Abstract S3-09: Patient-reported endocrine symptoms, sexual functioning and quality of life (QoL) in the IBCSG SOFT trial: Adjuvant treatment with tamoxifen (T) alone versus tamoxifen plus ovarian function suppression (OFS) in premenopausal women with hormone receptor-po
Authors: Ribi Karin , Luo Weixiu , Bernhard Juerg , Francis Prudence A , Bellet Meritxell , Burstein Harold J , Pavesi Lorenzo , Parmar Vani , Tondini Carlo , Visini Marilena , Torres Roberto , Karlsson Per , Spazzapan Simon , Avella Antoni , Ruhstaller Thomas , Puglisi Fabio , Regan Meredith M , Coates Alan S , Gelber Richard D , Fleming Gini F 
Published: May 2015

Abstract
Background: Relatively little is known about treatment-related endocrine symptoms, sexual function and QoL in premenopausal women receiving adjuvant endocrine therapy with or without OFS. SOFT is the first trial providing patient-reported data in premenopausal women undergoing OFS combined with T vs. tamoxifen alone for five years.
Methods: Between Nov 2003 and Apr 2011, 3,066 premenopausal patients with HR+ BC were enrolled in the phase III trial SOFT, of whom 2,045 were randomly assigned to receive adjuvant treatment with 5 years T or T+OFS. A third group received exemestane+OFS and is not included in this report. Prior chemotherapy was allowed, provided women had confirmed premenopausal estradiol levels within 8 months of completing chemotherapy. Patients completed a questionnaire consisting of several global (physical well-being, mood, coping effort, treatment burden) and symptom-specific indicators (hot flushes, vaginal discharge, vaginal dryness, joint pain, loss of sexual interest) at baseline, every 6 months for the first 24 months, and annually years 3 to 6. Differences between the two treatments will be tested early (6 months post-randomization), mid-treatment (24 months post-randomization), and late (60 months post-randomization) using repeated measures modeling overall and by chemotherapy stratum. We anticipated women receiving T+OFS would report more endocrine symptoms and worse sexual function over the whole observation period.
Results: The QoL analysis will present patient-reported outcomes including endocrine symptoms, sexual function, and global QoL domains over time. Differences between the treatments and the relative impact of endocrine symptoms on global domains will be evaluated. Current median follow-up is 5 yrs. The final analysis will be completed October 15, 2014. A separate abstract has been submitted for the efficacy analysis of this study. These results may be critical in assisting women and their doctors in weighing the risks and benefits of the two treatments.
Citation Format: Karin Ribi, Weixiu Luo, Juerg Bernhard, Prudence A Francis, Meritxell Bellet, Harold J Burstein, Lorenzo Pavesi, Vani Parmar, Carlo Tondini, Marilena Visini, Roberto Torres, Per Karlsson, Simon Spazzapan, Antoni Avella, Thomas Ruhstaller, Fabio Puglisi, Meredith M Regan, Alan S Coates, Richard D Gelber, Gini F Fleming. Patient-reported endocrine symptoms, sexual functioning and quality of life (QoL) in the IBCSG SOFT trial: Adjuvant treatment with tamoxifen (T) alone versus tamoxifen plus ovarian function suppression (OFS) in premenopausal women with hormone receptor-po [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr S3-09.