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Using 22C3 Anti-PD-L1 Antibody Concentrate on Biopsy and Cytology Samples from Non-small Cell Lung Cancer Patients
Published on: September 25, 2018
PD-L1 expression and its clinicopathologic and genomic correlation in the non-small cell lung carcinoma patients: An
Ekta Jain1, Shivani Sharma1, Aditi Aggarwal1
1Department of Pathology, CORE Diagnostics, 406, Udyog Vihar III, Gurgaon, Haryana 122001, India.
Background:
Immunotherapy with checkpoint inhibitor programmed death-1 (PD-1) and programmed death-ligand 1 (PD-L1) antibodies targeting the cellular immune checkpoints is the present area of interest showing promising results in patients with advanced non-small cell lung cancer (NSCLC). As there is paucity of PD-L1 expression data from the Indian perspective, we studied the correlation of clinicopathologic profile and oncogenic driver mutations in these patients.
Materials And Methods:
Samples from 252 advanced NSCLCs patients were studied for PD-L1 expression through immunohistochemistry using rabbit anti-human PD-L1 monoclonal antibody (clone SP263) on Ventana BenchMark ULTRA autostainer. Simultaneously, genetic mutations were studied by next generation sequencing (for EGFR, ALK, ROS, MET, and BRAF). PD-L1 expression was analyzed for association with clinicopathologic features and various mutations.
Results:
PD-L1 positivity was seen in 134 patients (53.2 %). It was twice more prevalent in males than females. No significant correlation was observed between PD-L1 expression with age, gender, site of testing (primary vs. metastatic tumors), smoking status, tumor laterality, stage, or histologic type; however, there was significant difference among solid and acinar types of adenocarcinoma combined together vs. other adenocarcinoma subtypes (p = 0.013), and well and moderately differentiated vs. poorly differentiated tumors (p = 0.022). When types/extent of PD-L1 positivity (≥25 %) were compared with demographics, clinical, and pathologic variables, significant differences were observed across the tumor grades (high-grade vs. low-grade) (p = 0.009) and stages (p = 0.039). The PD-L1 expression failed to demonstrate any statistical significance with oncogenic drivers. High PD-L1 expression (TPS ≥ 50) was observed in 27.6 % patients, and it was more prevalent in female patients (32.4 %), aged ≥60 years (33.8 %), smokers (27.3 %), poorly differentiated (36.8 %) and stage IV tumors (28.2 %). Exon 19 deletion was more prevalent in PD-L1 negative tumors whereas exon 21 substitution (L858R) was seen more in PD-L1 positive tumors.
Conclusions:
This is the largest Indian study demonstrating PD-L1 expression in NSCLC patients comparing with clinicopathologic and genomic parameters. PD-L1 expression was significantly associated with high-grade, solid, and acinar types of adenocarcinoma and advanced tumors. High PD-L1 expression was more prevalent in female patients, aged ≥60 years, smokers, and poorly differentiated and stage IV tumors (28.2 %). Exon 19 deletion was more in PD-L1 negative tumors whereas exon 21 substitution (L858R) was more in PD-L1 positive tumors. PD-L1 is a potential predictive marker stratifying patients who benefit from PD-1 pathway-targeted therapy.
Insights
This study found programmed death-ligand 1 (PD-L1) expression in advanced non-small cell lung cancer (NSCLC) is linked to tumor grade and stage, not specific gene mutations. High PD-L1 expression was more common in certain patient groups, suggesting its potential as a predictive marker for immunotherapy.
Area of Science:
- Oncology
- Immunotherapy
- Molecular Diagnostics
Background:
- Immunotherapy targeting programmed death-1 (PD-1) and programmed death-ligand 1 (PD-L1) shows promise in advanced non-small cell lung cancer (NSCLC).
- Limited data exists on PD-L1 expression in Indian NSCLC patients.
- This study investigates PD-L1 expression in relation to clinicopathologic features and driver mutations in Indian NSCLC patients.
Purpose of the Study:
- To assess PD-L1 expression levels in advanced NSCLC patients from India.
- To correlate PD-L1 expression with clinicopathologic characteristics.
- To examine the association between PD-L1 expression and common oncogenic driver mutations.
Main Methods:
- Immunohistochemistry was used to evaluate PD-L1 expression in 252 advanced NSCLC samples.
- Next-generation sequencing was performed to identify mutations in EGFR, ALK, ROS, MET, and BRAF.
- Statistical analyses were conducted to determine associations between PD-L1 expression, clinicopathologic variables, and mutations.
Main Results:
- PD-L1 positivity was observed in 53.2% of patients.
- PD-L1 expression showed significant associations with tumor grade and specific adenocarcinoma subtypes (solid, acinar).
- No significant correlation was found between PD-L1 expression and oncogenic driver mutations; however, different EGFR mutations (exon 19 deletion vs. exon 21 L858R) showed varied PD-L1 expression patterns.
Conclusions:
- PD-L1 expression is significantly associated with high-grade, advanced NSCLC and specific histological subtypes in the Indian population.
- High PD-L1 expression was more prevalent in females, older patients, smokers, and those with poorly differentiated and stage IV tumors.
- PD-L1 expression may serve as a predictive biomarker for response to PD-1 pathway-targeted therapies in NSCLC.
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