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J Clin Oncol. 2017 Sep 20;35(27):3113-3122. doi: 10.1200/JCO.2016.72.0946. Epub 2017 Jun 27.

Treatment Efficacy, Adherence, and Quality of Life Among Women Younger Than 35 Years in the International Breast Cancer Study Group TEXT and SOFT Adjuvant Endocrine Therapy Trials.

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Poornima Saha and Gini F. Fleming, The University of Chicago Medical Center, Chicago, IL; Meredith M. Regan, Weixiu Luo, Harold J. Burstein, and Richard D. Gelber, Dana-Farber Cancer Institute; Meredith M. Regan, Harold J. Burstein, and Richard D. Gelber, Harvard Medical School; Karen N. Price and Richard D. Gelber, Frontier Science and Technology Research Foundation; Richard D. Gelber, Harvard T.H. Chan School of Public Health, Boston, MA; Olivia Pagani, Institute of Oncology of Southern Switzerland, Lugano Viganello; Karin Ribi and Jürg Bernhard, International Breast Cancer Study Group Coordinating Center; Jürg Bernhard, Bern University Hospital, Inselspital, Bern, Switzerland; Prudence A. Francis, Peter MacCallum Cancer Center; St Vincent's Hospital; University of Melbourne, Melbourne; Josephine Stewart, Austin and Heidelberg Repatriation Medical Center, Heidelberg, Victoria; Prudence A. Francis, Josephine Stewart, and Michelle Nottage, University of Newcastle, Newcastle; Alan S. Coates, University of Sydney, Sydney, New South Wales; Michelle Nottage, Royal Brisbane Hospital, Brisbane, Queensland, Australia; Barbara A. Walley, University of Calgary; National Cancer Institute of Canada, Calgary, Alberta, Canada; Henry L. Gómez, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru; Vani Parmar, Tata Memorial Centre, Mumbai, India; Roberto Torres, Instituto Nacional del Cancer, Santiago de Chile, Chile; Meritxell Bellet, Vall d'Hebron Institute of Oncology; Vall d'Hebron University Hospital; Universitat Autònoma de Barcelona, Barcelona; Antonia Perelló, Hospital Universitari Son Espases, Palma de Mallorca, Spain; Faysal Dane, Marmara University Hospital, Istanbul, Turkey; Antonio Moreira, Instituto Português de Oncologia Francisco Gentil - Centro de Lisboa, Lisbon, Portugal; Daniel Vorobiof, Sandton Oncology Centre, Johannesburg, South Africa; and Aron Goldhirsch and Marco Colleoni, European Institute of Oncology, Milan, Italy.


Purpose To describe benefits and toxicities of adjuvant endocrine therapies in women younger than 35 years with breast cancer (n = 582) enrolled in the Suppression of Ovarian Function Trial (SOFT) and Tamoxifen and Exemestane Trial (TEXT). Methods In SOFT, women still premenopausal after surgery with or without chemotherapy were randomly assigned to tamoxifen alone, tamoxifen plus ovarian function suppression (OFS), or exemestane plus OFS. In TEXT, all received OFS with or without concomitant chemotherapy and were randomly assigned to exemestane plus OFS or tamoxifen plus OFS. We summarize treatment efficacy, quality of life, and adherence of the cohort of women younger than 35 years in SOFT and TEXT, alongside data from the cohort of older premenopausal women. Results For 240 human epidermal growth factor receptor 2-negative patients younger than 35 years enrolled in SOFT after receiving chemotherapy, the 5-year breast cancer-free interval (BCFI) was 67.1% (95% CI, 54.6% to 76.9%) with tamoxifen alone, 75.9% with tamoxifen plus OFS (95% CI, 64.0% to 84.4%), and 83.2% with exemestane plus OFS (95% CI, 72.7% to 90.0%). For 145 human epidermal growth factor receptor 2-negative patients younger than 35 years in TEXT, 5-year BCFI was 79.2% (95% CI, 66.2% to 87.7%) with tamoxifen plus OFS and 81.6% (95% CI, 69.8% to 89.2%) with exemestane plus OFS. The most prominent quality of life symptom for patients younger than 35 years receiving OFS was vasomotor symptoms, with the greatest worsening from baseline at 6 months (on the order of 30 to 40 points), but loss of sexual interest and difficulties in becoming aroused were also clinically meaningful (≥ 8-point change). The level of symptom burden was similar in older premenopausal women. A total of 19.8% of women younger than 35 years stopped all protocol-assigned endocrine therapy early. Conclusion In women younger than 35 years with hormone receptor-positive breast cancer, adjuvant OFS combined with tamoxifen or exemestane produces large improvements in BCFI compared with tamoxifen alone. Menopausal symptoms are significant but are not worse than those seen in older premenopausal women.

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