Can autoantibody tests enhance lung cancer screening?-an evaluation of EarlyCDT®-Lung in context of the German Lung Cancer Screening Intervention Trial (LUSI).

Abstract

BackgroundTumor-associated autoantibodies are considered promising markers for early lung cancer detection; so far, however, their capacity to detect cancer has been tested mostly in a clinical context, but not in population screening settings. This study evaluates the early detection accuracy, in terms of sensitivity and specificity, of EarlyCDT®-Lung—a test panel of seven tumor-associated autoantibodies optimized for lung cancer detection—using blood samples originally collected as part of the German Lung Cancer Screening Intervention Trial.MethodsThe EarlyCDT®-Lung test was performed for all participants with lung cancer detected via low-dose computed tomography and with available blood samples taken at detection, and for 180 retrospectively selected cancer-free participants at the end of follow-up: 90 randomly selected from among all cancer-free participants (baseline controls) and 90 randomly selected from among cancer-free participants with suspicious imaging findings (suspicious nodules controls). Sensitivity and specificity of lung cancer detection were estimated in the case group and the two control groups, respectively.ResultsIn the case group, the test panel showed a sensitivity of only 13.0% (95% CI: 4.9–26.3%). Specificity was estimated at 88.9% (95% CI: 80.5–94.5%) in the baseline control group, and 91.1% (95% CI: 83.2–96.1%) among controls presenting CT-detected nodules.ConclusionsThe test panel showed insufficient sensitivity for detecting lung cancer at an equally early stage as with low-dose computed tomography screening.