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.