Anastrozole for prevention of breast cancer in high-risk postmenopausal women (IBIS-II): an international, double-blind, randomised placebo-controlled trial

被引：442

作者：

Cuzick, Jack ^{[1
]}

Sestak, Ivana ^{[1
]}

Forbes, John F. ^{[2
]}

Dowsett, Mitch ^{[3
]}

Knox, Jill ^{[1
]}

Cawthorn, Simon ^{[5
]}

Saunders, Christobel ^{[6
]}

Roche, Nicola ^{[4
]}

Mansel, Robert E. ^{[7
]}

von Minckwitz, Gunter ^{[8
,9
]}

Bonanni, Bernardo ^{[10
]}

Palva, Tiina ^{[11
]}

Howell, Anthony ^{[12
]}

机构：

[1] Queen Mary Univ London, Wolfson Inst Prevent Med, Ctr Canc Prevent, London EC1M 6BQ, England

[2] Univ Newcastle, Calvary Mater Newcastle, Australian New Zealand Breast Canc Trials Grp, Waratah, NSW, Australia

[3] Royal Marsden NHS Trust, Acad Dept Biochem, London, England

[4] Royal Marsden NHS Trust, Breast Unit, London, England

[5] Southmead Hosp, Breast Care Ctr, Bristol, Avon, England

[6] Univ Western Australia, Crawley, WA, Australia

[7] Univ Wales Coll Cardiff, Coll Med, Dept Surg, Cardiff CF1 3NS, S Glam, Wales

[8] German Breast Grp, Neu Isenburg, Germany

[9] Univ Womens Hosp, Frankfurt, Germany

[10] European Inst Oncol, Div Chemoprevent & Genet, Milan, Italy

[11] Pirkanmaa Canc Soc, Tampere, Finland

[12] Genesis Breast Canc Prevent Ctr, Manchester, Lancs, England

来源：

LANCET | 2014年 / 383卷 / 9922期

基金：

英国医学研究理事会;

关键词：

AROMATASE INHIBITORS; ENDOMETRIAL CANCER; FOLLOW-UP; DRY EYE; TAMOXIFEN; ESTROGEN; METAANALYSIS; DENSITY;

D O I：

10.1016/S0140-6736(13)62292-8

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

Background Aromatase inhibitors effectively prevent breast cancer recurrence and development of new contralateral tumours in postmenopausal women. We assessed the efficacy and safety of the aromatase inhibitor anastrozole for prevention of breast cancer in postmenopausal women who are at high risk of the disease. Methods Between Feb 2, 2003, and Jan 31, 2012, we recruited postmenopausal women aged 40-70 years from 18 countries into an international, double-blind, randomised placebo-controlled trial. To be eligible, women had to be at increased risk of breast cancer (judged on the basis of specific criteria). Eligible women were randomly assigned (1:1) by central computer allocation to receive 1 mg oral anastrozole or matching placebo every day for 5 years. Randomisation was stratified by country and was done with blocks (size six, eight, or ten). All trial personnel, participants, and clinicians were masked to treatment allocation; only the trial statistician was unmasked. The primary endpoint was histologically confirmed breast cancer (invasive cancers or non-invasive ductal carcinoma in situ). Analyses were done by intention to treat. This trial is registered, number ISRCTN31488319. Findings 1920 women were randomly assigned to receive anastrozole and 1944 to placebo. After a median follow-up of 5.0 years (IQR 3.0-7.1), 40 women in the anastrozole group (2%) and 85 in the placebo group (4%) had developed breast cancer (hazard ratio 0.47, 95% CI 0.32-0.68, p<0.0001). The predicted cumulative incidence of all breast cancers after 7 years was 5.6% in the placebo group and 2.8% in the anastrozole group. 18 deaths were reported in the anastrozole group and 17 in the placebo group, and no specific causes were more common in one group than the other (p=0.836). Interpretation Anastrozole effectively reduces incidence of breast cancer in high-risk postmenopausal women. This finding, along with the fact that most of the side-effects associated with oestrogen deprivation were not attributable to treatment, provides support for the use of anastrozole in postmenopausal women at high risk of breast cancer.

引用

页码：1041 / 1048

页数：8

共 32 条

[31]

ESTROGENS AND ENDOMETRIAL CANCER - EFFECT OF OTHER RISK-FACTORS ON THE ASSOCIATION [J].