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

Kelly Anne Phillips, Meredith M. Regan, Karin Ribi, Prudence A. Francis, Fabio Puglisi, Meritxell Bellet, Simon Spazzapan, Per Karlsson, Daniel R. Budman, Khalil Zaman, Ehtesham A. Abdi, Susan M. Domchek, Yang Feng, Karen N. Price, Alan S. Coates, Richard D. Gelber, Paul Maruff, Frances Boyle, John F. Forbes, Tim AhlesGini F. Fleming, Jürg Bernhard

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish
Pages (from-to)956-964
Number of pages9
JournalBritish Journal of Cancer
Issue number9
Publication statusPublished - Apr 26 2016

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


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