JVS Diagnostics LLC, Skolkovo IC, Moscow, Russia.
Shemaykin-Ovchinnikov Institute of Bioorganic Chemistry RAS, Moscow, Russia.
Cancer Biomark. 2022;35(1):57-69. doi: 10.3233/CBM-210533.
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.
Evaluation of the diagnostic efficacy of CA 15-3 and CA-62 cancer markers combination for early stages of breast cancer (BC) detection.
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.
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.
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.
联合使用不同的肿瘤标志物通常用于预测肿瘤生长、评估癌症治疗反应以及提高恶性肿瘤的阳性诊断率。
评估 CA15-3 和 CA-62 联合用于早期乳腺癌（BC）检测的诊断效能。
本研究采用盲法，对包含血清 CA15-3 ELISA 和 CLIA-CA-62 检测的 488 份血清样本进行了 2 项临床验证，这些样本采用 TNM 分期。研究纳入了 300 名 BC 患者（254 例Ⅰ期和Ⅱ期、20 例导管原位癌（DCIS）和 26 例Ⅲ期和Ⅳ期患者）、47 名乳腺良性疾病患者和 141 名健康对照者。
当联合使用两种抗原（10<CA15-3<46U/ml 和 CA-62 ⩾6300U/ml）时，对于 DCIS 和Ⅰ期乳腺癌的检测具有 100%的特异性和 75%的敏感性（AUC=0.895），可排除假阳性结果。
盲法研究的结果表明，CA15-3 与 CA-62 的联合使用对于 DCIS 和Ⅰ期乳腺癌的检测具有 75%的敏感性和 100%的特异性，具有纳入现有筛查计划的潜力。
