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Concordance between Three PD-L1 Immunohistochemical Assays in Head and Neck Squamous Cell Carcinoma (HNSCC) in a
Elena Guerini Rocco1,2, Albino Eccher3, Ilaria Girolami4
1Division of Pathology, IEO, European Institute of Oncology IRCCS, 20141 Milan, Italy.
Abstract:
The introduction of immunotherapy targeting the programmed death-1 (PD-1)/programmed death-ligand-1 (PD-L1) axis has represented a turning point in the treatment of HNSCC. Harmonization studies comparing the different antibodies and immunohistochemistry platforms available for the evaluation of PD-L1 expression with Combined Positive Score (CPS) in HNSCC are strongly required. Tissue microarrays (TMA) constructed from formalin-fixed, paraffin-embedded (FFPE) tissue blocks of HNSCC tumor were stained with two commercial in-vitro diagnostic (IVD) PD-L1 immunohistochemical assays (22C3 pharmDx on Autostainer Link48 and Omnis platforms, and SP263) and were reviewed by seven trained pathologists to assess CPS. We found a very similar distribution for PD-L1 expression between 22C3 pharmDx assay with both platforms and SP263 assay and a strong significant correlation between the two assays in different platforms (p < 0.0001). The interobserver reliability among pathologists for the continuous scores of CPS with intraclass correlation coefficient (ICC) and the correlation between the two assays were both good. Moreover, the agreement rate between assays was high at all cut-offs, while the kappa values were from substantial to almost perfect. These data suggest the interchangeability of the two antibodies and of the different immunohistochemical platforms in the selection of patients with HNSCC for immunotherapy.
Insights
Immunotherapy for head and neck squamous cell carcinoma (HNSCC) shows promise. This study found two PD-L1 assays (22C3 and SP263) and platforms are interchangeable for patient selection in HNSCC immunotherapy.
Area of Science:
- Oncology
- Immunology
- Pathology
Background:
- Immunotherapy targeting the programmed death-1 (PD-1)/programmed death-ligand-1 (PD-L1) axis has transformed head and neck squamous cell carcinoma (HNSCC) treatment.
- Accurate PD-L1 expression assessment is crucial for selecting patients for immunotherapy.
Purpose of the Study:
- To harmonize PD-L1 evaluation in HNSCC using different antibodies and immunohistochemistry platforms.
- To assess the reliability and agreement between two commercial PD-L1 assays (22C3 pharmDx and SP263) for Combined Positive Score (CPS) determination.
Main Methods:
- Tissue microarrays (TMA) from HNSCC tumors were stained using 22C3 pharmDx (Autostainer Link48 and Omnis) and SP263 assays.
- Seven pathologists evaluated PD-L1 expression and determined CPS.
- Statistical analyses included correlation, intraclass correlation coefficient (ICC), and kappa values.
Main Results:
- A very similar distribution of PD-L1 expression was observed between the 22C3 pharmDx and SP263 assays.
- Strong significant correlations (p < 0.0001) were found between the assays across different platforms.
- Good interobserver reliability and substantial to almost perfect agreement rates were achieved at various cut-offs.
Conclusions:
- The 22C3 pharmDx and SP263 assays demonstrate interchangeability for PD-L1 assessment in HNSCC.
- Different immunohistochemistry platforms can be reliably used for patient selection in HNSCC immunotherapy.
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