Phillips Kelly-Anne, Regan Meredith M, Ribi Karin, Francis Prudence A, Puglisi Fabio, Bellet Meritxell, Spazzapan Simon, Karlsson Per, Budman Daniel R, Zaman Khalil, Abdi Ehtesham A, Domchek Susan M, Feng Yang, Price Karen N, Coates Alan S, Gelber Richard D, Maruff Paul, Boyle Frances, Forbes John F, Ahles Tim, Fleming Gini F, Bernhard Jürg
Division of Cancer Medicine, Peter MacCallum Cancer Centre, St Andrew's Place, East Melbourne, VIC 3002, Australia.
Sir Peter MacCallum Department of Oncology, The University of Melbourne, Grattan Street, Parkville, VIC 3010, Australia.
Br J Cancer. 2016 Apr 26;114(9):956-64. doi: 10.1038/bjc.2016.71. Epub 2016 Apr 19.
To examine the effect on cognitive function of adjuvant ovarian function suppression (OFS) for breast cancer.
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.
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.
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.
探讨辅助性卵巢功能抑制（OFS）对乳腺癌患者认知功能的影响。
卵巢功能抑制（SOFT）试验将激素受体阳性的绝经前乳腺癌女性随机分为三组，分别接受5年他莫昔芬+OFS、依西美坦+OFS或单纯他莫昔芬辅助内分泌治疗。Co-SOFT子研究在随机分组时（T0）和1年后（T1）评估客观认知功能和患者报告的结局；主要终点是通过综合客观认知功能评分测量的整体认知功能变化。使用Wilcoxon秩和检验比较他莫昔芬+OFS与依西美坦+OFS联合组和单纯他莫昔芬组的数据。
86名参与者中，74人接受了T0和T1认知测试；54人随机分配至OFS+他莫昔芬（28人）或依西美坦（26人）组，20人随机分配至单纯他莫昔芬组。无论先前的化疗状态如何，并在调整基线特征后，OFS+他莫昔芬或依西美坦组与单纯他莫昔芬组之间的综合认知功能评分变化无显著差异（均值±标准差，分别为-0.21±0.92和-0.04±0.49，P=0.71，效应大小=-0.20）。
Co-SOFT研究虽然受样本量小的限制，但没有证据表明在辅助口服内分泌治疗中添加OFS会对整体认知功能产生实质性影响。
