Evaluation of the diagnostic value of circulating tumor cells with CytoSorter^® CTC capture system in patients with breast cancer

Abstract

Purpose In this study, we aimed to investigate the viability of utilizing CytoSorter® system to detect circulating tumor cells (CTCs) and to evaluate the diagnostic value of CTCs in breast cancer (BC). Methods A total of 366 females patients suspected of having BC and 30 healthy female volunteers were enrolled in this study. CTCs were enriched by CytoSorter®, a microfluidic‐based CTCs capturing platform. CTC detection was performed before operation or biopsy. Based on the biopsy results, patients were divided into two groups, namely patients with BC and patients with benign breast diseases (BBD). Patients with BBD and healthy volunteers were serving as controls. The correlation between CTC enumeration and patients' clinicopathological characteristics was evaluated. The receiver operating characteristic (ROC) curve was plotted to assess the diagnostic potency of CytoSorter® system in BC. Results Based on the biopsy results, 130 BC patients at different cancer stages and 236 patients with BBD were enrolled in the study. Seven subjects were dropped out from the study. CTCs were detected in 109 of 128 BC patients, in one of 29 healthy volunteers, and in 37 of 232 patients with BBD. Maximum CTC counts detected in BC patients, healthy volunteers, and patients with BBD were 8, 1, and 4, respectively. Statistical analysis showed CTCs could be used to distinguish BC patients from healthy volunteers and patients with BBD (P < .0001). Circulating tumor cells were statistically associated with patients' cancer stage (P = .0126), tumor size (tumor node metastasis [TNM] T stage, P = .0253), cancer type (invasive vs noninvasive, P = .0141), and lymph node metastasis (P = .0436). More CTCs were found in patients at advanced cancer stage or TNM T stage and in patients with invasive tumor or lymph node metastasis. Furthermore, CTC detection rates in BC patients at Tis and T1‐4 stages were 50%, 81.67%, 91.07%, 100%, and 100%, respectively. When the CTC cut‐off value was set to 2, the ROC curve gave an area under the curve (AUC) of 0.86 with a specificity and sensitivity of 95.4% and 76.56%, respectively. Taken together, CTCs could be used as a diagnostic aid in assistance of cancer screening and staging. Conclusion Circulating tumor cells were successfully isolated in BC patients using CytoSorter® system. CTCs can be used to differentiate BC patients from the patients with BBD or healthy volunteers, and as a diagnostic aid for early cancer diagnosis and cancer staging.

Feasibility of circulating tumor cells (CTCs) combined with medical imaging examinations to screen for cancer and improve diagnosis in non-metastatic invasive breast cancer patients: a cohort study

“…Previous study with CytoSorter® in BC showed that CTC could re ect tumor burden and could be used as a diagnostic aid in BC screening and early diagnosis [8]. First we compared CTCs with BC patients' clinicopathological features and found that CTCs were associated with tumor stage and tumor size, but not with lymph node metastasis, patients' age and tumor molecular subtype and histology grade.…”

“…CytoSorter ® epithelial cells detection kit was used for CTC enrichment. CTC detection procedure was described as in the previous study [8]. Once the CTC enrichment was nished, the CytoChipNano micro uidic chip was removed from CytoSorter ® and proceed to the immuno uorescence staining of PanCK-FITC, CD45-PE and DAPI.…”

“…Studies have shown that CTC could re ect tumor burden in BC [5,8] (42), respectively. To determine whether CTCs were associated with BC patients' clinicopathological characteristics, statistical analyses were performed among different groups of BC patients based on their age, AJCC stages, tumor size, lymph node metastasis, molecular subtypes and histology grades.…”

“…Previous studies have shown that when CTC cut-off was set to 2 the greatest diagnostic potency in BC diagnosis can be achieved [8]. Therefore, next we would like to know whether CTCs would be more relevant to medical imaging examinations when the cut-off values were used.…”

“…Moreover, CTC can re ect the tumor burden, and can be used as a monitoring biomarker to assess patients' response to treatment and tumor recurrences [7]. Previous study with CytoSorter ® (Hangzhou Watson Biotech, Hangzhou, China) in BC has shown that CTCs could be used as a diagnostic aid in early diagnosis and screening of BC [8].…”