PIVKA-II – Clinical Value of Diagnostics https://clinicalvalue.com Thu, 27 Mar 2025 06:20:10 +0000 en-US hourly 1 https://wordpress.org/?v=6.6.2 https://i0.wp.com/clinicalvalue.com/wp-content/uploads/2023/01/apple-touch-icon.png?fit=32%2C32&ssl=1 PIVKA-II – Clinical Value of Diagnostics https://clinicalvalue.com 32 32 225041835 End-to-end liver disease management at Zhuhai People’s Hospital: Project Pearl https://clinicalvalue.com/end-to-end-liver-disease-management-at-zhuhai-peoples-hospital-project-pearl/ Wed, 04 Dec 2024 07:47:45 +0000 https://clinicalvalue.com/?p=9362 ...

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Every year, liver cancer claims 740,000 lives worldwide, with 42% of these deaths occurring in China. In China, the 5-year survival for hepatocellular carcinoma (HCC) patients is just 14.4%, and over 80% of liver cancer patients diagnosed are those with Hepatitis B. Despite this alarming statistic, early screening and comprehensive, end-to-end disease management approaches remained limited in China. This created a critical gap in care, one that Zhuhai People’s Hospital in collaboration with Roche, aimed to address with the initiation of Project Pearl in 2022.

Project Pearl is a pioneering multi-stakeholder initiative designed to provide holistic care to patients with chronic liver disease by enabling end-to-end chronic disease management involving healthcare professionals, hospital administration, and payors. At its core, the project leverages on the Liver Integrated Solution, comprising of two key digital solutions:

  • Liver Disease Pathway (LDP), a digital platform streamlining HCC screening workflow and offering a patient portal for better care management
  • Oncology Hub (OH), a clinical workflow for multidisciplinary team meetings and decision support system

This integrated solution empowers clinicians with the right information at the right time, ensuring informed, precise decision-making throughout the patient’s journey.

Let’s explore how the patient’s journey has evolved under this new framework. Upon their first hospital visit, patients with chronic liver disease are registered on the digital solution, and are evaluated with abdominal ultrasound, AFP, PIVKA-II, and GAAD, aimed at early detection of HCC. The patients’ data and reports are synchronized for physicians to view in real time. Meanwhile, risk stratification scores provide physicians with a clearer understanding of each patient’s likelihood of developing liver cancer, allowing for more personalized, periodic surveillance plans. Physicians are able to easily arrange follow-ups with the patients and track their disease progression over time. Beyond the hospital, an interoperable mobile platform extends support with follow-up reminders, report interpretation, patient education, and 1 on 1 consultation. This empowers patients to better understand their condition and also ensures they receive continuous, standardized care, essential for early detection and intervention. For physicians, the new patient journey not only streamlines operations but also enhances clinical effectiveness by enabling early detection, offering curative treatment options, and improving patient outcomes.

The entire clinical and operational workflow from screening and diagnosis and follow-up is now automated, making it easier to manage every step of care delivery. Once patients are diagnosed with HCC, they are seamlessly transitioned into a comprehensive treatment management system. This integrated approach addresses the following challenges that are commonly observed in MDT care delivery. Lack of standardized MDT clinical protocol, absence of robust post-treatment follow-up system, and limited capabilities to analyse and gain insights from treatment data. Upon transition, a patient’s 360 report is automatically generated to show their entire patient history. This empowers them with data-driven insights to deliver clinical, operational and economic outcomes to manage HCC treatment more effectively and confidently.

Ultimately, Project Pearl enables a win for all stakeholders. For patients, early detection and personalized care plans lead to better outcomes. For physicians, streamlines, standardized workflows and digitally-enabled decision-making support clinical practice in a timely and effective manner. For the health system, the project accelerates the goals of “Healthy China 2030”, improving outcomes at reduced costs. By improving both patient outcomes and healthcare efficiency, we are taking significant steps toward a future where liver cancer can be detected early and treated effectively, creating hope for thousands of lives.

Since its launch, Project Pearl has seem promising results. Till date, 4,972 patients had been screened, and 40 cases of HCC had been diagnosed. Remarkably, 39 of those cases were detected at an early stage, offering significantly better chances for curative treatment. These outcomes demonstrate the project’s real-world impact in transforming liver cancer care and improving patient outcomes.

