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Breast Cancer Research and Treatment

, Volume 152, Issue 3, pp 569–580 | Cite as

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

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

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

Keywords

Cognitive disorders Breast cancer Hormonotherapy Aromatase inhibitors Tamoxifen Chemobrain 

Notes

Acknowledgments

We thank the patients, Stéphanie Clisant and Yvette Vendel for advice while writing the protocol, Patrick Devos for his help in the statistical design of the study, and V Servent, A Mailliez, L Vanlemmens, Pierre Kerbrat, and Thierry Petit for the enrollment of patients.

Funding

Pfizer, Astra Zeneca, and Novartis financially supported this trial promoted by Oscar Lambret Center (Lille, France).

Complaince with Ethical Standards

Conflict of interest

The authors have no conflict of interest to declare.

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Copyright information

© Springer Science+Business Media New York 2015

Authors and Affiliations

  • Emilie Le Rhun
    • 1
    • 2
    • 3
  • Xavier Delbeuck
    • 4
  • Claudia Lefeuvre-Plesse
    • 5
  • Andrew Kramar
    • 6
  • Emilie Skrobala
    • 7
  • Florence Pasquier
    • 4
  • Jacques Bonneterre
    • 8
    • 9
  1. 1.Neurology, Breast Cancer UnitOscar Lambret CenterLille CedexFrance
  2. 2.NeurooncologyUniversity HospitalLilleFrance
  3. 3.Inserm U1192Villeneuve d’AscqFrance
  4. 4.Inserm U1171 and Memory CenterUniversity Hospital and University of LilleLilleFrance
  5. 5.Breast Unit, Department of Medical OncologyEugène Marquis CenterRennesFrance
  6. 6.Methodology and Biostatistics UnitOscar Lambret CenterLilleFrance
  7. 7.Biostatistics Unit, EA2694University Hospital and University of LilleLilleFrance
  8. 8.Breast Unit, Department of Medical OncologyOscar Lambret CenterLilleFrance
  9. 9.University of LilleLilleFrance

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