Surveillance – Clinical Value of Diagnostics https://clinicalvalue.com/en-au/ Mon, 08 Apr 2024 05:53:15 +0000 en-AU 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 Surveillance – Clinical Value of Diagnostics https://clinicalvalue.com/en-au/ 32 32 225041835 Looking to the Future – Blood-based Biomarkers for Liver Cancer Surveillance https://clinicalvalue.com/en-au/looking-to-the-future-blood-based-biomarkers-for-liver-cancer-surveillance/ Mon, 26 Feb 2024 14:04:01 +0000 https://clinicalvalue.com/?p=8072 ...

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Alpha-fetoprotein (AFP) is a blood-based biomarker that’s used together with ultrasound to detect liver cancer, but it’s by no means a perfect test. Experts are hopeful that emerging, specific blood-based biomarkers will prove useful in liver cancer surveillance — potentially as stand-alone tests.

What are some of the barriers to ultrasound surveillance?

For patients, some of the problems with ultrasound-based liver cancer surveillance include access to a clinic with an ultrasound machine, travel times and costs, as well as the inconvenience of attending appointments (1, 2). For clinicians, there may be differences in how the ultrasound is reported between sonographers (inter-observer variability) (1, 2).

What are the advantages of specific blood-based biomarkers over ultrasound alone?

Blood-based biomarker surveillance only requires a simple blood test. The risk of liver cancer is assessed using clinical scores, removing the need for ultrasound altogether (1, 2). Biomarker based surveillance may make it easier for patients to participate in liver cancer surveillance (1).

So, what blood-based biomarkers are currently used for liver cancer surveillance?

AFP is a blood-based biomarker currently used in hepatocellular carcinoma (HCC) surveillance in Australia (1). AFP tests are subsidised through the Medicare Benefits Schedule (MBS) for detecting and monitoring hepatic tumours (3). However, AFP use has been limited by its low sensitivity and suboptimal specificity (3).

While AFP is not used as a stand-alone surveillance test, it can help improve the detection of early-stage HCC when used together with ultrasound (1, 2).

What emerging biomarkers may be used for surveillance in the future?

There are two biomarkers showing promise for HCC surveillance, both of which are highly specific for the diagnosis of HCC (1):

  • lens culinaris agglutinin-reactive fraction of AFP (alpha-fetoprotein L3 or AFP-L3); and
  • des-gamma-carboxy prothrombin (DCP) (1).

Levels of these biomarkers are assessed using a simple blood test. The results of this blood test are used along with patient information to assess the risk of HCC. Two methods have been developed to calculate a clinical score, these are called GALAD and GAAD (1).

Both of these scores are still undergoing evaluation to check they have sufficient sensitivity and specificity (2). They are yet to be incorporated into clinical guidelines, or be subsidised by the MBS (3). If validated, the future use of non-invasive biomarkers for liver cancer surveillance holds promise, as it may allow for point-of-care testing with objective results (2).

GALAD

A serum biomarker-based model called GALAD can be used to predict the probability of HCC
in people with chronic liver disease (cirrhosis or chronic hepatitis B) (3).

The GALAD score is made up of (3):

G – gender (sex)
A – age
L – alpha-fetoprotein L3 (AFP-L3)
A – AFP
D – DCP

GAAD

Another clinical score using biomarkers is the GAAD score.

The GAAD clinical score is made up of (1):

G – gender (sex)
A – age
A – AFP
D – DCP

Further information

For a more in-depth discussion of blood-based biomarkers in HCC surveillance, see the Research Review Educational Series: Hepatocellular carcinoma surveillance and the emerging role of biomarker-based models (2023).

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HCC Monitoring and Surveillance Update – The Limbic https://clinicalvalue.com/en-au/hcc-monitoring-and-surveillance-update-the-limbic/ Wed, 01 Nov 2023 08:57:26 +0000 https://clinicalvalue.com/hcc-monitoring-and-surveillance-update-the-limbic/ ...

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HCC monitoring and surveillance udpate (resize)

In these series of videos produced by the limbic, A/Prof. Simone Strasser and A/Prof. Jessica Howell discuss:

  • how changes in the epidemiology of advanced liver disease – both in Australia and globally – present challenges to the surveillance and monitoring of hepatocellular carcinoma
  • discuss ways that specialists can ensure at-risk patients are undergoing surveillance for HCC
  • current and future approaches to HCC surveillance and monitoring

Watch the videos below:

The changing epidemiology of advanced liver disease and HCC

HCC surveillance in at-risk patients

Limitations of current HCC surveillance strategies and future solutions

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Patient-centric and ecosystem insights into hepatocellular carcinoma across Asia-Pacific – LEAP https://clinicalvalue.com/en-au/patient-centric-and-ecosystem-insights-into-hepatocellular-carcinoma-across-asia-pacific-leap/ Mon, 02 Oct 2023 02:36:24 +0000 https://clinicalvalue.com/patient-centric-and-ecosystem-insights-into-hepatocellular-carcinoma-across-asia-pacific-leap/ In this white paper, insights on the liver ecosystem are uncovered, with the intention of facilitating action among various stakeholders to reduce liver cancer incidence and mortality in APAC. Read the whitepaper to find out more about the various active initiatives and recommendations for next steps. ...

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Hepatocellular carcinoma (HCC) is largely preventable, with decades of time to intervene, yet millions still die from it. It is however not incomprehensible why this happens. The journey from liver disease to liver cancer is complex—a myriad of broken healthcare systems, patient behaviors, cultural influences, stigma, funding, and limited healthcare professional (HCP) capacity. At first glance, it seems overwhelming, leaving us with the question—where should we intervene?

