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Adjuvant ovarian function suppression and cognitive function in women with breast cancer

Journal article
Authors K. A. Phillips
M. M. Regan
K. Ribi
P. A. Francis
F. Puglisi
M. Bellet
S. Spazzapan
Per Karlsson
D. R. Budman
K. Zaman
E. A. Abdi
S. M. Domchek
Y. Feng
K. N. Price
A. S. Coates
R. D. Gelber
P. Maruff
F. Boyle
J. F. Forbes
T. Ahles
G. F. Fleming
J. Bernhard
Soft Investigators Co
Published in British Journal of Cancer
Volume 114
Issue 9
Pages 956-964
ISSN 0007-0920
Publication year 2016
Published at Institute of Clinical Sciences, Department of Oncology
Pages 956-964
Language en
Keywords breast cancer, ovarian function, cognitive function, quality of life, premenopausal, GnRH agonist, tamoxifen, exemestane, endocrine therapy, premenopausal women, randomized-trials, young-women, impairment, chemotherapy, exemestane, menopause, performance, alprazolam, Oncology
Subject categories Cancer and Oncology


Background: To examine the effect on cognitive function of adjuvant ovarian function suppression (OFS) for breast cancer. Methods: The Suppression of Ovarian Function (SOFT) trial randomised premenopausal women with hormone receptor-positive breast cancer to 5 years adjuvant endocrine therapy with tamoxifen + OFS, exemestane + OFS or tamoxifen alone. The Co-SOFT substudy assessed objective cognitive function and patient reported outcomes at randomisation (T0), and 1 year later (T1); the primary endpoint was change in global cognitive function, measured by the composite objective cognitive function score. Data were compared for the pooled tamoxifen + OFS and exemestane + OFS groups vs the tamoxifen alone group using the Wilcoxon rank-sum test. Results: Of 86 participants, 74 underwent both T0 and T1 cognitive testing; 54 randomised to OFS+ either tamoxifen (28) or exemestane (26) and 20 randomised to tamoxifen alone. There was no significant difference in the changes in the composite cognitive function scores between the OFS+ tamoxifen or exemestane groups and the tamoxifen group (mean +/- s.d., -0.21 +/- 0.92 vs -0.04 +/- 0.49, respectively, P = 0.71, effect size = -0.20), regardless of prior chemotherapy status, and adjusting for baseline characteristics. Conclusions: The Co-SOFT study, although limited by small samples size, provides no evidence that adding OFS to adjuvant oral endocrine therapy substantially affects global cognitive function.

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