title: A prospective, randomized study on hepatotoxicity of anastrozole compared with tamoxifen in women with breast cancer.
abstract: 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 3 years 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 15.1 months and 37.1 months, 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.
authors: Department of Surgery, Breast Disease Center, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.
authors: Ying
authors: Y
authors: Lin
authors: Jianlun
authors: J
authors: Liu
authors: Xiaohua
authors: X
authors: Zhang
authors: Li
authors: L
authors: Li
authors: Rui
authors: R
authors: Hu
authors: Jian
authors: J
authors: Liu
authors: Yongchuan
authors: Y
authors: Deng
authors: Dedian
authors: D
authors: Chen
authors: Yangbing
authors: Y
authors: Zhao
authors: Shengrong
authors: S
authors: Sun
authors: Rong
authors: R
authors: Ma
authors: Ying
authors: Y
authors: Zhao
authors: Jinping
authors: J
authors: Liu
authors: Yang
authors: Y
authors: Zhang
authors: Xijing
authors: X
authors: Wang
authors: Yafen
authors: Y
authors: Li
authors: Pingqing
authors: P
authors: He
authors: Enxiao
authors: E
authors: Li
authors: Zheli
authors: Z
authors: Xu
authors: Yaqun
authors: Y
authors: Wu
authors: Zhongsheng
authors: Z
authors: Tong
authors: Xiaojia
authors: X
authors: Wang
authors: Tao
authors: T
authors: Huang
authors: Zhongxiao
authors: Z
authors: Liang
authors: Shui
authors: S
authors: Wang
authors: Fengxi
authors: F
authors: Su
authors: Yunfei
authors: Y
authors: Lu
authors: Helong
authors: H
authors: Zhang
authors: Guosheng
authors: G
authors: Feng
authors: Shenming
authors: S
authors: Wang
mesh_terms: D000368:Aged; D000077384:Anastrozole; D001943:Breast Neoplasms / Q000188:drug therapy*; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D005234:Fatty Liver / Q000139:chemically induced*; D005260:Female; D006801:Humans; D008099:Liver / Q000187:drug effects / Q000378:metabolism; D008875:Middle Aged; D009570:Nitriles / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D013629:Tamoxifen / Q000009:adverse effects / Q000627:therapeutic use*; D017211:Treatment Failure; D014230:Triazoles / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D009570:Nitriles; D014230:Triazoles; D013629:Tamoxifen; D000077384:Anastrozole
keywords: Anastrozole; breast cancer; clinical trial; fatty liver disease; hepatotoxicity; tamoxifen