Diagnosis and monitoring of breast cancer with a novel circulating tumor cells enrichment device.

AIMS: Circulating tumor cells (CTCs) are a critical biomarker for cancer evaluation. The more excellent detection system for CTCs is in demand. PATIENTS & METHODS: One hundred and thirty-seven breast cancer patients, 97 patients with benign breast diseases, and 42 healthy volunteers were enrolled. Four milliliters of peripheral blood was used for CTCs detection. The performance was assessed by the receiver operator characteristic curve. A short-term follow-up with 23 patients was presented for real-time monitoring. RESULTS: In clinical, CTCs were found in 96.35% of patients with malignant breast cancer and 25.77% of patients with benign breast diseases but not in healthy group, by CytoBot® 2000. The sensitivity and specificity of 89.8% and 98.6%, respectively, when the cutoff value of 1.5 CTCs per 4 ml whole blood. Significant differences of CTC count were found between malignant and nonmalignant group (p < 0.0001), tumor progression (p < 0.0001), and tumor size (p < 0.0001). In follow-up, 82.61% of patients exhibited a reduction in CTC count, which corresponds with medical observation that benefits from treatment. Additionally, CD45(+) positive CTC showed with anomalous pattern during treatment. CONCLUSION: CTCs and this platform both have practical implications in clinical breast cancer diagnosis and monitoring.