α-Fetoprotein, Des-γ Carboxyprothrombin, and Lectin-Bound α-Fetoprotein in Early Hepatocellular Carcinoma

Jorge A. Marrero, Ziding Feng, Yinghui Wang, Mindie H. Nguyen, Alex S. Befeler, Lewis R. Roberts, K. Rajender Reddy, Denise Harnois, Josep M. Llovet, Daniel Normolle, Jackie Dalhgren, David Chia, Anna S. Lok, Paul D. Wagner, Sudhir Srivastava, Myron Schwartz

Research output: Contribution to journalArticle

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Abstract

Background & Aims: α-Fetoprotein (AFP) is widely used as a surveillance test for hepatocellular carcinoma (HCC) among patients with cirrhosis. Des-γ carboxy-prothrombin (DCP) and lectin-bound AFP (AFP-L3%) are potential surveillance tests for HCC. The aims of this study were to determine performance of DCP and AFP-L3% for the diagnosis of early HCC; whether they complement AFP; and what factors affect DCP, AFP-L3%, or AFP levels. Methods: We conducted a large phase 2 biomarker case-control study in 7 academic medical centers in the United States. Controls were patients with compensated cirrhosis and cases were patients with HCC. AFP, DCP, and AFP-L3% levels were measured blinded to clinical data in a central reference laboratory. Results: A total of 836 patients were enrolled: 417 (50%) were cirrhosis controls and 419 (50%) were HCC cases, of which 208 (49.6%) had early stage HCC (n = 77 very early, n = 131 early). AFP had the best area under the receiver operating characteristic curve (0.80, 95% confidence interval [CI]: 0.77-0.84), followed by DCP (0.72, 95% CI: 0.68-0.77) and AFP-L3% (0.66, 95% CI: 0.62-0.70) for early stage HCC. The optimal AFP cutoff value was 10.9 ng/mL leading to a sensitivity of 66%. When only those with very early HCC were evaluated, the area under the receiver operating characteristic curve for AFP was 0.78 (95% CI: 0.72-0.85) leading to a sensitivity of 65% at the same cutoff. Conclusions: AFP was more sensitive than DCP and AFP-L3% for the diagnosis of early and very early stage HCC at a new cutoff of 10.9 ng/mL.

Original languageEnglish (US)
Pages (from-to)110-118
Number of pages9
JournalGastroenterology
Volume137
Issue number1
DOIs
StatePublished - Jul 2009

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Fetal Proteins
Lectins
Hepatocellular Carcinoma
Prothrombin
Confidence Intervals
Fibrosis
ROC Curve

ASJC Scopus subject areas

  • Gastroenterology

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α-Fetoprotein, Des-γ Carboxyprothrombin, and Lectin-Bound α-Fetoprotein in Early Hepatocellular Carcinoma. / Marrero, Jorge A.; Feng, Ziding; Wang, Yinghui; Nguyen, Mindie H.; Befeler, Alex S.; Roberts, Lewis R.; Reddy, K. Rajender; Harnois, Denise; Llovet, Josep M.; Normolle, Daniel; Dalhgren, Jackie; Chia, David; Lok, Anna S.; Wagner, Paul D.; Srivastava, Sudhir; Schwartz, Myron.

In: Gastroenterology, Vol. 137, No. 1, 07.2009, p. 110-118.

Research output: Contribution to journalArticle

Marrero, JA, Feng, Z, Wang, Y, Nguyen, MH, Befeler, AS, Roberts, LR, Reddy, KR, Harnois, D, Llovet, JM, Normolle, D, Dalhgren, J, Chia, D, Lok, AS, Wagner, PD, Srivastava, S & Schwartz, M 2009, 'α-Fetoprotein, Des-γ Carboxyprothrombin, and Lectin-Bound α-Fetoprotein in Early Hepatocellular Carcinoma', Gastroenterology, vol. 137, no. 1, pp. 110-118. https://doi.org/10.1053/j.gastro.2009.04.005
Marrero, Jorge A. ; Feng, Ziding ; Wang, Yinghui ; Nguyen, Mindie H. ; Befeler, Alex S. ; Roberts, Lewis R. ; Reddy, K. Rajender ; Harnois, Denise ; Llovet, Josep M. ; Normolle, Daniel ; Dalhgren, Jackie ; Chia, David ; Lok, Anna S. ; Wagner, Paul D. ; Srivastava, Sudhir ; Schwartz, Myron. / α-Fetoprotein, Des-γ Carboxyprothrombin, and Lectin-Bound α-Fetoprotein in Early Hepatocellular Carcinoma. In: Gastroenterology. 2009 ; Vol. 137, No. 1. pp. 110-118.
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abstract = "Background & Aims: α-Fetoprotein (AFP) is widely used as a surveillance test for hepatocellular carcinoma (HCC) among patients with cirrhosis. Des-γ carboxy-prothrombin (DCP) and lectin-bound AFP (AFP-L3{\%}) are potential surveillance tests for HCC. The aims of this study were to determine performance of DCP and AFP-L3{\%} for the diagnosis of early HCC; whether they complement AFP; and what factors affect DCP, AFP-L3{\%}, or AFP levels. Methods: We conducted a large phase 2 biomarker case-control study in 7 academic medical centers in the United States. Controls were patients with compensated cirrhosis and cases were patients with HCC. AFP, DCP, and AFP-L3{\%} levels were measured blinded to clinical data in a central reference laboratory. Results: A total of 836 patients were enrolled: 417 (50{\%}) were cirrhosis controls and 419 (50{\%}) were HCC cases, of which 208 (49.6{\%}) had early stage HCC (n = 77 very early, n = 131 early). AFP had the best area under the receiver operating characteristic curve (0.80, 95{\%} confidence interval [CI]: 0.77-0.84), followed by DCP (0.72, 95{\%} CI: 0.68-0.77) and AFP-L3{\%} (0.66, 95{\%} CI: 0.62-0.70) for early stage HCC. The optimal AFP cutoff value was 10.9 ng/mL leading to a sensitivity of 66{\%}. When only those with very early HCC were evaluated, the area under the receiver operating characteristic curve for AFP was 0.78 (95{\%} CI: 0.72-0.85) leading to a sensitivity of 65{\%} at the same cutoff. Conclusions: AFP was more sensitive than DCP and AFP-L3{\%} for the diagnosis of early and very early stage HCC at a new cutoff of 10.9 ng/mL.",
author = "Marrero, {Jorge A.} and Ziding Feng and Yinghui Wang and Nguyen, {Mindie H.} and Befeler, {Alex S.} and Roberts, {Lewis R.} and Reddy, {K. Rajender} and Denise Harnois and Llovet, {Josep M.} and Daniel Normolle and Jackie Dalhgren and David Chia and Lok, {Anna S.} and Wagner, {Paul D.} and Sudhir Srivastava and Myron Schwartz",
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T1 - α-Fetoprotein, Des-γ Carboxyprothrombin, and Lectin-Bound α-Fetoprotein in Early Hepatocellular Carcinoma

