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A prospective, randomized study on hepatotoxicity of anastrozole compared with tamoxifen in women with breast cancer

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机构: [1]Department of Surgery, Breast Disease Center, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou [2]Department of Breast Surgery, GuangxiTumor Institute and Hospital, Nanning [3]Department of Breast Surgery, The First Affiliated Hospital of Wenzhou Medical College, Wenzhou [4]Departmentof Oncology, First Affiliated Hospital of Dalian Medical University, Dalian [5]Department of Breast Surgery, Sichuan Cancer Hospital, Chengdu [6]Departmentof Oncology, Fujian Provincial Tumor Hospital, Fuzhou [7]Department of Breast Surgery, Second Affiliated Hospital, College of Medicine, ZhejiangUniversity, Hangzhou [8]Department of Breast Surgery, Yunnan Tumor Hospital, Kunming [9]Department of Breast Surgery, West China Hospital, SichuanUniversity, Chengdu [10]Department of Breast and Thyroid Surgery, The People’s Hospital of Wuhan University, Wuhan [11]Department of Breast Surgery,QiLu Hospital of Shandong University, Jinan [12]Department of Breast Surgery, The First Affiliated Hospital, Shanxi Medical University, Taiyuan [13]Department of Breast Surgery, The People’s Hospital of Sichuan Province, Chengdu [14]Department of Medical Oncology, The Second Affiliated Hospital,Dalian Medical University, Dalian [15]Department of Surgical Oncology, The Second Affiliated Hospital, School of Medicine, Xi’an Jiaotong University, Xi’an [16]Department of Breast Surgery, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai [17]Department of General Surgery, ShanghaiSixth People0s Hospital, Shanghai [18]Department of Medical Oncology, The First Affiliated Hospital, School of Medicine, Xi’an Jiaotong University, Xi’an [19]Department of Breast and Thyroid Surgery, China-Japan Union Hospital of Jilin University, Changchun [20]Department of Breast and Thyroid Surgery,Tongji Affiliated Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan [21]Department of Breast Surgery, CancerInstitute and Hospital, Tianjin Medical University, Tianjin [22]Department of Oncology, Zhejiang Cancer Hospital, Hangzhou [23]Department of Breast andThyroid Surgery, Xiehe Affiliated Hospital, Tongji Medical College of Huazhong University of Science and Technology, Wuhan [24]Second Department ofInternal Medicine, The People’s Hospital of Guangxi Zhuang Autonomous Region, Nanning [25]Department of General Surgery, The People’s Hospital ofJiangsu Province/The First Affiliated Hospital of Nanjing Medical University, Nanjing [26]Department of Breast Surgery, The Second Affiliated Hospital, SunYat-sen University, Guangzhou [27]Department of Intestine and Gland Surgery, The First Affiliated Hospital, Guangxi Medical University, Nanning [28]Department of Oncology, Tangdu Hospital, The Fourth Military Medical University/The Second Affiliated Hospital, The Fourth Military Medical University,Xi’an, China
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关键词: Anastrozole breast cancer clinical trial fatty liver disease hepatotoxicity tamoxifen

摘要:
Tamoxifen and anastrozole are widely used as adjuvant treatment for early stage breast cancer, but their hepatotoxicity is not fully defined. We aimed to compare hepatotoxicity of anastrozole with tamoxifen in the adjuvant setting in postmenopausal breast cancer patients. Three hundred and fifty-three Chinese postmenopausal women with hormone receptor-positive early breast cancer were randomized to anastrozole or tamoxifen after optimal primary therapy. The primary end-point was fatty liver disease, defined as a liver-spleen ratio <0.9 as determined using a computed tomography scan. The secondary end-points included abnormal liver function and treatment failure during the 3-year follow up. The cumulative incidence of fatty liver disease after 3years was lower in the anastrozole arm than that of tamoxifen (14.6% vs 41.1%, P<0.0001; relative risk, 0.30; 95% CI, 0.21-0.45). However, there was no difference in the cumulative incidence of abnormal liver function (24.6% vs 24.7%, P=0.61). Interestingly, a higher treatment failure rate was observed in the tamoxifen arm compared with anastrozole and median times to treatment failure were 15.1months and 37.1months, respectively (P<0.0001; HR, 0.27; 95% CI, 0.20-0.37). The most commonly reported adverse events were reproductive system disorders' in the tamoxifen group (17.1%), and musculoskeletal disorders' in the anastrozole group (14.6%). Postmenopausal women with hormone receptor-positive breast cancer receiving adjuvant anastrozole displayed less fatty liver disease, suggesting that this drug had a more favorable hepatic safety profile than tamoxifen and may be preferred for patients with potential hepatic dysfunction.

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出版当年[2014]版:
大类 | 3 区 医学
小类 | 3 区 肿瘤学
最新[2023]版:
大类 | 2 区 医学
小类 | 2 区 肿瘤学
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出版当年[2014]版:
Q2 ONCOLOGY
最新[2023]版:
Q1 ONCOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2014版] 出版当年五年平均 出版前一年[2013版] 出版后一年[2015版]

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第一作者机构: [1]Department of Surgery, Breast Disease Center, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou
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通讯机构: [1]Department of Surgery, Breast Disease Center, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou [*1]Department of Surgery, Breast Disease Center, The First Affiliated Hospital, Sun Yat-Sen University, 58 Zhongshan Road II, Guangzhou 510080, China
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