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Leveraging Commercially Available Protein Assays as Biomarkers for Lung Cancer
Kevin Connor McGann1, Palina Woodhouse1, Heidi Chen2
1Department of Thoracic Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.
Summary
This study evaluated four blood protein biomarkers for diagnosing lung cancer in indeterminate pulmonary nodules. Combining biomarkers like HE-4 and CEA showed potential for improved lung cancer risk stratification.
Area of Science:
- Oncology
- Biomarker Discovery
- Pulmonary Medicine
Background:
- Lung cancer is a leading cause of cancer mortality.
- Blood-based biomarkers are underutilized in routine lung cancer diagnosis.
- Indeterminate pulmonary nodules (IPNs) require accurate risk assessment.
Purpose of the Study:
- To evaluate the diagnostic performance of four commercial blood protein assays in patients with IPNs.
- To assess the utility of Cytokeratin 19 fragment (CYFRA 21-1), carcinoembryonic antigen (CEA), cancer antigen 125 (CA-125), and human epididymis protein 4 (HE-4) for lung cancer detection.
- To determine if combining these biomarkers improves diagnostic accuracy.
Main Methods:
- Prospective specimen collection with retrospective blinded evaluation.
- Quantification of CYFRA 21-1, CEA, CA-125, and HE-4 using commercial immunoassays.
- Development and external validation of logistic regression models in training, testing, and multicenter cohorts (LTP-2).
Main Results:
- The study included 816 patients across training and validation cohorts.
- Individual biomarkers showed moderate diagnostic value (AUCs ranging from 0.48 to 0.65).
- Combining all four biomarkers achieved an AUC of 0.70 in the combined training/testing set and 0.61 in the external validation set.
Conclusions:
- CYFRA 21-1, CEA, CA-125, and HE-4 demonstrated diagnostic value in IPNs.
- External validation in the LTP-2 cohort confirmed the utility of these biomarkers.
- Commercial assays offer a feasible approach to enhance lung cancer risk stratification in clinical settings.