AU - Marrero, Jorge A.

AU - Feng, Ziding

AU - Wang, Yinghui

AU - Nguyen, Mindie H.

AU - Befeler, Alex S.

AU - Roberts, Lewis R.

AU - Reddy, K. Rajender

AU - Harnois, Denise

AU - Llovet, Josep M.

AU - Normolle, Daniel

AU - Dalhgren, Jackie

AU - Chia, David

AU - Lok, Anna S.

AU - Wagner, Paul D.

AU - Srivastava, Sudhir

AU - Schwartz, Myron

PY - 2009/7

Y1 - 2009/7

N2 - Background & Aims: α-Fetoprotein (AFP) is widely used as a surveillance test for hepatocellular carcinoma (HCC) among patients with cirrhosis. Des-γ carboxy-prothrombin (DCP) and lectin-bound AFP (AFP-L3%) are potential surveillance tests for HCC. The aims of this study were to determine performance of DCP and AFP-L3% for the diagnosis of early HCC; whether they complement AFP; and what factors affect DCP, AFP-L3%, or AFP levels. Methods: We conducted a large phase 2 biomarker case-control study in 7 academic medical centers in the United States. Controls were patients with compensated cirrhosis and cases were patients with HCC. AFP, DCP, and AFP-L3% levels were measured blinded to clinical data in a central reference laboratory. Results: A total of 836 patients were enrolled: 417 (50%) were cirrhosis controls and 419 (50%) were HCC cases, of which 208 (49.6%) had early stage HCC (n = 77 very early, n = 131 early). AFP had the best area under the receiver operating characteristic curve (0.80, 95% confidence interval [CI]: 0.77-0.84), followed by DCP (0.72, 95% CI: 0.68-0.77) and AFP-L3% (0.66, 95% CI: 0.62-0.70) for early stage HCC. The optimal AFP cutoff value was 10.9 ng/mL leading to a sensitivity of 66%. When only those with very early HCC were evaluated, the area under the receiver operating characteristic curve for AFP was 0.78 (95% CI: 0.72-0.85) leading to a sensitivity of 65% at the same cutoff. Conclusions: AFP was more sensitive than DCP and AFP-L3% for the diagnosis of early and very early stage HCC at a new cutoff of 10.9 ng/mL.

AB - Background & Aims: α-Fetoprotein (AFP) is widely used as a surveillance test for hepatocellular carcinoma (HCC) among patients with cirrhosis. Des-γ carboxy-prothrombin (DCP) and lectin-bound AFP (AFP-L3%) are potential surveillance tests for HCC. The aims of this study were to determine performance of DCP and AFP-L3% for the diagnosis of early HCC; whether they complement AFP; and what factors affect DCP, AFP-L3%, or AFP levels. Methods: We conducted a large phase 2 biomarker case-control study in 7 academic medical centers in the United States. Controls were patients with compensated cirrhosis and cases were patients with HCC. AFP, DCP, and AFP-L3% levels were measured blinded to clinical data in a central reference laboratory. Results: A total of 836 patients were enrolled: 417 (50%) were cirrhosis controls and 419 (50%) were HCC cases, of which 208 (49.6%) had early stage HCC (n = 77 very early, n = 131 early). AFP had the best area under the receiver operating characteristic curve (0.80, 95% confidence interval [CI]: 0.77-0.84), followed by DCP (0.72, 95% CI: 0.68-0.77) and AFP-L3% (0.66, 95% CI: 0.62-0.70) for early stage HCC. The optimal AFP cutoff value was 10.9 ng/mL leading to a sensitivity of 66%. When only those with very early HCC were evaluated, the area under the receiver operating characteristic curve for AFP was 0.78 (95% CI: 0.72-0.85) leading to a sensitivity of 65% at the same cutoff. Conclusions: AFP was more sensitive than DCP and AFP-L3% for the diagnosis of early and very early stage HCC at a new cutoff of 10.9 ng/mL.

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