- Title
- Use of anastrozole for breast cancer prevention (IBIS-II): long-term results of randomised controlled trial
- Creator
- Cuzick, Jack; Sestak, Ivanka; Forbes, John F.; Dowsett, Mitch; Cawthorn, Simon; Mansel, Robert E.; Loibl, Sibylle; Bonanni, Bernardo; Evans, D. Gareth; Howell, Anthony
- Relation
- NHMRC.300755 http://purl.org/au-research/grants/nhmrc/300755 & 569213 http://purl.org/au-research/grants/nhmrc/569213
- Relation
- The Lancet Vol. 395, Issue 10218, p. 117-122
- Publisher Link
- http://dx.doi.org/10.1016/S0140-6736(19)32955-1
- Publisher
- Lancet Publishing Group
- Resource Type
- journal article
- Date
- 2020
- Description
- Background: Two large clinical trials have shown a reduced rate of breast cancer development in high-risk women in the initial 5 years of follow-up after use of aromatase inhibitors (MAP.3 and International Breast Cancer Intervention Study II [IBIS-II]). Here, we report blinded long-term follow-up results for the IBIS-II trial, which compared anastrozole with placebo, with the objective of determining the efficacy of anastrozole for preventing breast cancer (both invasive and ductal carcinoma in situ) in the post-treatment period. Methods: IBIS-II is an international, randomised, double-blind, placebo-controlled trial. Postmenopausal women at increased risk of developing breast cancer were recruited and were randomly assigned (1:1) to either anastrozole (1 mg per day, oral) or matching placebo daily for 5 years. After treatment completion, women were followed on a yearly basis to collect data on breast cancer incidence, death, other cancers, and major adverse events (cardiovascular events and fractures). The primary outcome was all breast cancer. Findings: 3864 women were recruited between Feb 2, 2003, and Jan 31, 2012. 1920 women were randomly assigned to 5 years anastrozole and 1944 to placebo. After a median follow-up of 131 months (IQR 105–156), a 49% reduction in breast cancer was observed for anastrozole (85 vs 165 cases, hazard ratio [HR] 0·51, 95% CI 0·39–0·66, p<0·0001). The reduction was larger in the first 5 years (35 vsvsvs 70, HR 0·96, 95% CI 0·69–1·34, p=0·82) or for breast cancer (two anastrozole vs three placebo). A significant decrease in non-breast cancers was observed for anastrozole (147 vs 200, odds ratio 0·72, 95% CI 0·57–0·91, p=0·0042), owing primarily to non-melanoma skin cancer. No excess of fractures or cardiovascular disease was observed. Interpretation: This analysis has identified a significant continuing reduction in breast cancer with anastrozole in the post-treatment follow-up period, with no evidence of new late side-effects. Further follow-up is needed to assess the effect on breast cancer mortality.
- Subject
- cancer prevention; carcinoma; placebo; aromatase inhibitor; SDG 3; Sustainable Development Goals
- Identifier
- http://hdl.handle.net/1959.13/1440936
- Identifier
- uon:41264
- Identifier
- ISSN:0140-6736
- Language
- eng
- Reviewed
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