Hum. Reprod. Advance Access published online on October 28, 2004
Human Reproduction, doi:10.1093/humrep/deh567
© 2004 by European Society of Human Reproduction and Embryology
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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: The ‘Arimidex’, Tamoxifen, Alone or in Combination (ATAC) trial is a randomized, double-blind trial comparing anastrozole (‘Arimidex’), alone or in combination with tamoxifen, relative to tamoxifen alone as 5 year adjuvant treatment for post-menopausal women with early breast cancer. Since tamoxifen is associated with endometrial pathology, the ATAC endometrial sub-protocol was initiated to establish the background prevalence of intrauterine pathology, and to assess prospectively the incidence and nature of intrauterine changes following endocrine therapy. Another aim was to provide data from which advice could be generated on the best endometrium screening method for patients receiving tamoxifen. METHODS: Patients underwent endometrial assessments at entry to the sub-protocol. The baseline investigations comprised transvaginal ultrasound scanning (TVUS), a hysteroscopy and an endometrial biopsy. RESULTS: A total of 285 gynaecologically asymptomatic women from 31 centres in 10 countries entered the endometrial sub-protocol. The mean uterine volume was 47.7 cm3. The median endometrial thickness overall was 3 mm. Twenty-four histologically confirmed, pathological changes were observed. Twenty-three pathologies were confirmed by TVUS, and 21 were identified by hysteroscopy and confirmed by histopathology. Women with or without intrauterine pathology had median endometrial thickness of 5 and 3 mm respectively. CONCLUSIONS: The presence of pathology was associated with increased endometrial thickness. The relative sensitivity and specificity of hysteroscopy and endometrial thickness for the diagnosis of endometrial pathology was comparable to other studies. If screening of the endometrium prior to treatment is appropriate, this study supports the use of an endometrial thickness of 3 mm, as assessed by TVUS, as a threshold for needing further investigation. This study demonstrates that if the endometrial thickness is >3 mm, hysteroscopy and biopsy is the optimal method of detecting intrauterine pathology in women with breast cancer who are about to commence endocrine treatment. *Chairman of the ATAC endometrial sub-protocol.
Accepted September 24, 2004
Article
The ATAC (‘Arimidex’, Tamoxifen, Alone or in Combination) adjuvant breast cancer trial: baseline endometrial sub-protocol data on the effectiveness of transvaginal ultrasonography and diagnostic hysteroscopy
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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
Abstract Principal Investigator for the ATAC endometrial sub-protocol.Member of the ATAC Trial Steering Committee.
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