Abstract S6-03: Anastrozole versus tamoxifen for the prevention of loco-regional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in-situ (IBIS-II DCIS)

Abstract

Abstract Background: Third generation aromatase inhibitors are a more effective treatment option than tamoxifen for hormone receptor positive invasive breast cancer in postmenopausal women. However, it is not known whether anastrozole is more effective than tamoxifen in preventing the recurrence of breast cancer in women with hormone receptor (HR) positive ductal carcinoma in situ (DCIS). Here, we compare the efficacy of anastrozole versus tamoxifen in postmenopausal women with HR positive DCIS. Methods: A multi-centre randomised placebo-controlled trial of 1mg/day anastrozole (oral) vs. 20mg/day tamoxifen (oral) for five years was conducted in 2980 postmenopausal women with locally excised HR positive DCIS. The primary endpoint was to determine if anastrozole is at least as effective as tamoxifen in loco-regional control and prevention of contralateral disease. Secondary endpoints included breast cancer mortality, other cancers, cardiovascular disease, fractures, adverse events and non-breast cancer deaths. All analyses were done on an intention-to-treat basis and Cox proportional hazard were used to compute hazard ratios and corresponding confidence intervals for recurrence. Results: Between 2003 and 2012, a total of 2980 postmenopausal women were recruited into the IBIS-II DCIS trial. 1471 women were randomly assigned to receive anastrozole and 1509 women tamoxifen. Median follow-up for this first analysis is 6.8 years and 131 breast cancer recurrences have been recorded. Median age was 60.3 years (56.1-64.6), median BMI was 26.7 (23.6-30.7), and 45.6% of women had used hormone replacement therapy (HRT) before joining the trial. Of the 131 women with recurrent disease, 77 had a loco-regional recurrence and 51 reported contralateral disease. A total of 61 deaths were recorded. We will present a comprehensive analysis of the efficacy of anastrozole and tamoxifen for preventing loco-regional/contralateral breast cancer and major adverse events by intention to treat (ITT). Conclusions: To follow. Citation Format: Cuzick J, Forbes JF, Sestak I, Howell A, Bonanni B, Bundred N, Levy C, von Minckwitz G, Eiermann W, Neven P, Stierer M, Holcombe C, Coleman RE, Jones LJ, Ellis I. Anastrozole versus tamoxifen for the prevention of loco-regional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in-situ (IBIS-II DCIS). [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr S6-03.