ArticleModern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc2021
PD-L1 expression in gastric cancer: interchangeability of 22C3 and 28-8 pharmDx assays for responses to immunotherapy.
Article in Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 62 papers, 3 of them syntheses that pooled it.
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Who cites it
62 citing papers in PubMed, 3 syntheses or guidelines pooled it, 89 citations in OpenAlex.
- The optimal threshold of PD-L1 combined positive score to predict the benefit of PD-1 antibody plus chemotherapy for patients with HER2-negative gastric adenocarcinoma: a meta-analysis.Cancer immunology, immunotherapy : CII · 2024Pooled it
- Pooled it
- Pooled it
- Anlotinib plus toripalimab as a first-line treatment in patients with advanced gastric cancer and performance status 2: the phase II APICAL-GC trial.Nature communications · 2025Trial
- Real-world characterization of PD-L1 expression in patients with advanced esophagogastric adenocarcinoma in Spain.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Observational
- Clinical Interchangeability of 22C3 and 28 - 8 PD-L1 assays for patient selection in esophageal squamous cell carcinoma.Virchows Archiv : an international journal of pathology · 2026Article
- A deep learning-derived risk score model from digital pathology to forecast nivolumab outcomes in gastric carcinoma.British journal of cancer · 2026Article
- Exploring plasma cell-free RNA biomarkers for predicting immune checkpoint inhibitor efficacy in gastric cancer: a translational sub-study of the KSCC VOYAGER phase II trial.International journal of clinical oncology · 2026Article
- Comprehensive Overview of Gastric Cancer Immunohistochemistry: Key Biomarkers, Advanced Detection Methods, and Perspectives.Medicina (Kaunas, Lithuania) · 2026Review
- Article
- Review
- PD-L1 expression in gastric cancer assessed with antibodies 28-8 and 22C3.Scientific reports · 2025Observational
- Article
- Article
- Biomarkers in gastroesophageal cancer 2025: an updated consensus statement by the Spanish Society of Medical Oncology (SEOM) and the Spanish Society of Pathology (SEAP).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025Review
- The prognostic role of Claudin 18.2 in advanced gastric or gastroesophageal junction adenocarcinoma: a systematic literature review.ESMO gastrointestinal oncology · 2025Review
- Correlation of CLDN18.2 and Tumor Microenvironment in Gastric Cancer: A Systematic Review.Cancers · 2025Review
- Pulmonary Tumor Thrombotic Microangiopathy Associated With Gastric Cancer: Clinical Characteristics and Outcomes.Journal of gastric cancer · 2025Article
- Treatment Selection for Patients with HER2-Negative Metastatic Gastric Cancer Expressing Claudin 18.2 and PD-L1.Cancers · 2025Review
- The clinical significance of signal regulatory protein alpha expression in the immune environment of gastric cancer.International journal of clinical oncology · 2025Article
2 more citing papers are in PubMed but not listed here.
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Authors and funding
2 authors at 1 institution in 1 country.
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No grant is acknowledged in the PubMed record.
Abstract
Recent clinical trials have shown the promising therapeutic effects of pembrolizumab and nivolumab in patients with advanced gastric cancer. Currently, the programmed death ligand-1 (PD-L1) 22C3 pharmDx assay is the only companion diagnostic assay for assessing the safety and effectiveness of pembrolizumab. The purpose of this study was to compare 22C3 pharmDx and 28-8 pharmDx, a complementary diagnostic assay for nivolumab, in gastric cancer. In this study, 22C3 and 28-8 pharmDx assays were performed on the same formalin-fixed, paraffin-embedded tissue blocks of gastric adenocarcinoma clinical samples (n = 55). The concordance rate was evaluated using combined positive score (CPS) cutoffs of 1, 10, and 50. PD-L1 positivity with CPS ≥ 1 was 45.5% using the 22C3 pharmDx assay and 49.1% using the 28-8 pharmDx assay. At a CPS cutoff of 1, the overall percentage agreement was 96.4%. The positive and negative percentage agreements were 93.3% and 100%, respectively. All cases positive for PD-L1 using the 22C3 pharmDx assay were also positive using the 28-8 pharmDx assay. At a CPS cutoff of 10, the overall percentage agreement was 96.4%. At a CPS cutoff of 50, the two assays exhibited 100% concordance. Nonspecific cytoplasmic staining in the background tissues and tumor cells was often observed in the 28-8 pharmDx assay. When the results of the two assays were matched for response to immunotherapy, the overall response rate was higher in patients with a PD-L1 CPS ≥ 1 than in PD-L1-negative patients (22C3 pharmDx, P = 0.001; 28-8 pharmDx, P = 0.002). In conclusion, PD-L1 22C3 and 28-8 pharmDx assays were highly comparable at CPS cutoffs of 1, 10, and 50 in gastric cancer. These results provide evidence for the potential interchangeability of the two PD-L1 assays in gastric cancer.
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