Practice Guideline Update on the Use of Pharmacologic Interventions Including Tamoxifen, Raloxifene, and Aromatase Inhibition for Breast Cancer Risk R

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 and technology assessments reflect expert consensus based on the best available evidence. They are intended to assist physicians and patients in clinical decision-making and to identify questions and settings for further research. With the rapid flow of scientific information in oncology, new evidence can emerge between the time an updated guideline or assessment was submitted for publication, and when it is read or appears in print. Guidelines and assessments are not continually updated and may not reflect the most recent evidence. Guidelines and assessments 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 with the patient. Accordingly, adherence to any guideline or assessment 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 and assessments describe the use of procedures and therapies in clinical practice and cannot be assumed to apply to the use of 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 assessments, or for any errors or omissions.
Last Updated on 9/4/09