Role of PIVKA-II in screening for malignancies at a hepatobiliary and pancreatic disease center: A large-scale real-world study.

Background and aims: Protein induced by vitamin K absence or antagonist II (PIVKA-II) is a well-accepted biomarker for diagnosing hepatocellular carcinoma (HCC). Although nonspecific increase of PIVKA-II has been reported, real-world evidence remains scarce. Based on real-world data, this study aimed to comprehensively describe the use of PIVKA-II at a hepatobiliary and pancreatic disease center and to assess its utility for the initial screening of HCC or other hepatobiliary-pancreatic malignancies. Methods: This real-world retrospective study is based on the PIVKA-II results of 16,215 individuals and other relevant laboratory test (alpha-fetoprotein [AFP], carbohydrate antigen 19-9 [CA19-9], liver function, blood coagulation indicators, hepatitis B virus, and hepatitis C virus). However, only the first PIVKA-II results of 7809 eligible individuals were included. Between-group comparisons, correlation analysis, and receiver operating characteristic curve analysis were performed. Results: PIVKA-II results were abnormal in patients with HCC (55.9%), biliary carcinoma (BC, 13.4%), gastrointestinal and pancreatic cancer (6.3%), and benign diseases (23.5%) as well as in healthy individuals (0.92%). The area under the curve of PIVKA-II for detecting malignancies was 0.7754 (0.7620-0.7688), whereas that for detecting HCC was 0.7509 (0.7357-0.7662). Stratifying the PIVKA-II values or combining PIVKA-II with AFP or CA19-9 helped improve the diagnostic performance of PIVKA-II for HCC. PIVKA-II values were significantly positively correlated with AST in patients with HCC and with bilirubin in patients with BC. Conclusions: This study determined the role of PIVKA-II in malignancy screening at hepatobiliary and pancreatic disease centers. It was also noted that the diagnostic efficacy of PIVKA-II for HCC improved after combining PIVKA-II with AFP or stratifying its value.