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The relevance of the reference range for EGFR testing in non-small cell lung cancer patients
Pasquale Pisapia1, Alessandro Russo2, Caterina De Luca1
1Department of Public Health, University of Naples Federico II, Naples, Italy.
Introduction:
Identifying mutations in the epidermal growth factor receptor (EGFR) gene is crucial for individualized treatment of non-small cell lung cancer (NSCLC) patients. Accordingly, several methodologies and instruments are now commercially available to detect these alterations. The aim of this study was to examine the performance of next generation sequencing (NGS) in detecting both common and uncommon EGFR gene mutations in advanced NSCLC patients.
Methods:
We retrospectively retrieved molecular data from n = 1312 advanced stage NSCLC patients tested by our NGS DNA-based panel (namely SiRe® panel) from January 2018 to December 2022. We subsequently compared the NGS results with the reference ranges of the most popular real time PCR (RT-qPCR) assays (cobas® EGFR Mutation Test v2, EasyPGX® ready EGFR, Idylla™ EGFR mutation test, and therascreen® EGFR Plus RGQ).
Results:
Overall, NGS detected n = 234 mutations in n = 192 (15.9 %) patients. Conversely, when these results were compared with the reference ranges of the four most common commercially available RT-qPCR assays, far fewer mutations were identified: n = 18 (9.4 %), n = 17 (8.9 %), n = 17 (8.9 %), and n = 18 (9.4 %) mutations. These results suggest that if patients were tested solely using RT-qPCR assays, a substantial proportion would have been ineligible for targeted therapies.
Conclusions:
Our study highlights that NGS is able to identify a much higher number of actionable EGFR mutations than RT-qPCR approaches, thereby providing many more patients the opportunity to receive targeted EGFR treatments.
Insights
Next-generation sequencing (NGS) identifies significantly more epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer (NSCLC) than real-time PCR (RT-qPCR). This enables more patients to access crucial targeted therapies.
Area of Science:
- Oncology
- Genetics
- Molecular Diagnostics
Background:
- Identifying epidermal growth factor receptor (EGFR) gene mutations is critical for personalized non-small cell lung cancer (NSCLC) treatment.
- Various methods exist for detecting EGFR alterations, necessitating performance evaluation.
Purpose of the Study:
- To assess the efficacy of next-generation sequencing (NGS) in detecting common and uncommon EGFR mutations in advanced NSCLC patients.
- To compare NGS performance against established real-time quantitative PCR (RT-qPCR) assays.
Main Methods:
- Retrospective analysis of molecular data from 1312 advanced NSCLC patients tested via an NGS DNA-based panel (SiRe® panel) between January 2018 and December 2022.
- Comparison of NGS results with reference ranges from four popular RT-qPCR assays: cobas® EGFR Mutation Test v2, EasyPGX® ready EGFR, Idylla™ EGFR mutation test, and therascreen® EGFR Plus RGQ.
Main Results:
- NGS identified 234 mutations in 192 patients (15.9%).
- In contrast, RT-qPCR assays detected substantially fewer mutations: 18 (9.4%), 17 (8.9%), 17 (8.9%), and 18 (9.4%) respectively.
- A significant number of patients would be ineligible for targeted therapy if solely tested by RT-qPCR.
Conclusions:
- NGS demonstrates superior capability in identifying actionable EGFR mutations compared to RT-qPCR.
- This enhanced detection rate by NGS offers more advanced NSCLC patients access to vital targeted EGFR treatments.
