SP142 PD-L1 scoring shows high interobserver and intraobserver agreement in triple-negative breast carcinoma but overall low percentage agreement with other PD-L1 clones SP263 and 22C3

Jia-Min B. Pang, Belinda Castles, David J. Byrne, Peter Button, Shona Hendry, Sunil R. Lakhani, Vanathi Sivasubramaniam, Wendy A. Cooper, Jane Armes, Ewan K. A. Millar, Wendy Raymond, Samuel Roberts-Thomson, Beena Kumar, Marian Burr, Christina Selinger, Kate Harvey, Charles Chan, Jane Beith, David Clouston, Sandra A. O’TooleStephen B. Fox

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31 Citations (Scopus)

Abstract

SP142 programmed cell death ligand 1 (PD-L1) status predicts response to atezolizumab in triple-negative breast carcinoma (TNBC). Prevalence of VENTANA PD-L1 (SP142) Assay positivity, concordance with the VENTANA PD-L1 (SP263) Assay and Dako PD-L1 IHC 22C3 pharmDx assay, and association with clinicopathologic features were assessed in 447 TNBCs. SP142 PD-L1 intraobserver and interobserver agreement was investigated in a subset of 60 TNBCs, with scores enriched around the 1% cutoff. The effect of a 1-hour training video on pretraining and posttraining scores was ascertained. At a 1% cutoff, 34.2% of tumors were SP142 PD-L1 positive. SP142 PD-L1 positivity was significantly associated with tumor-infiltrating lymphocytes (P <0.01), and node negativity (P= 0.02), but not with tumor grade (P=0.35), tumor size (P=0.58), or BRCA mutation (P=0.53). Overall percentage agreement (OPA) for intraobserver and interobserver agreement was 95.0% and 93.7%, respectively, among 5 pathologists trained in TNBC SP142 PD-L1 scoring. In 5 TNBC SP142 PD-L1-naive pathologists, significantly higher OPA to the reference score was achieved after video training (posttraining OPA 85.7%, pretraining OPA 81.5%, P<0.05). PD-L1 status at a 1% cutoff was assessed by SP142 and SP263 in 420 cases, and by SP142 and 22C3 in 423 cases, with OPA of 88.1% and 85.8%, respectively. The VENTANA PD-L1 (SP142) Assay is reproducible for classifying TNBC PD-L1 status by trained observers; however, it is not analytically equivalent to the VENTANA PD-L1 (SP263) Assay and Dako PD-L1 IHC 22C3 pharmDx assay.
Original languageEnglish
Pages (from-to)1108-1117
Number of pages10
JournalAmerican Journal of Surgical Pathology
Volume45
Issue number8
DOIs
Publication statusPublished - 2021

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