GALAD demonstrates high sensitivity for HCC surveillance in a cohort of patients with cirrhosis.
GALAD demonstrates high sensitivity for HCC surveillance in a cohort of patients with cirrhosis.
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DOI：
10.1002/hep.32185
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发表时间：
2022-03
期刊：
影响因子：
--
通讯作者：
Parikh ND
中科院分区：
文献类型：
--
作者：
Singal AG;Tayob N;Mehta A;Marrero JA;El-Serag H;Jin Q;Saenz de Viteri C;Fobar A;Parikh ND
大多数肝细胞癌 (HCC) 患者在晚期才被诊断出来，这突出表明需要更准确的监测测试。尽管 HCC 早期检测的生物标志物在 II 期病例对照研究中拥有有希望的数据，但在实践中采用之前，队列研究的评估至关重要。我们利用了 Child Pugh A 型或 B 型肝硬化患者的前瞻性队列，对这些患者进行随访，直至发生 HCC、肝移植、死亡或失访。我们采用前瞻性样本采集、回顾性盲法评估 (PRoBE) 设计来评估 GALAD、纵向 GALAD 和 HES 算法的生物标志物——与甲胎蛋白 (AFP) 相比——使用患者水平的敏感性和筛查水平的特异性。在 397 名肝硬化患者中，42 名患者在中位 2.0 年的时间内发展为 HCC（57.1% 为早期）。与单时间点 GALAD (0.79, 95% CI 0.71 – 0.87)、AFP (0.77, 95% CI 0.69 – 0.85) 和 HES (0.76, 95% CI) 相比，纵向 GALAD 的 HCC 检测 c 统计量最高 (0.85, 95% CI 0.77 – 0.92) 0.67 – 0.83）。当特异性固定为 90% 时，单时间点和纵向 GALAD 对 HCC 的敏感性分别为 54.8% 和 66.7%，而 AFP 的敏感性为 40.5%。当仅限于 HCC 诊断前 6 个月内进行生物标志物评估的患者时，HCC 检测的敏感性较高，单时间点 (72.0%) 和纵向 GALAD (64.0%) 的敏感性分别最高。单时间点和纵向 GALAD 对早期 HCC 的敏感性分别为 53.8% 和 69.2%。 GALAD 在一组肝硬化患者中表现出对 HCC 检测的高敏感性。这些结果需要在大型 III 期数据集中进行验证。包括年龄、性别和三种生物标志物在内的血液检测小组能够准确检测肝硬化高危患者的肝癌。这些数据凸显了基于血液的筛查测试在改善肝癌早期检测方面的潜在价值。
Most patients with hepatocellular carcinoma (HCC) are diagnosed at a late stage, highlighting the need for more accurate surveillance tests. Although biomarkers for HCC early detection have promising data in phase II case-control studies, evaluation in cohort studies is critical prior to adoption in practice. We leveraged a prospective cohort of patients with Child Pugh A or B cirrhosis who were followed until incident HCC, liver transplantation, death, or lost to follow-up. We used a prospective specimen-collection, retrospective-blinded-evaluation (PRoBE) design for biomarker evaluation of GALAD, longitudinal GALAD and the HES algorithm –compared to alpha fetoprotein (AFP) – using patient-level sensitivity and screening-level specificity. Of 397 patients with cirrhosis, 42 patients developed HCC (57.1% early-stage) over a median of 2.0 years. Longitudinal GALAD had the highest c-statistic for HCC detection (0.85, 95%CI 0.77 – 0.92), compared to single-timepoint GALAD (0.79, 95%CI 0.71 – 0.87), AFP (0.77, 95%CI 0.69 – 0.85), and HES (0.76, 95%CI 0.67 – 0.83). When specificity was fixed at 90%, the sensitivity for HCC of single-timepoint and longitudinal GALAD was 54.8% and 66.7%, respectively, compared to 40.5% for AFP. Sensitivity for HCC detection was higher when restricted to patients with biomarker assessment within 6 months prior to HCC diagnosis, with the highest sensitivities observed for single-timepoint (72.0%) and longitudinal GALAD (64.0%), respectively. Sensitivity of single-timepoint and longitudinal GALAD for early-stage HCC was 53.8% and 69.2%, respectively. GALAD demonstrated high sensitivity for HCC detection in a cohort of patients with cirrhosis. Validation of these results are warranted in large phase III datasets. A blood-based panel including age, sex, and three biomarkers was able to accurately detect liver cancer in at-risk patients with cirrhosis. These data highlight the potential value of blood-based screening tests to improve early detection of liver cancer.
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DOI：
10.1016/j.cgh.2020.09.014
发表时间：
2021-09
期刊：
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
影响因子：
--
作者：
Singal AG;Patibandla S;Obi J;Fullington H;Parikh ND;Yopp AC;Marrero JA
通讯作者：
Marrero JA
影响因子：
12.6
作者：
Best, Jan;Bechmann, Lars P.;Canbay, Ali
通讯作者：
Canbay, Ali
DOI：
10.1016/j.cgh.2020.06.049
发表时间：
2021-05
期刊：
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
影响因子：
--
作者：
Singal AG;Tiro JA;Murphy CC;Blackwell JM;Kramer JR;Khan A;Liu Y;Zhang S;Phillips JL;Hernaez R
通讯作者：
Hernaez R
影响因子：
9.8
作者：
Feng, Ziding;Marrero, Jorge A.;El-Serag, Hashem B.
通讯作者：
El-Serag, Hashem B.
影响因子：
7.6
作者：
Simmons, O.;Fetzer, D. T.;Singal, A. G.
通讯作者：
Singal, A. G.