Performance of SPINK1 and SPINK1-based diagnostic model in detection of hepatocellular carcinoma.

OBJECTIVES To identify the SPINK1 or SPINK1-based model as a more reliable biomarker for the diagnosis of hepatocellular carcinoma (HCC). METHODS Serum samples and related laboratory parameters were collected from 540 subjects (119 healthy donors, 113 patients with chronic hepatitis B, 122 patients with liver cirrhosis, and 186 patients with HCC). SPINK1 was determined by ELISA assay. Differences in each variable were compared by one-way ANOVA or Kruskal-Wallis test. ROC (receiver operating characteristic) curve analysis was conducted to compare the diagnostic efficiency of alpha-fetoprotein (AFP), SPINK1, and a SPINK1-based combine model constructed by binary Logistic regression. RESULTS In detecting HCC using the other three groups as control, ROC curve analysis revealed that SPINK1 alone reached AUC of 0.899 (0.866-0.933), with the sensitivity of 0.812 of and specificity of 0.953. The combined model increased the AUC to 0.945 (0.926-0.964) with the sensitivity and specificity of 0.860 and 0.910, respectively. For AFP, significantly lower AUC (p < 0.0001) was shown, which was 0.695 (0.645-0.745) with the sensitivity and specificity of 0.634 and 0.718, respectively. In discriminating HCC from liver disease control, AUC of SPINK1 was 0.863(0.826-0.894), the sensitivity and specificity were 0.823 and 0.906, respectively. For combined model, the AUC, sensitivity, and specificity were 0.915 (0.884-0.940), 0.863, and 0.916, respectively. For detecting early-stage HCC, SPINK1 and combined model achieved the sensitivity of 0.788 and 0.818, respectively, much higher than AFP of 0.485 (p < 0.05); however, the difference between SPINK1 and combined model was not statistically significant (p = 1). CONCLUSION We provided solid evidence for SPINK1 as a robust serological tool for HCC diagnosis.