Objective: The authors performed a prospective trial to screen patients with chronic hepatitis B or C virus (HBV, HCV) infections to (1) determine the incidence of asymptomatic hepatocellular cancer and (2) identify the subgroups at highest risk to develop hepatocellular cancer.
Methods: Four hundred sixteen patients with chronic hepatitis of more than 5 years' duration were evaluated (340 HCV, 69 HBV, 7 both). All underwent hepatic ultrasound and measurement of serum alpha-fetoprotein every 3 months. Liver biopsy was performed on entry into the study to determine the severity of hepatitis-related liver injury.
Results: Initial screening identified asymptomatic hepatocellular cancer in 33 patients (7.9%). Three additional liver cancers were detected during the 1st year of follow-up, bringing the overall incidence to 8.6%. Treatment with curative intent was possible in 22 of these patients (61.1%), whereas 14 (38.9%) had advanced disease. Thirty-five of these hepatocellular cancers occurred in a subset of 140 patients (25% incidence) with liver biopsies showing severe chronic active hepatitis, cirrhosis, or both, and one hepatocellular cancer occurred among the 276 patients (0.4%) with histologically less severe liver injury (p < 0.0001, chi square test).
Conclusions: This screening study in patients with chronic HBV or HCV infection demonstrates (1) that the yield of asymptomatic hepatocellular cancer on initial screening is 7.9% and (2) that patients with severe chronic active hepatitis, cirrhosis, or both are at extremely high risk to develop hepatocellular cancer (25%). On the basis of these results and the finding of a significant number of small; treatable hepatocellular cancers (61.1%), the authors recommend hepatocellular cancer screening every 3 months for the subset of high-risk patients.