TY - JOUR
T1 - Des-γ-Carboxy Prothrombin and α-Fetoprotein as Biomarkers for the Early Detection of Hepatocellular Carcinoma
AU - Lok, Anna S.
AU - Sterling, Richard K.
AU - Everhart, James E.
AU - Wright, Elizabeth C.
AU - Hoefs, John C.
AU - Di Bisceglie, Adrian M.
AU - Morgan, Timothy R.
AU - Kim, Hae Young
AU - Lee, William M.
AU - Bonkovsky, Herbert L.
AU - Dienstag, Jules L.
N1 - Funding Information:
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.
Funding Information:
Massachusetts General Hospital, Boston, MA: (contract N01-DK-9-2319, grant M01RR-01066 , grant 1 UL1 RR025758-01 , Harvard Clinical and Translational Science Center) Raymond T. Chung, MD; Andrea E. Reid, MD; Atul K. Bhan, MD; Wallis A. Molchen; Cara C. Gooch.
Funding Information:
University of Colorado School of Medicine, Denver, CO: (contract N01-DK-9-2327, grant M01RR-00051 , grant 1 UL1 RR 025780-01 ) Gregory T. Everson, MD; S. Russell Nash, MD; Jennifer DeSanto, RN; Carol McKinley, RN.
Funding Information:
University of California-Irvine, Irvine, CA: (contract N01-DK-9-2320, grant M01RR-00827 ) John R. Craig, MD; M. Mazen Jamal, MD, MPH; Muhammad Sheikh, MD; Choon Park, RN.
Funding Information:
University of Texas Southwestern Medical Center, Dallas, TX: (contract N01-DK-9-2321, grant M01RR-00633 , grant 1 UL1 RR024982-01 , North and Central Texas Clinical and Translational Science Initiative) Thomas E. Rogers, MD; Peter F. Malet, MD; Janel Shelton; Nicole Crowder, LVN; Rivka Elbein, RN, BSN; Nancy Liston, MPH.
PY - 2010/2
Y1 - 2010/2
N2 - Background & Aims: The outcome of patients with hepatocellular carcinoma (HCC) remains poor because of late diagnosis. The aim of this study was to compare the accuracy of α-fetoprotein (AFP) and des-γ-carboxy prothrombin (DCP) in the early diagnosis of HCC. Methods: Among 1031 patients randomized in the Hepatitis C Antiviral Long-term Treatment Against Cirrhosis (HALT-C) Trial, a nested case-control study of 39 HCC cases (24 early stage) and 77 matched controls was conducted to compare the performance of AFP and DCP. Testing was performed on sera from 12 months prior (month -12) to the time of HCC diagnosis (month 0). Results: The sensitivity and specificity of DCP at month 0 was 74% and 86%, respectively, at a cutoff of 40 mAU/mL and 43% and 100%, respectively, at a cutoff of 150 mAU/mL. The sensitivity and specificity of AFP at month 0 was 61% and 81% at a cutoff of 20 ng/mL and 22% and 100% at a cutoff of 200 ng/mL. At month -12, the sensitivity and specificity at the low cutoff was 43% and 94%, respectively, for DCP and 47% and 75%, respectively, for AFP. Combining both markers increased the sensitivity to 91% at month 0 and 73% at month 12, but the specificity decreased to 74% and 71%, respectively. Diagnosis of early HCC was triggered by surveillance ultrasound in 14, doubling of AFP in 5, and combination of tests in 5 patients. Conclusions: Biomarkers are needed to complement ultrasound in the detection of early HCC, but neither DCP nor AFP is optimal.
AB - Background & Aims: The outcome of patients with hepatocellular carcinoma (HCC) remains poor because of late diagnosis. The aim of this study was to compare the accuracy of α-fetoprotein (AFP) and des-γ-carboxy prothrombin (DCP) in the early diagnosis of HCC. Methods: Among 1031 patients randomized in the Hepatitis C Antiviral Long-term Treatment Against Cirrhosis (HALT-C) Trial, a nested case-control study of 39 HCC cases (24 early stage) and 77 matched controls was conducted to compare the performance of AFP and DCP. Testing was performed on sera from 12 months prior (month -12) to the time of HCC diagnosis (month 0). Results: The sensitivity and specificity of DCP at month 0 was 74% and 86%, respectively, at a cutoff of 40 mAU/mL and 43% and 100%, respectively, at a cutoff of 150 mAU/mL. The sensitivity and specificity of AFP at month 0 was 61% and 81% at a cutoff of 20 ng/mL and 22% and 100% at a cutoff of 200 ng/mL. At month -12, the sensitivity and specificity at the low cutoff was 43% and 94%, respectively, for DCP and 47% and 75%, respectively, for AFP. Combining both markers increased the sensitivity to 91% at month 0 and 73% at month 12, but the specificity decreased to 74% and 71%, respectively. Diagnosis of early HCC was triggered by surveillance ultrasound in 14, doubling of AFP in 5, and combination of tests in 5 patients. Conclusions: Biomarkers are needed to complement ultrasound in the detection of early HCC, but neither DCP nor AFP is optimal.
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U2 - 10.1053/j.gastro.2009.10.031
DO - 10.1053/j.gastro.2009.10.031
M3 - Article
C2 - 19852963
AN - SCOPUS:75449103932
SN - 0016-5085
VL - 138
SP - 493
EP - 502
JO - Gastroenterology
JF - Gastroenterology
IS - 2
ER -