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

J Bernhard; W Luo; K Ribi; M Colleoni; HJ Burstein; C Tondini; G Pinotti; S Spazzapan; T Ruhstaller; F Puglisi; L Pavesi; V Parmar; MM Regan; O Pagani; GF Fleming; PA Francis; KN Price; AS Coates; RD Gelber; A Goldhirsch; BA 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

J Bernhard, W Luo, K Ribi, M Colleoni, HJ Burstein, C Tondini, G Pinotti, S Spazzapan, T Ruhstaller, F Puglisi, L Pavesi, V Parmar, MM Regan, O Pagani, GF Fleming, PA Francis, KN Price, AS Coates, RD Gelber, A 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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