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一项评估接受辅助激素治疗的绝经后乳腺癌患者认知功能的III期随机多中心试验。

A phase III randomized multicenter trial evaluating cognition in post-menopausal breast cancer patients receiving adjuvant hormonotherapy.

作者信息

Le Rhun Emilie, Delbeuck Xavier, Lefeuvre-Plesse Claudia, Kramar Andrew, Skrobala Emilie, Pasquier Florence, Bonneterre Jacques

机构信息

Neurology, Breast Cancer Unit, Oscar Lambret Center, 3 Rue Frederic Combemale, 59 020, Lille Cedex, France,

出版信息

Breast Cancer Res Treat. 2015 Aug;152(3):569-80. doi: 10.1007/s10549-015-3493-1. Epub 2015 Jul 11.


DOI:10.1007/s10549-015-3493-1
PMID:26160250
Abstract

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.

摘要

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。

相似文献

[1]
A phase III randomized multicenter trial evaluating cognition in post-menopausal breast cancer patients receiving adjuvant hormonotherapy.

Breast Cancer Res Treat. 2015-8

[2]
Reducing the risk for breast cancer recurrence after completion of tamoxifen treatment in postmenopausal women.

Clin Ther. 2007-8

[3]
Effects of tamoxifen and exemestane on cognitive functioning of postmenopausal patients with breast cancer: results from the neuropsychological side study of the tamoxifen and exemestane adjuvant multinational trial.

J Clin Oncol. 2010-2-8

[4]
Five years of letrozole compared with tamoxifen as initial adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer: update of study BIG 1-98.

J Clin Oncol. 2007-2-10

[5]
A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer.

N Engl J Med. 2005-12-29

[6]
Adjuvant letrozole versus tamoxifen according to centrally-assessed ERBB2 status for postmenopausal women with endocrine-responsive early breast cancer: supplementary results from the BIG 1-98 randomised trial.

Lancet Oncol. 2008-1

[7]
Obesity and endocrine therapy: host factors and breast cancer outcome.

Breast. 2013-8

[8]
[Optimal adjuvant hormone therapy in postmenopausal women with hormone-sensitive mammary carcinoma: tamoxifen and the aromatase inhibitors anastrozole, exemestane and letrozole].

Ned Tijdschr Geneeskd. 2006-12-30

[9]
Switching of postmenopausal women with endocrine-responsive early breast cancer to anastrozole after 2 years' adjuvant tamoxifen: combined results of ABCSG trial 8 and ARNO 95 trial.

Lancet. 2005

[10]
Effects of adjuvant exemestane versus anastrozole on bone mineral density for women with early breast cancer (MA.27B): a companion analysis of a randomised controlled trial.

Lancet Oncol. 2014-3-11

引用本文的文献

[1]
Cognitive effects of aromatase inhibitors in early breast cancer patients: a prospective study.

Breast Cancer Res Treat. 2025-10

[2]
Chemotherapy-related cognitive impairment: What we need to know and what we can do.

Asia Pac J Oncol Nurs. 2023-11-7

[3]
Memory Impairments and Wellbeing in Breast Cancer Patients: A Systematic Review.

J Clin Med. 2023-11-7

[4]
Effects of tamoxifen and exemestane on cognitive function in postmenopausal patients with breast cancer.

JNCI Cancer Spectr. 2023-3-1

[5]
Behavioral and transcriptomic effects of the cancer treatment tamoxifen in mice.

Front Neurosci. 2023-2-10

[6]
Effects of Endocrine Therapy on Cognitive Function in Patients with Breast Cancer: A Comprehensive Review.

Cancers (Basel). 2022-2-12

[7]
Long-Term Cognitive Dysfunction in Cancer Survivors.

Front Mol Biosci. 2021-12-14

[8]
Association Between Hormone-Modulating Breast Cancer Therapies and Incidence of Neurodegenerative Outcomes for Women With Breast Cancer.

JAMA Netw Open. 2020-3-2

[9]
Cancer-related cognitive impairment: an update on state of the art, detection, and management strategies in cancer survivors.

Ann Oncol. 2019-12-1

[10]
The dorsolateral prefrontal cortex is selectively involved in chemotherapy-related cognitive impairment in breast cancer patients with different hormone receptor expression.

Am J Cancer Res. 2019-8-1

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