Serum Levels of Alpha Fetoprotein Increased More Than 10 Years Before Detection of Hepatocellular Carcinoma.

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Ultrasound (US)-based screening has been recommended for patients with an increased risk of hepatocellular Carcinoma (HCC). US analysis is, however, limited in patients who are obese or have small tumors. Addition of measurement of serum level of alpha-fetoprotein (AFP) to US analysis can increase detection of HCC. We analyzed data from patients with chronic liver disease, collected over 15 years in an HCC surveillance program, to develop a model to assess risk of HCC.We collected data from 3450 patients with chronic liver disease undergoing US surveillance in Japan from March 1998 through April 2014 and followed for a median 8.83 years. We performed longitudinal discriminant analysis of serial AFP measurements (median number of observations/patient, 56; approximate every 3 months) to develop a model to determine risk of HCC. We validated the model using data from 2 cohorts of patients with chronic liver disease in Japan (404 and 2754 patients) and 1 cohort in Scotland (1596 patients).HCC was detected in 413 patients (median tumor diameter, 1.8 cm), during a median follow-up time of 6.60 years. In the development dataset, the model identified patients who developed HCC with an area under the curve of 0.78; it correctly identified 74.3% of patients who did develop HCC, and 72.9% of patients who did not. Overall, 73.1% of patients were correctly classified. The model could be used to assign patients to a high-risk group (27.5 HCCs/1000 patient-years) vs a low-risk group (4.9 HCCs/1000 patient-years). Similar performance was observed when the model was used to assess patients with cirrhosis. Analysis of the validation cohorts produced similar results.We developed and validated a model to identify patients with chronic liver disease who are at risk for HCC based on change in serum level of AFP over time. The model could be used to assign patients to high-risk vs low-risk groups, and might be used to select patients for surveillance.

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