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Pioneering Innovations in HCC Detection for Enhance Patient Outcomes – Chang Gung Memorial Hospital https://clinicalvalue.com/pioneering-innovations-in-hcc-detection-for-enhance-patient-outcomes-chang-gung-memorial-hospital/ Mon, 19 Aug 2024 08:29:36 +0000 https://clinicalvalue.com/?p=8918 ...

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Dr. Ming-Ling Chang and Dr. Chung-Guei Huang talk about their experience using PIVKA-II, and their expectations for digital algorithms in HCC surveillance

Interview transcript:

MLC: Ming-Ling Chang

CGH: Chung-Guei Huang

Introduction

MLC: Hi, everyone, I am Dr. Ming-Ling Chang. Currently, I am the Director of the Department of Hepatology and the Gastroenterology of the Chang Gung Memorial Hospital at the Lin-Kou.

CGH: Hello everyone, I am Dr. Chung-Guei Huang. Currently, I am the Director of Department of Medical Laboratory at Lin-Kou Chang Gung Memorial Hospital.

MLC: Chang Gung Memorial Hospital is the biggest chain hospital in
Taiwan with 10 branches and more than 11,000 beds. Chang Gung Memorial Hospital at Lin-Kou is the headquarter among this healthcare system.

CGH: Our laboratory has been CAP accredited since 2003, which means every report from our laboratory meet international standards requirements; we’ve been maintaining CAP accreditation for over 20 years. Beyond CAP accreditation, we also got National Golden Quality Award several times in the past 10 years. Over 1 million tests were reported from our laboratory every month.

What are the challenges in HCC surveillance & diagnosis and testing capacity in your institution?

MLC: In Chang Gung Memorial Hospital, for patients with liver disease, we usually recommend patients with hepatitis to visit our outpatient departments every six months; while those with cirrhosis might have to come every three months. We also conduct liver cancer surveillance by using ultrasound and the alpha fetoprotein, which is AFP. However, not all patients with liver cancer can be diagnosed early despite these measures. The main reason is that the detection rate of tumor by ultrasound is affected by factors such as tumor size, the presence of fatty liver and the liver fibrosis. Moreover, the traditional serum tumor marker AFP only rises in the serum of less than half of the patients with early liver cancer, and can be affected by hepatitis flare leading to false positive results. So, patients with early-stage liver cancer can’t receive timely treatment, and this crucially affects their survival.

CGH: Because of the robust national health insurance system, there are lots of medical behaviors such as blood testing. And the increasing testing loads prompting laboratories to integrate and optimized workflows continuously. Our team had been putting many efforts on streamlining processes for over one decade, making our lab smarter and more efficient, including the application of Artificial Intelligence, business intelligence system, HIMSS 7 close loop system, which helps us successfully release additional testing capacity.

What are the important factors for your lab to consider when selecting a tumor marker?

CGH: As a certificated laboratory, a well-validated assay with official registration approval like CE or FDA is definitely our first priority.

Please share your experience implementing PIVKA-II.

MLC: Currently, in Taiwan, under the National Health Insurance, patients with liver cirrhosis and hepatocellular carcinoma, which is HCC, are entitled to undergo PIVKA-II testing twice a year. This can be complemented with ultrasound and AFP testing. Given the complementary roles of PIVKA-II and AFP in HCC surveillance, their combined use enhances the sensitivity of HCC surveillance, especially for the detection of early-stage HCC. Within hospitals, there have been numerous cases of liver cancer without elevations in AFP levels that were identified through PIVKA-II testing. These patients may exhibit either significant or insignificant ultrasound findings, providing clinicians with greater confidence to proceed with further computer tomography, which is CT, or magnetic resonance imaging, which is MRI, to confirm the diagnosis of liver cancer.

What are your expectations for digital algorithms for HCC surveillance and how is your experience with the new HCC digital algorithm so far?
CGMH is evaluating a new HCC digital algorithm in a clinical study.

MLC: To assess the severity of liver disease, we commonly rely on some algorithms or scores such as fibrosis-4, which is FIB-4, or Child-Pugh score for clinical or decision making. So, there is considerable anticipation for scores like GAAD, which integrates high-risk factors for liver cancer including G for gender, A for age, A for AFP, and the D for DCP, which is PIVKA-II. This integration is expected to serve as an early liver cancer surveillance tool, enhancing efficacy of surveillance, facilitating treatment improvement, and improving patient survival rates. We are still on the road to accumulate the research data on GAAD. If the performance meets expectations, surely, we would like to enroll all patients with high risk for HCC to undergo regular surveillance with GAAD.

