Journal
BRITISH JOURNAL OF CANCER
Volume 114, Issue 9, Pages 956-964Publisher
SPRINGERNATURE
DOI: 10.1038/bjc.2016.71
Keywords
breast cancer; ovarian function; cognitive function; quality of life; premenopausal; GnRH agonist; tamoxifen; exemestane
Categories
Funding
- Australian National Health and Medical Research Council [454507]
- Breast Cancer Institute of Australia, the Fund Raising Department of the Australia and New Zealand Breast Cancer Trials Group (ANZBCTG)
- US NIH [SU10CA-035279-30, CA32102, U10-CA180821, CA21115, CA16116, U10-CA-12027, U10-CA-69651, U10-CA-37377, U10-CA-69974, CA077202]
- Frontier Science and Technology Research Foundation
- Swiss Group for Clinical Cancer Research (SAKK)
- US National Cancer Institute (NCI) [CA75362]
- Swiss Cancer Research/Oncosuisse
- NHMRC [351161, 510788]
- CCSRI [015469, 021039]
- Pfizer
- Ipsen
- National Breast Cancer Foundation [PRAC-13-04] Funding Source: researchfish
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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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