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Updated: May 4, 2026
Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
Preselection based on clinical characteristics in German non-small-cell lung cancer patients screened for EML4-ALK
Amanda Laura Helen Tufman1, Martin Edelmann, Fernando Gamarra
1*Division of Respiratory Medicine and Thoracic Oncology, Department of Internal Medicine V, Thoracic Oncology Centre Munich, Ludwig-Maximilians-Universität München, Munich, Germany; †Member of the German Center for Lung Research, Comprehensive Pneumology Center Munich, Munich, Germany; ‡Institute for Pathology, Ludwig-Maximilians Universität München, Munich, Germany; and §Department of Radiology, Ludwig-Maximilians Universität München, Munich, Germany.
Background:
The advent of multiple molecular targets in advanced non-small-cell lung cancer (NSCLC) has brought new treatments, but also new logistic and technical considerations, to the clinician. The small size of endoscopic biopsies and the increasing number of relevant but uncommon markers has increased the need for rational approaches to molecular testing. We present the results of clinical preselection before EML4-ALK testing in a German NSCLC cohort.
Methods:
Patients with stage IV NSCLC were included. Clinicians were encouraged to consider screening epidermal growth factor receptor wild-type adenocarcinoma patients with a limited smoking history, relatively young age, or who had benefited from chemotherapy for a relatively long period. Break-apart fluorescence in situ hybridization using archived paraffin tissue was performed in a central facility.
Results:
From April 2010 to September 2011 we included 61 patients: mean age 56.6 years, 41% women, 90% adenocarcinoma, 5% large-cell, and 5% squamous cell cancers. Only three patients had activating epidermal growth factor receptor mutations; 16.4% of patients were positive for EML4-ALK fusion. The anaplastic lymphoma kinase (ALK)-positive patients included 60% women, tended to be younger, had smoked less, and had received significantly more systemic therapy, on average 3.7 lines of treatment over 3 years, before ALK-testing compared with the ALK-negative patients. Long periods of progression-free survival were experienced by ALK-positive patients treated with pemetrexed, vinorelbine, or cetuximab.
Conclusions:
EML4-ALK fusion is uncommon, reported in about 5% of NSCLC patients; however, clinical preselection increased the yield of testing to 16.4%. EML4-ALK positive patients seem to have distinct clinical features and show long responses to a number of systemic therapies.
Insights
Clinical preselection for EML4-ALK testing in advanced non-small-cell lung cancer (NSCLC) identified more positive cases. This strategy improved diagnostic yield for EML4-ALK fusion in NSCLC patients.
Area of Science:
- Oncology
- Molecular Diagnostics
- Genetics
Background:
- Advanced non-small-cell lung cancer (NSCLC) presents challenges with multiple molecular targets and limited biopsy material.
- Rational molecular testing strategies are crucial for identifying actionable mutations in NSCLC.
Purpose of the Study:
- To evaluate the effectiveness of clinical preselection criteria for EML4-ALK fusion testing in a German NSCLC cohort.
- To assess the yield of EML4-ALK testing based on specific patient characteristics.
Main Methods:
- Stage IV NSCLC patients were analyzed.
- Clinicians used preselection criteria: EGFR wild-type, limited smoking history, younger age, or prolonged chemotherapy benefit.
- Break-apart fluorescence in situ hybridization (FISH) was performed on archived paraffin-embedded tumor tissue.
Main Results:
- Of 61 patients, 16.4% tested positive for EML4-ALK fusion, exceeding the general prevalence.
- ALK-positive patients were more likely to be younger, female, non-smokers, and had received extensive prior therapy.
- ALK-positive NSCLC patients showed prolonged progression-free survival with specific systemic therapies.
Conclusions:
- Clinical preselection significantly increased the detection rate of EML4-ALK fusion in NSCLC patients.
- EML4-ALK positive NSCLC cases exhibit distinct clinical features and respond well to certain systemic treatments.
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