A preliminary study of the clinical significance of folate receptor-positive circulating tumor cell in the management of hepatobiliary-pancreatic cancers

BACKGROUND: Hepatobiliary-pancreatic cancers (HBPs) are highly lethal, partly because of their usually late diagnosis. This multi-center, observational study aimed to explore the clinical significance of folate receptor-positive circulating tumor cell (FR+CTC) as a liquid biopsy approach in the differential diagnosis and management of HBPs. METHODS: We recruited 119 patients suspicious for HBPs and 60 cancer-free healthy individuals in the present study. Patients without definitive pathological assessment or without pre-operative FR+CTC analysis were excluded. FR+CTC was tested prior to surgery or tissue biopsy using the CytoploRare(®) Detection Kit. Serum biomarkers, including CA 125, CA 19-9, and CEA, were tested in selected patients. Post-operative FR+CTC analysis was also performed in a subset of the patients receiving surgical resection. RESULTS: With 8.65 FU/3 mL as the cut-off value, the sensitivity and specificity of FR+CTC in differential diagnosis were 98.1% and 79.1%, respectively. The detection rate of FR+CTC was superior to conventional serum biomarkers (CA 19-9 > CA 125 > CEA). For the 16patients with matched post-operative FR+CTC analysis, FR+CTC levels significantly reduced after surgery (P=0.0084). CONCLUSIONS: Our results demonstrated that FR+CTC analysis could be an efficacious non-invasive biomarker in differential diagnosis and surveillance of HBPs, though further investigation with a larger sample size is required.