Originally published as JCO Early Release 10.1200/JCO.2008.20.5179 on May 26 2009

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American Society of Clinical Oncology Clinical Practice Guideline Update on the Use of Pharmacologic Interventions Including Tamoxifen, Raloxifene, and Aromatase Inhibition for Breast Cancer Risk Reduction

From the Johns Hopkins Medical Institutions, Baltimore, MD; Harbor University of California, Los Angeles Medical Center, Los Angeles, CA; Patient Advocates In Research, Danville, CA; American Society of Clinical Oncology, Alexandria, VA; Maine Medical Center, Portland, ME; Fox Chase Cancer Center, Philadelphia, PA; Memorial Sloan-Kettering Cancer Center, New York, NY; Neag Comprehensive Cancer Center, Farmington, CT; Sunnybrook, Toronto, Ontario, Canada; The University of Texas M. D. Anderson Cancer Center; Baylor College of Medicine, Houston, TX; Dana-Farber Cancer Institute, Boston, MA; American Cancer Society, Atlanta, GA; Cancer Care Specialists of Central Illinois, Decatur, IL; Cancer Research UK, London, United Kingdom; and National Institutes of Health, Bethesda, MD.

Corresponding author: American Society of Clinical Oncology, Cancer Policy and Clinical Affairs, 2318 Mill Rd, Suite 800, Alexandria, VA 22314; email: guidelines{at}asco.org.

Purpose To update the 2002 American Society of Clinical Oncology guideline on pharmacologic interventions for breast cancer (BC) risk reduction.

Methods A literature search identified relevant randomized trials published since 2002. Primary outcome of interest was BC incidence (invasive and noninvasive). Secondary outcomes included BC mortality, adverse events, and net health benefits. An expert panel reviewed the literature and developed updated consensus guidelines.

Results Seventeen articles met inclusion criteria. In premenopausal women, tamoxifen for 5 years reduces the risk of BC for at least 10 years, particularly estrogen receptor (ER) –positive invasive tumors. Women 50 years of age experience fewer serious side effects. Vascular and vasomotor events do not persist post-treatment across all ages. In postmenopausal women, raloxifene and tamoxifen reduce the risk of ER-positive invasive BC with equal efficacy. Raloxifene is associated with a lower risk of thromboembolic disease, benign uterine conditions, and cataracts than tamoxifen in postmenopausal women. No evidence exists establishing whether a reduction in BC risk from either agent translates into reduced BC mortality.

Recommendations In women at increased risk for BC, tamoxifen (20 mg/d for 5 years) may be offered to reduce the risk of invasive ER-positive BC, with benefits for at least 10 years. In postmenopausal women, raloxifene (60 mg/d for 5 years) may also be considered. Use of aromatase inhibitors, fenretinide, or other selective estrogen receptor modulators to lower BC risk is not recommended outside of a clinical trial. Discussion of risks and benefits of preventive agents by health providers is critical to patient decision making.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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				American Society of Clinical Oncology Clinical Practice Guideline Update on the Use of Pharmacologic Interventions Including Tamoxifen, Raloxifene, and Aromatase Inhibition for Breast Cancer Risk Reduction J. Oncol. Pract, July 1, 2009; 5(4): 196 - 199. [Full Text] [PDF]