Abstract
BackgroundThe biomarkers alpha-fetoprotein (AFP) and protein induced by vitamin K absence/antagonist-II (PIVKA-II) may be useful for detecting early-stage hepatocellular carcinoma (HCC). We evaluated the performance of AFP and PIVKA-II levels, alone and in combination with clinical factors, for the early detection of HCC.MethodsIn a case–control study, serum AFP and PIVKA-II were measured using the ARCHITECT immunoassay analyzer system in a cohort of 119 patients with HCC, 215 patients with non-malignant liver disease, and 34 healthy subjects. Five predictive models for detecting HCC were developed based on age, gender, AFP, and/or PIVKA-II levels; the best model was validated in an independent cohort of 416 patients with HCC and 412 control subjects with cirrhosis.ResultsIn both cohorts, AFP and PIVKA-II concentrations were higher in patients with HCC compared to healthy controls and patients with non-malignant liver disease. The model that combined AFP and PIVKA-II, age, and gender had the highest AUC of 0.95 (0.95, 95% CI 0.93–0.98), with a sensitivity of 93% and a specificity of 84% in the development cohort, and an AUC of 0.87 (95% CI 0.85–0.90), sensitivity of 74%, and specificity of 85% in the validation cohort. When limiting the validation cohort to only early-stage HCC, the AUC was 0.85 (95% CI 0.81–0.88), sensitivity was 70%, and specificity was 86%.ConclusionsCompared to each biomarker alone, the combination of AFP and PIVKA-II with age and gender improved the accuracy of detecting HCC and differentiating HCC from non-malignant liver disease.
Highlights
The biomarkers alpha-fetoprotein (AFP) and protein induced by vitamin K absence/antagonist-II (PIVKA-II) may be useful for detecting early-stage hepatocellular carcinoma (HCC)
The biomarkers protein induced by vitamin K absence/ antagonist-II (PIVKA-II), known as des-gamma carboxyprothrombin (DCP), and AFP-L3, a glycosylated form of AFP that is more specific to liver cancer, have been investigated as additional HCC biomarkers
We further evaluated the performance of the ARCHITECT AFP and PIVKA-II assays, alone and in combination with clinical factors, for the detection of HCC in populations of patients with HCC in the US, including those with early-stage HCC and non-malignant liver disease
Summary
The biomarkers alpha-fetoprotein (AFP) and protein induced by vitamin K absence/antagonist-II (PIVKA-II) may be useful for detecting early-stage hepatocellular carcinoma (HCC). We evaluated the performance of AFP and PIVKA-II levels, alone and in combination with clinical factors, for the early detection of HCC. The 5-year survival rate is approximately 3% in patients with metastatic HCC [3], compared to 31% in patients with localized disease [2]. Surveillance primarily involves imaging, most commonly by ultrasound with or without alpha-fetoprotein (AFP) every 6 months, as recommended by the recent guidelines from the American Association for the Study of Liver Diseases (AASLD) [2, 4]. Early diagnosis of HCC by ultrasound alone is complicated by underlying cirrhosis and may increase the potential harms of surveillance, with low sensitivity and a high false negative
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
