GALAD demonstrates high sensitivity for HCC surveillance in a cohort of patients with cirrhosis

作者：Amit G. Singal, Nabihah Tayob, Anand S. Mehta, Jorge A. Marrero, Hashem El‐Serag, Qingchun Jin, Cristian Saenz de Viteri, Austin J. Fobar, Neehar D. Parikh · 发表于：Hepatology · 年份：2021 · DOI：10.1002/hep.32185 · 被引用次数：172 · 研究领域：Liver Disease and Transplantation、Liver Disease Diagnosis and Treatment、Hepatocellular Carcinoma Treatment and Prognosis

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 observ...