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Abstract
ObjectivesEarly 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 methodsThe 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. ResultsOverall 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 %. ConclusionThe 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.
Highlights
Lung cancer is the leading cause of cancer-related death world-wide and epidemiologic trends estimate a further increase in lung cancer deaths over the decades [1]
The current study finds insufficient sensitivity of the EarlyCDT® Lung test to be used as part of inclusion criteria in a low-dose computed tomography (CT) program for detection of lung cancer
Diagnostic work-up resulted in 30 % (75/246) of patients with a diagnosis of lung cancer, 5% (12/246) with lung metastases originating from primary tumors in other organs and 65 % (159/246) where cancer was ruled out
Summary
Lung cancer is the leading cause of cancer-related death world-wide and epidemiologic trends estimate a further increase in lung cancer deaths over the decades [1]. Several trials have addressed the application of a low-dose computed tomography (CT) screening program in a high-risk population to di agnose lung cancer at a resectable stage [3,4,5], the largest being the National Lung Screening Trial (NLST) [6] in USA and the Nelson trial [7] in the Netherlands and Belgium. The false positive rate (i.e. benign nodules) is very high in CT screenings causing 40 % of patients in the NLST to have a chest CT showing changes suspected of being lung cancer [6]. A comprehensive nodule manage ment program with an integrated malignancy risk tool is wanted [13]
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