A combination of the EarlyCDT-Lung Test followed by computed tomography (CT) imaging in Scottish patients at risk for lung cancer resulted in a significant decrease in late-stage diagnosis of lung cancer and may decrease lung cancer–specific mortality, according to research presented at International Association for the Study of Lung Cancer (IASLC) 2019 World Conference on Lung Cancer (WCLC). The research was presented by Frank Sullivan, PhD, of the University of St Andrews (Abstract PL02.03). Scotland has one of the highest rates of lung cancer in the world—approximately 460 men and 340 women for every 100,000 Scottish citizens are diagnosed with lung cancer every.
EarlyCDT-Lung Test
The EarlyCDT-Lung Test is a novel autoantibody diagnostic test for the early detection of lung cancer that allows stratification of individuals according to their risk of developing lung cancer. The test identifies 41% of lung cancers with a high specificity of 90%, compared to CT, which identifies 67% of lung cancers but with a low specificity of around 49%.
Dr. Sullivan and his team sought to determine whether using the EarlyCDT-Lung Test, followed by x-ray and CT, could identify those at high risk of lung cancer and reduce the incidence of patients with late-stage lung cancer or unclassified presentation at diagnosis compared to standard clinical practice.
Methods
In the study, 12,208 participants aged 50 to 75 years who had a high risk of developing lung cancer over the next 24 months were randomly assigned to either the study intervention or standard practice in the United Kingdom. Test-positive patients were offered a chest x-ray followed by a noncontrast thoracic CT scan. If the initial CT scan revealed no evidence of lung cancer, then subsequent CT scans were offered every 6 months for 24 months. Individuals with abnormalities were followed up over the study period or referred for clinical care as appropriate. All individuals entering the study were followed up via trial monitoring software linked to Scottish Health Records, including the Scottish Cancer Registry.
Results
One hundred and twenty-seven lung cancers were diagnosed in the study period (56 in the intervention group and 71 in the control arm), 9.8% of the intervention group had a positive EarlyCDT-Lung test, and 3.4% (n = 18) of these were diagnosed with lung cancer in the study period.
“Our results show that the combination of the EarlyCDT-Lung followed by CT imaging in those with a positive blood test results in a significant decrease in late-stage diagnosis of lung cancer, and may decrease all-cause and lung cancer–specific mortality.”— Frank Sullivan, PhD
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“The study was not powered to detect a difference in mortality after 2 years, however, there was a nonsignificant trend suggesting fewer deaths in the intervention arm compared to the control (87 vs 108, respectively). Similar results were noted relating to lung cancer–specific mortality (17 vs 24),” Dr. Sullivan said in a press release.
Dr. Sullivan added that significantly fewer participants in the intervention group were diagnosed with late-stage disease compared with the control group (33 vs 52).
“Our results show that the combination of the EarlyCDT-Lung followed by CT imaging in those with a positive blood test results in a significant decrease in late-stage diagnosis of lung cancer, and may decrease all-cause and lung cancer–specific mortality. We shall continue follow-up of all participants’ lung cancer and mortality outcomes at 5 years using Scottish Information Services Division data to study these effects further,” concluded the researchers.
Disclosure: For full disclosures of the study authors, visit wclc2019.iaslc.org.
