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HES V2.0 outperforms GALAD for detection of HCC: A phase 3 biomarker study in the United States.
El-Serag, Hashem B; Jin, Qingchun; Tayob, Nabihah; Salem, Emad; Luster, Michelle; Alsarraj, Abeer; Khaderi, Saira; Singal, Amit G; Marrero, Jorge A; Asrani, Sumeet K; Kanwal, Fasiha.
Afiliación
  • El-Serag HB; Section of Gastroenterology and Hepatology, Department of Medicine, Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas, USA.
  • Jin Q; Section of Health Services Research, Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas, USA.
  • Tayob N; Department of Data Science, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
  • Salem E; Department of Data Science, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
  • Luster M; Section of Gastroenterology and Hepatology, Department of Medicine, Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas, USA.
  • Alsarraj A; Section of Gastroenterology and Hepatology, Department of Medicine, Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas, USA.
  • Khaderi S; Section of Health Services Research, Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas, USA.
  • Singal AG; Section of Gastroenterology and Hepatology, Department of Medicine, Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas, USA.
  • Marrero JA; Department of Medicine, UT Southwestern Medical Center, Dallas, Texas, USA.
  • Asrani SK; Department of Medicine, Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
  • Kanwal F; Department of Medicine, Baylor University Medical Center, Dallas, Texas, USA.
Hepatology ; 2024 Jun 19.
Article en En | MEDLINE | ID: mdl-38899967
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Hepatology Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Hepatology Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos