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Entecavir vs Lamivudine for Prevention of Hepatitis B Virus Reactivation Among Patients With Untreated Diffuse Large B-Cell Lymphoma Receiving R-CHOP Chemotherapy A Randomized Clinical Trial
Huang, He1; Li, Xueying1; Zhu, Jun2; Ye, Sheng3; Zhang, Hongyu4; Wang, Wei5; Wu, Xiangyuan6; Peng, Jiewen7; Xu, Bing8; Lin, Yingcheng9; Cao, Yabing10; Li, Haoran1; Lin, Suxia11; Liu, Qing12; Lin, Tongyu1
刊名JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
2014-12-17
DOI10.1001/jama.2014.15704
312期:23页:2521-2530
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Medicine, General & Internal
研究领域[WOS]General & Internal Medicine
关键词[WOS]NON-HODGKINS-LYMPHOMA ; SEROPOSITIVE CANCER-PATIENTS ; CYTOTOXIC CHEMOTHERAPY ; HIGH PREVALENCE ; HBV REACTIVATION ; ELDERLY-PATIENTS ; PROPHYLACTIC LAMIVUDINE ; PREEMPTIVE LAMIVUDINE ; PLUS RITUXIMAB ; DES-LYMPHOMES
英文摘要

IMPORTANCE Hepatitis B virus (HBV) reactivation is a serious complication for patients with lymphoma treated with rituximab-containing chemotherapies, despite lamivudine prophylaxis treatment. An optimal prophylactic antiviral protocol has not been determined.

OBJECTIVE To compare the efficacy of entecavir and lamivudine in preventing HBV reactivation in patients seropositive for the hepatitis B surface antigen with untreated diffuse large B-cell lymphoma receiving chemotherapy treatment with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).

DESIGN, SETTING, AND PATIENTS Randomized, open-label, phase 3 study conducted from February 2008 through December 2012 at 10 medical centers in China. This study was a substudy of a parent study designed to compare a 3-week with a 2-week R-CHOP chemotherapy regimen for untreated diffuse large B-cell lymphoma. Patients enrolled in the parent study who were seropositive for the hepatitis B surface antigen and had normal liver function, serum HBV DNA levels of less than 10(3) copies/mL, and no prior antiviral therapy were randomized to entecavir (n = 61) or lamivudine (n = 60).

INTERVENTIONS Daily entecavir (0.5 mg) or lamivudine (100 mg) beginning 1week before the initiation of R-CHOP treatment to 6 months after completion of chemotherapy.

MAIN OUTCOMES AND MEASURES The primary efficacy end point was the incidence of HBV-related hepatitis. The secondary end points included rates of HBV reactivation, chemotherapy disruption due to hepatitis, and treatment-related adverse events.

RESULTS The date of last patient follow-up was May 25, 2013. Incidence of HBV-related hepatitis was significantly lower for the entecavir group vs the lamivudine group.

[GRAPHICS]

CONCLUSIONS AND RELEVANCE Among patients seropositive for the hepatitis B surface antigen with diffuse large B-cell lymphoma undergoing R-CHOP chemotherapy, the addition of entecavir compared with lamivudine resulted in a lower incidence of HBV-related hepatitis and HBV reactivation. If replicated, these findings support the use of entecavir in these patients.

语种英语
WOS记录号WOS:000346346900015
资助机构Foundation of 5010 Clinical Trials of Sun Yat-sen University
引用统计
被引频次:66[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/65476
专题北京大学临床肿瘤学院_肿瘤内科
北京大学临床肿瘤学院_淋巴肿瘤内科
作者单位1.Sun Yat Sen Univ, Ctr Canc, Dept Med Oncol, Guangzhou 510060, Guangdong, Peoples R China
2.Beijing Canc Hosp, Dept Med Oncol, Beijing, Peoples R China
3.First Peoples Hosp Foshan, Ctr Canc, Foshan, Peoples R China
4.Peoples Hosp Zhongshan, Ctr Canc, Zhongshan, Peoples R China
5.Sun Yat Sen Univ, Affiliated Hosp 1, Dept Med Oncol, Guangzhou 510060, Guangdong, Peoples R China
6.Sun Yat Sen Univ, Affiliated Hosp 5, Dept Med Oncol, Zhuhai, Peoples R China
7.Sun Yat Sen Univ, Affiliated Hosp 3, Dept Med Oncol, Guangzhou 510060, Guangdong, Peoples R China
8.Southern Med Univ, Dept Hematol, Southern Hosp, Guangzhou, Guangdong, Peoples R China
9.Shantou Univ, Coll Med, Dept Med Oncol, Canc Hosp, Shantou, Peoples R China
10.Sun Yat Sen Univ, Ctr Canc, Dept Pathol, Guangzhou 510060, Guangdong, Peoples R China
11.Sun Yat Sen Univ, Dept Epidemiol & Biostat, Dept Pathol, Guangzhou 510060, Guangdong, Peoples R China
12.Kiang Wu Hosp, Ctr Canc, Macao, Peoples R China
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GB/T 7714
Huang, He,Li, Xueying,Zhu, Jun,et al. Entecavir vs Lamivudine for Prevention of Hepatitis B Virus Reactivation Among Patients With Untreated Diffuse Large B-Cell Lymphoma Receiving R-CHOP Chemotherapy A Randomized Clinical Trial[J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION,2014,312(23):2521-2530.
APA Huang, He.,Li, Xueying.,Zhu, Jun.,Ye, Sheng.,Zhang, Hongyu.,...&Lin, Tongyu.(2014).Entecavir vs Lamivudine for Prevention of Hepatitis B Virus Reactivation Among Patients With Untreated Diffuse Large B-Cell Lymphoma Receiving R-CHOP Chemotherapy A Randomized Clinical Trial.JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION,312(23),2521-2530.
MLA Huang, He,et al."Entecavir vs Lamivudine for Prevention of Hepatitis B Virus Reactivation Among Patients With Untreated Diffuse Large B-Cell Lymphoma Receiving R-CHOP Chemotherapy A Randomized Clinical Trial".JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION 312.23(2014):2521-2530.
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