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Harmonization of Molecular Testing for Non-Small Cell Lung Cancer: Emphasis on PD-L1
Evgeny N Imyanitov1,2, Alexandr O Ivantsov1,2, Ilya V Tsimafeyeu3
1Department of Tumor Growth Biology, N.N. Petrov Institute of Oncology, St. Petersburg, Russia.
Abstract:
Comprehensive molecular testing plays a critical role in the choice of treatment for non-small lung cell cancer (NSCLC). The analysis of druggable alterations in EGFR, BRAF, MET, KRAS, ALK, ROS1, RET and NTRK1/2/3 genes is more or less standardized and can be achieved using a single diagnostic platform, e.g., next generation sequencing (NGS) or polymerase chain reaction (PCR). In contrast to above targets, PD-L1 testing requires the use of immunohistochemistry (IHC). There are multiple PD-L1 IHC assays, which utilize distinct antibodies and detection systems. These PD-L1 tests are tailored to distinct drugs, often rely on different thresholds and scoring guidelines, and are characterized by incomplete inter-laboratory and inter-observer reproducibility. Several studies evaluated the performance of PD-L1 RNA expression tests, as PCR-based RNA analysis is compatible with other NSCLC molecular testing platforms, can be performed in a semi-automated manner, and has a potential for proper standardization. These investigations revealed a correlation between PD-L1 protein and RNA expression; however, there were NSCLCs demonstrating decent amounts of PD-L1 transcript in the absence of PD-L1 IHC staining. Clinical studies are required to evaluate, which of the two PD-L1 testing approaches, i.e., RNA or protein expression measurement, has a better predictive value.
Insights
Comprehensive molecular testing guides non-small cell lung cancer (NSCLC) treatment. PD-L1 RNA testing shows promise for standardization, but clinical studies are needed to compare its predictive value against PD-L1 protein (IHC) testing.
Area of Science:
- Oncology
- Molecular Diagnostics
- Biomarker Analysis
Background:
- Comprehensive molecular testing is crucial for guiding non-small cell lung cancer (NSCLC) treatment decisions.
- Standardized analysis of actionable mutations (EGFR, KRAS, ALK, etc.) is achievable via platforms like NGS or PCR.
- PD-L1 testing, typically via immunohistochemistry (IHC), faces challenges in standardization due to assay variability and reproducibility issues.
Purpose of the Study:
- To evaluate PD-L1 RNA expression testing as a potential standardized alternative to PD-L1 IHC for NSCLC.
- To compare the correlation and clinical utility of PD-L1 RNA versus protein expression in NSCLC.
Main Methods:
- Review of studies evaluating PD-L1 RNA expression using PCR-based methods.
- Comparison of PD-L1 RNA expression data with existing PD-L1 IHC staining results.
- Analysis of NSCLC cases with discordant RNA and protein expression levels.
Main Results:
- PD-L1 RNA expression analysis is compatible with existing NSCLC molecular testing platforms and offers potential for standardization.
- A correlation exists between PD-L1 RNA and protein expression levels.
- Some NSCLC cases exhibit PD-L1 RNA expression without detectable PD-L1 protein staining via IHC.
Conclusions:
- PD-L1 RNA testing presents a viable, potentially more standardized approach for assessing PD-L1 status in NSCLC.
- Further clinical studies are essential to determine whether PD-L1 RNA or protein expression offers superior predictive value for treatment selection in NSCLC.
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