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Indirect Clinical Validation of a Programmed Death-Ligand 1 Laboratory-Developed Test for Gastric/Gastroesophageal Junction Adenocarcinoma with 22C3 Antibody Concentrate
- Title
- Indirect Clinical Validation of a Programmed Death-Ligand 1 Laboratory-Developed Test for Gastric/Gastroesophageal Junction Adenocarcinoma with 22C3 Antibody Concentrate
- Authors
- Kim, Ji Min; Kim, Binnari; Kim, Eunji; Jang, Minsun; Cho, Jun Hun; Lee, Hye Seung; Kwak, Yoonjin; Huang, Lingkang; Krishnan, Radha; Bai, Sally Y.; Mounawar, Mounia; Kim, Kyoung-Mee
- Ewha Authors
- 김지민
- SCOPUS Author ID
- 김지민
- Issue Date
- 2022
- Journal Title
- MOLECULAR DIAGNOSIS & THERAPY
- ISSN
- 1177-1062
1179-2000
- Citation
- MOLECULAR DIAGNOSIS & THERAPY vol. 26, no. 6, pp. 679 - 688
- Publisher
- ADIS INT LTD
- Indexed
- SCIE; SCOPUS
- Document Type
- Article
- 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.
- DOI
- 10.1007/s40291-022-00605-2
- Appears in Collections:
- 의료원 > 의료원 > Journal papers
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