CGH: The implementation and calculation framework of GAAD is a brand new trying for laboratories. However, with the rapid development of digitization, AI, and personalized medicine, laboratories are not only dealing with specimens and instruments but also digital algorithms. Facing the trends, laboratories have also strengthened efforts in digital medical talent and ensuring information security.

What advice would you give to other healthcare institutions or professionals looking to improve their HCC management?

MLC: To enhance screening efficacies for early liver cancer in Taiwan, which is a viral hepatitis endemic country, in addition to reinforcing public awareness of liver disease and encouraging regular surveillance among high-risk groups, the surveillance tools should be enhanced. It is important to follow health insurance coverage guidelines when incorporating PIVKA-II. Hopefully, in the future, digital algorithms like GAAD can be applied to further enhance early liver cancer detection rates.

CGH: The values of the testing data offers clinicians as evidence on clinical decisions. In recent years, we focused on the collaboration and communication with clinicians, which contributed to get a better understanding of their perspectives. This allowed us to integrate resources into what clinicians really need and enhancing the value of testing.

What is CGMH’s vision for liver disease and HCC management for the future?

MLC: Hopefully, through collaborative efforts across different units within the healthcare system, the caring for liver diseases, including hepatitis cirrhosis, and HCC, could be enhanced through effective screening, diagnosis, and treatment. In the future, the patients’ quality of life and the survival rates could be improved ultimately.

CGH: Delivering fast and accurate reports is a fundamental requirement for any laboratory. Additionally, we are actively introducing cutting-edge technologies to provide more valuable insights, thereby enhancing early diagnosis rates and patient survival rates.

The views and opinions expressed by Dr. Ming-Ling Chang and Dr. Chung-Guei Huang are their own views and opinions. Roche disclaims all liability in relation to these views and opinions.

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Urgent Global Need for PIVKA-II and AFP-L3 Measurements for Surveillance and Management of Hepatocellular Carcinoma https://clinicalvalue.com/urgent-global-need-for-pivka-ii-and-afp-l3-measurements-for-surveillance-and-management-of-hepatocellular-carcinoma/ Fri, 12 Apr 2024 02:47:09 +0000 https://clinicalvalue.com/?p=8271 ...

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Quick Summary

The incidence of AFP-negative HCC is increasing worldwide, particularly HCCs of nonviral etiology, such as MASLD/MASH. A high percentage of patients with MASLD/MASH-related HCC are positive for PIVKA-II, even those who are negative for AFP[1]. Higher levels of AFP-L3 have also been reported in cases of MASLD/MASH-related HCC [2]. Thus, the role of PIVKA-II and AFP-L3 measurements in HCC surveillance and diagnosis of AFP-negative HCCs has become more important.
This article by Prof Masatoshi Kudo details the importance of testing all 3 biomarkers, AFP, AFP-L3, and PIVKA-II, in HCC surveillance and management. He also discusses new algorithms, such as GALAD and GAAD, which incorporate these biomarkers have been useful in countries where access to imaging is limited.

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The Pursuit for Better Patient Outcomes – Innovating HCC Management at Siriraj Hospital https://clinicalvalue.com/the-pursuit-for-better-patient-outcomes-innovating-hcc-management-at-siriraj-hospital/ Tue, 13 Feb 2024 03:48:29 +0000 https://clinicalvalue.com/?p=8030 ...

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Prof Tawesak Tanwandee and Asst Prof Sansnee Senawong demonstrates how digital algorithms are used in Siriraj Hospital for the early detection of HCC

Interview transcript:

TT: Prof. Tawesak Tanwandee

SS: Asst. Prof. Sansnee Senawong

Introduction

TT: My name is Tawesak Tanwandee, Professor of Medicine, Head of Division of Gastroenterology, Faculty of Medicine, Siriraj Hospital.

SS: Hello, I am the Assistant Professor of Medicine, Sansanee Senawong, Chief of the Immunology Department, Faculty of Medicine, Siriraj Hospital, Mahidol University.

TT: Siriraj Hospital is the largest and the oldest hospital in Thailand. As it is a large and highly advanced hospital, a large number of patients come to Siriraj Hospital annually.

SS: The laboratory of the Department of Immunology was certified by the international standard ISO 15189 since May 2006. It has passed the continuous evaluation and inspection for the ISO 15189:2012 standards to date.

