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

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

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.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anastrozole
  • Androstadienes / adverse effects
  • Androstadienes / therapeutic use
  • Antineoplastic Agents, Hormonal / adverse effects*
  • Antineoplastic Agents, Hormonal / therapeutic use
  • Aromatase Inhibitors / adverse effects*
  • Aromatase Inhibitors / therapeutic use
  • Breast Neoplasms / drug therapy*
  • Chemotherapy, Adjuvant
  • Cognition Disorders / chemically induced*
  • Female
  • Humans
  • Letrozole
  • Memory / drug effects
  • Middle Aged
  • Nitriles / adverse effects
  • Nitriles / therapeutic use
  • Postmenopause
  • Psychomotor Performance / drug effects
  • Quality of Life
  • Tamoxifen / adverse effects
  • Tamoxifen / therapeutic use
  • Triazoles / adverse effects
  • Triazoles / therapeutic use

Substances

  • Androstadienes
  • Antineoplastic Agents, Hormonal
  • Aromatase Inhibitors
  • Nitriles
  • Triazoles
  • Tamoxifen
  • Anastrozole
  • Letrozole
  • exemestane