Comparison of three PD-L1 immunohistochemical assays in head and neck squamous cell carcinoma (HNSCC)

Ruiter, Emma J. de; Mulder, Frans J.; Koomen, Bregje M; Speel, Ernst J. M.; Hout, Mari F.C.M. van den; Roest, Reinout H. de; Bloemena, Elisabeth; Devriese, Lot A.; Willems, Stefan M.

doi:10.1038/s41379-020-0644-7

Cited by 111 publications

(95 citation statements)

References 19 publications

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“…A third study reported values between 73% and 98% from applying different positivity scores and cut-offs for each antibody clone used [ 9 ]. Recently, a large study demonstrated that the SP263 clone stained a higher percentage of cells, especially when the CPS was employed [ 17 ]. Moderate concordance was shown between three different PD-L1 assays, and considerable differences in PD-L1 positivity were observed when using clinically relevant cut-offs.…”

Section: Discussionmentioning

confidence: 99%

PD-L1 Testing and Squamous Cell Carcinoma of the Head and Neck: A Multicenter Study on the Diagnostic Reproducibility of Different Protocols

Crosta

Boldorini

Bono

et al. 2021

Cancers

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Immune checkpoint inhibitors for blocking the programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) axis are now available for squamous cell carcinoma of the head and neck (HNSCC) in relapsing and/or metastatic settings. In this work, we compared the resulting combined positive score (CPS) of PD-L1 using alternative methods adopted in routine clinical practice and determined the level of diagnostic agreement and inter-observer reliability in this setting. The study applied 5 different protocols on 40 tissue microarrays from HNSCC. The error rate of the individual protocols ranged from a minimum of 7% to a maximum of 21%, the sensitivity from 79% to 96%, and the specificity from 50% to 100%. In the intermediate group (1 ≤ CPS < 20), the majority of errors consisted of an underestimation of PD-L1 expression. In strong expressors, 5 out of 14 samples (36%) were correctly evaluated by all the protocols, but no protocol was able to correctly identify all the “strong expressors”. The overall inter-observer agreement in PD-L1 CPS reached 87%. The inter-observer reliability was moderate, with an ICC of 0.774 (95% CI (0.651; 0.871)). In conclusion, our study showed moderate interobserver reliability among different protocols. In order to improve the performances, adequate specific training to evaluate PD-L1 by CPS in the HNSCC setting should be coordinated.

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Section: Discussionmentioning

confidence: 99%

PD-L1 Testing and Squamous Cell Carcinoma of the Head and Neck: A Multicenter Study on the Diagnostic Reproducibility of Different Protocols

Crosta

Boldorini

Bono

et al. 2021

Cancers

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“…Compared to lung cancer, evidence for direct comparison among assays in HNSCC is scarce. De Ruiter at al 20 . compared the reference 22C3 assay with a 22C3 laboratory developed test (LDT) and the SP263 assay in 143 cases.…”

Section: Resultsmentioning

confidence: 99%

Challenges facing pathologists evaluating PD‐L1 in head & neck squamous cell carcinoma

Girolami

Pantanowitz

Barberis

et al. 2021

J Oral Pathology Medicine

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Background Programmed 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 literature After 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. Conclusions Differences 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.

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“…Similarly, in NSCLC, PD-L1 expression has been recently associated with the anatomical site of the biopsy, and its predictive value is also different for each site [ 120 ]. On the other hand, a recent comparative study among three different PD-L1 IHC assays showed moderate concordance among the assays and considerable differences in PD-L1 positivity [ 121 ]. The recent findings suggest that TEXs carrying functional PD-L1 can induce immunosuppression inhibiting Teff cells [ 122 ].…”

Section: Biomarkers Of Response To Immunotherapy In Hnsccmentioning

confidence: 99%

Immune Checkpoints Pathways in Head and Neck Squamous Cell Carcinoma

Veigas

Mahmoud

Merlo

et al. 2021

Cancers

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Head and neck squamous cell carcinoma (HNSCC) is a heterogeneous group of tumors usually diagnosed at an advanced stage and characterized by a poor prognosis. The main risk factors associated with its development include tobacco and alcohol consumption and Human Papillomavirus (HPV) infections. The immune system has a significant role in the oncogenesis and evolution of this cancer type. Notably, the immunosuppressive tumor microenvironment triggers immune escape through several mechanisms. The improved understanding of the antitumor immune response in solid tumors and the role of the immune checkpoint molecules and other immune regulators have led to the development of novel therapeutic strategies that revolutionized the clinical management of HNSCC. However, the limited overall response rate to immunotherapy urges identifying predictive biomarkers of response and resistance to treatment. Here, we review the role of the immune system and immune checkpoint pathways in HNSCC, the most relevant clinical findings linked to immunotherapeutic strategies and predictive biomarkers of response and future treatment perspectives.

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Comparison of three PD-L1 immunohistochemical assays in head and neck squamous cell carcinoma (HNSCC)

Cited by 111 publications

References 19 publications

PD-L1 Testing and Squamous Cell Carcinoma of the Head and Neck: A Multicenter Study on the Diagnostic Reproducibility of Different Protocols

PD-L1 Testing and Squamous Cell Carcinoma of the Head and Neck: A Multicenter Study on the Diagnostic Reproducibility of Different Protocols

Challenges facing pathologists evaluating PD‐L1 in head & neck squamous cell carcinoma

Immune Checkpoints Pathways in Head and Neck Squamous Cell Carcinoma

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