Heidi D. Nelson, MD, MPH; M.E. Beth Smith, DO; Jessica C. Griffin, MS; Rongwei Fu, PhD
Disclaimer: The findings and conclusions in this article are those of the authors, who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or the U.S. Department of Health and Human Services.
Acknowledgment: Andrew Hamilton, MLS, MS, conducted literature searches, and Miranda Pappas, MA; Jennifer Mitchell, BA; and Amanda Brunton, BS, provided assistance (all are affiliated with the Oregon Health & Science University). Linda Humphrey MD, MPH (Portland Veterans Affairs Medical Center), and Peggy Nygren, MA, contributed to earlier versions of the evidence review.
Grant Support: By AHRQ (contract HHSA-290-2007-10057-1-EPC3).
Potential Conflicts of Interest: Dr. Nelson: Grant (money to institution): AHRQ. Support for travel to meetings (money to institution): AHRQ. Dr. Smith: Grant (money to institution): AHRQ. Ms. Griffin: None disclosed. Dr. Fu: Grant (money to institution): AHRQ. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-2536.
Requests for Single Reprints: Heidi D. Nelson, MD, MPH, Pacific Northwest Evidence-based Practice Center, Oregon Health & Science University, Mailcode BICC, 3181 Southwest Sam Jackson Park Road, Portland, OR 97239-3098; e-mail, email@example.com.
Current Author Addresses: Drs. Nelson and Fu and Ms. Griffin: Pacific Northwest Evidence-based Practice Center, Oregon Health & Science University, Mailcode BICC, 3181 Southwest Sam Jackson Park Road, Portland, OR 97239-3098.
Dr. Smith: Oregon Health & Science University, Mailcode L475, 3181 Southwest Sam Jackson Park Road, Portland, OR 97239-3098.
Author Contributions: Conception and design: H.D. Nelson, M.E.B. Smith.
Analysis and interpretation of the data: H.D. Nelson, M.E.B. Smith, J.C. Griffin, R. Fu.
Drafting of the article: H.D. Nelson, M.E.B. Smith.
Critical revision of the article for important intellectual content: H.D. Nelson, M.E.B. Smith, J.C. Griffin, R. Fu.
Final approval of the article: H.D. Nelson, M.E.B. Smith, R. Fu.
Provision of study materials or patients: H.D. Nelson.
Statistical expertise: H.D. Nelson, R. Fu.
Obtaining of funding: H.D. Nelson.
Administrative, technical, or logistic support: H.D. Nelson, J.C. Griffin.
Collection and assembly of data: H.D. Nelson, M.E.B. Smith, J.C. Griffin, R. Fu.
Medications to reduce risk for primary breast cancer are recommended for women at increased risk; however, use is low.
To update evidence about the effectiveness and adverse effects of medications to reduce breast cancer risk, patient use of such medications, and methods for identifying women at increased risk for breast cancer.
MEDLINE and Cochrane databases (through 5 December 2012), Scopus, Web of Science, clinical trial registries, and reference lists.
English-language randomized trials of medication effectiveness and adverse effects, observational studies of adverse effects and patient use, and diagnostic accuracy studies of risk assessment.
Investigators independently extracted data on participants, study design, analysis, follow-up, and results, and a second investigator confirmed key data. Investigators independently dual-rated study quality and applicability using established criteria.
Seven good- and fair-quality trials indicated that tamoxifen and raloxifene reduced incidence of invasive breast cancer by 7 to 9 cases in 1000 women over 5 years compared with placebo. New results from STAR (Study of Tamoxifen and Raloxifene) showed that tamoxifen reduced breast cancer incidence more than raloxifene by 5 cases in 1000 women. Neither reduced breast cancer–specific or all-cause mortality rates. Both reduced the incidence of fractures, but tamoxifen increased the incidence of thromboembolic events more than raloxifene by 4 cases in 1000 women. Tamoxifen increased the incidence of endometrial cancer and cataracts compared with placebo and raloxifene. Trials provided limited and heterogeneous data on medication adherence and persistence. Many women do not take tamoxifen because of associated harms. Thirteen risk-stratification models were modest predictors of breast cancer.
Data on mortality and adherence measures and for women who are nonwhite, are premenopausal, or have comorbid conditions were lacking.
Medications reduced the incidence of invasive breast cancer and fractures and increased the incidence of thromboembolic events. Tamoxifen was more effective than raloxifene but also increased the incidence of endometrial cancer and cataracts. Use is limited by adverse effects and inaccurate methods to identify candidates.
Agency for Healthcare Research and Quality.
Nelson HD, Smith MB, Griffin JC, et al. Use of Medications to Reduce Risk for Primary Breast Cancer: A Systematic Review for the U.S. Preventive Services Task Force. Ann Intern Med. 2013;158:604–614. doi: https://doi.org/10.7326/0003-4819-158-8-201304160-00005
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Published: Ann Intern Med. 2013;158(8):604-614.
Breast Cancer, Cancer Screening/Prevention, Hematology/Oncology, Prevention/Screening.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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