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Abstract Details
Validation of the Updated Hepatocellular Carcinoma Early Detection Screening Algorithm in a Community-Based Cohort of Patients With Cirrhosis of Multiple Etiologies
Clin Gastroenterol Hepatol. 2021 Jul;19(7):1443-1450.e6. doi: 10.1016/j.cgh.2020.07.065.Epub 2020 Aug 5.
Nabihah Tayob1, Douglas A Corley2, Israel Christie3, Lucy Almers2, Ahmed K Rahal4, Peter Richardson3, Donna L White3, Jessica Davila3, Fasiha Kanwal3, Hashem B El-Serag5
Author information
1Department of Data Sciences, Dana-Farber Cancer Institute, Boston, Massachusetts; Department of Medicine, Harvard Medical School, Boston, Massachusetts.
2Kaiser Permanente, Northern California, San Francisco Medical Center, San Francisco, California; Division of Research, Oakland, California.
3Houston VA Health Services Research and Development Service Center of Excellence, Houston, Texas; Section of Health Services Research, Michael E. DeBakey VA Medical Center, Houston, Texas; Department of Medicine, Baylor College of Medicine, Houston, Texas.
4Department of Medicine, Baylor College of Medicine, Houston, Texas.
5Houston VA Health Services Research and Development Service Center of Excellence, Houston, Texas; Section of Health Services Research, Michael E. DeBakey VA Medical Center, Houston, Texas; Department of Medicine, Baylor College of Medicine, Houston, Texas.
Background & aims: The Hepatocellular carcinoma (HCC) Early detection Screening (HES) algorithm has been proposed to improve the performance of the serum alpha-fetoprotein (AFP) test in surveillance for HCC. The HES algorithm incorporates data on age, level of alanine aminotransferase, platelet count, and rate of AFP change to increase likelihood of earlier detection and thereby reduce HCC-related mortality. We updated the HES algorithm to include etiology of cirrhosis and validated it in a community-based cohort.
Methods: We collected data from the Veterans Health Administration, from 2010 through 2015, on etiologies for HCC, including hepatitis C, hepatitis B, alcoholic liver disease, and non-alcoholic fatty liver disease. We used these data to update the HES algorithm and tested its accuracy using data from patients with cirrhosis in the Kaiser Permanente Northern California healthcare system (validation cohort).
Results: Among the 7432 patients with cirrhosis in the validation cohort, 1102 were diagnosed with HCC during a median follow-up time of 3.21 years; 709 patients had early-stage HCC. The HES algorithm identified patients who would receive a diagnosis of early-stage HCC within the next 6 months with 51.20% sensitivity and 90.00% specificity, compared with 46.02% sensitivity for the AFP test alone (5.18% absolute improvement; P = .0015). In HCC screening, a positive result from HES or AFP test leads to follow-up evaluation with more sensitive imaging methods. The number of early-stage HCC cases detected per 1000 imaging analyses were 136.46 with the HES algorithm vs 118.01 with the AFP test alone (P < .0005). The HES algorithm identified 56.00% of patients with HCC in the 6 months before their diagnosis despite no detection of nodules by surveillance ultrasound; the AFP test identified only 50.00% of these patients.
Conclusions: We validated the HES algorithm using data from a diverse community-based cohort of patients with cirrhosis. The algorithm offers a modest but useful advantage over the AFP test alone in detection of early-stage HCC with virtually no added cost.