Morten Borg1, Sara W C Wen2, Line Nederby3, Torben Frøstrup Hansen4, Anders Jakobsen5, Rikke Fredslund Andersen6, Ulla Møller Weinreich7, Ole Hilberg8. 1. Department of Respiratory Diseases, Aalborg University Hospital, Mølleparkvej 4, 9000 Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Søndre Skovvej 15, 9000 Aalborg, Denmark. Electronic address: moklb@rn.dk. 2. Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark, Beriderbakken 4, 7100 Vejle, Denmark; Institute of Regional Health Research, University of Southern Denmark, J.B. Winsløws Vej 19, 3, 5000 Odense C, Denmark. Electronic address: sara.witting.christensen.wen@rsyd.dk. 3. Department of Clinical Biochemistry, Vejle Hospital, University Hospital of Southern Denmark, Beriderbakken 4, 7100 Vejle, Denmark. Electronic address: line.nederby@rsyd.dk. 4. Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark, Beriderbakken 4, 7100 Vejle, Denmark; Institute of Regional Health Research, University of Southern Denmark, J.B. Winsløws Vej 19, 3, 5000 Odense C, Denmark. Electronic address: torben.hansen@rsyd.dk. 5. Department of Oncology, Vejle Hospital, University Hospital of Southern Denmark, Beriderbakken 4, 7100 Vejle, Denmark; Institute of Regional Health Research, University of Southern Denmark, J.B. Winsløws Vej 19, 3, 5000 Odense C, Denmark. Electronic address: anders.jakobsen@rsyd.dk. 6. Department of Clinical Biochemistry, Vejle Hospital, University Hospital of Southern Denmark, Beriderbakken 4, 7100 Vejle, Denmark. Electronic address: rikke.fredslund.andersen@rsyd.dk. 7. Department of Respiratory Diseases, Aalborg University Hospital, Mølleparkvej 4, 9000 Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Søndre Skovvej 15, 9000 Aalborg, Denmark. Electronic address: ulw@rn.dk. 8. Institute of Regional Health Research, University of Southern Denmark, J.B. Winsløws Vej 19, 3, 5000 Odense C, Denmark; Department of Internal Medicine, Vejle Hospital, University Hospital of Southern Denmark, Beriderbakken 4, 7100 Vejle, Denmark. Electronic address: ole.hilberg@rsyd.dk.
Abstract
OBJECTIVES: 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.
OBJECTIVES: 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 cancerpatients was 21 %, while this was 40 % in stage III-IV lung cancerpatients. 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 cancerpatients 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.
Authors: Lynsey Rachael Brown; Frank Sullivan; Shaun Treweek; Anne Haddow; Rodney Mountain; Colin Selby; Mara van Beusekom Journal: BMC Public Health Date: 2022-04-23 Impact factor: 4.135
Authors: Morten Borg; Sara Witting Christensen Wen; Torben Frøstrup Hansen; Anders Jakobsen; Rikke Fredslund Andersen; Ole Hilberg; Ulla Møller Weinreich; Line Nederby Journal: J Int Med Res Date: 2022-06 Impact factor: 1.573