Some cancers like breast cancer have high incidence but comparatively low mortality1. Liver cancer is the opposite; it often goes undetected until it reaches a late stage, resulting in dismal prognosis. Late presentation is a top issue in liver cancer. Without pain receptors, the liver has minimal symptoms until it is damaged beyond cure. People usually die within 6 – 22 months of a late-stage HCC diagnosis.2 HCC is known as the ‘silent killer’ and is typically diagnosed at a late stage, which has a <5% 5-year survival rate. If diagnosed early, the 5-year survival rate increases to 40 – 70%.3&4

Given the complexity, there is no single solution. Rather, it will take concerted action from multiple stakeholders in the system to bring about positive change. That said, there are logical places to start. First, we need to understand the ecosystem. An ecosystem represents factors required to deliver a service, in this case, liver care. It helps identify solution, scope, and strategy by providing a holistic view of actors, processes, flow, influence, and relationships.

Hepatitis B and C are the major causes of chronic liver disease and liver cancer in the world. An ongoing infection causes inflammation in the liver. This extended inflammation can cause scarring, called cirrhosis, and can ultimately lead to liver cancer. The Asia-Pacific region bears the highest overall burden of HBV, with 59% of those living with chronic HBV, 26% of new infections, and 79% of deaths.5 Given the shifting etiology with rising fatty liver disease, there is a pressing need to re-assess risk factors and stratify patients to ensure we are not failing to detect. Being able to optimize surveillance protocols based on patient risk will improve efficiency and ability to catch early HCC and drastically improve survival.

To further maximize the benefit of a surveillance program, or any other initiative, it is important to consider surrounding opportunities up- and down-stream. For example, surveillance programs will benefit from upstream awareness efforts to improve throughput, and down-stream availability of treatments. This paper provides an appreciation for the end-to-end patient journey and their needs along the way. Fundamentally, it advocates for the improvement of human life in the midst of receiving liver care, both clinically and experientially.

Roche_LEAP 2023_gif_v1a (1)

From the research, a central theme emerged – ultrasound used in HCC surveillance is a major bottleneck. It is the cause of delayed or even missed diagnosis, and stark inequities in care. Biomarkers such as PIVKA-II complementing AFP show promise in lessening this problem while also offering improved sensitivity and specificity for HCC detection.

This White Paper intends to facilitate concerted action among HCPs, patient advocacy groups, payers, and policy makers to reduce liver cancer incidence and mortality in APAC. It shares both holistic ecosystem and detailed human-centric insights as a starting point for change. Working with Key Opinion Leaders (KOLs) we provide tangible examples of active initiatives, and recommendations for taking the next steps.

Download or read the white paper below to find out more.

Stay tuned for interviews with select KOLs featured in the white paper, as they share about their insights and learning points on the initiatives piloted in their country.

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Building modern hepatocellular carcinoma surveillance programmes: taking steps to address a leading cause of liver cancer death in Asia https://clinicalvalue.com/en-au/building-modern-hepatocellular-carcinoma-surveillance-programmes-taking-steps-to-address-a-leading-cause-of-liver-cancer-death-in-asia/ Wed, 23 Aug 2023 02:51:53 +0000 https://clinicalvalue.com/building-modern-hepatocellular-carcinoma-surveillance-programmes-taking-steps-to-address-a-leading-cause-of-liver-cancer-death-in-asia/ In this whitepaper, HCC surveillance programs in Asia were analysed. The learnings from well established HCC surveillance programs, as well as the challenges in areas that have not implemented such programs have highlighted 7 priorities for implementing an HCC surveillance program....

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Quick Summary

HCC is a leading cause of cancer mortality in Asia. Causes of HCC include viral hepatitis B and C infections, with recent increases in metabolic disorders, such as NAFLD, also playing a factor.

Early HCC interventions are highly effective and can lead to improved patient outcomes and survival. Therefore, HCC surveillance programs are pivotal in detecting HCC early and making the appropriate interventions.

In this whitepaper, HCC surveillance programs in Asia were analysed. The learnings from well established HCC surveillance programs in Asia, as well as the challenges in areas that have not implemented such programs have highlighted 7 priorities for implementing an HCC surveillance program:

  1. Include HCC surveillance in national program and strategic plans
    HCC surveillance programs should be fit into the national health strategy where appropriate, taking into account the local incidence and prevelance rates, and existing priorities and resources.
  2. Secure sustainable funding commitments
    Long-term resourcing and financing is key to making HCC survaillance programs successful. The current health financign system in the area, and ability to pay should be assessed, while exploring various funding methods such as centralised healthcare coverage or private insurance.
  3. Collect, analyse, and utilise data to inform program design
    The development of HCC surveillance program should be based on data, such as HCC epidemiology, patient outcomes, human and economic cost of HCC. These data should be collected and analysed.
  4. Adopt optimal technologies to advance HCC surveillance
    Technology can help to improve access to HCC surveillance programs, as well as improve patient outcomes by detecting HCC early. Some examples include: including additional biomarkers such as PIVKA-II, using biomarker based digital algorithms and diagnostic models, using more advanced imaging techniques, and adapting IT systems to support surveillance programs.
  5. Mobilise existing resources for HCC surveillance
    Tapping on exisiting resources to expand capacity for HCC care and surveillance., For example increasing the range of HCPs who can diagnose and manage HCC like primary and community HCPs, expanding private healthcare capacity in HCC care.
  6. Engage a broad spectrum of stakeholders to further surveillance goals
    Governmental decision-makers, physicians, patients and PAGs, payers and industry need to come together to drive implementation of a robust HCC surveillance programs that address needs of all stakeholders.
  7. Raise awareness and provide education on the need for HCC suveillance
    Raising the knowledge among the general population and HCPs on HCC and the importance of surveillance can improve uptake and compliance to surveillance programs.

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