Clinical Utility of Des-γ-Carboxy Prothrombin (DCP) as a Biomarker for Hepatocellular Carcinoma (HCC)
Year: 2006
Type: article
Study design: Observational Study
Abstract: Purpose: HCC is a significant cause of morbidity in pts with chronic liver disease. Biomarkers such as alpha fetoprotein (AFP) are limited by their low sensitivity and specificity. DCP is a novel tumor marker for HCC. However, there are limited prospective data on its clinical utility. Methods: This prospective study enrolled 494 pts from 7 sites with chronic HCV or HBV with either newly diagnosed HCC (N = 54) or at risk for HCC by virtue of having either liver cirrhosis (LC) or chronic hepatitis (CH), N = 440. Pts were monitored throughout the study with imaging and DCP measurements every 3 months and followed for at least 21 months. The primary endpoint was the development of HCC based on histology or accepted imaging criteria. Pts without HCC at entry were classified into 2 groups for analysis: (i) HCC developing during the study, and (ii) LC/CH without evidence of HCC. Pts with less than 21 months of follow up and an abnormal DCP were not included in this analysis (N = 124). Results: 316 pts (mean age 52.2, 71.8% male, 76.3% LC, 69.0% from HCV, 8.9% had HBV and 22.2% had HCV and HBV) were analyzed. During the study, 39 pts developed HCC while 401 did not (annual incidence of 5%). A positive DCP was determined by the optimum cut off of 7.5 ng/mL obtained from ROC analysis. During the study, 14.2% had a positive DCP. The incidence of HCC in those with a positive DCP was 42.2% compared to 7.4% in those with DCP < 7.5 ng/mL. Thus, the relative risk of having HCC in pts with a positive DCP was 5.7. The sensitivity, specificity, positive predictive value, and negative predictive value (NPV) were 48.7%, 90.6%, 42.2%, and 92.6% respectively. Conclusions: Those with an elevated DCP have a higher incidence of HCC compared to those who do not. The high specificity (90.6%) and NPV (92.6) suggest that DCP may have additional clinical utility in managing pts at risk for HCC. Future analyses are needed on the value of DCP alone or in combination with AFP and AFP-L3%.
Language: English
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,390
OpenAlex ID: W2978452299