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Article type: Research Article
Authors: Tcherkassova, Jannetaa; * | Prostyakova, Annab | Tsurkan, Sergeya | Ragoulin, Vladislava | Boroda, Alexanderc | Sekacheva, Marinac
Affiliations: [a] JVS Diagnostics LLC, Skolkovo IC, Moscow, Russia | [b] Shemaykin-Ovchinnikov Institute of Bioorganic Chemistry RAS, Moscow, Russia | [c] World-Class Research Center “Digital Biodesign and Personalized Healthcare”, Sechenov First Moscow State Medical University, Moscow, Russia
Correspondence: [*] Corresponding author: Janneta Tcherkassova, JVS Diagnostics, Skolkovo, Bolshoi Boulevard 42/1, Moscow, Russia. Tel.: +7 9663188683; E-mail: [email protected].
Abstract: BACKGROUND: Combination of different cancer markers is often used for predicting tumor growth, for the response to cancer therapy, and for increase in the positive diagnosis ratio in the malignant tumors. OBJECTIVE: Evaluation of the diagnostic efficacy of CA 15-3 and CA-62 cancer markers combination for early stages of breast cancer (BC) detection. METHODS: This blind study was performed on 2 clinically validated Sets that included serum measurements of CA 15-3 ELISA and CLIA-CA-62 assays in 488 serum samples with TNM classification. A study included 300 BC patients (254 at Stages I and II, 20 with ductal carcinoma in situ (DCIS), and 26 Stages III and IV patients), 47 patients with breast benign diseases, and 141 healthy controls. RESULTS: Sensitivity for DCIS & Stage I breast cancer detection was 75% at 100% Specificity (AUC = 0.895) using a following combination of two antigens: 10 < CA15-3 < 46 U/ml and CA-62 ⩾ 6300 U/ml, which allows eliminating false positive results. CONCLUSIONS: The results obtained in a blind study demonstrate that a combination of CA15-3 with CA-62 yields 75% Sensitivity at 100% Specificity for DCIS and Stage I breast cancer detection, which has a potential to be integrated into existing screening programs.
Keywords: Breast cancer (BC), Stage I, CA 15-3, CA-62, cancer marker
DOI: 10.3233/CBM-210533
Journal: Cancer Biomarkers, vol. 35, no. 1, pp. 57-69, 2022
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