A Phase 3 Biomarker Validation of GALAD for the Detection of Hepatocellular Carcinoma in Cirrhosis.

Autor:	Marsh TL; Biostatistics Program, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washinton., Parikh ND; Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan., Roberts LR; Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, Minnesota., Schwartz ME; Recanati/Miller Transplant Institute, Mt Sinai Medical Center, New York, New York., Nguyen MH; Division of Gastroenterology and Hepatology and Department of Epidemiology and Population Health, Stanford University, Palo Alto, California., Befeler A; Division of Gastroenterology, Saint Louis University, St. Louis, Missouri., Page-Lester S; Biostatistics Program, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washinton., Tayob N; Department of Data Science, Dana Farber Cancer Institute, Boston, Massachusetts., Srivastava S; Cancer Biomarkers Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland., Rinaudo JA; Cancer Biomarkers Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland., Singal AG; Division of Digestive and Liver Disease, UT Southwestern, Dallas, Texas; (10)Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, Pennsylvania., Reddy KR; Biostatistics Program, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washinton., Marrero JA; Biostatistics Program, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, Washinton. Electronic address: jorge.marrero@pennmedicine.upenn.edu.
Jazyk:	angličtina
Zdroj:	Gastroenterology [Gastroenterology] 2024 Sep 16. Date of Electronic Publication: 2024 Sep 16.
DOI:	10.1053/j.gastro.2024.09.008
Abstrakt:	Background & Aims: Better surveillance tests for hepatocellular carcinoma (HCC) are needed. The GALAD score (gender, age, α-fetoprotein [AFP] L3, AFP, and des carboxyprothrombin) has been shown to have excellent sensitivity and specificity for HCC in phase 2 studies. We performed a phase 3 biomarker validation study to compare GALAD with AFP in detecting HCC. Methods: This is a prospective study of patients with cirrhosis enrolled at 7 centers. Surveillance for HCC was performed every 6 months at each site, and HCC diagnosis was confirmed per American Association for the Study of Liver Diseases guidelines. Blood for biomarker research was obtained at each follow-up visit and stored in a biorepository. Measurements of AFP, AFP-L3, and des-γ carboxyprothrombin) were performed in a FujiFilm laboratory by staff blinded to clinical data. The performance of GALAD in detecting HCC was retrospectively evaluated within 12 months before the clinical diagnosis. All analyses were conducted by an unblinded statistician in the EDRN data management and coordinating center. Results: A total of 1,558 patients with cirrhosis were enrolled and followed for a median of 2.2 years. A total of 109 patients developed HCC (76 very early or early stage), with an annual incident rate of 2.4%. The areas under the curve for AFP and GALAD within 12 months before HCC were 0.66 and 0.78 (P < .001), respectively. Using a cutoff for GALAD of -1.36, the specificity was 82%, and the sensitivity at 12 months before HCC diagnosis was 62%. For comparison, performance of AFP at 82% specificity showed 41% sensitivity at 12 months before HCC diagnosis (P = .001). Conclusions: GALAD score, compared to AFP, improves the detection of HCC within 12 months before the actual diagnosis. (Copyright © 2024 AGA Institute. All rights reserved.)
Databáze:	MEDLINE
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