Original articlePancreas, biliary tract, and liverImproved Detection of Hepatocellular Carcinoma by Using a Longitudinal Alpha-Fetoprotein Screening Algorithm
Section snippets
Hepatitis C Antiviral Long-term Treatment against Cirrhosis Trial Design
The HALT-C trial enrolled patients with chronic hepatitis C in a randomized controlled trial in which the patients had to have at least stage 3 fibrosis (bridging fibrosis or cirrhosis) by the Ishak scoring system (range, 0–6) and a history of failure to respond to previous interferon-based therapy. All patients had radiologic imaging to exclude HCC before enrollment. The trial aimed to determine whether long-term low-dose pegylated interferon therapy was a safe and efficacious treatment in
Data Description
Of the 1050 patients in the HALT-C trial, 1048 patients with HCC outcome data and serial AFP measurements were included in this analysis. On the basis of the baseline biopsy, 427 were diagnosed with cirrhosis and 621 with advanced fibrosis. Among patients with cirrhosis at baseline biopsy, 361 had more than 12 months of follow-up from enrollment and were not diagnosed with HCC during a median follow-up period of 78 months (range, 15–109 months), and 48 had confirmed HCC during study follow-up.
Discussion
By using data from the HALT-C trial, a large prospective trial involving more than 1000 patients with advanced fibrosis or cirrhosis caused by chronic hepatitis C infection who were followed for a median of 80 months, we observed statistically significant gains in the sensitivity of AFP when serial biomarker measurements were incorporated into the screening algorithm. In this study, we found that when specificity at the screening level was set at 90%, ie, FPR of 10%, the PEB algorithm increased
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Conflicts of interest This author discloses the following: Anna S. F. Lok was one of the HALT-C investigators. The remaining authors disclose no conflicts.
Funding Kim-Anh Do and Ziding Feng are partially supported by a Cancer Center Support Grant (NCI grant P30CA016672). Ziding Feng is partially supported by EDRN grant (NCI grant U24086368). Nabihah Tayob is partially supported by start-up and incentive funds to Kim-Anh Do and Ziding Feng.