Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 김지민 | * |
dc.date.accessioned | 2023-01-04T16:31:16Z | - |
dc.date.available | 2023-01-04T16:31:16Z | - |
dc.date.issued | 2022 | * |
dc.identifier.issn | 1177-1062 | * |
dc.identifier.issn | 1179-2000 | * |
dc.identifier.other | OAK-32558 | * |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/263026 | - |
dc.description.abstract | Background The PD-L1 IHC 22C3 pharmDx used on the Dako Autostainer Link 48 (ASL48) staining platform is an established method for assessing programmed death-ligand 1 (PD-L1) expression in tumor tissue and determining patient eligibility for pembrolizumab treatment; however, the availability of this platform is limited in Europe and Asia. Objectives The aims of this study were to develop and optimize protocols for the PD-L1 22C3 antibody concentrate with multiple immunohistochemistry staining platforms and to validate these protocols using PD-L1 combined positive score (CPS) with a cut-off of >= 1 in gastric or gastroesophageal junction adenocarcinoma. Design The 22C3 antibody concentrate was tested and optimized protocols were developed for use with three staining platforms: Dako ASL48, Ventana BenchMark ULTRA, and Leica BOND-MAX. Tumor specimens (N = 120) from patients with gastric or gastroesophageal junction adenocarcinoma were used for the validation study; these specimens were evaluated independently by three pathologists for PD-L1 CPS as a continuous variable and using a cut-off of >= 1. PD-L1 IHC 22C3 pharmDx used on the Dako ASL48 platform served as the reference or gold standard. Results The intraclass correlation coefficient of CPS as a continuous variable between the gold standard and each staining platform assessed was 0.910-0.989. When CPS was dichotomized based on a cut-off of >= 1, depending on the pathologist and the platform used, positive percentage agreement was 81-99% and negative percentage agreement was 90-100%. Interobserver agreement using the gold standard showed substantial agreement (kappa = 0.779). Conclusion The PD-L1 22C3 antibody concentrate can potentially be used with the laboratory-developed test on three commercially available immunohistochemistry staining platforms to determine PD-L1 expression in tumor samples from patients with gastric or gastroesophageal junction adenocarcinoma. | * |
dc.language | English | * |
dc.publisher | ADIS INT LTD | * |
dc.title | Indirect Clinical Validation of a Programmed Death-Ligand 1 Laboratory-Developed Test for Gastric/Gastroesophageal Junction Adenocarcinoma with 22C3 Antibody Concentrate | * |
dc.type | Article | * |
dc.relation.issue | 6 | * |
dc.relation.volume | 26 | * |
dc.relation.index | SCIE | * |
dc.relation.index | SCOPUS | * |
dc.relation.startpage | 679 | * |
dc.relation.lastpage | 688 | * |
dc.relation.journaltitle | MOLECULAR DIAGNOSIS & THERAPY | * |
dc.identifier.doi | 10.1007/s40291-022-00605-2 | * |
dc.identifier.wosid | WOS:000859530300001 | * |
dc.author.google | Kim, Ji Min | * |
dc.author.google | Kim, Binnari | * |
dc.author.google | Kim, Eunji | * |
dc.author.google | Jang, Minsun | * |
dc.author.google | Cho, Jun Hun | * |
dc.author.google | Lee, Hye Seung | * |
dc.author.google | Kwak, Yoonjin | * |
dc.author.google | Huang, Lingkang | * |
dc.author.google | Krishnan, Radha | * |
dc.author.google | Bai, Sally Y. | * |
dc.author.google | Mounawar, Mounia | * |
dc.author.google | Kim, Kyoung-Mee | * |
dc.contributor.scopusid | 김지민(57245539100) | * |
dc.date.modifydate | 20240315113115 | * |