Genomics Research Centre, Academia Sinica, Taipei, Taiwan.
Lancet Oncol. 2011 Jun;12(6):568-74. doi: 10.1016/S1470-2045(11)70077-8. Epub 2011 Apr 14.
Therapy for chronic hepatitis B reduces the risk of progressing to hepatocellular carcinoma (HCC); however, there is no suitable and accurate means to assess risk. This study aimed to develop and validate a simple scoring system to predict HCC risk in patients with chronic hepatitis B.
The development cohort consisted of 3584 patients without cirrhosis from the community-based Taiwanese REVEAL-HBV study (of whom 131 developed HCC during follow-up), and a validation cohort of 1505 patients from three hospitals in Hong Kong and South Korea (of whom 111 developed HCC during follow-up). We used Cox multivariate proportional hazards model to predict risk of HCC at 3, 5, and 10 years. Variables included in the risk score were sex, age, serum alanine aminotransferase concentration, HBeAg status, and serum HBV DNA level. We calculated the area under receiver operating curve (AUROC) and calibration of predicted and observed HCC risk.
A 17-point risk score was developed, with HCC risk ranging from 0·0% to 23·6% at 3 years, 0·0% to 47·4% at 5 years, and 0·0% to 81·6% at 10 years for patients with the lowest and highest HCC risk, respectively. AUROCs to predict risk were 0·811 (95% CI 0·790-0·831) at 3 years, 0·796 (0·775-0·816) at 5 years, and 0·769 (0·747-0·790) at 10 years in the validation cohort, and 0·902 (0·884-0·918), 0·783 (0·759-0·806), and 0·806 (0·783-0·828), respectively, after exclusion of 277 patients in the validation cohort with cirrhosis. Predicted risk was well calibrated with Kaplan-Meier observed HCC risk.
A simple-to-use risk score that uses baseline clinical variables was developed and validated. The score accurately estimates the risk of developing HCC at 3, 5, and 10 years in patients with chronic hepatitis B. Clinicians can use this score to assess risk of HCC in patients with chronic hepatitis B and subsequently make evidence-based decisions about their clinical management.
The Academia Sinica; the National Health Research Institute, Taiwan; and Bristol-Myers Squibb.
慢性乙型肝炎的治疗可降低发展为肝细胞癌（HCC）的风险；然而，目前尚无合适且准确的方法来评估风险。本研究旨在开发和验证一种简单的评分系统，以预测慢性乙型肝炎患者的 HCC 风险。
该研究的开发队列包括来自社区的台湾 REVEAL-HBV 研究的 3584 例无肝硬化患者（其中 131 例在随访期间发生 HCC），以及来自香港和韩国的三家医院的验证队列的 1505 例患者（其中 111 例在随访期间发生 HCC）。我们使用 Cox 多变量比例风险模型来预测 HCC 在 3、5 和 10 年内的风险。风险评分纳入的变量包括性别、年龄、血清丙氨酸氨基转移酶浓度、HBeAg 状态和血清 HBV DNA 水平。我们计算了接收者操作特征曲线（AUROC）的面积和预测 HCC 风险的校准。
开发了一个 17 分的风险评分，对于 HCC 风险最低和最高的患者，3 年时 HCC 风险范围分别为 0.0%至 23.6%，5 年时为 0.0%至 47.4%，10 年时为 0.0%至 81.6%。验证队列中的 AUROCs 分别为 3 年时 0.811（95%CI 0.790-0.831），5 年时 0.796（0.775-0.816），10 年时 0.769（0.747-0.790），排除验证队列中 277 例肝硬化患者后，分别为 0.902（0.884-0.918）、0.783（0.759-0.806）和 0.806（0.783-0.828）。预测风险与 Kaplan-Meier 观察到的 HCC 风险具有良好的校准度。
本研究开发并验证了一种基于基线临床变量的简单易用的风险评分。该评分可准确估计慢性乙型肝炎患者在 3、5 和 10 年内发生 HCC 的风险。临床医生可以使用该评分来评估慢性乙型肝炎患者的 HCC 风险，然后根据其临床管理做出循证决策。
中国科学院；台湾国家卫生研究院；百时美施贵宝公司。
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