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

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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

Kala Visvanathan, Rowan Chlebowski, Patricia Hurley, Nananda F. Col, Mary Ropka, Deborah Collyar, Monica Morrow, Carolyn Runowicz, Kathleen I. Pritchard, Karen Hagerty, Banu Arun, Judy Garber, Victor Vogel, James L. Wade, Powel Brown, Jack Cuzick, Barnett S. Kramer, Scott M. Lippman

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

Methods: A literature search identified relevant randomized trials published since 2002. Primary outcome of interest was BCa incidence (invasive and non-invasive). Secondary outcomes included BCa 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 five years reduces the risk of BCa for at least 10 years, particularly estrogen receptor positive (ER+) invasive tumors. Women = 50 years 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+ invasive BCa with equal efficacy. Raloxifene is associated with lower risk of thromboembolic disease, benign uterine conditions, and cataracts than tamoxifen in postmenopausal women. No evidence exists establishing whether a reduction in BCa risk from either agent translates into reduced BCa mortality.

Recommendations: In women at increased risk for BCa, tamoxifen (20 mg/d for five years) may be offered to reduce the risk of invasive ER+ BCa, with benefits for at least 10 years. In postmenopausal women, raloxifene (60mg/d for five years) may also be considered. Use of aromatase inhibitors, fenretinide, or other selective estrogen receptor modulators to lower BCa 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. articles met inclusion criteria. In premenopausal women, tamoxifen for five years reduces the risk of BCa for at least 10 years, particularly estrogen receptor positive (ER+) invasive tumors. Women = 50 years 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+ invasive BCa with equal efficacy. Raloxifene is associated with lower risk of thromboembolic disease, benign uterine conditions, and cataracts than tamoxifen in postmenopausal women. No evidence exists establishing whether a reduction in BCa risk from either agent translates into reduced BCa mortality.

ASCO’s practice guidelines reflect expert consensus based on clinical evidence and literature available at the time they are written and are intended to assist physicians in clinical decision-making and identify questions and settings for further research. Due to the rapid flow of scientific information in oncology, new evidence may have emerged since the time a guideline was submitted for publication. Guidelines are not continually updated and may not reflect the most recent evidence. Guidelines address only the topics specifically identified in the guideline and are not applicable to interventions, diseases or stages of disease not specifically identified. Guidelines cannot account for individual variation among patients and cannot be considered inclusive of all proper methods of care or exclusive of other treatments. It is the responsibility of the treating physician or other health care provider, relying on independent experience and knowledge of the patient, to determine the best course of treatment for the patient. Accordingly, adherence to any guideline is voluntary, with the ultimate determination regarding its application to be made by the physician in light of each patient's individual circumstances and preferences. ASCO guidelines describe the use of procedures and therapies in clinical practice and cannot be assumed to apply to the use of these interventions in the context of clinical trials. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of ASCO's guidelines, or for any errors or omissions.

Last Updated on 9/4/09