Woo Wing Hang, Muhammad Nawawi Khairul Najmi, Chew Deborah Chia Hsin, Kok Wei Hao, Wong Zhiqin, Azman Azlanudin, Yaacob Nur Yazmin, Mansor Munirah Md, Othman Hanita, Ali Raja Affendi Raja
Gastroenterology and Hepatology Unit, Department of Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Malaysia.
GUT Research Group, Faculty of Medicine, Universiti Kebangsaan Malaysia, Malaysia.
Clin Exp Hepatol. 2025 Mar;11(1):81-87. doi: 10.5114/ceh.2025.148321. Epub 2025 Mar 25.
Hepatocellular carcinoma (HCC) in Malaysia is a growing health concern, despite regular liver ultrasound and α-fetoprotein (AFP) surveillance. The GALAD model incorporates AFP, lens culinaris agglutinin- reactive α-fetoprotein (AFP-L3), protein induced by vitamin K antagonist-II (PIVKA-II), gender and age to predict the probability of HCC. Our objective was to evaluate the diagnostic ability of GALAD compared to AFP in HCC screening.
A single-centre, case control study recruited newly diagnosed HCC and cirrhotic patients. Serum biomarkers were quantified using a microfluidic-based automated immunoanalyzer. The diagnostic ability of AFP, AFP-L3, PIVKA-II and GALAD was assessed using receiver operating characteristic curve (ROC) and corresponding area under the curve (AUC) analysis.
Among the 44 HCC cases, GALAD score achieved the highest AUC value of 0.94 (95% confidence interval [CI]: 0.90-0.98, < 0.0001) significantly surpassing AFP (0.89), AFP-L3 (0.84) and PIVKA-II (0.88). The GALAD score demonstrated 84.1% sensitivity and 93.8% specificity at the standard cut-off (-0.63) and 88.6%/92.2% at its best cut-off (-1.035) for detecting any stage of HCC, outperforming AFP (79.5%/92.2%), AFP-L3 (59.1%/94.9%) and PIVKA-II (79.5%/84.9%). The sensitivity of the GALAD score was 100% in earlystage HCC (BCLC0/A).
GALAD outperformed conventional biomarkers, facilitating early detection, improved treatment options and ultimately a higher survival rate for HCC patients.
尽管有定期肝脏超声和甲胎蛋白（AFP）监测，但马来西亚肝细胞癌（HCC）仍是一个日益严重的健康问题。GALAD模型纳入了AFP、刀豆球蛋白A反应性甲胎蛋白（AFP-L3）、维生素K拮抗剂-II诱导蛋白（PIVKA-II）、性别和年龄来预测HCC的发生概率。我们的目的是评估GALAD与AFP在HCC筛查中的诊断能力。
一项单中心病例对照研究招募了新诊断的HCC和肝硬化患者。使用基于微流控的自动免疫分析仪对血清生物标志物进行定量。使用受试者工作特征曲线（ROC）和相应的曲线下面积（AUC）分析评估AFP、AFP-L3、PIVKA-II和GALAD的诊断能力。
在44例HCC病例中，GALAD评分的AUC值最高，为0.94（95%置信区间[CI]：0.90-0.98，P<0.0001），显著超过AFP（0.89）、AFP-L3（0.84）和PIVKA-II（0.88）。GALAD评分在标准临界值（-0.63）时的灵敏度为84.1%，特异性为93.8%，在最佳临界值（-1.035）时检测任何阶段HCC的灵敏度/特异性为88.6%/92.2%，优于AFP（79.5%/92.2%）、AFP-L3（59.1%/94.9%）和PIVKA-II（79.5%/84.9%）。GALAD评分在早期HCC（BCLC0/A）中的灵敏度为100%。
GALAD优于传统生物标志物，有助于早期发现，改善治疗选择，并最终提高HCC患者的生存率。
