PDF(Pubmed)
Abstract：
BACKGROUND: To investigate whether protein induced by vitamin K antagonist-II (PIVKA-II) combined with alpha-fetoprotein (AFP) can improve the diagnostic and differential diagnostic accuracy of childhood hepatic tumors.
METHODS: A multi-center prospective observational study was performed at nine regional institutions around China. Children with hepatic mass (Group T) were divided into hepatoblastoma group (Group THB) and hemangioendothelioma group (Group THE), children with extrahepatic abdominal mass (Group C). Peripheral blood was collected from each patient prior to surgery or chemotherapy. The area under the curve (AUROC) was used to evaluate the diagnostic efficiency of PIVKA-II and the combined tumor markers with AFP.
RESULTS: The mean levels of PIVKA-II and AFP were both significantly higher in Group T than Group C (p = 0.001, p < 0.001), in Group THB than Group THE (p = 0.018, p = 0.013) and in advanced HB than non-advanced HB (p = 0.001, p = 0.021). For the diagnosis of childhood hepatic tumors, AUROC of PIVKA-II (cut-off value 32.6 mAU/mL) and AFP (cut-off value 120 ng/mL) was 0.867 and 0.857. The differential diagnostic value of PIVKA-II and AFP in hepatoblastoma from hemangioendothelioma was further assessed, AUROC of PIVKA-II (cut-off value 47.1mAU/mL) and AFP (cut-off value 560 ng/mL) was 0.876 and 0.743. The combined markers showed higher AUROC (0.891, 0.895 respectively) than PIVKA-II or AFP alone.
CONCLUSIONS: The serum level of PIVKA-II was significantly higher in children with hepatic tumors, especially those with malignant tumors. The combination of PIVKA-II with AFP further increased the diagnostic performance.
BACKGROUND: Clinical Trials, NCT03645655. Registered 20 August 2018, https://www.
RESULTS: gov/ct2/show/NCT03645655 .
METHODS: A multi-center prospective observational study was performed at nine regional institutions around China. Children with hepatic mass (Group T) were divided into hepatoblastoma group (Group THB) and hemangioendothelioma group (Group THE), children with extrahepatic abdominal mass (Group C). Peripheral blood was collected from each patient prior to surgery or chemotherapy. The area under the curve (AUROC) was used to evaluate the diagnostic efficiency of PIVKA-II and the combined tumor markers with AFP.
RESULTS: The mean levels of PIVKA-II and AFP were both significantly higher in Group T than Group C (p = 0.001, p < 0.001), in Group THB than Group THE (p = 0.018, p = 0.013) and in advanced HB than non-advanced HB (p = 0.001, p = 0.021). For the diagnosis of childhood hepatic tumors, AUROC of PIVKA-II (cut-off value 32.6 mAU/mL) and AFP (cut-off value 120 ng/mL) was 0.867 and 0.857. The differential diagnostic value of PIVKA-II and AFP in hepatoblastoma from hemangioendothelioma was further assessed, AUROC of PIVKA-II (cut-off value 47.1mAU/mL) and AFP (cut-off value 560 ng/mL) was 0.876 and 0.743. The combined markers showed higher AUROC (0.891, 0.895 respectively) than PIVKA-II or AFP alone.
CONCLUSIONS: The serum level of PIVKA-II was significantly higher in children with hepatic tumors, especially those with malignant tumors. The combination of PIVKA-II with AFP further increased the diagnostic performance.
BACKGROUND: Clinical Trials, NCT03645655. Registered 20 August 2018, https://www.
RESULTS: gov/ct2/show/NCT03645655 .
摘要：
背景：探讨维生素K拮抗剂-II（PIVKA-II）联合甲胎蛋白（AFP）诱导的蛋白质是否可以提高儿童肝脏肿瘤的诊断和鉴别诊断准确性。
方法：在中国9个地区机构进行了一项多中心前瞻性观察研究。将肝肿块患儿(T组)分为肝母细胞瘤组(THB组)和血管内皮瘤组(THE组),儿童肝外腹部肿块（C组）。在手术或化疗之前从每个患者收集外周血。曲线下面积（AUROC）用于评估PIVKA-II和AFP联合肿瘤标志物的诊断效率。
结果：T组PIVKA-II和AFP的平均水平均明显高于C组（p=0.001，p<0.001），THB组高于THE组(p=0.018,p=0.013),晚期HB高于非晚期HB(p=0.001,p=0.021)。对于儿童肝肿瘤的诊断，PIVKA-II(截断值32.6mAU/mL)和AFP(截断值120ng/mL)的AUROC为0.867和0.857。进一步评估了PIVKA-II和AFP在肝母细胞瘤和血管内皮瘤中的鉴别诊断价值，PIVKA-II(截断值47.1mAU/mL)和AFP(截断值560ng/mL)的AUROC为0.876和0.743。组合的标志物显示出比单独的PIVKA-II或AFP更高的AUROC(分别为0.891、0.895)。
结论：肝肿瘤患儿血清PIVKA-Ⅱ水平明显增高，尤其是那些患有恶性肿瘤的人。PIVKA-II与AFP的组合进一步提高了诊断性能。
背景：临床试验，NCT03645655。2018年8月20日注册，https://www.
结果：gov/ct2/show/NCT03645655。
方法：在中国9个地区机构进行了一项多中心前瞻性观察研究。将肝肿块患儿(T组)分为肝母细胞瘤组(THB组)和血管内皮瘤组(THE组),儿童肝外腹部肿块（C组）。在手术或化疗之前从每个患者收集外周血。曲线下面积（AUROC）用于评估PIVKA-II和AFP联合肿瘤标志物的诊断效率。
结果：T组PIVKA-II和AFP的平均水平均明显高于C组（p=0.001，p<0.001），THB组高于THE组(p=0.018,p=0.013),晚期HB高于非晚期HB(p=0.001,p=0.021)。对于儿童肝肿瘤的诊断，PIVKA-II(截断值32.6mAU/mL)和AFP(截断值120ng/mL)的AUROC为0.867和0.857。进一步评估了PIVKA-II和AFP在肝母细胞瘤和血管内皮瘤中的鉴别诊断价值，PIVKA-II(截断值47.1mAU/mL)和AFP(截断值560ng/mL)的AUROC为0.876和0.743。组合的标志物显示出比单独的PIVKA-II或AFP更高的AUROC(分别为0.891、0.895)。
结论：肝肿瘤患儿血清PIVKA-Ⅱ水平明显增高，尤其是那些患有恶性肿瘤的人。PIVKA-II与AFP的组合进一步提高了诊断性能。
背景：临床试验，NCT03645655。2018年8月20日注册，https://www.
结果：gov/ct2/show/NCT03645655。
