TY - JOUR
T1 - A harmonization study for the use of 22C3 PD-L1 immunohistochemical staining on ventana's platform
AU - Neuman, Tzahi
AU - London, Michal
AU - Kania-Almog, Juliane
AU - Litvin, Anna
AU - Zohar, Yaniv
AU - Fridel, Ludmila
AU - Sandbank, Judith
AU - Barshak, Iris
AU - Vainer, Gilad W.
N1 - Publisher Copyright:
© 2016 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.
PY - 2016/11/13
Y1 - 2016/11/13
N2 - Introduction: Immunotherapy is a novel treatment for lung cancer. Pembrolizumab (Merck Sharp and Dohme, Kenilworth, NJ) is a monoclonal antibody against programmed cell death 1 that has been approved for use with NSCLC together with a companion diagnostic by Dako (Carpinteria, CA). Ventana's BenchMark XT (Ventana Medical Systems, Tucson, AZ) is a widely used immunohistochemical (IHC) platform. However, data on its reliability and reproducibility with the 22C3 antibody are scant. Methods: We performed a comprehensive calibration of 22C3 programmed cell death ligand 1 (PD-L1) staining on the BenchMark XT platform using Dako's prediluted 22C3 anti-PD-L1 primary antibody with two of Ventana's detection systems. Forty-one random cases of NSCLC were then independently evaluated by two pathologists. Each case was scored using Dako-or Ventana-stained slides. The scores obtained with the two 22C3 Ventana assays were compared with those obtained using the Dako 22C3 IHC platform. Results: The Dako IHC platform stratified eight, seven, and 26 cases as being strongly positive, weakly positive, and negative for PD-L1, respectively, whereas 36 of 41 cases (87.8%) had the same results with Ventana's UltraView 22C3 protocol (Pearson's correlation score 0.91, p < 0.0001). Moreover, 35 of 41 cases (85.3%) had the same results with Ventana's OptiView 22C3 protocol (Pearson's correlation score 0.89, p < 0.0001). Conclusions: The results of this study demonstrate that the same PD-L1 IHC algorithm can be reliably applied toVentana's BenchMark XT platform. Furthermore, we were able to detect all of the strongly positive cases with high interobserver and intraobserveragreementbyusingtheVentanaplatform.These findings suggest that the Ventana platform can be used to stratify patients for pembrolizumab-based immunotherapy.
AB - Introduction: Immunotherapy is a novel treatment for lung cancer. Pembrolizumab (Merck Sharp and Dohme, Kenilworth, NJ) is a monoclonal antibody against programmed cell death 1 that has been approved for use with NSCLC together with a companion diagnostic by Dako (Carpinteria, CA). Ventana's BenchMark XT (Ventana Medical Systems, Tucson, AZ) is a widely used immunohistochemical (IHC) platform. However, data on its reliability and reproducibility with the 22C3 antibody are scant. Methods: We performed a comprehensive calibration of 22C3 programmed cell death ligand 1 (PD-L1) staining on the BenchMark XT platform using Dako's prediluted 22C3 anti-PD-L1 primary antibody with two of Ventana's detection systems. Forty-one random cases of NSCLC were then independently evaluated by two pathologists. Each case was scored using Dako-or Ventana-stained slides. The scores obtained with the two 22C3 Ventana assays were compared with those obtained using the Dako 22C3 IHC platform. Results: The Dako IHC platform stratified eight, seven, and 26 cases as being strongly positive, weakly positive, and negative for PD-L1, respectively, whereas 36 of 41 cases (87.8%) had the same results with Ventana's UltraView 22C3 protocol (Pearson's correlation score 0.91, p < 0.0001). Moreover, 35 of 41 cases (85.3%) had the same results with Ventana's OptiView 22C3 protocol (Pearson's correlation score 0.89, p < 0.0001). Conclusions: The results of this study demonstrate that the same PD-L1 IHC algorithm can be reliably applied toVentana's BenchMark XT platform. Furthermore, we were able to detect all of the strongly positive cases with high interobserver and intraobserveragreementbyusingtheVentanaplatform.These findings suggest that the Ventana platform can be used to stratify patients for pembrolizumab-based immunotherapy.
KW - Dako
KW - Harmonization
KW - IHC
KW - PD-L1
KW - Ventana
UR - http://www.scopus.com/inward/record.url?scp=84995903906&partnerID=8YFLogxK
U2 - 10.1016/j.jtho.2016.08.146
DO - 10.1016/j.jtho.2016.08.146
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AN - SCOPUS:84995903906
SN - 1556-0864
VL - 11
SP - 1863
EP - 1868
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 11
ER -