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Hum. Reprod. Advance Access originally published online on October 6, 2005
Human Reproduction 2006 21(2):545-553; doi:10.1093/humrep/dei322
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© The Author 2005. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

The ATAC (‘Arimidex’, Tamoxifen, Alone or in Combination) adjuvant breast cancer trial: first results of the endometrial sub-protocol following 2 years of treatment

S. Duffy1,9, T.L. Jackson2, M. Lansdown1, K. Philips3, M. Wells4, S. Pollard5, G. Clack6, M. Coibion7, A.R. Bianco8 on behalf of the ATAC Trialists’ Group

1 Department of Obstetrics and Gynaecology, St James’ University Hospital, Leeds LS9 7TF, 2 The James Cook University Hospital, Middlesbrough TS4 3BW, 3 Castle Hill Hospital, Cottingham, North Humberside HU16 5JQ, 4 Royal Hallamshire Hospital, Sheffield S10 2JF, 5 Northern and Yorkshire Clinical Trials Research Unit, Leeds LS2 9NG, 6 AstraZeneca, Macclesfield SK10 4TF, UK, 7 Bordet Institute, 1000 Brussels, Belgium and 8 Universita Degli Studi Di Napoli Federico II, Napoli 5-80131, Italy

9 To whom correspondence should be addressed at: Department of Obstetrics and GynaecologyLevel 09 Gledhow WingSt James’ University Hospital, Leeds LS9 7TF, UK. E-mail: Medsrd{at}stjames.leeds.ac.uk

BACKGROUND: Tamoxifen treatment results in a doubling of the risk of endometrial cancer after 1–2 years of treatment and a quadrupling after 5 years. Anastrozole, a third-generation aromatase inhibitor, with superior efficacy to tamoxifen, may also offer tolerability benefits in terms of effects on the endometrium. METHODS AND RESULTS: A sub-protocol of the ATAC trial compared the incidence/type of intrauterine changes following treatment with these agents in a subgroup of patients (n = 285) from the main trial. After 2 years anastrozole treatment, endometrial thickness remained ≤ 5 mm (baseline: 3.0 mm); in patients receiving tamoxifen, endometrial thickness increased by 3.2 mm to 7.0 mm, with a similar trend in the combination group. At baseline, 26/285 patients (9.1%) had endometrial abnormalities, most commonly polyps. After 2 years the number of endometrial abnormalities appeared lower with anastrozole treatment compared with tamoxifen although these differences were not statistically significant (odds ratio: 0.44; 95% confidence interval 0.146, 1.314; P = 0.14). Most abnormalities occurred within the first year of treatment (anastrozole: 4/6; tamoxifen: 7/10; combination: 10/16; total: 21/32). Fewer patients in the anastrozole group (1.4%) required medical intervention (tamoxifen 12.5%; combination 13.6%). CONCLUSIONS: Fewer endometrial abnormalities occurred during 2 years treatment with anastrozole compared with tamoxifen although statistical significance was not reached in this sub-protocol analysis.

Key words: anastrozole/ATAC/breast cancer/endometrial pathology/tamoxifen


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Clin. Cancer Res.Home page
B. Gerber, A. Krause, T. Reimer, I. Mylonas, J. Makovitzky, G. Kundt, and W. Janni
Anastrozole versus Tamoxifen Treatment in Postmenopausal Women with Endocrine-Responsive Breast Cancer and Tamoxifen-Induced Endometrial Pathology
Clin. Cancer Res., February 15, 2006; 12(4): 1245 - 1250.
[Abstract] [Full Text] [PDF]



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