Key result
Combining AFP and PIVKA-II improves HBV-related HCC detection over AFP alone, yielding an AUC of ~0.92.
Why the study?
The diagnostic value of AFP and PIVKA-II in HBV-related hepatocellular carcinoma and their relationship with vascular invasion, tumor differentiation, and size were not fully established.
Do AFP and PIVKA-II serum levels accurately diagnose HBV-related HCC and predict vascular invasion and tumor differentiation?
Case-Control (n=433)
No
Do AFP and PIVKA-II serum levels accurately diagnose HBV-related HCC and predict vascular invasion and tumor differentiation?
Effect estimate: AUC 0.917 (95% CI 0.886-0.948)
p-value: p=<0.001
Combined detection of AFP and PIVKA-II improves the diagnostic accuracy for HBV-related HCC and helps predict vascular invasion and tumor differentiation.
PIVKA-II or combined testing may aid HBV-related HCC diagnosis and vascular invasion prediction; leaves open prospective validation before changing surveillance.
Background: To explore the value of alpha fetoprotein (AFP) and protein induced by vitamin K absence or antagonist-II (PIVKA-II) in diagnosis of HBV-related hepatocellular carcinoma (HCC) and their relationship with vascular invasion, tumor differentiation and size. Methods: A total of 433 participants were enrolled in this study including 266 cases with HBV-related HCC, 87 cases with HBV DNA positive benign liver disease and 80 healthy individuals. Then we explored the correlation between AFP, PIVKA-II serum level and several pathological features such as vascular invasion, tumor differentiation and size. The value of these two markers used singly or jointly in diagnosing HBV-related HCC was evaluated by receiver operating characteristic (ROC) curve. The ROC curve was also plotted to identify AFP, PIVKA-II serum cut-off values that would best distinguish HBV-related HCC patients with and without vascular invasion.Results: The level of AFP and PIVKA-II in HBV-related HCC group was significantly higher (Z was 7.428, 11.243 respectively, all P<0.01). When AFP and PIVKA-II were used as the individual tumor marker, the areas under the ROC curve (AUC) of HBV-related HCC diagnosis were 0.765 (95% CI, 0.713～0.8170) for AFP, 0.901 (95% CI, 0.868～0.935) for PIVKA-II, and 0.917 (95% CI, 0.886～0.948) for AFP and PIVKA-II simultaneously. The serum levels of AFP and PIVKA-II were positively correlated with tumor differentiation and size. High AFP and PIVKA-II expression was significantly associated with the presence of vascular invasion (P was 0.007 and 0.014 respectively). The AFP level >64.4ng/ml or PIVKA-II level >957.61mAU/ml was the best critical value to predict the presence of vascular invasion. Conclusion: Our results validate that AFP and PIVKA-II play a significant role in the diagnosis of HBV-related HCC. The diagnostic value of AFP and PIVKA-II combined detection or single assay of PIVKA-II is higher than that of separate assay of AFP. Moreover, their concentration has important clinical value in judging tumor size, tumor cell differentiation and vascular invasion.
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Si et al. (2020) conducted a case-control in HBV-related hepatocellular carcinoma (n=433). AFP and PIVKA-II serum levels vs. Benign liver disease and healthy controls was evaluated on Diagnosis of HBV-related HCC (Area under the ROC curve for combined AFP and PIVKA-II) (AUC 0.917, 95% CI 0.886-0.948, p=<0.001). Combined detection of AFP and PIVKA-II accurately diagnosed HBV-related hepatocellular carcinoma with an AUC of 0.917, significantly outperforming AFP alone.
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