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. 2021 Jan 14;13(2):292.
doi: 10.3390/cancers13020292.

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

Simona Crosta  1 , Renzo Boldorini  2 , Francesca Bono  1 , Virginia Brambilla  1 , Emanuele Dainese  3 , Nicola Fusco  4 , Andrea Gianatti  5 , Vincenzo L'Imperio  1 , Patrizia Morbini  6 , Fabio Pagni  1
Affiliations

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

Simona Crosta et al. Cancers (Basel). .

Abstract

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.

Keywords: HNSCC; PD-L1; head and neck carcinoma; pembrolizumab.

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Conflict of interest statement

The authors declare absence of conflict of interests in the management of this paper.

Figures

Figure 1
Figure 1
Case no. 24: overestimation of the staining in punctate necrosis areas (A) ((B) ×20). The case was classified as CPS 0 with the GS.
Figure 2
Figure 2
Case no. 34 with CPS = 2 using the GS (A) (×20) and interpreted as negative with protocol 1, although faint and very focal staining was present in restricted areas (B) (×20).
See this image and copyright information in PMC

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