Department of Experimental Medicine, "Sapienza" University of Rome, Policlinico Umberto I, Rome, Italy.
Department of Molecular Medicine, "Sapienza" University of Rome, Policlinico Umberto I, Rome, Italy.
PLoS One. 2021 May 20;16(5):e0251656. doi: 10.1371/journal.pone.0251656. eCollection 2021.
Pancreatic adenocarcinoma (PDAC) is an incurable cancer without adequate tumor markers. Our previous study has showed a better diagnostic performance of Protein Induced by Vitamin K Absence II (PIVKA-II) compared to currently used PDAC biomarkers. To corroborate our previous data with a larger sample size and to assess a possible role of PIVKA-II in predicting surgical success. Additionally, to further evaluate the hypothesis of a direct PIVKA-II production by PDAC cells, we examined PIVKA-II tissue expression in a case of PDAC using immunofluorescence.
We enrolled 76 newly diagnosed PDAC patients and selected 11 patients to determine PIVKA-II levels also after surgical resection. An immunofluorescence (IF) study of PIVKA-II tissue expression was carried out in one of them. PIVKA-II serum values were measured by chemiluminescent enzyme immunoassay method (CLEIA) on LUMIPULSE G1200 (Fujirebio-Europe, Belgium).
PIVKA-II serum levels were above the cut-off at baseline in 71 patients (94%) with a median value of 464 mAU/Ml (range 27-40783 mAU/mL); the sensitivity and specificity were 78.67% and 90.67% respectively. Patients with pre-operative PIVKA-II positivity showed a significant decrease (P < 0.015) of median PIVKA-II serum concentrations after surgery: 820 (91-40783) mAU/mL at diagnosis vs 123 (31-4666) mAU/mL post-operatively. IF assay on PDAC sections demonstrated PIVKA-II expression in cancer cells.
These data are the first showing a decreased PIVKA-II serum levels after surgery in PDAC patients and reporting PIVKA-II expression in PDAC tissue. Further studies are needed to confirm these findings and to determine PIVKA-II usefulness in diagnosing and monitoring PDAC patients.
胰腺癌（PDAC）是一种无法治愈的癌症，目前缺乏有效的肿瘤标志物。我们之前的研究表明，蛋白诱导的维生素 K 缺乏 II（PIVKA-II）在诊断 PDAC 方面的性能优于目前使用的 PDAC 生物标志物。为了用更大的样本量证实我们之前的数据，并评估 PIVKA-II 在预测手术成功方面的可能作用。此外，为了进一步验证 PDAC 细胞直接产生 PIVKA-II 的假设，我们使用免疫荧光法检查了一例 PDAC 中的 PIVKA-II 组织表达。
我们招募了 76 名新诊断的 PDAC 患者，并选择了 11 名患者在手术后也测定 PIVKA-II 水平。对其中一名患者进行了 PIVKA-II 组织表达的免疫荧光（IF）研究。使用化学发光酶免疫测定法（CLEIA）在 LUMIPULSE G1200（Fujirebio-Europe，比利时）上测量 PIVKA-II 血清值。
71 名患者（94%）的 PIVKA-II 血清水平在基线时高于临界值，中位数为 464 mAU/ml（范围 27-40783 mAU/ml）；敏感性和特异性分别为 78.67%和 90.67%。术前 PIVKA-II 阳性患者手术后 PIVKA-II 血清浓度明显下降（P<0.015）：诊断时为 820（91-40783）mAU/ml，术后为 123（31-4666）mAU/ml。PDAC 切片的 IF 检测显示 PIVKA-II 在癌细胞中表达。
这些数据首次显示 PDAC 患者手术后 PIVKA-II 血清水平降低，并报告 PDAC 组织中 PIVKA-II 的表达。需要进一步的研究来证实这些发现，并确定 PIVKA-II 在诊断和监测 PDAC 患者方面的有用性。
