Performance of the EarlyCDT® Lung test in detection of lung cancer and pulmonary metastases in a high-risk cohort

Abstract

Early detection of lung cancer is pivotal for an optimal prognosis. CT screening is currently implemented in USA. To decrease the amount of CT scans, the application of a blood-based biomarker as part of screening criteria is desirable. Materials and methods: The EarlyCDT® Lung test was performed in a high-risk cohort composed 246 patients referred from their GP on suspicion of lung cancer. Blood samples were taken at first visit and patients underwent diagnostic workup on suspicion of lung cancer resulting in either a malignant diagnosis or ruled out cancer. Sensitivity and specificity of the EarlyCDT® Lung were calculated in the cohort and subgroups based on age, smoking history, sex and lung cancer stage. Results: Overall sensitivity in the cohort was 33 % for lung cancer and 31 % for primary lung cancer and lung metastases combined. Sensitivity in age groups was 11 % (60 years or below), 31 % (61− 75 years) and 55 % (>75 years). In patients with at least 10 tobacco pack years, sensitivity was 33 % while the sensitivity in patients with at least 50 tobacco pack years was 44 %. The assay sensitivity in stage I-II lung cancer patients was 21 %, while this was 40 % in stage III-IV lung cancer patients. In a subgroup of patients that met current CT screening criteria (age 55-80 years and minimum 30 tobacco pack years) the sensitivity was 37 %. Conclusion:The rationale of screening for lung cancer is to find patients in an early and resectable stage. However, the EarlyCDT® Lung test performed best in elderly, late stage lung cancer patients with a heavy smoking history. Based on these results, the current study finds insufficient sensitivity of the EarlyCDT® Lung test to be used as part of inclusion criteria in a low-dose CT program for detection of lung cancer.

Natural killer cell activity as a biomarker for the diagnosis of lung cancer in high-risk patients

“…It is likely that the performance will improve if NKA is combined with other relevant biomarkers, such as autoantibodies, carcinoembryonic antigen (CEA), C-terminus of cytokeratin 19, cancer antigen-125 and pro-surfactant protein B measured in serum. 29 , 30 In gastric cancer, a combination of NKA, CEA and/or cancer antigen 19-9 improved sensitivity compared with each biomarker alone. 12 In contrast, NKA alone does not appear suitable for screening purposes as it was unable to distinguish patients with stage I and II lung cancer from control subjects.…”

The combination of a seven-autoantibody panel with computed tomography scanning can enhance the diagnostic efficiency of non-small cell lung cancer

“…In several European studies of EarlyCDT-Lung, the sevenautoantibody panel (p53, NY-ESO-1, GBU4-5, CAGE, SOX2, HuD, and MAGE A4) were confirmed to have 88%-91% specificity and 11%-39% sensitivity (12,(27)(28)(29). At present, a number of studies on the use of a 7-AAB panels (p53, PGP9.5, SOX2, GAGE7, GBU4-5, MAGEA1 and CAGE) in the diagnosis of early lung cancer have also been carried out in China.…”

Cost-effectiveness of Low-Dose Computed Tomography With a Plasma-Based Biomarker for Lung Cancer Screening in China

“…Blood- and serum-based biomarkers are promising adjuncts to LDCT in lung cancer screening. 11 , 12 Biomarkers with high specificity for early detection of lung cancer may help alleviate the problem of the high false-positive rate when using LDCT alone in a screening program. Micro-RNA signature classifier (MSC), one of the biomarkers that have entered phase 4 of development, may be useful in conjunction with LDCT for lung cancer detection.…”