Patient-reported outcomes with adjuvant exemestane versus tamoxifen in premenopausal women with early breast cancer undergoing ovarian suppression (TEXT and SOFT): a combined analysis of two phase 3 randomised trials

Juerg Bernhard; Weixiu Luo; Karin Ribi; Marco Colleoni; Harold J Burstein; Carlo Tondini; Graziella Pinotti; Simon Spazzapan; Thomas Ruhstaller; Fabio Puglisi; Lorenzo Pavesi; Vani Parmar; Meredith M Regan; Olivia Pagani; Gini F Fleming; Prudence A Francis; Karen N Price; Alan S Coates; Richard D Gelber; Aron Goldhirsch; Barbara A Walley

Journal article

Patient-reported outcomes with adjuvant exemestane versus tamoxifen in premenopausal women with early breast cancer undergoing ovarian suppression (TEXT and SOFT): a combined analysis of two phase 3 randomised trials

Juerg Bernhard, Weixiu Luo, Karin Ribi, Marco Colleoni, Harold J Burstein, Carlo Tondini, Graziella Pinotti, Simon Spazzapan, Thomas Ruhstaller, Fabio Puglisi, Lorenzo Pavesi, Vani Parmar, Meredith M Regan, Olivia Pagani, Gini F Fleming, Prudence A Francis, Karen N Price, Alan S Coates, Richard D Gelber, Aron Goldhirsch Show all

LANCET ONCOLOGY | ELSEVIER SCIENCE INC | Published : 2015

DOI: 10.1016/S1470-2045(15)00049-2

Abstract

BACKGROUND: The combined efficacy analysis of the TEXT and SOFT trials showed a significant disease-free survival benefit with exemestane plus ovarian function suppression (OFS) compared with tamoxifen plus OFS. We present patient-reported outcomes from these trials. METHODS: Between Nov 7, 2003, and April 7, 2011, 4717 premenopausal women with hormone-receptor positive breast cancer were enrolled in TEXT or SOFT to receive unmasked adjuvant treatment with 5 years of exemestane plus OFS or tamoxifen plus OFS. Gonadotropin-releasing hormone analogue triptorelin, bilateral oophorectomy, or bilateral ovarian irradiation were used to achieve OFS. Chemotherapy use was optional. Randomisation with..

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