Noninvasive Testing for Early-Stage Lung Cancer Chemoprevention Therapy
Lung cancer screening using sputum testing has been difficult because sputum contains few malignant cells and they are difficult to detect. However, research has shown that sputum contains diagnostic malignant cells and could serve as a means of lung cancer detection if those cells could be detected and correctly characterized.
The Lung Cell Evaluation Device (LuCED) test is a commercially available, physician-ordered, take-home sputum test for early-stage lung cancer that detects abnormal cells that are exfoliated from tumors into sputum. It has been shown to promote cancer case detection with more than 92% sensitivity and more than 95% specificity.
In this study, researchers assessed the performance of the LuCED test as a noninvasive method to detect endobronchial dysplasia. More than 23,000 normal, 690 cancer, and 65 moderate-to-severe dysplasia cells from patient sputum were analyzed. Each individual cell was imaged in 3 dimensions to measure structural biomarkers.
Results of this analysis were categorized into 2 diagnostic indications: (1) cancer versus all other cell types; and (2) moderate-to-severe dysplasia versus all other cell types. Using thresholds chosen to yield case specificity that exceeds 95%, cell classification sensitivity of 75% was measured for cancer and dysplasia detection. Because abnormal sputum typically contains at least 3 abnormal cells, cancer case detection sensitivity approximated 98%.
Researchers concluded that the LuCED test can detect endobronchial dysplasia in the lung with an estimated 98% case sensitivity and 95% case specificity. Noninvasive detection of dysplasia by this type of testing may allow future intervention with agents that reverse dysplasia and prevent lung cancer.
Meyer M, et al. WCLC 2016. Abstract MA 01.02. ID 3866.