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Annals of Oncology Advance Access published online on August 28, 2009
Annals of Oncology, doi:10.1093/annonc/mdp358
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© The Author 2009. Published by Oxford University Press [on behalf of the European Society for Medical Oncology].
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/2.5/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Long-term endometrial effects in postmenopausal women with early breast cancer participating in the Intergroup Exemestane Study (IES)—a randomised controlled trial of exemestane versus continued tamoxifen after 2–3 years tamoxifen

G. Bertelli1,*, E. Hall2, E. Ireland2, C. F. Snowdon2, J. Jassem3, K. Drosik4, H. Karnicka-Mlodkowska5, R. C. Coombes6 and J. M. Bliss2

1 Department of Oncology, Singleton Hospital, South West Wales Cancer Institute, Swansea
2 ICR-CTSU, Section of Clinical Trials, Institute of Cancer Research, Sutton, UK
3 Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland
4 Department of Oncology, Regional Cancer Center, Opole, USA
5 Department of Chemotherapy, Maritime Hospital, Gdynia, Poland
6 Cancer Research UK Department of Cancer Medicine, Imperial College London, Hammersmith Hospitals Trust, London, UK

* Correspondence to: Dr G. Bertelli, Department of Oncology, Singleton Hospital, Swansea SA2 8QA, UK. Tel: +44-1792285826; Fax: +44-1792285826; E-mail: gianfilippo.bertelli{at}swansea-tr.wales.nhs.uk

Background: The antiestrogen tamoxifen may have partial estrogen-like effects on the postmenopausal uterus. Aromatase inhibitors (AIs) are increasingly used after initial tamoxifen in the adjuvant treatment of postmenopausal early breast cancer due to their mechanism of action: a potential benefit being a reduction of uterine abnormalities caused by tamoxifen.

Patients and methods: Sonographic uterine effects of the steroidal AI exemestane were studied in 219 women participating in the Intergroup Exemestane Study: a large trial in postmenopausal women with estrogen receptor-positive (or unknown) early breast cancer, disease free after 2–3 years of tamoxifen, randomly assigned to continue tamoxifen or switch to exemestane to complete 5 years adjuvant treatment. The primary end point was the proportion of patients with abnormal (≥5 mm) endometrial thickness (ET) on transvaginal ultrasound 24 months after randomisation.

Results: The analysis included 183 patients. Two years after randomisation, the proportion of patients with abnormal ET was significantly lower in the exemestane compared with tamoxifen arm (36% versus 62%, respectively; P = 0.004). This difference emerged within 6 months of switching treatment (43.5% versus 65.2%, respectively; P = 0.01) and disappeared within 12 months of treatment completion (30.8% versus 34.7%, respectively; P = 0.67).

Conclusion: Switching from tamoxifen to exemestane significantly reverses endometrial thickening associated with continued tamoxifen.

adjuvant treatment, aromatase inhibitors, breast cancer, endometrium, exemestane, tamoxifen

Received for publication April 9, 2009. Revision received June 10, 2009. Accepted for publication June 12, 2009.


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