TT: As we are a large hospital, we receive patients from other hospitals. The patients who are referred to our hospital are mostly terminally ill. They are already in the terminal stage of cancer.

What is the unmet need in HCC surveillance and diagnosis in Siriraj Hospital?

SS: In Thailand, liver cancer is one of the most common and leading causes of death in cancer patients in the country. We find that over 70% of patients who die of liver cancer are not admitted to the surveillance program, resulting in delayed diagnosis at the terminal stage and they pass away soon after.

TT: For patients at risk of liver cancer, we don’t always have the chance to screen them sufficiently at an early stage. Moreover, an early stage of liver cancer has no visible symptoms. Therefore, the patient does not realize they need to be tested.

SS: In terms of liver cancer, there are still challenges regarding the effectiveness of liver cancer surveillance.

TT: The standard practice for liver cancer surveillance today is composed of ultrasound scans and blood (biomarker) tests to check alpha fetoprotein (AFP) levels every 6 months.

SS: However, we find that the sensitivity rate is as low as 63%.

TT: Due to ultrasound capacity limitations, patients may have to wait for months or even a year for a scan. Ultrasound also relies heavily on the doctor conducting the scan and how meticulous they are. Patients who are obese or have been diagnosed with liver cirrhosis, may be difficult to detect liver cancer by ultrasound.

SS: As a laboratory, when choosing a test or a platform for our services, we must take into account the challenge of reporting laboratory results quickly and efficiently to keep up with the increasing laboratory workloads. Also, it has to minimize human errors as much as possible. We need to find an appropriate system that can support various biomarker testing and is reliable.

What is your clinical experience with PIVKA-II? How has it brought value to HCC diagnosis?

TT: The data from studies show that PIVKA-II was quicker to detect early stages of liver cancer in patients. Checking the levels of AFP and PIVKA-II at the same time is much more convenient to doctors. Therefore, a single blood test from the patient allows both tests to be run. When testing both, we see for some patients, that the level of AFP is normal but the PIVKA-II level is abnormal. This helps to alert the doctor to abnormalities in the patient.

SS: Providing PIVKA-II to use in our laboratory will help improve the efficiency of early liver cancer surveillance in the future.

What is your experience using digital algorithms? How does the digital algorithm bring value to enable early HCC diagnosis?

TT: There are about 50-60 patients who have used the digital algorithm. And it has been very beneficial to some patients.

SS: But due to the limitations of ultrasound access combined with the sensitivity performance of AFP, considering to add new biomarkers such as PIVKA-II and  the digital algorithm will play a very important role.

TT: When applying the digital algorithm, in practice, we have to add two other factors, age and gender. Sometimes, abnormalities in the AFP level or PIVKA-II level is detected. But the digital algorithm shows it as normal. The algorithm makes surveillance more accurate.

SS: According to many studies and the reports from the doctors who directly treat the patients, it was found that using PIVKA-II and the digital algorithm, compared to the results of AFP and ultrasound, which is considered standard/conventional practice, helps detect liver cancer at an early stage more efficiently.

What does your workflow using the digital algorithm look like?

TT: The digital algorithm has simplified the workflow. Every time a patient has a health check, it’s standard practice to run a blood test to check the liver health. With the blood sample, we can run the digital algorithm at the same time. This means the patient only needs to give one blood sample. Everything is done in one visit.

SS: After collecting the samples, the laboratory performs AFP, PIVKA-II, and digital algorithm tests. After the AFP and PIVKA-II test results are reported, the laboratory results will be combined with gender and age to automatically calculate the score. The result will be sent to the LIS or HIS system of the hospital, allowing the doctors to see the test results quickly. This makes the laboratory workflow more convenient and reporting of results faster.

TT: It’s very easy to interpret the result because there is only ‘positive’ or ‘negative’ (score). The doctors don’t need to interpret complicated numbers. When an abnormality in the digital algorithm is found, the doctor should conduct further (confirmatory) testing, especially using medical imaging techniques such as X-ray, CT or MRI scans.

What’s your expectation for the digital algorithm in the future?

TT: If we use the digital algorithm or PIVKA-II in addition to AFP, the liver cancer surveillance will likely be more accurate because this test already shares the same platform as their regular blood tests. And this will help us to decide if the patient is at risk of cancer, or need further surveillance tests. We might be able to detect the liver cancer at an earlier stage in more patients and provide successful treatment.

