Hum. Reprod. Advance Access published online on October 6, 2005
Human Reproduction, doi:10.1093/humrep/dei322
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1 Department of Obstetrics and Gynaecology, St James’ University Hospital, Leeds LS9 7TF, UK
* To whom correspondence should be addressed. 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
Received July 4, 2005
Revised August 22, 2005
Accepted August 26, 2005
Article
The ATAC (Arimidex, Tamoxifen, Alone or in Combination) adjuvant breast cancer trial: first results of the endometrial sub-protocol following 2 years of treatment
2 The James Cook University Hospital, Middlesbrough TS4 3BW, UK
3 Castle Hill Hospital, Cottingham, North Humberside HU16 5JQ, UK
4 Royal Hallamshire Hospital, Sheffield S10 2JF, UK
5 Northern and Yorkshire Clinical Trials Research Unit, Leeds LS2 9NG, UK
6 AstraZeneca, Macclesfield SK10 4TF, UK
7 Bordet Institute, 1000 Brussels, Belgium
8 Universita Degli Studi Di Napoli Federico II, Napoli 5-80131, Italy
S. Duffy, E-mail: Medsrd{at}stjames.leeds.ac.uk
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Abstract
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.![]()
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