Diagnostic performance of tumor markers AFP and PIVKA-II in Chinese hepatocellular carcinoma patients

Abstract

Alpha-fetoprotein is an effective biomarker as an aid in hepatocellular carcinoma detection in many countries. However, alpha-fetoprotein has its limitations, especially in early hepatocellular carcinoma diagnosis. Protein induced by vitamin K absence or antagonist-II is another biomarker that is used for hepatocellular carcinoma detection. The aim of this study is to compare the diagnostic performance of alpha-fetoprotein and protein induced by vitamin K absence or antagonist-II alone and in combination to explore improving biomarker performance as an aid in early hepatocellular carcinoma detection. In this study a total of 582 serum samples including 132 hepatocellular carcinoma patients, 250 non-hepatocellular carcinoma patients, and 200 healthy volunteers were collected. Alpha-fetoprotein and protein induced by vitamin K absence or antagonist-II levels were measured by both chemiluminescent enzyme immunoassay on LUMIPULSE platform and by chemiluminescent microparticle immunoassay on ARCHITECT platform. Receiver operation characteristic curve analyses were performed for each biomarker and in combination. The results showed that Alpha-fetoprotein and protein induced by vitamin K absence or antagonist-II in combination have shown higher area under the curve compared to alpha-fetoprotein alone for diagnosis in whole patients (0.906 vs 0.870) in hepatocellular carcinoma early-stage patients (0.809 vs 0.77) and in hepatitis B virus-related hepatocellular carcinoma patients (0.851 vs 0.788) with ARCHITECT platform. Protein induced by vitamin K absence or antagonist-II showed higher area under the curve than alpha-fetoprotein for diagnosis of hepatitis B virus-related hepatocellular carcinoma patients (0.901 vs 0.788).We conclude that Combining alpha-fetoprotein and protein induced by vitamin K absence or antagonist-II may improve the diagnostic value for early detection of hepatocellular carcinoma. Protein induced by vitamin K absence or antagonist-II performs better than alpha-fetoprotein in diagnosis of hepatitis B virus-related hepatocellular carcinoma patients.

Evaluation of Serum Des-Gamma-Carboxy Prothrombin for the Diagnosis of Hepatitis B Virus-Related Hepatocellular Carcinoma: A Meta-Analysis

“…A total of 144 studies were identified from the searches conducted, of which five [ 9 , 24 , 31 – 33 ] studies were considered suitable for inclusion in the meta-analysis, after exclusion of reviews, case reports, duplications, conference proceedings, and other unsuitable studies. All included studies were published in English.…”

“…All included studies adopted a retrospective design, and this was not regarded as the representative of the patient spectrum. In addition, three [ 24 , 31 , 32 ] studies did not clearly describe the exclusion criteria applied. However, other items were effectively reported, and all six studies scored an “A.”…”

“…The 40 mAU/mL cutoff point in the serum had been established in the population with heterogeneous etiologies [ 19 ]. The same cutoff point of 40 mAU/mL was employed in three studies [ 9 , 24 , 31 ] (two from Korea and one from China), whereas the cutoff points of 32.09 mAU/mL [ 32 ] and 40.5 m AU/mL [ 33 ] were employed in the other two studies (both from China). The study with the lowest cutoff point of 32.09 mAU/mL [ 32 ] investigated early-stage HBV-related HCC.…”

“…Within the context of increased sensitivity, DCP has been considered for the diagnosis, treatment response, recurrence monitoring, and prognosis of HBV-related HCC [ 24 – 28 ]. However, the precise diagnostic efficacy has never been fully evaluated.…”

<p>Validation of the GALAD Model and Establishment of GAAP Model for Diagnosis of Hepatocellular Carcinoma in Chinese Patients</p>

“… 9 PIVKA-II has higher sensitivity and specificity values than AFP for HCC diagnosis; combining PIVKA-II with AFP increases these values even more. 10 , 11 PIVKA-II is recommended as a tumor marker for HCC surveillance by the American Association for the Study of Liver Diseases (AASLD), the European Association for the Study of Liver (EASL), and the Japan Society of Hepatology, and has been widely used in those regions. AFP is not recommended by AASLD and EASL because of its lower sensitivity and specificity values.…”