What is Siriraj  Hospital’s vision for the liver disease and HCC management?

TT: In patients who have been screened and found to have liver cancer, over 90% of them live longer than 5 years. In this case, it changes the patient’s life. If we can use other surveillance methods such as PIVKA-II or the digital algorithm, it might help to improve surveillance effectiveness.

SS: The department is very pleased to have been a part of an important step in using digital diagnostic tools which are helping liver cancer patients have a better quality of life and increase the survival rate.

TT: At Siriraj Hospital, we provide knowledge and raise awareness for everyone, which includes both patients and healthcare workers. So, the patients who are at risk of liver cancer, can receive surveillance regularly. We hope that in the future, every patient who is at risk of liver cancer, everyone in Siriraj Hospital, will receive the surveillance process regularly.

The views and opinions expressed by Prof. Tawesak Tanwandee and Asst. Prof. Sansnee Senawong are their own views and opinions. Roche disclaims all liability in relation to these views and opinions.

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Advancing Liver Health Ecosystem for Improve Patient Outcomes: A Hong Kong Perspective https://clinicalvalue.com/advancing-liver-health-ecosystem-for-improve-patient-outcomes-a-hong-kong-perspective/ Mon, 18 Sep 2023 01:40:01 +0000 https://clinicalvalue.com/?p=7289 In this interview with Prof Yuen, Chief of Division of Gastroenterology and Hepatology in the University of Hong Kong, explore Hong Kong's current liver health ecosystem, some of the challenges in liver screening, and Prof Yuen's hopes for the future of liver health in Hong Kong. ...

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Prof MF Yuen & Ronald Lo discuss the liver health ecosystem in Hong Kong, including hepatitis screening and HCC surveillance

Find out more about PIVKA-II in Hepatocellular Carcinoma (HCC) detection, or download our HCC Detection (HD) expert pack by filling in the form below:

Get the latest updates in the liver space with our HCC detection (HD) expert pack.

Includes:

  • Highlights and a PDF copy of the latest APAC regional consensus for PIVKA-II and AFP in HCC
  • APASL 2023 Congress Report
  • Updates on future studies and patient cases

Interview transcript:

Ronald Lo:

Hello everyone! Welcome to this video. I’m Ronald, the General Manager of Roche Diagnostics Hong Kong. It’s my honour today to invite Professor Yuen to have a discussion around the topics of hepatitis and hepatocellular carcinoma (HCC). Hello Professor Yuen.

Prof. MF Yuen:

Hi, I am Professor MF Yuen, the Chief of Division of Gastroenterology and Hepatology in the University of Hong Kong.

Ronald Lo:

Again, thank you so much for joining us today. So the first question I would like to get your advice would be, what is the current liver health landscape in Hong Kong; and what are the unmet needs in hepatitis screening and HCC detection in Hong Kong?

Prof. MF Yuen:

At present, Hong Kong still has a high prevalence of 7.8% hepatitis B population, amounting more than 550,000 people. According to the most recent statistics, there were more than 1,700 new cases of liver cancer in 2020. And it is known that more than 80% of Hepatocellular Carcinoma are caused by Hepatitis B infection. Even with this high rate, we do not have population screening program for Hepatitis B infection, and the surveillance for HCC is also suboptimal with respect to the lack of routine regular ultrasound of the liver for Hepatitis B patients. It is mainly due to manpower and financial constraint in the public hospital sector. On top of all these, we do not have a well-organised strategy to deliver disease information to our population. Majority of people do not know the serious disease consequence of Hepatitis B infection which may lead to early death. They also lack of knowledge of early treatment would prevent all these deleterious outcomes.

Ronald Lo:

So I would like to learn from you more, what are the recent advances in the diagnosis of HCC; and how do you see these impacting patient care and the chronic liver disease management in Hong Kong?

Prof. MF Yuen:

From Asian experience, the use of additional biomarkers, such as PIVKA-II, can significantly increase the pick-up rate of HCC at early stage, increase the likelihood for curative treatments, and thus improve the survival. New digital algorithms combining age, gender and biomarkers, such as GAAD and GALAD, have been proposed since 2013, and currently undergoing clinical validations. Recent data presented during APASL 2023 demonstrated that the use of PIVKA-II based algorithm is more cost-effective than current standard of care among Hepatitis B or cirrhotic patients in Hong Kong, which allows an earlier HCC detection and a reduced cost in subsequent HCC treatment.

