Genomics Research Center, Academia Sinica, Graduate Institute of Epidemiology, College of Public Health and Graduate Institute of Clinical Medicine, College of Medicine, National Taiwan University, Toronto, Ontario, Canada.
J Clin Oncol. 2010 May 10;28(14):2437-44. doi: 10.1200/JCO.2009.27.4456. Epub 2010 Apr 5.
Counseling patients with chronic hepatitis B virus (HBV) on their individual risk of liver disease progression is challenging. This study aimed to develop nomograms for predicting hepatocellular carcinoma risk in patients with chronic hepatitis B.
Two thirds of the Risk Evaluation of Viral Load Elevation and Associated Liver Disease/Cancer-Hepatitis B Virus (REVEAL-HBV) study cohort was allocated for model derivation (n = 2,435), and the remaining third was allocated for model validation (n = 1,218). Previously confirmed independent risk predictors included in three Cox proportional hazards regression models were sex, age, family history of hepatocellular carcinoma, alcohol consumption habit, serum ALT level, hepatitis B envelope antigen (HBeAg) serostatus, serum HBV DNA level, and HBV genotype. Regression coefficients were rounded into integer risk scores, and predicted risk over 5- and 10-year periods for each risk score was calculated and depicted in nomograms. The predictive accuracy was evaluated using the area under the receiver operating characteristic curve (AUROC) and the correlation between predicted and observed hepatocellular carcinoma risk.
All selected risk predictors were statistically significant in all models. In each model, either HBeAg seropositivity or HBeAg seronegativity with high viral load (HBV DNA level >or= 100,000 copies/mL) and genotype C infection had the highest risk scores. All AUROCs for risk prediction nomogram were >or= 0.82 in both model derivation and validation sets. The correlation coefficients between the observed hepatocellular carcinoma risk and the nomogram-predicted risk were greater than 0.90 in all model derivation and validation sets.
These easy-to-use nomograms based on noninvasive clinical characteristics can accurately predict the risk of hepatocellular carcinoma in patients with chronic hepatitis B. They may facilitate risk communication between patients and clinicians.
为慢性乙型肝炎病毒(HBV)患者提供个体化疾病进展风险的咨询具有挑战性。本研究旨在开发预测慢性乙型肝炎患者肝细胞癌风险的列线图。
REVEAL-HBV 研究队列的三分之二被分配用于模型推导(n=2435),其余三分之一被分配用于模型验证(n=1218)。在三个 Cox 比例风险回归模型中纳入了先前确认的独立风险预测因子,包括性别、年龄、肝癌家族史、饮酒习惯、血清丙氨酸氨基转移酶(ALT)水平、乙型肝炎表面抗原(HBeAg)血清状态、血清 HBV DNA 水平和 HBV 基因型。回归系数四舍五入为整数风险评分,并计算每个风险评分的 5 年和 10 年预测风险,并在列线图中描绘。使用接受者操作特征曲线下面积(AUROC)和预测与观察到的肝细胞癌风险之间的相关性来评估预测准确性。
所有选定的风险预测因子在所有模型中均具有统计学意义。在每个模型中,HBeAg 阳性或 HBeAg 阴性伴高病毒载量(HBV DNA 水平>100,000 拷贝/ml)和基因型 C 感染的风险评分最高。在模型推导和验证集中,所有风险预测列线图的 AUROC 均>0.82。在所有模型推导和验证集中,观察到的肝细胞癌风险与列线图预测风险之间的相关系数均大于 0.90。
这些基于非侵入性临床特征的易于使用的列线图可以准确预测慢性乙型肝炎患者肝细胞癌的风险。它们可能有助于患者和临床医生之间的风险沟通。