Inadequate evidence on screening with alpha-fetoprotein and/or ultrasound of the liver for patients with chronic hepatitis B

Wun YT, Dickinson JA

Published Online:

January 21, 2009

There is inadequate evidence to decide whether screening for liver cancer with alpha-fetoprotein and/or ultrasound of the liver compared to no screening is beneficial to patients infected with the hepatitis B virus. Only two randomised trials could be included. One trial compared bi-annual screening with alpha-fetoprotein plus ultrasound against no screening for five years. More liver cancers were detected in the screened group, but the two groups did not differ significantly regarding liver cancer mortality. Another trial compared alpha-fetoprotein plus ultrasound screening against alpha-fetoprotein screening. This trial, with an inadequate sample size, showed no significant difference between the groups regarding number of cancers detected.

Abstract (click to read)

Background:

Chronic hepatitis B infection may cause liver cancer (hepatocellular carcinoma (HCC)). Alpha-fetoprotein (AFP) and liver ultrasonography (US) are used to screen these patients for HCC. It is uncertain whether screening is worthwhile.

Objectives:

To review randomised trials on screening for HCC with alpha-fetoprotein and/or liver ultrasonography among people with hepatitis B surface antigen (HBsAg) whether asymptomatic or with clinical liver disease.

Search strategy:

Relevant reports were searched from electronic databases until August 2002 (The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Controlled Trials Register, MEDLINE, EMBASE, HealthStar, and the Chinese Medical Literature Electronic Databases, MedCyber) supplemented with manual searches on the bibliographies of papers found and communication to people familiar with chronic hepatitis B.

Selection criteria:

Randomised trials on screening for liver cancer were included irrespective of language. Studies were excluded if the hepatitis B status was uncertain, if patients were not adequately followed, if the screening tests were not sensitive, widely-used ones, or if the test was used for diagnosis rather than screening for HCC.

Data collection and analysis:

We analysed independently all the studies considered for inclusion. We wrote to the relevant authors for further information. Data were analysed with Peto's odds ratio (OR) with 95% confidence interval (CI).

Main results:

Two trials met the selection criteria. One trial (n = 18,816) compared bi-annual AFP plus US screening with no screening for five years. No data on all-cause mortality were available. The two groups did not differ significantly regarding HCC mortality (OR 0.81; 95% CI 0.54 to 1.22). Number of patients with HCC was significantly increased in the screened group (OR 1.37; 95% CI 1.00 to 1.88). Most HCCs in the screened group, but none in the control group, were at an early stage. The survival rate of patients with resected HCC in the screened group reached 52.7% after three and five years, but was 0% for those in the control group. The authors' estimated lead-time for HCC was 5.4 months, suggesting that screening prolonged the survival of HCC. Another trial (n = 1069) compared AFP plus US versus AFP screening, but could not decide which approach was superior due to the small sample size (number of detected HCC: OR 0.74; 95% CI 0.26 to 2.12).

Authors' conclusions:

There are not enough quality trials to support or refute screening of HBsAg-positive patients for HCC. It is possible that screening may be effective, but also that harm caused by screening/treatment may outweigh any gain. More and better-designed large randomised trials are required.

This record should be cited as:

Wun YT, Dickinson JA. Alpha-fetoprotein and/or liver ultrasonography for liver cancer screening in patients with chronic hepatitis B. Cochrane Database of Systematic Reviews 2003, Issue 2. Art. No.: CD002799. DOI: 10.1002/14651858.CD002799

Assessed as up to date:

November 23, 2002

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Primary Review Group:

Hepato-Biliary Group

Cochrane Summaries^beta

Independent high-quality evidence for health care decision making

Inadequate evidence on screening with alpha-fetoprotein and/or ultrasound of the liver for patients with chronic hepatitis B

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