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Using 22C3 Anti-PD-L1 Antibody Concentrate on Biopsy and Cytology Samples from Non-small Cell Lung Cancer Patients
- Source :
- J Vis Exp
- Publication Year :
- 2018
-
Abstract
- Pembrolizumab monotherapy has been approved for the first- and second-line treatment of patients with PD-L1-expressing advanced non-small cell lung cancer (NSCLC). Testing for PD-L1 expression with the PD-L1 immunohistochemistry (IHC) 22C3 companion diagnostic assay, which gives a tumor proportion score (TPS), has been validated on tumor tissue. We developed an optimized laboratory-developed test (LDT) that uses the 22C3 antibody (Ab) concentrate on a widely available IHC autostainer for biopsy and cytology specimens. The PD-L1 TPS was evaluated with 120 paired whole-tumor tissue sections and biopsy samples and with 70 paired biopsy and cytology samples (bronchial washes, n = 40; pleural effusions, n = 30). The 22C3 Ab concentrate-based LDT showed a high concordance rate between biopsy (~100%) and cytology (~95%) specimens when compared to PD-L1 IHC expression determined using the PD-L1 IHC 22C3 companion assay at both TPS cut points (≥1%, ≥50%). The optimized LDT presented here, using the 22C3 Ab concentrate to determine the PD-L1 expression in both tumor tissue and in cytology specimens, will expand the ability of laboratories worldwide to assess the eligibility of patients with NSCLC for treatment with pembrolizumab monotherapy in a reliable and reproducible manner.
- Subjects :
- Pathology
medicine.medical_specialty
Cancer Research
Lung Neoplasms
General Chemical Engineering
Concordance
Biopsy
Cytological Techniques
Pembrolizumab
General Biochemistry, Genetics and Molecular Biology
03 medical and health sciences
0302 clinical medicine
Cytology
Carcinoma, Non-Small-Cell Lung
medicine
Biomarkers, Tumor
Humans
Lung cancer
General Immunology and Microbiology
medicine.diagnostic_test
biology
business.industry
General Neuroscience
medicine.disease
030220 oncology & carcinogenesis
biology.protein
Immunohistochemistry
030211 gastroenterology & hepatology
Antibody
business
Companion diagnostic
Subjects
Details
- ISSN :
- 1940087X
- Issue :
- 139
- Database :
- OpenAIRE
- Journal :
- Journal of visualized experiments : JoVE
- Accession number :
- edsair.doi.dedup.....2c0b072a352ac273a969bb2c31702574