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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
- Source :
- Cancer Research and Treatment : Official Journal of Korean Cancer Association
- Publication Year :
- 2020
- Publisher :
- Korean Cancer Association, 2020.
-
Abstract
- 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.
- Subjects :
- 0301 basic medicine
Cancer Research
medicine.medical_specialty
Clinical Decision-Making
Gastroenterology
B7-H1 Antigen
Programmed cell death ligand 1
SP263 assay
03 medical and health sciences
0302 clinical medicine
Predictive Value of Tests
Stomach Neoplasms
Internal medicine
PD-L1
Biomarkers, Tumor
medicine
Humans
Tissue microarray
biology
business.industry
Patient Selection
Cancer
Advanced gastric cancer
medicine.disease
Immunohistochemistry
Gastric neoplasms
030104 developmental biology
Oncology
030220 oncology & carcinogenesis
biology.protein
Original Article
Reagent Kits, Diagnostic
business
22C3 pharmDx
Programmed death
Subjects
Details
- ISSN :
- 20059256 and 15982998
- Volume :
- 52
- Database :
- OpenAIRE
- Journal :
- Cancer Research and Treatment
- Accession number :
- edsair.doi.dedup.....9502abf7ae1eae2f9a6cb563c8991cbb