Reliable non-invasive biomarkers for the surveillance of patients at risk of hepatocellular carcinoma (HCC) development represent an unmet medical need. Recently, the liver-cancer-specific isoform of serine protease inhibitor Kazal (LC-SPIK) has been proposed as a valuable biomarker for the detection of HCC in patients with chronic liver disease of viral etiology. In the present study, we assessed the diagnostic accuracy of LC-SPIK, alone or in combination with standard serologic biomarkers (i.e., alpha-fetoprotein and protein induced by vitamin K absence or antagonist-II, PIVKA-II), for the detection of HCC among patients with dysmetabolic liver disease. A total of 120 patients with non-alcoholic fatty liver disease (NAFLD), including 62 patients with a diagnosis of HCC and 58 with cirrhosis but without tumor, were retrospectively analyzed. The serum levels of LC-SPIK were measured by enzyme-linked immunosorbent assay (ImCare Biotech, Doylestown, PA). The serum LC-SPIK values were significantly different between patients with HCC (24.3, 17.6-39.8 ng/mL) and those with cirrhosis but without tumor (11.7, 8.7-18.2 ng/mL) (p < 0.001). By receiver operating characteristic curve analysis, we observed an area under the curve (AUC) of 0.841 for the detection of HCC; the combination with PIVKA-II further increased the accuracy to AUC = 0.926 (cross-validation). The promising results observed in the present pilot study foster additional research to investigate the usefulness of LC-SPIK for the stratification of the risk of HCC development in patients with NAFLD and advanced liver disease.

Liver Cancer-Specific Isoform of Serine Protease Inhibitor Kazal for the Detection of Hepatocellular Carcinoma: Results from a Pilot Study in Patients with Dysmetabolic Liver Disease

Caviglia G. P.
Co-first
;
Nicolosi A.
Co-first
;
Abate M. L.;Carucci P.;Rosso C.;Rolle E.;Armandi A.;Aneli S.;Olivero A.;Risso A.;Ribaldone D. G.;Saracco G. M.;Gaia S.
Co-last
;
Bugianesi E.
Co-last
2022-01-01

Abstract

Reliable non-invasive biomarkers for the surveillance of patients at risk of hepatocellular carcinoma (HCC) development represent an unmet medical need. Recently, the liver-cancer-specific isoform of serine protease inhibitor Kazal (LC-SPIK) has been proposed as a valuable biomarker for the detection of HCC in patients with chronic liver disease of viral etiology. In the present study, we assessed the diagnostic accuracy of LC-SPIK, alone or in combination with standard serologic biomarkers (i.e., alpha-fetoprotein and protein induced by vitamin K absence or antagonist-II, PIVKA-II), for the detection of HCC among patients with dysmetabolic liver disease. A total of 120 patients with non-alcoholic fatty liver disease (NAFLD), including 62 patients with a diagnosis of HCC and 58 with cirrhosis but without tumor, were retrospectively analyzed. The serum levels of LC-SPIK were measured by enzyme-linked immunosorbent assay (ImCare Biotech, Doylestown, PA). The serum LC-SPIK values were significantly different between patients with HCC (24.3, 17.6-39.8 ng/mL) and those with cirrhosis but without tumor (11.7, 8.7-18.2 ng/mL) (p < 0.001). By receiver operating characteristic curve analysis, we observed an area under the curve (AUC) of 0.841 for the detection of HCC; the combination with PIVKA-II further increased the accuracy to AUC = 0.926 (cross-validation). The promising results observed in the present pilot study foster additional research to investigate the usefulness of LC-SPIK for the stratification of the risk of HCC development in patients with NAFLD and advanced liver disease.
2022
29
8
5457
5465
diagnostic accuracy; HCC; LC-SPIK; NAFLD; PIVKA-II; Biomarkers; Humans; Liver Cirrhosis; Pilot Projects; Protein Isoforms; Retrospective Studies; Serine Proteinase Inhibitors; Carcinoma, Hepatocellular; Liver Neoplasms; Non-alcoholic Fatty Liver Disease
Caviglia G.P.; Nicolosi A.; Abate M.L.; Carucci P.; Rosso C.; Rolle E.; Armandi A.; Aneli S.; Olivero A.; Risso A.; Ribaldone D.G.; Fermer C.; Saracco G.M.; Gaia S.; Bugianesi E.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2318/1873238
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