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. 2021 Jun;160(7):2572-2584.
doi: 10.1053/j.gastro.2021.01.233. Epub 2021 Mar 9.

International Liver Cancer Association (ILCA) White Paper on Biomarker Development for Hepatocellular Carcinoma

Amit G Singal  1 , Yujin Hoshida  2 , David J Pinato  3 , Jorge Marrero  2 , Jean-Charles Nault  4 , Valerie Paradis  5 , Nabihah Tayob  6 , Morris Sherman  7 , Young Suk Lim  8 , Ziding Feng  9 , Anna S Lok  10 , Jo Ann Rinaudo  11 , Sudhir Srivastava  11 , Josep M Llovet  12 , Augusto Villanueva  13
Affiliations

International Liver Cancer Association (ILCA) White Paper on Biomarker Development for Hepatocellular Carcinoma

Amit G Singal et al. Gastroenterology. 2021 Jun.
No abstract available

Keywords: Biomarkers; Cirrhosis; Liver Cancer.

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Figures

Figure 1.
Figure 1.
Summary figure of the main clinical indications where biomarkers are needed to improve outcomes in patients with HCC. A risk stratification biomarker aims to predict future development of HCC and can differentiate high- and low-risk patients. An early detection biomarker aims to detect HCC at an early stage. A diagnostic biomarker can confirm or exclude presence of HCC in patients with clinical concern of HCC. A prognostic biomarker predicts cancer outcomes and can differentiate favorable vs poor prognosis (eg, survival). A treatment response biomarker aims to predict favorable or unfavorable response to treatment. Used with permission from ©Mount Sinai Health System.
Figure 2.
Figure 2.
Visual summary of the natural history of HCC that focus on key differences and challenges when designing studies to evaluate risk stratification vs early detection biomarkers. For risk stratification biomarkers, it is crucial to ensure that the patients are free of HCC. This includes a 2-year period to minimize the risk of undetectable microscopic HCC, which is a potential confounder in these studies. Used with permission from ©Mount Sinai Health System.
Figure 3.
Figure 3.
Levels of evidence in biomarker studies. (Top) Main study designs, key characteristics, and levels of evidence assigned for each design. (Bottom) Highlights the main outcomes and some key limitations of each study design.
Figure 4.
Figure 4.
Biomarker-based clinical trial designs testing new therapies. Depiction of the 4 most frequently used clinical trial designs to test the utility of biomarkers as a selection tool for new therapies. In the biomarker-based strategy, patients are randomized to a biomarker-based strategy or no stratification before they are allocated to the treatment arm. In the biomarker-stratified design, patients are stratified based on the biomarker and then randomized to receive the experimental drug or placebo. Both, patients with the biomarker and those without are included in the study. In the targeted design, only the patients with the biomarker are randomized to the drug trial (eg, trial of ramucirumab in patients with high AFP levels). The umbrella trial design allocates specific therapies based on predicted molecular alterations detected with the biomarker, which generally includes an array of different molecular alterations.
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