利用免疫荧光和细胞病理学评估,从转移性乳腺癌患者的外周血中鉴定经 FDA 批准的 Parsortix® PC1 系统捕获的循环肿瘤细胞。

IF 11.4 1区 医学 Q1 ONCOLOGY Journal of Experimental & Clinical Cancer Research Pub Date : 2024-08-21 DOI:10.1186/s13046-024-03149-x
Mariacristina Ciccioli, Kyukwang Kim, Negar Khazan, Joseph D Khoury, Martin J Cooke, M Craig Miller, Daniel J O'Shannessy, Anne-Sophie Pailhes-Jimenez, Richard G Moore
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引用次数: 0

摘要

循环肿瘤细胞 (CTC) 可作为一种非侵入性的肿瘤材料来源,用于实时调查个人疾病。Parsortix® PC1 系统是首款通过 FDA 认证的医疗设备,可从转移性乳腺癌(MBC)患者的外周血中捕获和采集 CTCs,用于后续的用户验证下游分析。本研究旨在确定使用免疫荧光(IF)或赖特-吉氏(WG)染色法鉴定出 CTC 的 MBC 患者和自我申报的女性健康志愿者(HV)的比例。76 名健康志愿者和 76 名乳腺癌患者的外周血在 Parsortix® PC1 系统上进行处理。采集的细胞被置于带电载玻片上并进行免疫荧光染色,以识别表达上皮标记的 CTC。随后对免疫荧光载玻片进行 WG 染色,并根据恶性细胞的形态特征进行 CTC 鉴定分析。所有检测均由对每位受检者的临床状况保密的操作人员进行。45.3% (≥ 1) / 24.0% (≥ 5) 的 MBC 患者(范围 = 0 - 125,平均 = 7)和 6.9% (≥ 1) / 2.8% (≥ 5) 的 HV 患者(范围 = 0 - 28,平均 = 1)在 IF 切片上鉴定出了 CTC。在≥1个CTC的MBC患者中,70.6%只有CK + /EpCAM- CTC,没有EpCAM + /CK- CTC。在 56.0% 的 CTC 阳性患者中发现了 CTC 簇。在 WG 染色的切片上,42.9%(≥ 1)/21.4%(≥ 5)的 MBC 患者(范围 = 0 - 41,平均 = 4)和 4.3%(≥ 1)/2.9%(≥ 5)的 HV 患者(范围 = 0 - 14,平均 = 0)中发现了 CTC。这项研究表明,与 HVs 相比,Parsortix® PC1 系统在结合 IF 和 WG 细胞形态学评估时,能从更大比例的 MBC 患者身上捕获和收获 CTCs。以前曾描述过未确诊疾病的受试者体内存在上皮细胞,但其意义尚不明确。有趣的是,已鉴定的 CTC 中有很大一部分不表达 EpCAM,这凸显了基于 EpCAM 方法的局限性。
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Identification of circulating tumor cells captured by the FDA-cleared Parsortix® PC1 system from the peripheral blood of metastatic breast cancer patients using immunofluorescence and cytopathological evaluations.

Circulating Tumor Cells (CTCs) may serve as a non-invasive source of tumor material to investigate an individual's disease in real-time. The Parsortix® PC1 System, the first FDA-cleared medical device for the capture and harvest of CTCs from peripheral blood of metastatic breast cancer (MBC) patients for use in subsequent user-validated downstream analyses, enables the epitope-independent capture of CTCs with diverse phenotypes based on cell size and deformability. The aim of this study was to determine the proportion of MBC patients and self-declared female healthy volunteers (HVs) that had CTCs identified using immunofluorescence (IF) or Wright-Giemsa (WG) staining. Peripheral blood from 76 HVs and 76 MBC patients was processed on Parsortix® PC1 Systems. Harvested cells were cytospun onto a charged slide and immunofluorescently stained for identification of CTCs expressing epithelial markers. The IF slides were subsequently WG-stained and analyzed for CTC identification based on morphological features of malignant cells. All testing was performed by operators blinded to the clinical status of each subject. CTCs were identified on the IF slides in 45.3% (≥ 1) / 24.0% (≥ 5) of the MBC patients (range = 0 - 125, mean = 7) and in 6.9% (≥ 1) / 2.8% (≥ 5) of the HVs (range = 0 - 28, mean = 1). Among the MBC patients with ≥ 1 CTC, 70.6% had only CK + /EpCAM- CTCs, with none having EpCAM + /CK- CTCs. CTC clusters were identified in 56.0% of the CTC-positive patients. On the WG-stained slides, CTCs were identified in 42.9% (≥ 1) / 21.4% (≥ 5) of the MBC patients (range = 0 - 41, mean = 4) and 4.3% (≥ 1) / 2.9% (≥ 5) of the HVs (range = 0 - 14, mean = 0). This study demonstrated the ability of the Parsortix® PC1 System to capture and harvest CTCs from a significantly larger proportion of MBC patients compared to HVs when coupled with both IF and WG cytomorphological assessment. The presence of epithelial cells in subjects without diagnosed disease has been previously described, with their significance being unclear. Interestingly, a high proportion of the identified CTCs did not express EpCAM, highlighting the limitations of using EpCAM-based approaches.

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来源期刊
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期刊介绍: The Journal of Experimental & Clinical Cancer Research is an esteemed peer-reviewed publication that focuses on cancer research, encompassing everything from fundamental discoveries to practical applications. We welcome submissions that showcase groundbreaking advancements in the field of cancer research, especially those that bridge the gap between laboratory findings and clinical implementation. Our goal is to foster a deeper understanding of cancer, improve prevention and detection strategies, facilitate accurate diagnosis, and enhance treatment options. We are particularly interested in manuscripts that shed light on the mechanisms behind the development and progression of cancer, including metastasis. Additionally, we encourage submissions that explore molecular alterations or biomarkers that can help predict the efficacy of different treatments or identify drug resistance. Translational research related to targeted therapies, personalized medicine, tumor immunotherapy, and innovative approaches applicable to clinical investigations are also of great interest to us. We provide a platform for the dissemination of large-scale molecular characterizations of human tumors and encourage researchers to share their insights, discoveries, and methodologies with the wider scientific community. By publishing high-quality research articles, reviews, and commentaries, the Journal of Experimental & Clinical Cancer Research strives to contribute to the continuous improvement of cancer care and make a meaningful impact on patients' lives.
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