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Updated: May 20, 2026
Ultra-Fast Amplicon-Based Next-Generation Sequencing in Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
EML4-ALK testing in non-small cell carcinomas of the lung: a review with recommendations
Erik Thunnissen1, Lukas Bubendorf, Manfred Dietel
1Department of Pathology, VU University Medical Centre, Amsterdam, The Netherlands. e.thunnissen@vumc.nl
Abstract:
In non-small cell lung cancer, epidermal growth factor receptor gene mutations and anaplastic lymphoma kinase (ALK) gene rearrangements have a major impact upon the level of response to treatment with specific tyrosine kinase inhibitors. This review describes the molecular basis of ALK inhibition, summarizes current data on the effectiveness and safety of ALK inhibition therapy, describes the different testing methodologies with their advantages and disadvantages, provides a suggested testing algorithm and puts forward a proposal for an external quality assessment program in ALK testing.
Insights
Anaplastic lymphoma kinase (ALK) rearrangements impact treatment response in non-small cell lung cancer. This review covers ALK inhibition, testing methods, and quality assessment for better patient outcomes.
Area of Science:
- Oncology
- Molecular Biology
- Pharmacology
Background:
- Epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) rearrangements are key biomarkers in non-small cell lung cancer (NSCLC).
- These genetic alterations significantly influence patient response to tyrosine kinase inhibitor (TKI) therapies.
Purpose of the Study:
- To review the molecular mechanisms of ALK inhibition.
- To summarize current evidence on ALK inhibition therapy's efficacy and safety.
- To discuss ALK testing methodologies and propose a quality assessment program.
Main Methods:
- Literature review of ALK inhibition.
- Analysis of clinical trial data for ALK-targeted therapies.
- Evaluation of diagnostic testing methods for ALK rearrangements (e.g., FISH, IHC, NGS).
- Development of a proposed ALK testing algorithm and quality assurance framework.
Main Results:
- ALK inhibition targets specific molecular pathways in NSCLC.
- ALK inhibitors demonstrate significant clinical benefit in ALK-rearranged NSCLC patients.
- Various testing methods have distinct performance characteristics, impacting diagnostic accuracy.
- A standardized testing algorithm and external quality assessment are crucial for reliable results.
Conclusions:
- ALK testing is essential for guiding NSCLC treatment decisions.
- Optimized testing strategies and quality control are vital for effective ALK-targeted therapy.
- Further research should focus on refining testing methodologies and expanding quality assurance programs.
