新型自动化微流控系统检测循环肿瘤细胞计数和 HER2 表达对转移性乳腺癌的预后意义。
The prognostic significance of circulating tumor cell enumeration and HER2 expression by a novel automated microfluidic system in metastatic breast cancer.
机构信息
Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, China.
Department of Oncology, the First Affiliated Hospital of Zhengzhou University, No.1 Eastern Jianshe Road, Zhengzhou, Henan, 450052, China.
出版信息
BMC Cancer. 2024 Aug 29;24(1):1067. doi: 10.1186/s12885-024-12818-1.
BACKGROUND
The prognostic value of circulating tumor cells (CTCs) in metastatic breast cancer (MBC) has been extensively studied and verified by the CellSearch® system. Varieties of microfluidic systems have been developed to improve capture efficiency with the lack of standardization and automation. This study systematically verified the positive threshold for prognosis and its guidance value in anti-HER2 therapy based on a novel automated microfluidic system OmiCell®.
METHODS
CTCs isolation, enumeration and labeling were performed using the OmiCell® system. CTCs identification and reporting were performed using the DeepSight® scanning system.
RESULTS
The capture efficiency and specificity of OmiCell® system was 91.9% and 90%, respectively. Then, 65 MBC patients with known HER2 status of their metastatic tumors were enrolled. In the cohort, we detected ≥ 1 CTCs in 59 patients (90.8%, range: 1-55 CTCs, median = 6), < 8 CTCs in 45 (69.2%) and ≥ 8 CTCs in 20 (30.8%) patients at baseline. The patients with < 8 CTCs had longer PFS than ≥ 8 CTCs (median, 7 vs. 4.4 months, p = 0.028). CTC enumeration was found to be an independent prognostic factor in our cohort. Moreover, we found a weak concordance between tissue HER2 (tHER2) status and the corresponding CTCs (k = 0.16, p = 0.266). The patients with tHER2 positive and cHER2 negative had better PFS compared with patients with both tHER2 and cHER2 positive (median, 8.2 vs. 3.3 months, p = 0.022).
CONCLUSIONS
This clinical study shows the prognosis value of a new threshold of CTC number and meanwhile the guidance value of cHER2 status in anti-HER2 therapy.
背景
循环肿瘤细胞（CTCs）在转移性乳腺癌（MBC）中的预后价值已通过 CellSearch®系统得到广泛研究和验证。各种微流控系统已被开发出来，以提高捕获效率，但缺乏标准化和自动化。本研究基于新型自动化微流控系统 OmiCell®，系统验证了预后的阳性阈值及其在抗 HER2 治疗中的指导价值。
方法
使用 OmiCell®系统进行 CTC 分离、计数和标记。使用 DeepSight®扫描系统进行 CTC 鉴定和报告。
结果
OmiCell®系统的捕获效率和特异性分别为 91.9%和 90%。然后，共纳入 65 名已知转移性肿瘤 HER2 状态的 MBC 患者。在该队列中，我们在 59 名患者（90.8%，范围：1-55 个 CTC，中位数=6）中检测到≥1 个 CTC，45 名（69.2%）患者中<8 个 CTC，20 名（30.8%）患者中≥8 个 CTC。基线时<8 个 CTC 的患者 PFS 长于≥8 个 CTC 的患者（中位数，7 个月 vs. 4.4 个月，p=0.028）。在我们的队列中，CTC 计数被发现是独立的预后因素。此外，我们发现组织 HER2（tHER2）状态与相应的 CTCs 之间存在弱一致性（k=0.16，p=0.266）。tHER2 阳性和 cHER2 阴性的患者与 tHER2 和 cHER2 均阳性的患者相比，PFS 更好（中位数，8.2 个月 vs. 3.3 个月，p=0.022）。
结论
本临床研究显示了新的 CTC 数量阈值的预后价值，同时显示了 cHER2 状态在抗 HER2 治疗中的指导价值。
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