TY - JOUR T1 - Clinical Utility of Combined Circulating Tumor Cell and Circulating Tumor DNA Assays for Diagnosis of Primary Lung Cancer JF - Anticancer Research JO - Anticancer Res SP - 3435 LP - 3444 DO - 10.21873/anticanres.14329 VL - 40 IS - 6 AU - SEONG MI MOON AU - JI-HO KIM AU - SEONG KEUN KIM AU - SEONWOO KIM AU - HYUK-JUNG KWON AU - JIN-SIK BAE AU - SUNGHOON LEE AU - HYE SEON LEE AU - MI-YOUNG CHOI AU - BYUNG HEE JEON AU - BYEONG-HO JEONG AU - KYUNGJONG LEE AU - HONG KWAN KIM AU - JHINGOOK KIM AU - SANG-WON UM Y1 - 2020/06/01 UR - http://ar.iiarjournals.org/content/40/6/3435.abstract N2 - Background/Aim: Although it has been suggested that circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) might be used in a complementary manner in lung cancer diagnosis, limited confirmatory data are available. In this prospective study, we evaluated the diagnostic performance of each assay separately and in combination. Patients and Methods: From March 2018 to January 2019, patients with suspected primary lung cancer, who underwent routine lung cancer work-up and peripheral blood sampling, were prospectively enrolled in the study. Epithelial cell adhesion molecule and cytokeratin served as markers of CTCs. In terms of ctDNA analysis, single-nucleotide variants were evaluated via next-generation sequencing. Results: We analyzed 111 patients, including 99 with primary lung cancer and 12 with benign pulmonary disease. The median number of CTCs in 10 ml of blood was 3. The most frequently detected single nucleotide variants of ctDNA were TP53, CDKN2A, and EGFR. The diagnostic sensitivity of conventional tumor marker (combination of carcinoembryonic antigen/CYFRA 21-1/neuron-specific enolase) was 66.7%, while those of the ctDNA and CTC assays were 72.7% and 65.7%, respectively. The sensitivity of the CTC/ctDNA combination (95.0%) was significantly greater than those of the CTC (p<0.001), ctDNA (p<0.001), or conventional tumor marker (p<0.001) alone. Subgroup analysis revealed that the sensitivity of the combination assay was greater than those of the CTC or ctDNA assays alone, regardless of tumor stage or histopathology type. Conclusion: The CTC/ctDNA combination assay enhanced the sensitivity of primary lung cancer diagnosis. The combination assay strategy may be clinically useful and could enhance the early detection of lung cancer (ClinicalTrials.gov number: NCT03479099). ER -