DR‐70 immunoassay for the surveillance of hepatocellular carcinoma

Background and Aim:  Although alpha-fetoprotein (AFP) is a widely used serological marker for hepatocellular carcinoma (HCC), its utility is limited due to its unsatisfactory sensitivity. Meanwhile, a newly developed immunoassay—DR-70—has been reported to have a good sensitivity for HCC in a small-scale study. The aim of this study was to determine the clinical value of DR-70 for the surveillance of HCC. Methods:  Serum levels of DR-70 and AFP were measured in 103 patients with HCC, 50 healthy volunteers, and 33 patients with chronic liver disease. In addition, we investigated the prognostic value of DR-70 in patients with HCC correlating with the clinical staging—Cancer of the Liver Italian Program (CLIP) score and Barcelona Clinic Liver Cancer (BCLC) classification. Results:  Based on the receiver operating characteristic curve with area under the curve of 0.836, the DR-70 cut-off value for detecting HCC was determined to be 0.75 µg/mL. DR-70 provided a sensitivity of 81.6% and a specificity of 77.1%, and correlated well with the CLIP score and BCLC classification. The combination of DR-70 and AFP increased the sensitivity to 91.2%. The prognosis for patients with HCC with DR-70 level > 0.75 µg/mL was worse than that for those with DR-70 ≤ 0.75 µg/mL. Among the patients with early stage HCC (CLIP score 0–2), DR-70 > 0.75 µg/mL independently predicted a poor survival. Conclusions:  DR-70 immunoassay is complementary to AFP for the detection of HCC and has a good correlation with clinical staging and prognosis.