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Liver Cancer

It's more than a test. 

IT’S OVERCOMING MAJOR CHALLENGES IN HCC DIAGNOSIS AND MAGAGEMENT.

 

For in vitro diagnostic use.

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The Global impact of HCC

By 2040, an estimated 1.4 million cases and 1.3 million deaths will be attributable to primary liver cancer.1

Only 40% of HCC is diagnosed at earlier stages.2

The 5-year survival rate of HCC is <20%.3

Hepatocellular carcinoma (HCC) is the most common form of primary liver cancer, accounting for up to ~85% of cases.4 The expected survival for patients with HCC is >5 years when detected at the earliest stages, compared to 10 months when detected at an advanced stage.5–7 

In addition, ~70% of patients are likely to experience disease recurrence within 5 years after surgical treatment.8 

 

 

INCORPORATING BIOMARKER PIVKA-II INTO THE HCC PATIENT JOURNEY

Approximately 70% of HCC cases in Japan and Taiwan are detected at earlier stages.9 This is likely due to comprehensive programmes that identify all at-risk adults and enrolling them in regular, intensive surveillance programs that use tumor biomarkers and liver imaging.9,10

1. HIGH RISK PATIENT UNDER SURVEILLANCE

Incorporating PIVKA-II to current standard surveillance methods could improve the diagnostic accuracy of detecting early-stage HCC.11–13
 

2. ULTRASOUND DETECTION OF NODULES  

Ultrasound imaging only has a 47% sensitivity for detecting early-stage HCC.14
 

3. Monitoring

Measuring PIVKA-II and other biomarker levels before and after treatment can be clinically useful for monitoring treatment outcomes and prognosis, and in predicting recurrence and survival.15
 

 

INTERNATIONAL GUIDELINE RECOMMENDATIONS FOR HCC SURVEILLANCE

Although guideline mention of biomarkers is mixed, over the past few decades their inclusion has been increasing, led by Japan. 

AASLD18  
APASL19  
 
EASL20
JSH21
Screening interval      
 

Every 6 months

Every 6 months

Every 6 months

Every 6 months for high-risk patients 

Every 3 to 4 months for extremely high-risk patients 
Imaging modality

Ultrasound

Ultrasound      

Ultrasound

Ultrasound 

For extremely high-risk patients and/or for patients whose liver is difficult to scan by ultrasound, a CT (computerized tomography) or MRI (magnetic resonance imagining) can be performed in combination with ultrasound
Tumor Biomarkers      



  
 

AFP

AFP

Not recommended        


 

AFP ( alpha-fetoprotein), DCP (des-γ-carboxyprothrombin) (PIVKA-II) and AFP-L3 fraction

Disclaimer: refer to each manufacturer's 'instructions for use' for products which are validated for use in alignment with HCC surveillance recommendations. 

AASLD = American Association for the Study of Liver Diseases; AFP = alpha-fetoprotein; APASL = The Asian Pacific Association for the Study of the Liver; EASL = European Association for the Study of the Liver; HBV = hepatitis B virus; HCC = hepatocellular carcinoma; JSH = Japan Society of Hepatology;  PIVKA-II = protein induced by vitamin K absence or antagonist-II. 

THE PIVKA-II BIOMARKER ASSAY FROM ABBOTT CAN HELP TO:16

Improve the effectiveness of HCC surveillance

Monitor disease progression and treatment response

Identify disease recurrence

  • PIVKA-II is to be used as an aid for diagnosis of HCC, monitoring of high-risk patients (hepatitis C virus infections, hepatitis/cirrhosis, hepatitis B virus infections) for development of HCC and in management of HCC.16,17
  • PIVKA-II levels are determined to aid in the diagnosis and prognosis of patients with HCC and in monitoring HCC patients under therapy.16,17

Related publications

Authors summarize the PIVKA-II assay, it's value to a HCC panel, and the proven analytical and clinical performances.

 

PublicationDescription
Analytical and Clinical Performance Evaluation of the Abbott Architect PIVKA Assay
Protein induced by vitamin K absence (PIVKA) is measured using various assays and is used to help diagnose hepatocellular carcinoma. The present study evaluated the analytical and clinical performances of the recently released Abbott Architect PIVKA assay.
PIVKA-II as a Potential New Biomarker for Hepatocellular Carcinoma – A Pilot Study.
This study aimed to evaluate the clinical contribution of protein induced by vitamin K absence (PIVKA-II) for hepatocellular carcinoma (HCC) diagnostics and compare it to a routinely used tumour marker.

