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PD-L1 Testing in Gastric Cancer by the Combined Positive Score of the 22C3 PharmDx and SP263 Assay with Clinically Relevant Cut-offs
PURPOSE: We provide a comparison between 22C3 pharmDx and SP263 assay, for evaluating programmed death ligand 1 (PD-L1) expression in advanced gastric cancer (GC) patients. MATERIALS AND METHODS: The PD-L1 immunohistochemistry by 22C3 pharmDx and SP263 assays was performed in the center of the tumor...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Korean Cancer Association
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7373862/ https://www.ncbi.nlm.nih.gov/pubmed/32019283 http://dx.doi.org/10.4143/crt.2019.718 |
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author | Park, Yujun Koh, Jiwon Na, Hee Young Kwak, Yoonjin Lee, Keun-Wook Ahn, Sang-Hoon Park, Do Joong Kim, Hyung-Ho Lee, Hye Seung |
author_facet | Park, Yujun Koh, Jiwon Na, Hee Young Kwak, Yoonjin Lee, Keun-Wook Ahn, Sang-Hoon Park, Do Joong Kim, Hyung-Ho Lee, Hye Seung |
author_sort | Park, Yujun |
collection | PubMed |
description | PURPOSE: We provide a comparison between 22C3 pharmDx and SP263 assay, for evaluating programmed death ligand 1 (PD-L1) expression in advanced gastric cancer (GC) patients. MATERIALS AND METHODS: The PD-L1 immunohistochemistry by 22C3 pharmDx and SP263 assays was performed in the center of the tumor (CT) and invasive margin (IM) in 379 GC tissues using tissue microarrays and interpreted as combined positive score (CPS) and tumor proportion score (TPS). Of the total samples, 55 samples were independently reviewed by five pathologists. RESULTS: The two assays showed a high correlation in both the CPS and TPS. At a CPS ≥ 1 cut-off, 219 (57.8%) and 231 (60.9%) GCs were positive for PD-L1 with the 22C3 and SP263 assays, and at ≥ 10 cut-off, 37 (9.8%) and 36 (9.5%) GCs were positive, respectively. The overall percent agreement (OPA) was greater than 90% with CPS ≥ 1 and ≥ 10 cut-offs, and TPS ≥ 1% and ≥ 10% cut-offs. There was higher OPA between the two assays with a CPS cut-off ≥ 10 (99.2%) than ≥ 1 (94.7%). The percent agreement between the CT and IM was higher with a CPS cut-off ≥ 10 (92.9%) than ≥ 1 (77.6%). Patient with positive expression at CPS ≥ 5 cut-off had a significantly better outcomes in both assays. Interobserver variability among five pathologists was higher than the assay variability. CONCLUSION: Two assays for PD-L1 expression in GC showed high agreement. These results provide guidance for selecting eligible patients with GC for pembrolizumab treatment. |
format | Online Article Text |
id | pubmed-7373862 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Korean Cancer Association |
record_format | MEDLINE/PubMed |
spelling | pubmed-73738622020-07-30 PD-L1 Testing in Gastric Cancer by the Combined Positive Score of the 22C3 PharmDx and SP263 Assay with Clinically Relevant Cut-offs Park, Yujun Koh, Jiwon Na, Hee Young Kwak, Yoonjin Lee, Keun-Wook Ahn, Sang-Hoon Park, Do Joong Kim, Hyung-Ho Lee, Hye Seung Cancer Res Treat Original Article PURPOSE: We provide a comparison between 22C3 pharmDx and SP263 assay, for evaluating programmed death ligand 1 (PD-L1) expression in advanced gastric cancer (GC) patients. MATERIALS AND METHODS: The PD-L1 immunohistochemistry by 22C3 pharmDx and SP263 assays was performed in the center of the tumor (CT) and invasive margin (IM) in 379 GC tissues using tissue microarrays and interpreted as combined positive score (CPS) and tumor proportion score (TPS). Of the total samples, 55 samples were independently reviewed by five pathologists. RESULTS: The two assays showed a high correlation in both the CPS and TPS. At a CPS ≥ 1 cut-off, 219 (57.8%) and 231 (60.9%) GCs were positive for PD-L1 with the 22C3 and SP263 assays, and at ≥ 10 cut-off, 37 (9.8%) and 36 (9.5%) GCs were positive, respectively. The overall percent agreement (OPA) was greater than 90% with CPS ≥ 1 and ≥ 10 cut-offs, and TPS ≥ 1% and ≥ 10% cut-offs. There was higher OPA between the two assays with a CPS cut-off ≥ 10 (99.2%) than ≥ 1 (94.7%). The percent agreement between the CT and IM was higher with a CPS cut-off ≥ 10 (92.9%) than ≥ 1 (77.6%). Patient with positive expression at CPS ≥ 5 cut-off had a significantly better outcomes in both assays. Interobserver variability among five pathologists was higher than the assay variability. CONCLUSION: Two assays for PD-L1 expression in GC showed high agreement. These results provide guidance for selecting eligible patients with GC for pembrolizumab treatment. Korean Cancer Association 2020-07 2020-01-10 /pmc/articles/PMC7373862/ /pubmed/32019283 http://dx.doi.org/10.4143/crt.2019.718 Text en Copyright © 2020 by the Korean Cancer Association This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Park, Yujun Koh, Jiwon Na, Hee Young Kwak, Yoonjin Lee, Keun-Wook Ahn, Sang-Hoon Park, Do Joong Kim, Hyung-Ho Lee, Hye Seung PD-L1 Testing in Gastric Cancer by the Combined Positive Score of the 22C3 PharmDx and SP263 Assay with Clinically Relevant Cut-offs |
title | PD-L1 Testing in Gastric Cancer by the Combined Positive Score of the 22C3 PharmDx and SP263 Assay with Clinically Relevant Cut-offs |
title_full | PD-L1 Testing in Gastric Cancer by the Combined Positive Score of the 22C3 PharmDx and SP263 Assay with Clinically Relevant Cut-offs |
title_fullStr | PD-L1 Testing in Gastric Cancer by the Combined Positive Score of the 22C3 PharmDx and SP263 Assay with Clinically Relevant Cut-offs |
title_full_unstemmed | PD-L1 Testing in Gastric Cancer by the Combined Positive Score of the 22C3 PharmDx and SP263 Assay with Clinically Relevant Cut-offs |
title_short | PD-L1 Testing in Gastric Cancer by the Combined Positive Score of the 22C3 PharmDx and SP263 Assay with Clinically Relevant Cut-offs |
title_sort | pd-l1 testing in gastric cancer by the combined positive score of the 22c3 pharmdx and sp263 assay with clinically relevant cut-offs |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7373862/ https://www.ncbi.nlm.nih.gov/pubmed/32019283 http://dx.doi.org/10.4143/crt.2019.718 |
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