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Updated: Feb 21, 2026

Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
Predictive and Prognostic Value of CYFRA 21-1 for Advanced Non-small Cell Lung Cancer Treated with EGFR-TKIs
Akira Takeuchi1, Tetsuya Oguri2, Kazuki Sone1
1Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Background:
Tyrosine kinase inhibitors (TKIs) directed against epidermal growth factor receptor (EGFR) are important in the treatment of non-small cell lung cancer (NSCLC), especially those harboring EGFR mutations. But little is known regarding the clinical value of serum tumor marker levels measured prior to treatment.
Patients And Methods:
We retrospectively reviewed 95 patients with advanced NSCLC treated with EGFR-TKIs, and inspected the relationship between serum tumor marker levels and clinical outcome.
Results:
Forty-three patients with an elevated serum level of cytokeratin 19 fragment (CYFRA 21-1) had shorter progression-free (PFS) and overall (OS) survival than 52 patients with normal serum CYFRA 21-1 levels (99 vs. 123.5 days p=0.011; and 385 vs. 607 days, respectively, p=0.001). Regardless of EGFR mutation status, patients had shorter progression-free survival when serum CYFRA 21-1 was elevated.
Conclusion:
Serum CYFRA 21-1 level may be a predictive factor for patients with NSCLC treated with EGFR-TKIs, regardless of EGFR mutation status.
Insights
Elevated serum cytokeratin 19 fragment (CYFRA 21-1) levels predict shorter survival in non-small cell lung cancer (NSCLC) patients treated with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs). This finding holds true regardless of EGFR mutation status.
Area of Science:
- Oncology
- Biomarkers
- Lung Cancer Research
Background:
- Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are crucial for treating non-small cell lung cancer (NSCLC), particularly with EGFR mutations.
- The clinical significance of pre-treatment serum tumor marker levels in NSCLC patients receiving EGFR-TKIs is not well-established.
Purpose of the Study:
- To investigate the clinical value of serum tumor marker levels before treatment in advanced NSCLC patients undergoing EGFR-TKI therapy.
- To determine if serum CYFRA 21-1 levels can predict treatment outcomes in NSCLC patients treated with EGFR-TKIs.
Main Methods:
- Retrospective review of 95 advanced NSCLC patients treated with EGFR-TKIs.
- Analysis of the relationship between pre-treatment serum tumor marker levels, specifically CYFRA 21-1, and clinical outcomes (progression-free survival and overall survival).
Main Results:
- Patients with elevated serum CYFRA 21-1 (n=43) had significantly shorter progression-free survival (99 days) and overall survival (385 days) compared to those with normal levels (n=52) (123.5 days and 607 days, respectively).
- Elevated serum CYFRA 21-1 was associated with shorter progression-free survival irrespective of the patient's EGFR mutation status.
Conclusions:
- Serum CYFRA 21-1 level is a potential predictive factor for treatment response in NSCLC patients receiving EGFR-TKIs.
- This predictive value of serum CYFRA 21-1 is independent of EGFR mutation status, offering a broadly applicable biomarker.
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