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References
  1. Rumgay H. et al. Global burden of primary liver cancer in 2020 and predictions to 2040. Journal of Hepatology. 2022.
  2. Singal AG. et al. Detection of hepatocellular carcinoma at advanced stages among patients in the HALT-C trial: where did surveillance fail? Am J Gastroenterol. 2013;108(3):425–432. doi:10.1038/ajg.2012.449.
  3. Brar G, Greten TF, Graubard BI, et al. Hepatocellular carcinoma survival by etiology: a SEER-Medicare database analysis. Hepatol Commun. 2020;4(10):1541-1551. doi:10.1002/hep4.1564.
  4. Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of Incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209-249. doi:10.3322/caac.21660.
  5. Barcena-Varela M, Lujambio A. The Endless Sources of Hepatocellular Carcinoma Heterogeneity. Cancers. 2021;13(11), 2621. doi:https://doi.org/10.3390/cancers13112621.
  6. Guan MC, Wang MD, Liu SY, et al. Early diagnosis and therapeutic strategies for hepatocellular carcinoma: From bench to bedside. World J Gastrointest Oncology 2021;13(4):197-215.
  7. Fitzmorris P, Singal AK. Surveillance and Diagnosis of Hepatocellular Carcinoma. Gastroenterol Hepatol. 2015(1):38-46.
  8. Xu XF., Xing H., Han J., et al., 2019. Risk Factors, Patterns, and Outcomes of Late Recurrence After Liver Resection for Hepatocellular Carcinoma: A Multicenter Study From China. JAMA Surg.154:209–217. doi: 10.1001/jamasurg.2018.4334.
  9. Yang JD., Hainaut P., Gores GJ., et al., A global view of hepatocellular carcinoma: trends, risk, prevention and management. Nat Rev Gastroenterol Hepatol. 2019 Oct;16(10):589-604. doi: 10.1038/s41575-019-0186-y.
  10.  Kudo M. 2012. Japan's Successful Model of Nationwide Hepatocellular Carcinoma Surveillance Highlighting the Urgent Need for Global Surveillance. Liver Cancer. 1:141–143.  doi:10.1159/000342749.
  11. Seo SI., Kim HS., Kim WJ., et al., 2015Diagnostic value of PIVKA-II and alpha-fetoprotein in hepatitis B virus-associated hepatocellular carcinoma. World J Gastroenterol. 21(13):3928-35. doi: 10.3748/wjg.v21.i13.3928. PMID: 25852278
  1. Saitta C., Raffa G., Alibrandi A., et al., 2017PIVKA-II is a useful tool for diagnostic characterization of ultrasound-detected liver nodules in cirrhotic patients. Medicine. 96(26):e7266. doi:10.1097/MD.0000000000007266.
  2. Park SJ., Jang JY., Jeong SW., et al., 2017. Usefulness of AFP, AFP-L3, and PIVKA-II, and their combinations in diagnosing hepatocellular carcinoma. Medicine. 96:e5811.  doi:10.1097/MD.0000000000005811.
  3. Adeniji N, Dhanasekaran R. 2021. Current and Emerging Tools for Hepatocellular Carcinoma Surveillance. Hepatology Communications.5:1972-1986.  doi: https://doi.org/10.1002/hep4.1823.
  4. Park H, Park JY, et al. 2013.Clinical Significance of AFP and PIVKA-II Responses for Monitoring Treatment Outcomes and Predicting Prognosis in Patients with Hepatocellular Carcinoma. BioMed Research International.
  5. Alinity i PIVKA-II [package insert]. November 2018. 01R1722. 01R1732.
  6. Yu R., Tan Z., Xiang X., et al., 2017.Effectiveness of PIVKA-II in the detection of hepatocellular carcinoma based on real-world clinical data. BMC Cancer. 17:608.  doi:10.1186/s12885-017-3609-6.
  7. Singal A, et al. AASLD Practice Guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma. Hepatology 78(6):p 1922-1965, December 2023. | DOI: 10.1097/HEP.0000000000000466.
  8. Omata M, Cheng AL, Kokudo N, et al. Asia–Pacific clinical practice guidelines on the management of hepatocellular carcinoma: a 2017 update. Hepatol Int. 2017 (11:317–370).
  9. Galle PR, Forner A, Llovet JM, et al. European Association for the Study of the Liver Clinical Practice Guidelines: Management of hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):182-236. doi: 10.1016/j.jhep.2018.03.019.
  10. Kukudo N, Takemura N, Hasegawa K, et al. Clinical practice guidelines for hepatocellular carcinoma: The Japan Society of Hepatology 2017 (4th JSH HCC guidelines) 2019 update. Heaptology Research. 2019.doi: 10.1111/hepr.13411.

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