Le Rhun Emilie, Delbeuck Xavier, Lefeuvre-Plesse Claudia, Kramar Andrew, Skrobala Emilie, Pasquier Florence, Bonneterre Jacques
Neurology, Breast Cancer Unit, Oscar Lambret Center, 3 Rue Frederic Combemale, 59 020, Lille Cedex, France,
Breast Cancer Res Treat. 2015 Aug;152(3):569-80. doi: 10.1007/s10549-015-3493-1. Epub 2015 Jul 11.
Cognitive impairment, especially verbal episodic memory and executive function impairments, has been considered to be a possible adverse effect of aromatase inhibitors (AI). This phase III open-label study compared the impact of tamoxifen and AI on verbal episodic memory (Rey auditory verbal learning test-RAVLT) and other cognitive functions (visual memory, psychomotor speed, and executive functions) after 6 and 12 months of treatment in breast cancer patients undergoing adjuvant hormonotherapy. Menopausal chemo-naïve patients with resectable breast cancer were randomly assigned (1:1) at the end of the radiotherapy to receive tamoxifen or AI. Neuropsychological assessments, self-reported quality of life, and depression assessments were performed at baseline, before any hormonal treatment, and at 6 and 12 months. Mixed design analysis models of variance was used to compare the evolution of the scores between the groups during follow-up. A total of 74 evaluable patients were enrolled (Tamoxifen arm, n = 37; AI arm, n = 37; letrozole n = 18; anastrozole n = 16; exemestane n = 3). The median age at inclusion was 61 years (range, minimum 49-maximum 69). The patient and breast cancer characteristics were well balanced between arms. After 6 months, no significant differential effect of AI or tamoxifen was observed on the RAVLT. Moreover, considering the other cognitive measures and the quality of life questionnaires, there were also no differences between the groups during the 1-year follow-up. In this study, AI has not demonstrated worse adverse effects on cognitive functions than tamoxifen during a 1-year follow-up.
认知障碍,尤其是言语情景记忆和执行功能障碍,被认为是芳香化酶抑制剂(AI)可能产生的不良反应。这项III期开放标签研究比较了他莫昔芬和AI对接受辅助激素治疗的乳腺癌患者在治疗6个月和12个月后言语情景记忆(雷伊听觉词语学习测验-RAVLT)及其他认知功能(视觉记忆、精神运动速度和执行功能)的影响。绝经后未接受过化疗的可切除乳腺癌患者在放疗结束时被随机分配(1:1)接受他莫昔芬或AI。在基线时、任何激素治疗前以及6个月和12个月时进行神经心理学评估、自我报告的生活质量评估和抑郁评估。采用混合设计方差分析模型比较随访期间两组评分的变化情况。共纳入74例可评估患者(他莫昔芬组,n = 37;AI组,n = 37;来曲唑组n = 18;阿那曲唑组n = 16;依西美坦组n = 3)。纳入时的中位年龄为61岁(范围,最小49 - 最大69岁)。两组患者及乳腺癌特征均衡。6个月后,未观察到AI或他莫昔芬对RAVLT有显著差异效应。此外,考虑到其他认知测量和生活质量问卷,在1年的随访期间两组之间也没有差异。在本研究中,在1年的随访期间,AI对认知功能的不良影响并未比他莫昔芬更严重。
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