[Circulating tumor cells in patients with breast tumors were detected by a novel device: a multicenter, clinical trial in China]

Zhonghua Yi Xue Za Zhi. 2017 Jun 27;97(24):1857-1861. doi: 10.3760/cma.j.issn.0376-2491.2017.24.003.
[Article in Chinese]


Objective: Circulating tumor cells (CTC) have become an important part of liquid biopsy, which have underwent a process from simple counting to molecular typing and genotyping. To this end, we used Cellcollector to verify the effectiveness and safety of CTC detection in patients with breast tumor, and to conduct the following analysis. Methods: One hundred and ninety patients who received treatment in six leading Chinese cancer centers were involved from April to August in 2016. Among which, 127 patients were diagnosed as metastatic breast cancer, and the other 63 patients as benign breast tumors. Results: In metastatic breast cancer group, 74.8%(95/127) were CTC positive. While in benign tumor group, they were all CTC negative patients. The area under the Receiver Operating Characteristic curve were 0.832(95%CI: 0.784-0.879). The sensitivity of Cellcollector was 74.8%, specificity was 100% (Youden index 0.748). A total of 117 patients in MBC groups received a second detection of Cellcollector after 3-4 weeks, among which 44.4% (52/117) were CTC positive patients. The incidence of adverse events and severe adverse events in MBC was 66.9%(85/127) and 39.8% (53/127). Furthermore, we used Cellcollector to perform the HER2 testing and gene sequencing. Conclusions:In vivo isolation of CTCs overcomes blood volume limitations compared to other approaches. The further application of molecular typing and gene typing might help to implement CTC-based "liquid biopsies" into clinical decision making.

目的: 利用Cellcollector检测平台,验证其检测复发转移性乳腺癌患者循环肿瘤细胞(CTC)的有效性及安全性,并利用捕获的CTC进行后续分析。 方法: 选取2016年4—8月多中心患者,分为复发转移性乳腺癌患者(n=127)及确诊为良性肿瘤患者(n=63),利用Cellcollector进行CTC计数及后续研究分析。 结果: MBC患者中,行新一线治疗前CTC检出率达到74.8%(95/127),良性患者组中CTC检出率为0。ROC曲线下面积达0.832(95%CI:0.784~0.879),Cellcollector技术灵敏度74.8%,特异度100%(约登指数0.748)。治疗3~4周后,MBC组中有117例接受二次检测,CTC检出率为44.4%(52/117)。MBC组中,不良反应的发生率为66.9%(85/127),重要不良事件发生率为39.8%(53/127),主要与病情及治疗反应相关。利用Cellcollector捕获的CTC可以进行HER2染色及后续基因测序分析。 结论: Cellcollector技术可以检测复发转移性乳腺癌患者的CTC,同时还可以利用捕获的肿瘤细胞进行后续研究分析。.

Keywords: Breast tumor; Capture efficiency; Circulating tumor cells; Further application.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Biomarkers, Tumor
  • Breast Neoplasms / diagnosis*
  • Cell Count
  • China
  • Humans
  • Neoplasm Metastasis
  • Neoplastic Cells, Circulating*
  • Receptor, ErbB-2


  • Biomarkers, Tumor
  • Receptor, ErbB-2