A prospective, randomized study on hepatotoxicity of anastrozole compared with tamoxifen in women with breast cancer.
Bottom Line: 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.
Affiliation: Department of Surgery, Breast Disease Center, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.Show MeSH
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Mentions: Between September 2007 and February 2009, 353 estrogen receptor (ER)- and progesterone receptor (PgR)-positive breast cancer patients (175 and 178 patients in the tamoxifen and anastrozole arms, respectively) were randomized in 28 Chinese centers. The last patient completed the last visit on 28 December 2011. Eleven patients in the tamoxifen group did not receive treatment during the study. Therefore, the full analysis set was added as a supportive sensitivity analysis set to the primary analysis to determine the difference between the two groups. The overall study design and detailed disposition of subjects are presented in Figure1. Patients' demographic and disease characteristics are shown in Table1. All patient characteristics were similar between the two arms. The median age was 59.6 years.
Affiliation: Department of Surgery, Breast Disease Center, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China.