Crook Timothy, Leonard Robert, Mokbel Kefah, Thompson Alastair, Michell Michael, Page Raymond, Vaid Ashok, Mehrotra Ravi, Ranade Anantbhushan, Limaye Sewanti, Patil Darshana, Akolkar Dadasaheb, Datta Vineet, Fulmali Pradip, Apurwa Sachin, Schuster Stefan, Srinivasan Ajay, Datar Rajan
Department of Oncology, The London Clinic, London W1G 6BW, UK.
Department of Oncology, Cromwell Hospital, London SW5 0TU, UK.
Cancers (Basel). 2022 Jul 9;14(14):3341. doi: 10.3390/cancers14143341.
The early detection of breast cancer (BrC) is associated with improved survival. We describe a blood-based breast cancer detection test based on functional enrichment of breast-adenocarcinoma-associated circulating tumor cells (BrAD-CTCs) and their identification via multiplexed fluorescence immunocytochemistry (ICC) profiling for GCDFP15, GATA3, EpCAM, PanCK, and CD45 status.
The ability of the test to differentiate BrC cases ( = 548) from healthy women ( = 9632) was evaluated in a case-control clinical study. The ability of the test to differentiate BrC cases from those with benign breast conditions was evaluated in a prospective clinical study of women ( = 141) suspected of BrC.
The test accurately detects BrAD-CTCs in breast cancers, irrespective of age, ethnicity, disease stage, grade, or hormone receptor status. Analytical validation established the high accuracy and reliability of the test under intended use conditions. The test detects and differentiates BrC cases from healthy women with 100% specificity and 92.07% overall sensitivity in a case-control study. In a prospective clinical study, the test shows 93.1% specificity and 94.64% overall sensitivity in differentiating breast cancer cases ( = 112) from benign breast conditions ( = 29).
The findings reported in this manuscript support the clinical potential of this test for blood-based BrC detection.
乳腺癌的早期检测与生存率提高相关。我们描述了一种基于血液的乳腺癌检测试验，该试验基于乳腺腺癌相关循环肿瘤细胞（BrAD-CTCs）的功能富集，并通过对GCDFP15、GATA3、EpCAM、PanCK和CD45状态的多重荧光免疫细胞化学（ICC）分析来识别这些细胞。
在一项病例对照临床研究中评估了该试验区分乳腺癌病例（n = 548）与健康女性（n = 9632）的能力。在一项对141名疑似乳腺癌女性的前瞻性临床研究中评估了该试验区分乳腺癌病例与良性乳腺疾病患者的能力。
该试验能准确检测乳腺癌中的BrAD-CTCs，无论年龄、种族、疾病分期、分级或激素受体状态如何。分析验证确定了该试验在预期使用条件下的高准确性和可靠性。在一项病例对照研究中，该试验检测并区分乳腺癌病例与健康女性，特异性为100%，总体敏感性为92.07%。在一项前瞻性临床研究中，该试验在区分乳腺癌病例（n = 112）与良性乳腺疾病（n = 29）时，特异性为93.1%，总体敏感性为94.64%。
本手稿中报告的研究结果支持了该试验用于基于血液的乳腺癌检测的临床潜力。
