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 > 64.4 ng/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.

中文翻译：

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AFP和PIVKA-II在HBV相关肝细胞癌诊断及血管浸润和肿瘤分化预测中的价值

背景 探讨甲胎蛋白（AFP）和维生素K缺失或拮抗剂-II诱导蛋白（PIVKA-II）在HBV相关肝细胞癌（HCC）诊断中的价值及其与血管侵犯、肿瘤分化和大小的关系。方法共纳入433例受试者，其中HBV相关HCC 266例，HBV DNA阳性良性肝病87例，健康人80例。然后我们探讨了 AFP、PIVKA-II 血清水平与血管侵犯、肿瘤分化和大小等几个病理特征之间的相关性。这两种标志物单独或联合用于诊断HBV相关HCC的价值通过受试者工作特征（ROC）曲线进行评估。还绘制了 ROC 曲线以识别 AFP，PIVKA-II 血清临界值最能区分有无血管侵犯的 HBV 相关 HCC 患者。结果HBV相关HCC组AFP和PIVKA-II水平显着升高（Z分别为7.428、11.243，均P < 0.01）。当使用 AFP 和 PIVKA-II 作为个体肿瘤标志物时，HBV 相关 HCC 诊断的 ROC 曲线下面积（AUC）为 AFP 的 0.765（95% CI，0.713 ~ 0.8170），0.901（95% CI，0.868） ~ 0.935) 对于 PIVKA-II，同时对于 AFP 和 PIVKA-II 为 0.917 (95% CI, 0.886 ~ 0.948)。AFP和PIVKA-II的血清水平与肿瘤分化和大小呈正相关。高 AFP 和 PIVKA-II 表达与血管侵犯的存在显着相关（P 分别为 0.007 和 0.014）。AFP 水平 > 64.4 ng/ml 或 PIVKA-II 水平 > 957。61mAU/ml 是预测血管侵犯存在的最佳临界值。结论 我们的结果证实了 AFP 和 PIVKA-II 在 HBV 相关 HCC 的诊断中起重要作用。AFP与PIVKA-II联合检测或单独检测PIVKA-II的诊断价值高于单独检测AFP。此外，它们的浓度在判断肿瘤大小、肿瘤细胞分化和血管侵袭方面具有重要的临床价值。