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循环肿瘤细胞采集仪捕集乳腺肿瘤患者循环上皮细胞的多中心临床观察 被引量:9

Circulating tumor cells in patients with breast tumors were detected by a novel device: a multicenter, clinical trial in China
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摘要 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%C/: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。 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:O. 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 Celleollector 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.
出处 《中华医学杂志》 CAS CSCD 北大核心 2017年第24期1857-1861,共5页 National Medical Journal of China
基金 国家自然科学基金(81472477)
关键词 循环肿瘤细胞 乳腺肿瘤 捕获效能 应用研究 Circulating tumor cells Breast tumor Capture efficiency Further application
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