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Abstract Details
Blood-based biomarkers for hepatocellular carcinoma screening: Approaching the end of the ultrasound era?
J Hepatol. 2022 Sep 8;S0168-8278(22)03067-7. doi: 10.1016/j.jhep.2022.08.036.Online ahead of print.
1Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, MI; Rogel Cancer Center, University of Michigan, Ann Arbor, MI. Electronic address: ndparikh@med.umich.edu.
2Department of Biostatistics, Dana Farber Cancer Center, Boston, MA.
3Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Abstract
Hepatocellular carcinoma (HCC) is a leading cause of cancer-related death worldwide, in part due inadequate early detection strategies. Current recommendations for screening consist of semiannual abdominal ultrasound with or without serum alpha fetoprotein in patients with cirrhosis and in demographic subgroups with chronic hepatitis B infection. However, this screening strategy has several deficiencies, including suboptimal early-stage sensitivity, false positives with subsequent harms, inter-operator variability in ultrasound performance, and poor adherence. A blood-based biomarker with sufficient performance characteristics for early-stage disease, could overcome several of these barriers to improving early-stage detection. However; prior to use of a biomarker for screening in clinical practice, a multistep validation is required in order to understand test performance characteristics. These steps include case-control validation, followed by validation in prospective cohorts of at-risk patients. Until recently, we lacked adequate longitudinal validation cohorts for HCC early detection; however, several validation cohorts are maturing, including the Hepatocellular Carcinoma Early Detection Study and the Texas Hepatocellular Carcinoma Consortium, which will allow for rigorous validation of candidate biomarkers. While there are several promising biomarkers awaiting validation, in order to supplant abdominal ultrasound, a candidate biomarker must show adequate test performance as well as overcome practical hurdles to ensure adoption in clinical practice. The promise of blood-based biomarker is significant, especially given the limitations of ultrasound-based screening; however, adequate validation and several logistical considerations are required prior to clinical implementation.