Clinical Advances in Liver, Pancreas, and Biliary TractDes-γ-Carboxy Prothrombin and α-Fetoprotein as Biomarkers for the Early Detection of Hepatocellular Carcinoma
Section snippets
HALT-C Trial Design, HCC Definition, and Surveillance
The design of the HALT-C Trial has been described previously.27, 28 All patients were required to have an ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI) with no evidence of hepatic mass lesions suspicious for HCC and a serum AFP <200 ng/mL prior to enrollment (except for 3 patients who had AFP values of 206, 212, and 315 ng/mL). Liver biopsy specimens were reviewed in conference by a panel of 12 hepatic pathologists, who used the Ishak scoring system to stage fibrosis
Baseline AFP and DCP Values of All Randomized Patients
Of the 1050 patients randomized, baseline AFP and/or DCP values were not available in 19. Thus, 1031 (98.2%) patients were included in this analysis. Baseline characteristics of these patients (39 HCC cases, 77 matched controls, and 915 other non-HCC patients) are shown in Table 1. The mean age of these 1031 patients was 50 years, 29% were women, and 18% were black. Cirrhosis was present on baseline biopsy specimens in 41% of patients. Half (49%) of the patients were randomized to maintenance
Discussion
This analysis took advantage of the large cohort of at-risk patients followed prospectively in the HALT-C Trial to compare the accuracy of AFP and DCP in the early detection of HCC and to determine factors that might affect the performance of these markers. The availability of samples before the diagnosis of HCC allowed for the comparison of the accuracy of AFP and DCP in differentiating HCC cases from matched controls before clinical diagnosis, an important feature in HCC surveillance. DCP had
Acknowledgments
This is publication No. 45 from the HALT-C Trial Group.
The HALT-C Trial is registered with clinicaltrials.gov (No. NCT00006164).
H.L.B.'s current address is Carolinas Medical Center, Charlotte, North Carolina.
In addition to the authors of this manuscript, the following individuals were instrumental in the planning, conduct, and/or care of patients enrolled in this study at each of the participating institutions as follows:
University of Massachusetts Medical Center, Worcester, MA: (contract
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Conflicts of interest The authors disclose the following:
Financial relationships of the authors with Hoffmann-La Roche, Inc., are as follows: A.S. Lok is a consultant; R.K. Sterling is a consultant, receives research support, and is on the speaker's bureau; J.C. Hoefs is on the speaker's bureau; T.R. Morgan is a consultant, on the speaker's bureau, and receives research support; A.M. Di Bisceglie is a consultant, on the speaker's bureau, and receives research support; W.M. Lee receives research support; and H.L. Bonkovsky receives research support. Financial relationships of the authors with Eisai Co, Ltd, are as follows: A.S. Lok receives research support. The remaining authors disclose no conflicts.
Funding Supported by the National Institute of Diabetes & Digestive & Kidney Diseases (contract numbers are listed below); the National Institute of Allergy and Infectious Diseases (NIAID); the National Cancer Institute; the National Center for Minority Health and Health Disparities; by General Clinical Research Center and Clinical and Translational Science Center grants from the National Center for Research Resources and National Institutes of Health (grant numbers are listed below); by Eisai Co, Ltd, through a Materials Cooperative Research and Development Agreement (M-CRADA) with the National Institutes of Health for testing of des-γ-carboxy prothrombin; and by Hoffmann–La Roche, Inc, through a Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health.
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