Ronald Lo:

Let’s switch the gear a bit. So how do you think we can improve the coordination and integration of care among various healthcare providers and systems?

Prof. MF Yuen:

I think the most important step would be the active involvement of different concerned parties, including health care sectors from government, private institutions, policy makers, patient groups, and different NGOs, to establish a core committee which could liaise with different stakeholders to ensure the implementation of different measures to enhance diagnosis rate, screening strategy and treatment.

Ronald Lo:

And to add on, how do you see the future of liver health in Hong Kong, and what steps do you believe need to be taken to improve the patient outcomes?

Prof. MF Yuen:

The future of liver health in Hong Kong depends on whether we could have a statutory body which taking charge of planning, liaising and implementing different measures at different levels.

Ronald Lo:

Thank you Professor. So probably would be my last question. So how do you see the role of the government and the policy in addressing the liver health ecosystem?

Prof. MF Yuen:

Hong Kong government has been working on different policy making processes and decisions by involving different committees. However, the decisiveness should be more enhanced so that policy can be rolled out at a timely manner.

Ronald Lo:

Professor Yuen, thank you so much for your time today and your inspiring insights on the topics of hepatitis and HCC. And I’m sure that there are always many areas that we could further work on together to improve patient outcomes. And thanks a lot for contributing to the “Combating Cancer” educational platform as well. Thank you so much, thank you!

The views and opinions expressed by Prof. MF Yuen are his own views and opinions. Roche disclaims all liability in relation to these views and opinions.

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Leading the Way for HCC Surveillance and Diagnosis: Prof. Henry LY Chan https://clinicalvalue.com/leading-the-way-for-hcc-surveillance-and-diagnosis-prof-henry-ly-chan/ Fri, 23 Jun 2023 01:22:29 +0000 https://clinicalvalue.com/?p=6996 In this video, Prof Henry LY Chan, Deputy Chief Manager at Union Hospital Hong Kong, discusses how PIVKA-II can complement AFP and Ultrasound in assisting clinicians in the early detection and overall management of HCC, and his clinical experience with PIVKA-II. ...

The post Leading the Way for HCC Surveillance and Diagnosis: Prof. Henry LY Chan appeared first on Clinical Value of Diagnostics.

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Prof Henry LY Chan discusses liver cancer tumor markers for early HCC detection

Find out more about PIVKA-II in Hepatocellular Carcinoma (HCC) detection, or download our HCC Detection (HD) expert pack by filling in the form below:

Get the latest updates in the liver space with our HCC detection (HD) expert pack.

Includes:

  • Highlights and a PDF copy of the latest APAC regional consensus for PIVKA-II and AFP in HCC
  • APASL 2023 Congress Report
  • Updates on future studies and patient cases

Interview transcript:

Introduction

I am Professor Henry Chan, a honorary clinical professor of the Chinese University of Hong Kong and deputy chief hospital manager of Union Hospital Hong Kong.

What is the unmet need in HCC surveillance and diagnosis?

Liver cancer is the 5th commonest cancer and 3rd commonest cancer mortality in Hong Kong. Most patients suffering from liver cancer are having underlying chronic liver disease such as viral hepatitis or fatty liver. As early liver cancer has no symptoms, regular surveillance is required to pick up small cancer, which are potentially curable by liver resection or loco-ablative therapy. On the other hand, systemic therapy for advanced liver cancer is not a very successful option. As patients with chronic liver disease are usually asymptomatic, one challenge on HCC surveillance is adherence of these patients to a regular program. Patient education and convenient testing will be pivotal to the success of HCC surveillance.

What is your current HCC surveillance practice and how is PIVKA-II implemented?

The standard tests for HCC surveillance is ultrasound of the liver and alfa-fetoprotein testing. The recommended interval of surveillance is 6 months to match the tumor doubling time of HCC. As there are limitations for both ultrasound and alfa-fetoprotein, these 2 investigations should be used together. For example, ultrasound may be difficult in patients with liver cirrhosis or obesity. On the other hand, alfa-fetoprotein may have limited sensitivity for small HCC. PIVKA II is a biomarker elevated in HCC with a completely different mechanism as AFP. There are ample data suggesting that testing AFP and PIVKA II together can improve the sensitivity for small HCC.

What clinical situations do you think are the most appropriate to use PIVKA-II for HCC surveillance?

