Diagnostic Performance of Serum <scp>AKR1B10</scp> in Early‐Stage and <scp>AFP</scp> ‐Negative Hepatocellular Carcinoma: A Multicentre Study

OBJECTIVE: Aldo-keto reductase 1B10 (AKR1B10) is overexpressed in hepatocellular carcinoma (HCC). This study aimed to evaluate its diagnostic efficacy for early and alpha-fetoprotein (AFP)-negative HCC, and its potential role in assessing radical resection and early recurrence. METHODS: A large-scale multicentre clinical study enrolled 1 352 subjects from three medical centres, including HCC, benign liver diseases, and non-hepatocyte cancers. Serum samples were collected for AKR1B10 and AFP testing, and clinical and imaging data were collected for analysis. RESULTS: Serum AKR1B10 markedly increased in HCC patients to 1419.51 ± 89.09 pg/mL, compared to 177.96 ± 9.78 pg/mL in healthy controls. Receiver operating characteristic (ROC) curve analysis showed that for HCC diagnosis, AKR1B10 had an Area under the curve (AUC) of 0.866, sensitivity of 73.10%, and specificity of 95.24%, compared to AFP with 0.750, 64.27%, and 82.14%, respectively. In early HCC, AKR1B10 yielded an AUC of 0.800, a sensitivity of 65.8%, and a specificity of 91.67%, better than AFP (0.717, 59.83%, and 88.1%, respectively). AKR1B10 was positive in 69.27% of AFP-negative HCC cases and showed an AUC of 0.852, a sensitivity of 72.2%, and a specificity of 90.48%. In patients with HCC undergoing curative resection, serum AKR1B10 levels declined to normal within 3-5 days. At 1-3 months after surgery, serum AKR1B10 had a concordance of 94.41% with imaging data, compared to 70.63% for AFP. CONCLUSION: AKR1B10 is a useful serum marker for the diagnosis of early and AFP-negative HCC and shows potential in assessing curative resection and early recurrence.