HES V2.0 outperforms GALAD for detection of HCC: A phase 3 biomarker study in the United States
Year: 2024
Type: article
Study design: Observational Study
Abstract: BACKGROUND AND AIMS: The original hepatocellular carcinoma early detection screening (HES) score, which combines alpha-fetoprotein (AFP) with age, alanine aminotransferase, and platelets, has better performance than AFP alone for early HCC detection. We have developed HES V2.0 by adding AFP-L3 and des-gamma-carboxy prothrombin to the score and compared its performance to GALAD and ASAP scores among patients with cirrhosis. APPROACH AND RESULTS: We conducted a prospective-specimen collection, retrospective-blinded-evaluation phase 3 biomarker cohort study in patients with cirrhosis enrolled in imaging and AFP surveillance. True-positive rate (TPR)/sensitivity and false-positive rate for any or early HCC were calculated for GALAD, ASAP, and HES V2.0 scores within 6, 12, and 24 months of HCC diagnosis. We calculated the AUROC curve and estimated TPR based on an optimal threshold at a fixed false-positive rate of 10%. We analyzed 2331 patients, of whom 125 developed HCC (71% in the early stages). For any HCC, HES V2.0 had higher TPR than GALAD overall (+7.2%), at 6 months (+3.6%), at 12 months (+7.2%), and 24 months (+13.0%) before HCC diagnosis. HES V2.0 had higher TPR than ASAP for all time points (+5.9% to +12.0%). For early HCC, HES V2.0 had higher sensitivity/TPR than GALAD overall (+6.7%), at 12 months (+6.3%), and 24 months (+14.6%) but not at 6 months (+0.0%) and higher than ASAP for all time points (+13.4% to +18.0%). CONCLUSIONS: In a prospective cohort study, HES V2.0 had a significantly higher performance for identifying new HCC, including early stage, than GALAD or ASAP.
Source: Hepatology
Language: English
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $2,900
Awards: G1147702603, G1287937551, G1292721935, G1376554346, G1482796469, G1897178486, The Texas Collaborative Center for Hepatocellular Cancer, G2336518868, G246836764, G2473728259, G2849904280, G3272752000, A Novel Risk Stratification and Early Detection Strategy to Reduce Liver Cancer Mortality, G3563973317, G3958905460, The Texas Hepatocellular Carcinoma Consortium (THCCC), G5592312262, G5833555967, G6182568868, Surveillance for Hepatocellular Carcinoma among HCV-infected Veterans, Translation of a biomarker panel for the early detection of hepatocellular carcinoma, G6667331430, G672140788, G7325247512, G746270568, NOVEL METABOLOMICS AND RADIOMICS FOR PREDICTING HCC RISK, G8282101904, G8403065596, G8855760815, G9000014417, G9000015758, G9000055217, G9000057601, G9000079109, G9000124353, G9000180643, Clinical Validation Center for Hepatocellular Carcinoma, Consortium on Translational Research in Early Detection of Liver Cancer:Data Management and Coordinating Center (DMCC)
OpenAlex ID: W4399805120