Published on August 10, 2010 vol. 28 no. 23 3784-3796
Harold J. Burstein, Ann Alexis Prestrud, Jerry Seidenfeld, Holly Anderson, Thomas A. Buchholz, Nancy E. Davidson, Karen E. Gelmon, Sharon H. Giordano, Clifford A. Hudis, Jennifer Malin, Eleftherios P. Mamounas, Diana Rowden, Alexander J. Solky, MaryFran R. Sowers, Vered Stearns, Eric P. Winer, Mark R. Somerfield, Jennifer J. Griggs
Objective: To develop evidence-based guidelines, based on a systematic review, for endocrine therapy for postmenopausal women with hormone receptor-positive breast cancer.
Methods: A literature search identified relevant randomized trials. Databases searched included MEDLINE, PREMEDLINE, the Cochrane Collaboration Library, ASCO and SABCS. The primary outcomes of interest were disease-free survival, overall survival, and time to contralateral breast cancer. Secondary outcomes included adverse events and quality of life. An expert panel reviewed the literature, considering twelve major trials, and developed updated recommendations.
Results: An adjuvant treatment strategy incorporating an aromatase inhibitor (AI) as primary (initial endocrine therapy), sequential (using both tamoxifen and an AI in either order) or extended (AI after five years of tamoxifen) therapy reduces the risk of breast cancer recurrence compared to five years of tamoxifen alone. Data suggest that including an AI as primary monotherapy or as sequential treatment after two to three years of tamoxifen yields similar outcomes. Tamoxifen and aromatase inhibitors differ in their side effect profiles and these differences may inform treatment preferences.
Recommendations: The Update Committee recommends that postmenopausal women with hormone receptor-positive breast cancer consider incorporating an aromatase inhibitor therapy at some point during adjuvant treatment, either as upfront therapy or as sequential treatment after tamoxifen. The optimal timing and duration of endocrine treatment remain unresolved. The Committee supports careful consideration of side effect profiles and patient preferences in deciding whether and when to incorporate AI therapy.
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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: 7/12/10
