下观察到的肝癌发病率慢性乙型肝炎患者治疗恩替卡韦：枚

StephenW

Am J Gastroenterol 2016; 111:1297–1304; doi:10.1038/ajg.2016.257; published online 21 June 2016

        Lower Observed Hepatocellular Carcinoma Incidence in Chronic Hepatitis B Patients Treated With Entecavir: Results of the ENUMERATE Study

Joseph Ahn MD, MS, AGAF, FACG1, Joseph K Lim MD2, Hannah M Lee MD3, Anna S Lok MD4, Mindie Nguyen MD5, Calvin Q Pan MD6, Ajitha Mannalithara PhD5, Helen Te MD7, K. Rajender Reddy MD8, Huy Trinh MD9, Danny Chu MD10, Tram Tran MD11, Daryl Lau MD12, Truong-Sinh Leduc MD13, Albert Min MD14, Loc Trong Le MD15, Ho Bae MD16, Sang Van Tran MD17, Son Do MD18, Hie-Won L Hann MD19, Clifford Wong MD20, Steven Han MD21, Anjana Pillai MD22, James S Park MD23, Myron Tong MD22, Steve Scaglione MD24, Jocelyn Woog JD25 and W. Ray Kim MD5

• 1Division of Gastroenterology and Hepatology, Oregon Health and Science University, Portland, Oregon, USA
• 2Department of Digestive Diseases, Yale University, New Haven, Connecticut, USA
• 3Gastroenterology/Hepatology Division, Virginia Commonwealth University, Richmond, Virginia, USA
• 4Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan, USA
• 5Division of Gastroenterology and Hepatology, Stanford University, Stanford, California, USA
• 6Department of Medicine, NYU Langone, New York City, New York, USA
• 7Digestive Disease Center, University of Chicago, Chicago, Illinois, USA
• 8Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, Pennsylvania, USA
• 9San Jose GI, San Jose, California, USA
• 10NYU School of Medicine, New York City, New York, USA
• 11Department of Medicine, Cedars Sinai Medical Center, Los Angeles, California, USA
• 12Department of Gastroenterology and Hepatology, BIDMC, Boston, Massachusetts, USA
• 13Leduc Medical Group, Fountain Valley, California, USA
• 14Division of Gastroenterology, Mount Sinai Beth Israel, New York City, New York, USA
• 15Woodholme Gastroenterology Associates, Pikeville, Maryland, USA
• 16Asian Pacific Liver Center, Los Angeles, California, USA
• 17Falls Church Family Practice, Falls Church, Virginia, USA
• 18Digestive Health Associates of Texas, Plano, Texas, USA
• 19Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA
• 20San Francisco, California, USA
• 21University of California, Los Angeles, Los Angeles, California, USA
• 22Emory University, Atlanta, Georgia, USA
• 23NYU Langone, New York City, New York, USA
• 24Loyola University, Maywood, Illinois, USA
• 25Asian Health Foundation, Philadelphia, Pennsylvania, USA
  

Correspondence: Joseph Ahn, MD, MS, AGAF, FACG, Division of Gastroenterology and Hepatology, Oregon Health and Science University, 3181 SW Sam Jackson Park Road, L-461, Portland, Oregon 97239, USA. E-mail: [email protected]

Received 1 March 2016; Accepted 1 May 2016
Advance online publication 21 June 2016

Top of pageAbstractOBJECTIVES:

Data from the United States are lacking regarding the impact of entecavir (ETV) on the risk of hepatocellular carcinoma (HCC). Our aim is to determine whether treatment with ETV is associated with a reduced HCC risk by calculating the expected HCC incidence based on the Risk Estimation for Hepatocellular Carcinoma in Chronic Hepatitis B (REACH-B) model and comparing it with the observed HCC incidence.

METHODS:

The incidence of HCC in US patients treated with ETV between 2005 and 2013 in a retrospective cohort was obtained. The predicted HCC incidence was calculated using the REACH-B model. The standardized incidence ratios (SIRs) were calculated as a ratio of observed over predicted HCC cases.

RESULTS:

Of 841 patients, 646 (65% male, 84% Asian, median age 47 years, 36% hepatitis B e antigen positive, 9.4% with cirrhosis) met the inclusion criteria. Over a median follow-up of 4 years, 17 (2.6%) cases of HCC were diagnosed, including 8 out of 61 (13.1%) patients with cirrhosis and 9 out of 585 (1.5%) without cirrhosis. Compared with those without HCC, the 17 patients with HCC were older at 53 years vs. 47 years and more likely to have cirrhosis at 47.1% vs. 8.4%. Among patients without cirrhosis, the observed HCC incidence was significantly lower than predicted by the fourth year (SIR, 0.37; 95% confidence interval: 0.166–0.82). A sensitivity analysis that comprised all patients, including those with cirrhosis, showed that at the maximum follow-up time of 8.2 years, a significantly lower than predicted HCC incidence was noted with an SIR of 0.56 (95% confidence interval: 0.35–0.905).

CONCLUSIONS:

Based on the REACH-B model, long-term ETV therapy was associated with a lower than predicted HCC incidence. However, the risk of HCC persisted, and careful HCC surveillance remains warranted despite the anti-viral treatment.