There are data from Japan and China suggesting that AFP is not as sensitive as PIVKA II to detect small HCC in patients with alcohol-related liver disease and non-alcoholic fatty liver disease. Although more studies may be needed to confirm this finding, PIVKA II may be a good biomarker for HCC in patients with liver cirrhosis secondary to these 2 conditions. Another group of patients are those known to have difficult ultrasound, including obese patients and patients with cirrhotic nodules. Adding PIVKA II to the HCC surveillance program may compensate the inadequacy of USG. Ultimately, if cost is not a concern, I think PIVKA II should be used together with AFP in all patients for HCC surveillance.

What are your expectations for digital algorithms that aid in diagnosis of HCC, and how can they add value to overall clinical decisions in addition to biomarkers?

A digital algorithm composed of biomarkers and clinical parameters can generate a single score to inform the probability of HCC. It can facilitate a simple interpretation of the biomarker results in the context of the patients, and will be particularly useful for non-experts to carry out HCC surveillance. One challenge to implement digital algorithms is the education of clinical practitioners to interpret the meaning of the scores.

What advice would you give to your fellow colleagues?

When I was working in the public hospital, I was annoyed by the long waiting time for an ultrasound, which may take up to 2 years. I think PIVKA II is a good alternative for this unmet need. Using PIVKA II together with AFP can improve the sensitivity to pick up early HCC during this window period without ultrasound. This is particularly important for patients with alcohol-related liver disease and non-alcoholic fatty liver when the sensitivity of AFP for early HCC is low.

The views and opinions expressed by Prof. Henry LY Chan are his own views and opinions. Roche disclaims all liability in relation to these views and opinions.

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Serum PIVKA-II and alpha-fetoprotein at virological remission predicts hepatocellular carcinoma in chronic hepatitis B related cirrhosis https://clinicalvalue.com/serum-pivka-ii-and-alpha-fetoprotein-at-virological-remission-predicts-hepatocellular-carcinoma-in-chronic-hepatitis-b-related-cirrhosis/ Mon, 19 Jun 2023 03:35:33 +0000 https://clinicalvalue.com/?p=6878 This study aimed to investigate the role of serum PIVKA-II and alpha-fetoprotein in predicting HCC and mortality in cirrhotic CHB patients at virological remission following NA therapy.

Su TH, Peng CY, Chang SH, Tseng TC, Liu CJ, Chen CL, Liu CH, Yang HC, Chen PJ, Kao JH...

The post Serum PIVKA-II and alpha-fetoprotein at virological remission predicts hepatocellular carcinoma in chronic hepatitis B related cirrhosis appeared first on Clinical Value of Diagnostics.

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Quick Summary

The risk of hepatocellular carcinoma (HCC) is reduced but not eliminated after nucleos(t)ide analogue (NA) therapy in chronic hepatitis B (CHB). This study aimed to investigate the role of serum Prothrombin Induced by Vitamin K Absence or Antagonist-II (PIVKA-II) and alpha-fetoprotein in predicting HCC and mortality in cirrhotic CHB patients at virological remission (VR) following NA therapy. 

 

Patients with CHB-related cirrhosis undergoing NA therapy from two medical centers in Taiwan were retrospectively included. Serum PIVKA-II were quantified by an automated chemiluminescence assay. Multivariable Cox proportional hazards regression models were used to identify predictors for HCC and death. Serial on-treatment PIVKA-II levels after VR were investigated.

The post Serum PIVKA-II and alpha-fetoprotein at virological remission predicts hepatocellular carcinoma in chronic hepatitis B related cirrhosis appeared first on Clinical Value of Diagnostics.

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Do combined assays of serum AFP, AFP-L3, DCP, GP73, and DKK-1 efficiently improve the clinical values of biomarkers in decision-making for hepatocellular carcinoma? A meta-analysis https://clinicalvalue.com/do-combined-assays-of-serum-afp-afp-l3-dcp-gp73-and-dkk-1-efficiently-improve-the-clinical-values-of-biomarkers-in-decision-making-for-hepatocellular-carcinoma-a-meta-analysis/ Mon, 19 Jun 2023 03:35:08 +0000 https://clinicalvalue.com/?p=6869 This meta-analysis aims to provide insight on the efficacy of using combined biomarkers, AFP, AFP-L3, DCP, DKK-1, and GP73, for clinical decision-making for patients with HCC.

