| Background:China is a big country with high prevalence of liver disease.In particular,Hepatocellular carcinoma(HCC)is still one of the major liver malignancies,which ranks the third cause of cancer-related deaths and threatens people’s health in China.Each year China contributes to more than half of the world HCC cases.For a long time,Alpha-fetoprotein(AFP)has been used as a biomarker for HCC diagnosis worldwide.However,not all the HCC cases express positive of AFP,especially in early-stage hepatocellular carcinoma.In recent years,a number of studies indicated that protein induced by vitamin K absence or antagonist-Ⅱ(PIVKA-Ⅱ)has a good performance for HCC diagnosis and can be used as a biomarker for prediction of microvascular invasion(MVI)and prognosis.Nonetheless,the diagnosis performance and clinical application of PIVKA-Ⅱ has not reached an agreement in China.Objective:To evaluate the diagnostic value of serum PIVKA-Ⅱ for HCC and predicted performance of PIVKA-Ⅱ for microvascular invasion in southern Fujian area.Methods:Base on the data provided by the Department of Hepatic Surgery,the First Affiliated Hospital of Xiamen University,the study collected 101 HCC patients who underwent curative hepatectomy and 61 non-HCC cancer patients were enrolled as controls.We conducted a case-control study to compare the diagnostic value of PIVKA-Ⅱ and AFP serum levels for hepatocellular carcinoma,observe the diagnostic improvement when combine the two biomarkers.The level of PIVKA-Ⅱ was determined by chemiluminescence enzyme immunoassay,the serum Alpha-fetoprotein level was measured by chemiluminescent microparticle immunoassay.We collected different preoperative serum markers of the HCC patients and compared the predicted performance for microvascular invasion of HCC,mainly study PIVKA-Ⅱ.Result:(1)The sensitivity and specihcity of serum PIVKA-Ⅱ in the diagnosis of HCC were 86.14%and 78.95%at a cutoff of 40mAU/mL.The sensitivity and specificity of AFP were 68.32%and 89.47%at a cutoff of 20 ng/mL.The combination of serum PIVKA-Ⅱ and AFP in the diagnosis of HCC had a sensitivity and specificity of 94.06%and 76.32%,respectively.(2)The sensitivity and specificity of serum PIVKA-Ⅱ in the diagnosis of very early and early stage HCC were 66.67%and 78.95%at a cutoff of 40mAU/mL.The sensitivity and specificity of very early and early stage HCC diagnosis of serum AFP were 58.58%and 89.47%at a cutoff of 20 ng/mL.The combination of two biomarkers in the diagnosis of very early and early stage HCC had a sensitivity and specificity of 87.88%and 76.32%.(3)The area under receiving operating curve(AUROC)of PIVKA-Ⅱ was 0.886(95%CI:0.820-0.952),Which was higher than the AUROC for AFP:0.844(95%CI:0.769-0.920).In combination,the AUROC increased to 0.924(95%Cl:0.863-0.986).(4)Via the ROC,the best cutoff value of serum PIVKA-Ⅱ was 48.50mAU/mL with sensitivity of 85.1%and specificity of 86.8%.The optimal cutoff value of serum AFP was 8.20ng/mL with the sensitivity and specificity of 77.2%and 89.5%.(5)The level of PIVKA-Ⅱ≥ 150mAu/m was an independent predictor of microvascular invasion(OR=5.131,95%CI:1.067-24.663,P=0.041)Conclusion:(1)PIVKA-Ⅱ was more efficient for the diagnosis of HCC than AFP,and PIVKA-Ⅱcould be used as an early screening biomarker of HCC.(2)The combination of PIVKA-Ⅱ and AFP gave a better performance for hepatocellular carcinoma diagnosis.(3)PIVKA-Ⅱ could be used as a potential biomarker of HCC microvascular invasion. |
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