StephenW

牛J Gastroenterol 2016年; 111：1297至1304年; DOI：10.1038 / ajg.2016.257; 2016年六月21网上公布
下观察到的肝癌发病率慢性乙型肝炎患者治疗恩替卡韦：枚举的研究结果

约瑟夫·安MD，MS，AGAF，FACG1，约瑟夫ķ林MD2，汉娜中号李MD3，安娜小号乐MD4，Mindie阮MD5，卡尔文Q潘MD6，Ajitha Mannalithara PhD5，海伦特MD7，K. Rajender雷迪MD8，伊郑氏MD9，丹尼·楚MD10，电车陈德良MD11，达里尔刘MD12，张庭，双曲正弦勒杜克MD13，阿尔伯特敏MD14，禄仲乐MD15，何裴MD16，桑陈泰文MD17，儿子怎么才好MD18，枝韩币大号翰MD19，克利福德黄MD20，史蒂芬汉MD21，安佳娜皮莱MD22，詹姆斯公园MD23，迈伦通MD22，史蒂夫Scaglione不服气MD24，乔斯林Woog JD25和W.雷金MD5

    胃肠病学和肝病，俄勒冈健康与科学大学，俄勒冈州波特兰市，美国1区
    消化系统疾病，耶鲁大学，纽黑文，康涅狄格，美国教研室
    3Gastroenterology /肝病科，弗吉尼亚联邦大学，里士满，弗吉尼亚州，美国
    胃肠病学和肝病，密歇根大学安娜堡分校，密歇根州，美国4Division
    胃肠病学和肝病，斯坦福大学，斯坦福大学，美国加利福尼亚州的5Division
    医药，纽约大学兰贡，纽约市，纽约州，美国的6Department
    7Digestive疾病中心，芝加哥大学，芝加哥，伊利诺伊，美国
    胃肠病学和肝病，宾夕法尼亚大学，费城，宾夕法尼亚州，美国8Division
    9San何塞GI，圣何塞，加利福尼亚，美国
    医药，纽约市，纽约州，美国的10NYU学校
    医药，雪松Sinai医疗中心，洛杉矶，美国加利福尼亚州的11Department
    胃肠病学和肝病，BIDMC，马萨诸塞州波士顿，美国12Department
    13Leduc医疗集团，喷泉谷，加利福尼亚州，美国
    消化14Division，西奈山贝斯以色列，纽约市，纽约州，美国
    15Woodholme消化内科协会，派克维尔，美国马里兰州
    16Asian亚太肝病中心，洛杉矶，加利福尼亚，美国
    17Falls教会家庭实践，弗吉尼亚州福尔斯彻奇，美国
    得克萨斯州，得克萨斯州普莱诺，美国18Digestive健康协会
    19Thomas杰弗逊大学医院，费城，宾夕法尼亚州，美国
    20San旧金山，加利福尼亚，美国
    美国加州，洛杉矶，洛杉矶，美国加利福尼亚州的21University
    22Emory大学，美国佐治亚州亚特兰大，美国
    23NYU朗格尼，纽约市，纽约州，美国
    24Loyola大学，梅伍德，伊利诺伊州，美国
    25Asian健康基金会，费城，宾夕法尼亚州，美国

函授：约瑟夫·安，MD，MS，AGAF，FACG，消化内科和肝病，俄勒冈健康与科学大学，3181 SW山姆杰克逊公园路，L-461，波特兰，俄勒冈州97239，USA的分部。电子信箱：[email protected]

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抽象
目的：

来自美国的数据缺乏对恩替卡韦对肝细胞癌（HCC）的风险的影响（ETV）。我们的目标是，以确定是否与ETV治疗与通过计算基于慢性乙型肝炎（REACH-B）模型风险估计肝癌预期HCC发生率，并将其与HCC观察比较，发病减少肝癌的风险。
方法：

得肝癌在一个回顾性队列2005年和2013年间，恩替卡韦治疗的美国患者的发病率。预测肝癌发病率是使用REACH-B模型计算。的标准化发病率（SIRS）计算为超过预测的HCC病例观察到的比率。
结果：

841例，646（65％为男性，84％为亚裔，平均年龄47岁，36％乙肝e抗原阳性，9.4％的肝硬化）符合纳入标准。在4年的中位随访，17（2.6％），肝癌的病例被诊断，包括无肝硬化8出61（13.1％）肝硬化患者和9个585（1.5％）。与那些无肝癌相比，17例肝癌患者年龄在53岁vs.47年，并更有可能在47.1％和8.4％有肝硬化。在患者无肝硬化，观察到的HCC发生率显著低于在第四年的预测（SIR，0.37; 95％置信区间：0.166-0.82）。该包括所有的患者，包括那些肝硬化，敏感性分析表明，在8.2岁最大随访时间，较显著下预测肝癌发生与0.56的SIR注意到（95％置信区间：0.35-0.905） 。
结论：

基于所述REACH-B型，长期ETV治疗用比预测肝癌发生率较低的相关联。然而，肝癌的风险依然存在，尽管抗病毒治疗小心HCC监测仍然保证的。