Suttichaimongkol Tanita, Mitpracha Manoon, Tangvoraphonkchai Kawin, Sadee Phuangphaka, Sawanyawisuth Kittisak, Sukeepaisarnjaroen Wattana
Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen - Thailand.
Division of Gastroenterology, Department of Medicine, Khon Kaen Regional Hospital, Khon Kaen - Thailand.
J Circ Biomark. 2023 Feb 17;12:12-16. doi: 10.33393/jcb.2023.2453. eCollection 2023 Jan-Dec.
Hepatocellular carcinoma (HCC) is a lethal cancer. Two biomarkers were used for HCC diagnosis including alpha-fetoprotein (AFP) and protein induced by vitamin K absence-II or antagonist (PIVKA-II). However, data on biomarkers and HCC diagnosis are not consistent. This study aimed to evaluate if PIVKA-II, AFP, or a combination of both biomarkers had the best diagnostic properties for HCC.
This was a prospective study and enrolled patients 18 years or over with a high risk for HCC. AFP and PIVKA-II levels were calculated for HCC diagnosis. Diagnostic properties of both biomarkers were reported with sensitivity, specificity, and a receiver operating characteristic (ROC) curve.
There were 260 patients with high risk for HCC in this cohort. Of those, 219 patients were diagnosed with HCC: confirmed by biopsy in 7 patients (2.69%) and by imaging in the others. Median values of AFP and PIVKA-II were 56 ng/mL and 348 mAU/mL, respectively. PIVKA-II level of 40 mAU/mL had sensitivity of 80.80%, while AFP of 10 ng/mL had sensitivity of 75.80%. A combination of PIVKA-II at 100 mAU/mL or over and AFP of 11 ng/mL gave sensitivity of 60.30%. The ROC curve of PIVKA-II plus AFP was significantly higher than the AFP alone (0.855 vs. 0.796; p = 0.027), but not significantly different from the PIVKA-II alone (0.855 vs. 0.832; p = 0.130).
PIVKA-II may have more diagnostic yield for HCC compared with AFP. It can be used alone without a combination with AFP.
肝细胞癌（HCC）是一种致命性癌症。两种生物标志物被用于HCC诊断，包括甲胎蛋白（AFP）和维生素K缺乏诱导蛋白-II或拮抗剂（PIVKA-II）。然而，关于生物标志物与HCC诊断的数据并不一致。本研究旨在评估PIVKA-II、AFP或这两种生物标志物的组合是否对HCC具有最佳诊断性能。
这是一项前瞻性研究，纳入了18岁及以上的HCC高危患者。计算AFP和PIVKA-II水平以用于HCC诊断。报告了两种生物标志物的诊断性能，包括敏感性、特异性和受试者工作特征（ROC）曲线。
该队列中有260例HCC高危患者。其中，219例患者被诊断为HCC：7例（2.69%）经活检确诊，其余经影像学确诊。AFP和PIVKA-II的中位数分别为56 ng/mL和348 mAU/mL。PIVKA-II水平为40 mAU/mL时敏感性为80.80%，而AFP为10 ng/mL时敏感性为75.80%。PIVKA-II为100 mAU/mL及以上且AFP为11 ng/mL的组合敏感性为60.30%。PIVKA-II加AFP的ROC曲线显著高于单独的AFP（0.855对0.796；p = 0.027），但与单独的PIVKA-II无显著差异（0.855对0.832；p = 0.130）。
与AFP相比，PIVKA-II对HCC可能具有更高的诊断价值。它可以单独使用，无需与AFP联合。
