The ATAC adjuvant breast cancer trial in postmenopausal women: baseline endometrial subprotocol data
The ATAC ( Arimidex, Tamoxifen, Alone or in Combination) trial is a randomised, double-blind trial comparing ‘Arimidex’ (anastrozole), alone or in combination with tamoxifen, relative to tamoxifen alone as a five year adjuvant treatment for postmenopausal women with early breast cancer. Because tamo...
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Published in | BJOG : an international journal of obstetrics and gynaecology Vol. 110; no. 12; pp. 1099 - 1106 |
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Main Authors | , , , , , , , , , |
Format | Journal Article |
Language | English |
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Elsevier B.V
01.12.2003
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Abstract | The ATAC (
Arimidex,
Tamoxifen,
Alone or in
Combination) trial is a randomised, double-blind trial comparing ‘Arimidex’ (anastrozole), alone or in combination with tamoxifen, relative to tamoxifen alone as a five year adjuvant treatment for postmenopausal women with early breast cancer. Because tamoxifen is associated with endometrial pathology, the ATAC endometrial subprotocol was initiated to establish the background prevalence of pathology, and to assess prospectively the incidence and nature of intrauterine changes before and following endocrine therapy.
International.
Two hundred and eighty-five women entered the subprotocol: the mean age was 60 years (range 44–80 years); 113 women (40%) had taken hormone replacement therapy prior to randomisation, and 238 women were parous (84%). The age at onset of the menopause was 32–58 years, with the majority becoming menopausal between 46 and 55 years of age. Two hundred and seventy-two women had a hysteroscopy before they commenced trial medication. Hysteroscopy was performed successfully in 265 women. In six women, failure of hysteroscopy at baseline led to withdrawal from the study. Three of the women who withdrew had a pipelle biopsy taken. Therefore, the total number of endometrial biopsies at baseline was 268.
To assess the demographic characteristics of women entering the endometrial subprotocol and their hysteroscopic and histological findings before commencing trial medication.
At hysteroscopy, there was a diagnosis of endometrial polyps in 34 women (13%), fibroids in 16 women (6%) and one case of suspicious endometrium, which was confirmed as a polyp on histology. Only 21 of the 34 polyps seen hysteroscopically were proven histologically (62% accuracy of hysteroscopy). Final histology found the prevalence of endometrial diagnostic categories as follows: 123 inactive endometrium (46%), 20 benign polyps (7%), 17 secretory endometrium (6%), 7 proliferative endometrium (3%), 3 atypical hyperplasia (2 in a polyp), 1 simple hyperplasia (in a polyp) and 1 fibroid. The remaining women had pipelle samples with insufficient tissue obtained, indicating a normal endometrial cavity.
This is the first study of such size in gynaecologically asymptomatic breast cancer patients. This paper describes the findings in individual patients before any trial treatment was given. In this baseline group, 82% (219/268) of women had a normal endometrial cavity; 18% (49/268) had endometrial activity (proliferative or secretory endometrium in 9%) or an intracavity abnormality (hyperplasia, polyps and a fibroid in 9%). In total, 36% of biopsies had insufficient tissue for diagnosis, which in combination with a normal hysteroscopy was classed as normal. The appearance of a polyp hysteroscopically in this group was not proven histologically in approximately 40% of cases. The development of uterine pathology over time in the ATAC study will subsequently be assessed against the findings of this baseline paper. |
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AbstractList | The ATAC (
Arimidex,
Tamoxifen,
Alone or in
Combination) trial is a randomised, double-blind trial comparing ‘Arimidex’ (anastrozole), alone or in combination with tamoxifen, relative to tamoxifen alone as a five year adjuvant treatment for postmenopausal women with early breast cancer. Because tamoxifen is associated with endometrial pathology, the ATAC endometrial subprotocol was initiated to establish the background prevalence of pathology, and to assess prospectively the incidence and nature of intrauterine changes before and following endocrine therapy.
International.
Two hundred and eighty-five women entered the subprotocol: the mean age was 60 years (range 44–80 years); 113 women (40%) had taken hormone replacement therapy prior to randomisation, and 238 women were parous (84%). The age at onset of the menopause was 32–58 years, with the majority becoming menopausal between 46 and 55 years of age. Two hundred and seventy-two women had a hysteroscopy before they commenced trial medication. Hysteroscopy was performed successfully in 265 women. In six women, failure of hysteroscopy at baseline led to withdrawal from the study. Three of the women who withdrew had a pipelle biopsy taken. Therefore, the total number of endometrial biopsies at baseline was 268.
