Concordance among four commercially available, validated programmed cell death ligand-1 assays in urothelial carcinoma.
Diagn Pathol
; 14(1): 99, 2019 Sep 02.
Article
en En
| MEDLINE
| ID: mdl-31477145
ABSTRACT
BACKGROUND:
Antibodies targeting the programmed cell death-1 (PD-1)/PD-ligand 1 (PD-1/PD-L1) checkpoint have shown promising clinical activity in patients with advanced urothelial carcinoma (UC). Expression of PD-L1 in UC tumors has been investigated using different antibody clones, staining protocols, and scoring algorithms. The aim was to establish the extent of concordance among PD-L1 immunohistochemistry (IHC) assays.METHODS:
Tumor biopsy samples (N = 335) were assessed using four commercially available PD-L1 assays VENTANA SP263, VENTANA SP142, PD-L1 IHC 28-8 pharmDx, and PD-L1 IHC 22C3 pharmDx. PD-L1 analytical staining and classification concordance, including agreement between clinically relevant scoring algorithms, were investigated using overall/positive/negative percentage agreement (OPA/PPA/NPA).RESULTS:
Good analytical correlation was observed among the VENTANA SP263, PD-L1 IHC 22C3 pharmDx, and PD-L1 IHC 28-8 pharmDx assays for tumor cell (TC) and immune cell (IC) PD-L1 staining with Spearman rank coefficients of 0.92-0.93 for TCs and 0.88-0.91 for ICs. However, concordance (preset criterion ≥85%) between patient PD-L1 status when applying the TC or ICICArea ≥ 25% (VENTANA SP263) cutoff was only achieved for PD-L1 IHC 22C3 pharmDx versus VENTANA SP263 (OPA 92.2%, PPA 86.4%, NPA 95.4%). Differences were observed between patient populations with UC tumors classified as PD-L1 high versus PD-L1 low/negative using combined positive score (CPS) ≥1, CPS ≥10, IC ≥5%, and TC/IC ≥25%.CONCLUSIONS:
The VENTANA SP263 and PD-L1 IHC 22C3 pharmDx assays are analytically similar in UC. When the different PD-L1 assays were combined with their specified clinical scoring algorithms, differences were seen in patient classification driven by substantial differences in scoring approaches.Palabras clave
Texto completo:
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Bases de datos:
MEDLINE
Asunto principal:
Neoplasias de la Vejiga Urinaria
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Inmunohistoquímica
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Carcinoma de Células Transicionales
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Biomarcadores de Tumor
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Antígeno B7-H1
Tipo de estudio:
Guideline
Límite:
Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Diagn Pathol
Asunto de la revista:
PATOLOGIA
Año:
2019
Tipo del documento:
Article
País de afiliación:
Reino Unido