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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 - 30/06/15

Doi : 10.1016/S1470-2045(15)00049-2 
Jürg Bernhard, DrPhD a, ⁎ , Weixiu Luo, MD b, Karin Ribi, PhD c, Marco Colleoni, MD d, Harold J Burstein, MD e, Carlo Tondini, MD f, Graziella Pinotti, MD g, Simon Spazzapan, MD h, Thomas Ruhstaller, MD i, Fabio Puglisi, MD j, Lorenzo Pavesi, MD k, Vani Parmar, MBBS l, Meredith M Regan, ScD m, Olivia Pagani, MD n, Gini F Fleming, MD o, Prudence A Francis, MD p, Karen N Price, BS q, Alan S Coates, MD r, Richard D Gelber, PhD s, Aron Goldhirsch, MD t, u, Barbara A Walley, MD v
a International Breast Cancer Study Group Coordinating Center and Bern University Hospital, Inselspital, Bern, Switzerland 
b International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute, Boston, MA, USA 
c International Breast Cancer Study Group Coordinating Center, Bern, Switzerland 
d Division of Medical Senology, European Institute of Oncology and International Breast Cancer Study Group, Milan, Italy 
e Dana-Farber Cancer Institute and Alliance for Clinical Trials in Oncology, Boston, MA, USA 
f Medical Oncology, Osp Papa Giovanni XXIII and International Breast Cancer Study Group, Bergamo, Italy 
g Medical Oncology, Ospedale di Circolo and Fondazione Macchi, and International Breast Cancer Study Group, Varese, Italy 
h Medical Oncology, Centro di Riferimento Oncologico, and International Breast Cancer Study Group, Aviano, Italy 
i Breast Center, Kantonsspital St Gallen, Swiss Group for Clinical Cancer Research (SAKK), and International Breast Cancer Study Group, St Gallen, Switzerland 
j Department of Oncology, University Hospital of Udine, University of Udine and International Breast Cancer Study Group, Udine, Italy 
k Oncology Unit, Salvatore Maugeri Foundation, and International Breast Cancer Study Group, Pavia, Italy 
l Surgical Oncology, Breast Services, Tata Memorial Hospital, and International Breast Cancer Study Group, Mumbai, India 
m International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA 
n Institute of Oncology of Southern Switzerland, Swiss Group for Clinical Cancer Research, and International Breast Cancer Study Group, Lugano Viganello, Switzerland 
o University of Chicago Medical Center and Alliance for Clinical Trials in Oncology, Chicago, IL, USA 
p Peter MacCallum Cancer Center, St Vincent’s Hospital, University of Melbourne, Melbourne and Australia and New Zealand Breast Cancer Trials Group, Newcastle, NSW, Australia, and International Breast Cancer Study Group 
q International Breast Cancer Study Group Statistical Center, Frontier Science and Technology Research Foundation, Boston, MA, USA 
r International Breast Cancer Study Group and University of Sydney, Sydney, NSW, Australia 
s International Breast Cancer Study Group Statistical Center, Dana-Farber Cancer Institute, Harvard Medical School, Harvard School of Public Health, Frontier Science and Technology Research Foundation, Boston, MA, USA 
t Program for Breast Health (Senology), European Institute of Oncology, Milan, Italy 
u International Breast Cancer Study Group, Bern, Switzerland 
v Tom Baker Cancer Centre and National Cancer Institute of Canada Clinical Trials Group, Calgary, AB, Canada 

* Correspondence to: Dr Jürg Bernhard, International Breast Cancer Study Group Coordinating Center, Effingerstrasse 40, 3008 Bern, Switzerland

Summary

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 permuted blocks was done with the International Breast Cancer Study Group’s internet-based system and was stratified by chemotherapy use and status of lymph nodes. Patients completed a quality of life (QoL) form comprising several global and symptom indicators at baseline, every 6 months for 24 months, and then every year during years 3 to 6. Differences in the change of QoL from baseline between the two treatments were tested at 6 months, 24 months, and 60 months with mixed-models for repeated measures for each trial with and without chemotherapy and overall. The analysis was by intention to treat. At the time of analysis, the median follow-up was 5·7 years (IQR 3·7–6·9); treatment and follow-up of patients continue. The trials are registered with ClinicalTrials.gov, as NCT00066703 (TEXT) and NCT00066690 (SOFT).

Findings

Patients on tamoxifen plus OFS were more affected by hot flushes and sweats over 5 years than were those on exemestane plus OFS, although these symptoms improved. Patients on exemestane plus OFS reported more vaginal dryness, greater loss of sexual interest, and difficulties becoming aroused than did patients on tamoxifen plus OFS; these differences persisted over time. An increase in bone or joint pain was more pronounced, particularly in the short term, in patients on exemestane plus OFS than patients on tamoxifen plus OFS. Changes in global QoL indicators from baseline were small and similar between treatments over the 5 years.

Interpretation

Overall, from a QoL perspective, there is no strong indication to favour either exemestane plus OFS or tamoxifen plus OFS. The distinct effects of the two treatments on the burden of endocrine symptoms need to be addressed with patients individually.

Funding

Pfizer, International Breast Cancer Study Group, and US National Cancer Institute.

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Vol 16 - N° 7

P. 848-858 - juillet 2015 Retour au numéro
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