Clinical Advances in Liver, Pancreas, and Biliary Tractα-Fetoprotein, Des-γ Carboxyprothrombin, and Lectin-Bound α-Fetoprotein in Early Hepatocellular Carcinoma
Section snippets
Study Design
We performed a large, EDRN-defined, phase 2 biomarker case-control study. Cases included consecutive adult patients with HCC seen between February 2005 and August 2007 at 7 medical centers in the United States (University of Michigan, Mayo Clinic-Minnesota, Mayo Clinic-Florida, Mt. Sinai Medical Center-New York, University of Pennsylvania, Saint Louis University, and Stanford University). Assays were performed at the University of California at Los Angeles in a blinded fashion to clinical data,
Patient Characteristics
A total of 859 patients were approached. Five cases and 18 controls were excluded because of the sample not being collected according to protocol or because they did not meet eligibility criteria. A total of 836 patients were included in this study, of which 417 (50%) were cirrhosis controls without HCC and 419 (50%) were HCC cases. Of the cases, 208 (49.6%) were considered early stage HCC: BCLC stage A (n = 131, 63%) and BCLC stage 0 (n = 77, 37%). The characteristics of these patients are
Discussion
In the largest study of biomarkers for the diagnosis of early stage HCC, we showed that AFP had a sensitivity of 66% and specificity of 81%, at a new cutoff of 10.9 ng/mL. AFP had the best AUC in tumors at the BCLC stage 0 and BCLC states A when compared with other markers. Importantly, AFP had the best performance of all the markers for BCLC stage 0 HCC, the detection of which is the main goal of a surveillance program.
AFP has been the most widely utilized serologic test for HCC. In a previous
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Conflicts of interest The authors disclose no conflicts.
Funding Supported by Early Detection Research Network of the National Cancer Institute (CA-084986), by grant DK064909 (to J.A.M), and by test kits provided by Wako Diagnostics and Eisai.