HES V2.0 outperforms GALAD for detection of HCC: A phase 3 biomarker study in the United States.

We have developed HES V2.0 by adding AFP-L3 and des-gamma-carboxy prothrombin to the score and compared its performance to GALAD and ASAP scores among patients with cirrhosis.

我们通过将AFP-L3和去γ-羧基凝血酶原添加到评分中，开发了HES V2.0，并将其性能与GALAD和ASAP评分在肝硬化患者中进行了比较。

approach_and_results

We conducted a prospective-specimen collection, retrospective-blinded-evaluation phase 3 biomarker cohort study in patients with cirrhosis enrolled in imaging and AFP surveillance.

我们开展了一项前瞻性样本收集、回顾性盲法评估的3期生物标志物队列研究，研究对象为接受影像和甲胎蛋白（AFP）监测的肝硬化患者。

True-positive rate (TPR)/sensitivity and false-positive rate for any or early HCC were calculated for GALAD, ASAP, and HES V2.0 scores within 6, 12, and 24 months of HCC diagnosis.

在肝细胞癌（HCC）诊断后的6个月、12个月和24个月内，计算了GALAD、ASAP和HES V2.0评分对于任何或早期HCC的真阳性率（TPR）/敏感性和假阳性率。

We calculated the AUROC curve and estimated TPR based on an optimal threshold at a fixed false-positive rate of 10%.

我们计算了AUROC曲线，并在固定假阳性率为10%的情况下，根据最佳阈值估计了TPR。

We analyzed 2331 patients, of whom 125 developed HCC (71% in the early stages).

我们分析了2331名患者，其中125名发展为肝细胞癌（早期阶段占71%）。

For any HCC, HES V2.0 had higher TPR than GALAD overall (+7.2%), at 6 months (+3.6%), at 12 months (+7.2%), and 24 months (+13.0%) before HCC diagnosis.

对于任何肝细胞癌（HCC），HES V2.0的整体真阳性率（TPR）比GALAD高（+7.2%），在诊断前的6个月（+3.6%）、12个月（+7.2%）和24个月（+13.0%）也是如此。

HES V2.0 had higher TPR than ASAP for all time points (+5.9% to +12.0%).

对于所有时间点，HES V2.0的真阳性率（TPR）均高于ASAP（+5.9%至+12.0%）。

For early HCC, HES V2.0 had higher sensitivity/TPR than GALAD overall (+6.7%), at 12 months (+6.3%), and 24 months (+14.6%) but not at 6 months (+0.0%) and higher than ASAP for all time points (+13.4% to +18.0%).

在早期肝细胞癌（HCC）中，HES V2.0的敏感性/真阳性率（TPR）总体上比GALAD高（+6.7%），在12个月（+6.3%）和24个月（+14.6%）时也是如此，但在6个月时没有差异（+0.0%），并且在所有时间点上比ASAP的敏感性/TPR都要高（+13.4%至+18.0%）。

Conclusions

In a prospective cohort study, HES V2.0 had a significantly higher performance for identifying new HCC, including early stage, than GALAD or ASAP.

在一项前瞻性队列研究中，HES V2.0在识别新发HCC（包括早期阶段）方面的性能显著高于GALAD或ASAP。