CYFRA 21-1 as a novel diagnostic serum biomarker in pancreatic cancer.

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191 Background: CYFRA 21-1 is a fragment of cytokeratin 19, a structure protein and part of intermediate filament proteins contributing to stability of epithelial cells. Serum concentration of CYFRA 21-1 is known to be elevated in many types of epithelial malignancies, and especially it has a prognostic and predictive value in patients with non-small cell lung cancer. We assessed serum CYFRA 21-1 and studied its clinical significance in patients with pancreatic cancer. Methods: The sera from 52 patients diagnosed with pancreatic cancer was collected between May 2012 and August 2013 at Incheon St. Mary’s hospital, Catholic University of Korea, School of Medicine and was measured for CYFRA 21-1 and CA 19-9. 48 patients had an advanced disease at presentation, 2 patients had a locally advanced disease, and 2 patients presented with a local disease. Control blood samples were obtained from 31 healthy individuals and 48 patients with nonmalignant hepatic or pancreatobiliary disease. We measured CYFRA 21-1 using two-step sandwich, chemiluminescent microparticle immunoassay, Architect i2000SR (Abbott Laboratories, Ltd., Il, USA). Results: Serum concentration of CYFRA 21-1 was significantly elevated in patients with pancreatic cancer compared with control group. (p=.000) CYFRA 21-1 ( >1.96 ng/ml as determined by the ROC curve) had a sensitivity, specificity, positive predictive value, and negative predictive value of 86.5%, 79.7%, 73.8%, 90% for the diagnosis of pancreatic cancer. Additionally, CA 19-9 ( >35 U/ml determined by our institute’s criteria) had a sensitivity, specificity, positive predictive value, and negative predictive value of 67.3%, 89.9%, 69.1%, 81.6%. The area under curve for CYFRA 21-1 and CA 19-9 was 86.3% and 81.5%, respectively. Conclusions: CYFRA 21-1 has a potential to become a novel serum biomarker for the diagnosis of pancreatic cancer. Serum concentration of CYFRA 21-1 in combination with CA 19-9 can be useful in clinical practice to diagnose pancreatic cancer.

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