Key opinion leaders (KOLs) in the US, 5EU* and China have confirmed that they are not satisfied with the current state of surveillance programs for hepatocellular carcinoma (HCC), according to research by GlobalData. The data and analytics company also notes that these KOLs feel there are no imminent plans to implement better nationwide programs, despite the crucial importance of HCC surveillance and early detection.

Mandana Emamzadeh, PhD, Healthcare Analyst at GlobalData, comments: “Early detection of HCC is essential as it expands the available treatment options to patients and increases chance of recovery. The surveillance and screening of patients with chronic liver disease is recommended by HCC guidelines worldwide, but there is still a worrying lack of focus in improving these services in key major countries. For example, surveillance in the US, 5EU and China lags considerably behind the surveillance in Japan, which has a noteworthy impact on the stage of HCC at diagnosis.”

Due to the high frequency of HCC in Asia, Japan established a nationwide HCC surveillance program in the 1980s, which, to date, is unparalleled. This allows for earlier detection of HCC in Japan, which, according to primary research by GlobalData, has led to the majority of patients being diagnosed at Barcelona Clinic Liver Cancer (BCLC) stage 0 or A: the earliest stages of disease. While some countries commonly use specific methods – from imaging tests such as ultrasound, to magnetic resonance imaging (MRI), computerized tomography (CT) and biomarkers such as alpha-fetoprotein (AFP) – Japanese patients typically receive a combination of all of these.

Emamzadeh notes: “GlobalData’s research revealed that only 5.7% of patients are diagnosed in BCLC Stage C in Japan, and 62% are diagnosed at Stage A. This is in contrast to the US, where only 31% of patients are diagnosed in Stage C and 28% in Stage A. Japan’s program has seen better outcomes overall for its patients and should be benchmark for others.”

Despite the crucial importance of the HCC surveillance programs, few efforts have been made to address the issue. The FDA granted Breakthrough Device Designation for Roche’s Elecsys GALAD score** last year to support earlier diagnosis of HCC. However, this system is still under development to improve diagnostic workflows throughout chronic liver disease management.

Additionally, researchers in the North American Liver Cancer Consortium and Michigan Medicine conducted a choice-based joint survey to investigate the preference of 179 cirrhosis patients on HCC surveillance modalities. The patients prioritized the attributes of surveillance benefits, followed by test logistics, financial harm, convenience, and physical harm. Furthermore, patients preferred abbreviated MRI (29.0%), MRI (23.3%), or novel blood-based biomarkers (20.9%) over ultrasound alone (3.4%) or with AFP (8.8%).

Emamzadeh adds: “Although surveillance can prolong chronic liver disease patients’ lifespan by detecting HCC at curable stages, currently the focus of the pharmaceutical industry is on drug development in the late-stage, with therapies that do not achieve a cure. As a result, HCC surveillance remains a significant unmet need, and more effort is needed to monitor patients with chronic liver disease and improve their quality of life.”

* 5EU: France, Germany, Italy, Spain and the UK

** GALAD combines gender, age, Lens culinaris agglutinin-reactive AFP [AFP-L3], total AFP and des-γ-carboxyprothrombin [DCP]) scores