• Amye J Tevaarwerk, Molin Wang, Fengmin Zhao, John H Fetting, David Cella, Lynne I Wagner, Silvana Martino, James N Ingle, Joseph A Sparano, Lawrence J Solin, William C Wood, and Nicholas J Robert.
• Amye J. Tevaarwerk, University of Wisconsin, Madison, WI; Molin Wang, Harvard University; Fengmin Zhao, Dana-Farber Cancer Institute, Boston, MA; John H. Fetting, Johns Hopkins University, Baltimore, MD; David Cella and Lynne I. Wagner, Northwestern University, Chicago, IL; Silvana Martino, Angeles Clinic and Research Institute, Santa Monica, CA; James N. Ingle, Mayo Clinic, Rochester, MN; Joseph A. Sparano, Montefiore Medical Center, Bronx, NY; Lawrence J. Solin, Albert Einstein Medical Center, Philadelphia, PA; William C. Wood, Emory University, Atlanta, GA; and Nicholas J. Robert, Virginia Cancer Specialists, Fairfax, VA. at4@medicine.wisc.edu.
• J. Clin. Oncol. 2014 Dec 10;32(35):3948-58.

PurposeThe effects of ovarian function suppression (OFS) on survival and patient-reported outcomes were evaluated in a phase III trial in which premenopausal women were randomly assigned to tamoxifen with or without OFS.Patients And MethodsPremenopausal women with axillary node-negative, hormone receptor-positive breast cancer tumors measuring ≤ 3 cm were randomly assigned to tamoxifen alone versus tamoxifen plus OFS; adjuvant chemotherapy was not permitted. Primary end points were disease-free survival (DFS) and overall survival (OS). Secondary end points included toxicity and patient-reported outcomes. Patient-reported outcome data included health-related quality of life, menopausal symptoms, and sexual function. These were evaluated at baseline, 6 months, 12 months, and then annually for up to 5 years after registration.ResultsIn all, 345 premenopausal women were enrolled: 171 on tamoxifen alone and 174 on tamoxifen plus OFS. With a median follow-up of 9.9 years, there was no significant difference between arms for DFS (5-year rate: 87.9% v 89.7%; log-rank P = .62) or OS (5-year rate: 95.2% v 97.6%; log-rank P = .67). Grade 3 or higher toxicity was more common in the tamoxifen plus OFS arm (22.4% v 12.3%; P = .004). Patients treated with tamoxifen plus OFS had more menopausal symptoms, lower sexual activity, and inferior health-related quality of life at 3-year follow-up (P < .01 for all). Differences diminished with further follow-up.ConclusionWhen added to tamoxifen, OFS results in more menopausal symptoms and sexual dysfunction, which contributes to inferior self-reported health-related quality of life. Because of early closure, this study is underpowered for drawing conclusions about the impact on survival when adding OFS to tamoxifen.© 2014 by American Society of Clinical Oncology.

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