The potential of PIVKA-II as a treatment response biomarker in hepatocellular carcinoma: a prospective United Kingdom cohort study
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Vandana M. Sagar1,*, Kathyrn Herring2,*, Stuart Curbishley1, James Hodson3, Peter Fletcher4, Salil Karkhanis5, Homoyon Mehrzad5, Pankaj Punia2, Tahir Shah6, Shishir Shetty1,6,# and Yuk Ting Ma1,2,#
1 Institute of Immunology and Immunotherapy, University of Birmingham, Birmingham, UK
2 The Cancer Centre, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
3 Institute of Translational Medicine, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
4 Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, UK
5 Department of Radiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
6 The Liver Unit, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK
* These authors contributed equally to this work (joint first authors)
# These authors contributed equally to this work (joint senior authors)
|Yuk Ting Ma,||email:||firstname.lastname@example.org|
Keywords: hepatocellular carcinoma; biomarker; PIVKA-II
Received: May 31, 2021 Accepted: November 10, 2021 Published: November 23, 2021
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.
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