6736(18)31999‐8 | |
dc.identifier.citedreference | Burtness B, Harrington KJ, Greil R, et al. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE‐048): a randomised, open‐label, phase 3 study. Lancet. 2019; 394: 1915 ‐ 1928. https://doi.org/10.1016/S0140‐6736(19)32591‐7 | |
dc.identifier.citedreference | Canning M, Guo G, Yu M, et al. Heterogeneity of the head and neck squamous cell carcinoma immune landscape and its impact on immunotherapy. Front Cell Dev Biol. 2019; 7: 52. https://doi.org/10.3389/fcell.2019.00052 | |
dc.identifier.citedreference | Ferris RL, Blumenschein GJ, Fayette J, et al. Nivolumab vs investigator’s choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2‐year long‐term survival update of CheckMate 141 with analyses by tumor PD‐L1 expression. Oral Oncol. 2018; 81: 45 ‐ 51. https://doi.org/10.1016/j.oraloncology.2018.04.008 | |
dc.identifier.citedreference | Harrington KJ, Ferris RL, Blumenschein G, et al. Nivolumab versus standard, single‐agent therapy of investigator’s choice in recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141): health‐related quality‐of‐life results from a randomised, phase 3 trial. Lancet Oncol. 2017; 18: 1104 ‐ 1115. https://doi.org/10.1016/S1470‐2045(17)30421‐7 | |
dc.identifier.citedreference | Ferris RL, Blumenschein GJ, Fayette J, et al. Nivolumab for recurrent squamous‐cell carcinoma of the head and neck. N Engl J Med. 2016; 375: 1856 ‐ 1867. https://doi.org/10.1056/NEJMoa1602252 | |
dc.identifier.citedreference | Ferris RL, Licitra L, Fayette J, et al. Nivolumab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: efficacy and safety in checkmate 141 by prior cetuximab use. Clin Cancer Res. 2019; 25: 5221 ‐ 5230. https://doi.org/10.1158/1078‐0432.CCR‐18‐3944 | |
dc.identifier.citedreference | Ries J, Agaimy A, Wehrhan F, et al. Importance of the PD‐1/PD‐L1 axis for malignant transformation and risk assessment of oral leukoplakia. Biomedicines. 2021; 9: 194. https://doi.org/10.3390/biomedicines9020194 | |
dc.identifier.citedreference | Girolami I, Pantanowitz L, Munari E, et al. Prevalence of PD‐L1 expression in head and neck squamous precancerous lesions: a systematic review and meta‐analysis. Head Neck. 2020; 42: 3018‐3030. Published online June 22, 2020:hed.26339. https://doi.org/10.1002/hed.26339 | |
dc.working.doi | NO | en |
dc.owningcollname | Interdisciplinary and Peer-Reviewed |
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