{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,27]],"date-time":"2026-06-27T00:33:59Z","timestamp":1782520439417,"version":"3.54.5"},"reference-count":40,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"35","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2014,12,10]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p>The 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p>Premenopausal women with axillary node-negative, hormone receptor\u2013positive breast cancer tumors measuring \u2264 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In 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 &lt; .01 for all). Differences diminished with further follow-up.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>When 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.<\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2014.55.6993","type":"journal-article","created":{"date-parts":[[2014,10,28]],"date-time":"2014-10-28T07:25:15Z","timestamp":1414481115000},"page":"3948-3958","source":"Crossref","is-referenced-by-count":124,"title":["Phase III Comparison of Tamoxifen Versus Tamoxifen Plus Ovarian Function Suppression in Premenopausal Women With Node-Negative, Hormone Receptor\u2013Positive Breast Cancer (E-3193, INT-0142): A Trial of the Eastern Cooperative Oncology Group"],"prefix":"10.1200","volume":"32","author":[{"given":"Amye J.","family":"Tevaarwerk","sequence":"first","affiliation":[{"name":"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,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Molin","family":"Wang","sequence":"additional","affiliation":[{"name":"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. 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