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

Ilaria Girolami1, Liron Pantanowitz2, Massimo Barberis3

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Journal of Oral Pathology & Medicine : Official Publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology
|June 22, 2021
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Summary

Assessing programmed death-ligand 1 (PD-L1) expression in head and neck cancer requires consistent diagnostic assays. While some PD-L1 assays show moderate concordance, further research is needed to confirm interchangeability for effective immunotherapy.

Keywords:
combined positive scorehead and neck squamous cell carcinomaimmunohistochemical assayprogrammed death-ligand 1review

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Area of Science:

  • Oncology
  • Immunotherapy
  • Diagnostic Pathology

Background:

  • Programmed death-ligand 1 (PD-L1) expression (Combined Positive Score [CPS] ≥1) is crucial for checkpoint inhibitor therapy in recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
  • The 22C3 pharmDx Dako assay is the FDA-approved companion diagnostic for pembrolizumab in HNSCC.
  • Laboratories utilize diverse platforms and clones, prompting investigation into assay interchangeability.

Purpose of the Study:

  • To evaluate the concordance and interchangeability of different immunohistochemical assays for PD-L1 expression in HNSCC.
  • To assess the performance characteristics of various PD-L1 clones and platforms in HNSCC diagnostics.

Main Methods:

  • Literature review of studies comparing PD-L1 immunohistochemical assays in HNSCC.
  • Analysis of concordance rates and qualitative performance (e.g., immune cell staining) across different assays.

Main Results:

  • Concordance among PD-L1 assays ranges from fair to moderate.
  • Assay SP263 tends to yield higher positivity rates; assay SP142 shows better immune cell staining.
  • Pathologists demonstrate high concordance in assessing PD-L1 CPS, especially with SP263.

Conclusions:

  • Variations in platforms, procedures, and study designs limit quantitative synthesis of evidence.
  • Further research is essential to establish the interchangeability of PD-L1 assays in HNSCC for clinical decision-making.