GALAD demonstrates high sensitivity for HCC surveillance in a cohort of patients with cirrhosis
Year: 2021
Type: article
Study design: Observational Study
Abstract: BACKGROUND AND AIMS: Most patients with HCC are diagnosed at a late stage, highlighting the need for more accurate surveillance tests. Although biomarkers for HCC early detection have promising data in Phase 2 case-control studies, evaluation in cohort studies is critical prior to adoption in practice. We leveraged a prospective cohort of patients with Child-Pugh A or B cirrhosis who were followed until incident HCC, liver transplantation, death, or loss to follow-up. We used a prospective specimen collection, retrospective, blinded evaluation design for biomarker evaluation of GALAD (gender × age × log alpha-fetoprotein [AFP] × des-gamma-carboxy prothrombin), longitudinal GALAD, and the HCC Early Detection Screening (HES) algorithm-compared to AFP-using patient-level sensitivity and screening-level specificity. APPROACH AND RESULTS: Of 397 patients with cirrhosis, 42 developed HCC (57.1% early stage) over a median of 2.0 years. Longitudinal GALAD had the highest c-statistic for HCC detection (0.85; 95% CI, 0.77-0.92) compared to single-time point GALAD (0.79; 95% CI, 0.71-0.87), AFP (0.77; 95% CI, 0.69-0.85), and HES (0.76; 95% CI, 0.67-0.83). When specificity was fixed at 90%, the sensitivity for HCC of single-time point and longitudinal GALAD was 54.8% and 66.7%, respectively, compared to 40.5% for AFP. Sensitivity for HCC detection was higher when restricted to patients with biomarker assessment within 6 months prior to HCC diagnosis, with the highest sensitivities observed for single-time point GALAD (72.0%) and longitudinal GALAD (64.0%), respectively. Sensitivity of single-time point and longitudinal GALAD for early-stage HCC was 53.8% and 69.2%, respectively. CONCLUSION: GALAD demonstrated high sensitivity for HCC detection in a cohort of patients with cirrhosis. Validation of these results is warranted in large Phase 3 data sets.
Source: Hepatology
DOI: 10.1002/hep.32185
Language: English
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Awards: G1376554346, G1951959510, G3882544053, G4682996774, G5833555967, G6134377953, Translation of a biomarker panel for the early detection of hepatocellular carcinoma, G7030266610, G752583419, G7901845425, G9000055217, G9000057601, G9000214999, G9000315951, Consortium on Translational Research in Early Detection of Liver Cancer:Data Management and Coordinating Center (DMCC)
OpenAlex ID: W3204744768