A randomized controlled trial of US vs US + biomarkers for the diagnosis of hepatocellular carcinoma: an interim report

Sherman, Matthew L.; Feld, J.; Yamada, Hiroyuki; Mori, Y.; Janssen, H.

doi:10.1016/s0168-8278(17)30288-x

Cited by 7 publications

(6 citation statements)

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“…A recent interim report of a randomized controlled trial (ultrasound þ biomarker vs. ultrasound alone) showed that addition of three biomarkers (AFP, AFP-L3%, and DCP) increased the sensitivity of HCC surveillance in comparison with ultrasound alone, although number of new HCC cases was small (n ¼ 20; ref. 31). Similarly, an interim analysis of a small phase III biomarker study showed that a GALAD score >1.95 had a sensitivity of 90% 6 months prior to HCC diagnosis.…”

Section: Discussionmentioning

confidence: 94%

GALAD Score for Hepatocellular Carcinoma Detection in Comparison with Liver Ultrasound and Proposal of GALADUS Score

Yang

Addissie

Mara

et al. 2019

Cancer Epidemiology, Biomarkers &Amp; Prevention

156

153

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Background: The GALAD score is a serum biomarkerbased model that predicts the probability of having hepatocellular carcinoma (HCC) in patients with chronic liver disease. We aimed to assess the performance of the GALAD score in comparison with liver ultrasound for detection of HCC.Methods: A single-center cohort of 111 HCC patients and 180 controls with cirrhosis or chronic hepatitis B and a multicenter cohort of 233 early HCC and 412 cirrhosis patients from the Early Detection Research Network (EDRN) phase II HCC Study were analyzed.Results: The area under the ROC curve (AUC) of the GALAD score for HCC detection was 0.95 [95% confidence interval (CI), 0.93-97], which was higher than the AUC of ultrasound (0.82, P <0.01). At a cutoff of À0.76, the GALAD score had a sensitivity of 91% and a specificity of 85% for HCC detection. The AUC of the GALAD score for early-stage HCC detection remained high at 0.92 (95% CI, 0.88-0.96; cutoff À1.18, sensitivity 92%, specificity 79%). The AUC of the GALAD score for HCC detection was 0.88 (95% CI, 0.85-0.91) in the EDRN cohort. The combination of GALAD and ultrasound (GALADUS score) further improved the performance of the GALAD score in the single-center cohort, achieving an AUC of 0.98 (95% CI, 0.96-0.99; cutoff À0.18, sensitivity 95%, specificity 91%). a For the calculation of AUC, the continuous GALAD score is used, whereas for sensitivity and specificity, we used the GALAD cutoff. b P value looking at difference in AUC between GALAD and ultrasound.Yang et al.

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Section: Discussionmentioning

confidence: 94%

GALAD Score for Hepatocellular Carcinoma Detection in Comparison with Liver Ultrasound and Proposal of GALADUS Score

Yang

Addissie

Mara

et al. 2019

Cancer Epidemiology, Biomarkers &Amp; Prevention

156

153

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“…Two other phase 3/4 biomarker studies are currently under way in patients with cirrhosis and mostly with HCV infection. According to their interim analysis, the use of serum biomarkers resulted in a considerable improvement in sensitivity for HCC detection at an early stage, despite increasing the false‐positive rate …”

Section: Discussionmentioning

confidence: 99%

Longitudinal Assessment of Three Serum Biomarkers to Detect Very Early‐Stage Hepatocellular Carcinoma

et al. 2019

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“…Two markers that received much attention are a glycoform of AFP, lectin-binding AFP-3 (AFP-L3), and des-gamma-carboxyprothrombin (DCP), also known as prothrombin induced by vitamin K absence-II (PIVKA-II), which is a non-functional protein produced by HCC. A randomized controlled trial evaluating HCC surveillance through ultrasound with or without AFP, AFP-L3 and DCP has demonstrated that the association of these biomarkers with ultrasound increases sensitivity while decreasing specificity [ 19 ]. In another study in which samples from four prospective Korean cohorts were analyzed, AFP performed better than AFP-L3 and DCP up to 12 months prior to the diagnosis of HCC.…”

Section: Protein Biomarkersmentioning

confidence: 99%

Serum Biomarkers for the Prediction of Hepatocellular Carcinoma

Debes

Romagnoli²,

Prieto³

et al. 2021

Cancers

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Hepatocellular carcinoma (HCC) is a leading cause of global cancer death. Major etiologies of HCC relate to chronic viral infections as well as metabolic conditions. The survival rate of people with HCC is very low and has been attributed to late diagnosis with limited treatment options. Combining ultrasound and the biomarker alpha-fetoprotein (AFP) is currently one of the most widely used screening combinations for HCC. However, the clinical utility of AFP is controversial, and the frequency and operator-dependence of ultrasound lead to a variable degree of sensitivity and specificity across the globe. In this review, we summarize recent developments in the search for non-invasive serum biomarkers for early detection of HCC to improve prognosis and outcome for patients. We focus on tumor-associated protein markers, immune mediators (cytokines and chemokines), and micro-RNAs in serum or circulating extracellular vesicles and examine their potential for clinical application.

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A randomized controlled trial of US vs US + biomarkers for the diagnosis of hepatocellular carcinoma: an interim report

Cited by 7 publications

References 0 publications

GALAD Score for Hepatocellular Carcinoma Detection in Comparison with Liver Ultrasound and Proposal of GALADUS Score

GALAD Score for Hepatocellular Carcinoma Detection in Comparison with Liver Ultrasound and Proposal of GALADUS Score

Longitudinal Assessment of Three Serum Biomarkers to Detect Very Early‐Stage Hepatocellular Carcinoma

Serum Biomarkers for the Prediction of Hepatocellular Carcinoma

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