Fang YS, Wu Q, Zhao HC, Zhou Y, Ye L, Liu SS, Li XX, Du WD...

The post Do combined assays of serum AFP, AFP-L3, DCP, GP73, and DKK-1 efficiently improve the clinical values of biomarkers in decision-making for hepatocellular carcinoma? A meta-analysis appeared first on Clinical Value of Diagnostics.

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Quick Summary

Serum biomarkers are valuable for clinical decision-making for patients with hepatocellular carcinoma (HCC), among which the most promising are AFP, AFP-L3, DCP, DKK-1, and GP73; however, the efficacy of using combined biomarkers remains controversial. This meta-analysis provides insights regarding this topic.

 

PubMed, Embase, and Cochrane Library were systematically surveyed, and 28 qualified articles published since January 2015 were identified. A random-effects model was used to assess pooled sensitivity, specificity, positive and negative likelihood ratios (PLRs and NLPs), and diagnostic odds ratio (DOR).

The post Do combined assays of serum AFP, AFP-L3, DCP, GP73, and DKK-1 efficiently improve the clinical values of biomarkers in decision-making for hepatocellular carcinoma? A meta-analysis appeared first on Clinical Value of Diagnostics.

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The prognostic values of serum markers in hepatocellular carcinoma after invasive therapies based on real-world data https://clinicalvalue.com/the-prognostic-values-of-serum-markers-in-hepatocellular-carcinoma-after-invasive-therapies-based-on-real-world-data/ Mon, 19 Jun 2023 03:34:59 +0000 https://clinicalvalue.com/?p=6885 The purpose of this study is to evaluate the prognostic values of serum markers in HCC, with retrospective data.

Li B, Liu A, Wen Y, Yang G, Zhao J, Li X, Mao Y, Li B...

The post The prognostic values of serum markers in hepatocellular carcinoma after invasive therapies based on real-world data appeared first on Clinical Value of Diagnostics.

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Quick Summary

Hepatocellular carcinoma (HCC) is one of the most common malignancies with poor prognosis, and the mortality rate remains high. More than 70% of HCC patients have recurrence within 5 years after treatment. The purpose of this study is to evaluate the prognostic values of serum markers with retrospective data.

 

Real‐world data (RWD) was applied to analyze the prognostic values of six serum markers for HCC patients after treatment, including α‐fetoprotein (AFP), α‐fetoprotein‐L3 (AFP‐L3), Golgi protein73 (GP73), alanine aminotransferase (ALT), albumin (ALB), and total bilirubin (TBil). A total of 268 cases were enrolled to analyze recurrence‐free survival (RFS), and 104 cases were used to analyze overall survival (OS).

The post The prognostic values of serum markers in hepatocellular carcinoma after invasive therapies based on real-world data appeared first on Clinical Value of Diagnostics.

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The Diagnostic Value of Serum PIVKA-II Alone or in Combination with AFP in Chinese Hepatocellular Carcinoma Patients https://clinicalvalue.com/hcc-early-detection-china-pivka-ii-afp-insights/ Mon, 19 Jun 2023 03:34:08 +0000 https://clinicalvalue.com/?p=6882 This study aims to investigate the diagnostic role of PIVKA-II alone or in combination with AFP in Chinese HCC patients.

Xu F, Zhang L, He W, Song D, Ji X, Shao J...

The post The Diagnostic Value of Serum PIVKA-II Alone or in Combination with AFP in Chinese Hepatocellular Carcinoma Patients appeared first on Clinical Value of Diagnostics.

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Quick Summary

At present, the diagnostic accuracy of alpha-fetoprotein (AFP) for hepatocellular carcinoma (HCC) surveillance is insufficient. It remains controversial whether prothrombin induced by vitamin K absence II (PIVKA-II) has a better diagnostic value than AFP for HCC patients.This study aims to investigate the diagnostic role of PIVKA-II alone or in combination with AFP in Chinese HCC patients.

 

Serum AFP and PIVKA-II levels were detected and analyzed in 308 HCC afflicted patients and 120 unafflicted controls. The receiver operator curve (ROC) and area under the curve (AUC) were conducted to evaluate the clinical value of AFP and PIVKA-II for diagnosing HCC and early HCC.

The post The Diagnostic Value of Serum PIVKA-II Alone or in Combination with AFP in Chinese Hepatocellular Carcinoma Patients appeared first on Clinical Value of Diagnostics.

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