Abstract
Prothrombin induced by vitamin K absence II (PIVKA-II) has recently been validated internationally as a diagnostic biomarker for hepatocellular carcinoma (HCC), as part of the GALAD model. However, its role as a treatment response biomarker has been less well explored. We, therefore, undertook a prospective study at a tertiary centre in the UK to evaluate the role of PIVKA-II as a treatment response biomarker in patients with early, intermediate and advanced stage HCC. In a cohort of 141 patients, we found that PIVKA-II levels tracked concordantly with treatment response in the majority of patients, across a range of different treatment modalities. We also found that rises in PIVKA-II levels almost always predated radiological progression. Among AFP non-secretors, PIVKA-II was found to be informative in 60% of cases. In a small cohort of patients undergoing liver transplantation, pre-transplant PIVKA-II levels predicted for microvascular invasion and poorer differentiation. Our results demonstrate the potential utility of PIVKA-II as a treatment response biomarker and in predicting microvascular invasion, in a Western population. PIVKA-II demonstrated improved performance over AFP but, as a single biomarker, its performance was still limited. Further larger prospective studies are recommended to evaluate PIVKA-II as a treatment response biomarker, within the GALAD model.
Highlights
Hepatocellular carcinoma (HCC) is the seventh most common cancer and the third most common cause of cancer-related death worldwide [1]
Alpha-fetoprotein (AFP) is the most widely used biomarker for HCC worldwide but, due to its suboptimal sensitivity and specificity in surveillance, the previous American Association for the Study of Liver Diseases (AASLD) and the current European Association for the Study of the Liver (EASL) guidelines for surveillance recommend six-monthly ultrasound imaging (US) alone [5, 6]
A total of 141 patients with hepatocellular carcinoma were enrolled between March 2016 and March 2018
Summary
Hepatocellular carcinoma (HCC) is the seventh most common cancer and the third most common cause of cancer-related death worldwide [1]. Current Clinical Practice guidelines recommend HCC surveillance in high risk individuals, to increase the detection of early-stage HCC, increase curative treatments and improve survival [4, 5]. Alpha-fetoprotein (AFP) is the most widely used biomarker for HCC worldwide but, due to its suboptimal sensitivity and specificity in surveillance (fluctuating low levels that may be due to flare of viral hepatitis and small proportion of early stage tumours secreting AFP), the previous American Association for the Study of Liver Diseases (AASLD) and the current European Association for the Study of the Liver (EASL) guidelines for surveillance recommend six-monthly ultrasound imaging (US) alone [5, 6]. There remains an unmet need for better serum biomarkers
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