To assess the demographic characteristics of women entering the endometrial subprotocol and their hysteroscopic and histological findings before commencing trial medication.
At hysteroscopy, there was a diagnosis of endometrial polyps in 34 women (13%), fibroids in 16 women (6%) and one case of suspicious endometrium, which was confirmed as a polyp on histology. Only 21 of the 34 polyps seen hysteroscopically were proven histologically (62% accuracy of hysteroscopy). Final histology found the prevalence of endometrial diagnostic categories as follows: 123 inactive endometrium (46%), 20 benign polyps (7%), 17 secretory endometrium (6%), 7 proliferative endometrium (3%), 3 atypical hyperplasia (2 in a polyp), 1 simple hyperplasia (in a polyp) and 1 fibroid. The remaining women had pipelle samples with insufficient tissue obtained, indicating a normal endometrial cavity.
This is the first study of such size in gynaecologically asymptomatic breast cancer patients. This paper describes the findings in individual patients before any trial treatment was given. In this baseline group, 82% (219/268) of women had a normal endometrial cavity; 18% (49/268) had endometrial activity (proliferative or secretory endometrium in 9%) or an intracavity abnormality (hyperplasia, polyps and a fibroid in 9%). In total, 36% of biopsies had insufficient tissue for diagnosis, which in combination with a normal hysteroscopy was classed as normal. The appearance of a polyp hysteroscopically in this group was not proven histologically in approximately 40% of cases. The development of uterine pathology over time in the ATAC study will subsequently be assessed against the findings of this baseline paper. |
Author | Pollard, S Cuzick, J Bianco, A.R Jackson, T.L Coibion, M Wells, M Clack, G Duffy, S Lansdown, M Philips, K |
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References_xml | – volume: 14 start-page: 2000 year: 1996 end-page: 2011 ident: BIB19 article-title: Anastrozole, a potent and selective aromatase inhibitor, versus megestrol acetate in postmenopausal women with advanced breast cancer: results of overview analysis of two Phase III trials publication-title: J Clin Oncol contributor: fullname: Howell – volume: 356 start-page: 881 year: 2000 end-page: 887 ident: BIB12 article-title: Risk and prognosis of endometrial cancer after tamoxifen for breast cancer publication-title: Lancet contributor: fullname: Van Leeuwen – volume: 351 start-page: 1451 year: 1998 end-page: 1467 ident: BIB2 article-title: Tamoxifen for early breast cancer: an overview of the randomised trials publication-title: Lancet – volume: 359 start-page: 2131 year: 2002 end-page: 2139 ident: BIB17 article-title: Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial publication-title: Lancet – volume: 75 start-page: 207 year: 1985 end-page: 217 ident: BIB16 article-title: Multiple cancer—an epidemiologic exercise in Finland publication-title: J Natl Cancer Inst contributor: fullname: Saxen – volume: 81 start-page: 660 year: 1993 end-page: 664 ident: BIB3 article-title: Endometrial changes in postmenopausal breast cancer receiving tamoxifen publication-title: Obstet Gynecol contributor: fullname: Laatikainen – volume: 35 start-page: 235 year: 1990 end-page: 238 ident: BIB10 article-title: Hysteroscopic follow-up during tamoxifen treatment publication-title: Eur J Obstet Gynecol Reprod Biol contributor: fullname: De Muylder – volume: 17 start-page: 369 year: 1986 end-page: 374 ident: BIB23 article-title: Panoramic diagnostic microhysteroscopy: analysis of results obtained from 976 patients publication-title: Acta Eur Fertil contributor: fullname: Sartori – volume: 85 start-page: 1850 year: 1993 end-page: 1855 ident: BIB7 article-title: Descriptive clinicopathologic study of 17 patients with endometrial cancer during or after adjuvant tamoxifen in early breast cancer publication-title: J Natl Cancer Inst contributor: fullname: Moberger – volume: 88 start-page: 87 year: 1996 end-page: 92 ident: BIB24 article-title: 2500 outpatient diagnostic hysteroscopies publication-title: Obstet Gynecol contributor: fullname: Magos – volume: 66 start-page: 253 year: 1996 end-page: 366 ident: BIB1 publication-title: IARC monographs on the evaluation of carcinogenic risks to humans. 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Snippet | The ATAC (
Arimidex,
Tamoxifen,
Alone or in
Combination) trial is a randomised, double-blind trial comparing ‘Arimidex’ (anastrozole), alone or in combination... |
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Title | The ATAC adjuvant breast cancer trial in postmenopausal women: baseline endometrial subprotocol data |
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