BARCELONA -- Use of the EarlyCDT-Lung test in combination with chest X-ray and CT imaging led to the detection of lung cancer at an earlier, more treatable stage, according to results of a randomized trial conducted in Scotland and presented during the presidential symposium of International Association for the Study of Lung Cancer World Conference on Lung Cancer.
EarlyCDT-Lung (Oncimmune) is an autoantibody diagnosis test that stratifies individuals according to their risk for developing lung cancer based on the presence of seven antigens, p53, NY-ESO-1, CAGE, GBU4-5, SOX2, HuD and MAGE-A4. Data have shown that the test identifies 41% of lung cancers with 90% specificity, whereas CT scanning identifies 67% of lung cancers with 49% specificity.
Frank Sullivan, FRSE, FRCP, FRCGP, professor of primary care medicine and medical school director of research at University of St. Andrews in the United Kingdom, and colleagues evaluated whether the use of EarlyCDT-Lung followed by chest X-ray and CT scanning would identify individuals at high risk for lung cancer and reduce the incidence of late-stage lung cancer or unclassified presentation at diagnosis.
"The people we were targeting were asymptomatic," Sullivan said during a press conference. "We went to the practices themselves in the most deprived areas of Scotland and searched through the records to find patients who had more than 20 pack-years of smoking history or a first-degree family history of lung cancer. They also had to be fit enough for surgery with an ECOG performance score of 0 to 2."
The analysis included 12,209 patients aged 50 to 75 years at high risk for lung cancer who were randomly assigned the study intervention (n = 6,088) or standard of care in Scotland (n = 6,121).
Patients in the intervention group who tested positive with EarlyCDT-Lung underwent an immediate chest X-ray and CT scan with follow-up every 6 months for 2 years. Patients with negative results underwent standard care.
The difference between the number of patients with stage III, stage IV or unclassified lung cancer at diagnosis served as the study's primary endpoint.
Overall, 127 patients received a lung cancer diagnosis during the study period, which included 56 patients in the intervention group and 71 in the control group. In total, 9.8% of those in the intervention group tested positive on EarlyCDT-Lung, and 3.4% (n = 18) were diagnosed with lung cancer during the study.