1. The ATAC ('Arimidex', tamoxifen, alone or in combination) adjuvant breast cancer trial: First results of the endometrial sub-protocol following 2 years of treatment.
- Author
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Jones A., Omara-Boto T.A., Onwude J., Phillips K., Price J., Samtaney N., Seif M., Doe A., Foster E., Woolas R., Buyse M., Wale C., Margolese R., Body J.J., Duffy S., Jackson T.L., Lansdown M., Philips K., Wells M., Pollard S., Clack G., Coibion M., Bianco A.R., Adams J., Baum M., Buzdar A., Cella D., Coleman R., Constenla M., Cuzick J., Distler W., Dowset M., Eastell R., Fallowfield L.J., Forbes J., George W.D., Gray J., Guastalla J.-P., Hellmund R., Hoctin-Boes G., Houghton J., Williams N., Howell A., Klijn J.G.M., Locker G.Y., Mackey J., Mansel R.E., Nabholtz J.M., Naglkalnai T., Nicolucci A., Nylen U., Sainsbury R., Sapunar F., Suarez-Mendez V.J., Tobias J.S., Friedlander M., Richardson G., Makar A., Neven P., Mention J., Distler D.W., Eiermann W., Mouritis M., Wamsteker, Campos O., Candeias O.R., Landers G., Llombart A., Menjon S., Repolles M., Lindahl B., Ingvar C., Bharbra K., Bjornsson S., Charnock F., Cutner A., De Bono M., Evans-Jones J., Glass M., Holt S., Kremer, O'Donovan P., Jones A., Omara-Boto T.A., Onwude J., Phillips K., Price J., Samtaney N., Seif M., Doe A., Foster E., Woolas R., Buyse M., Wale C., Margolese R., Body J.J., Duffy S., Jackson T.L., Lansdown M., Philips K., Wells M., Pollard S., Clack G., Coibion M., Bianco A.R., Adams J., Baum M., Buzdar A., Cella D., Coleman R., Constenla M., Cuzick J., Distler W., Dowset M., Eastell R., Fallowfield L.J., Forbes J., George W.D., Gray J., Guastalla J.-P., Hellmund R., Hoctin-Boes G., Houghton J., Williams N., Howell A., Klijn J.G.M., Locker G.Y., Mackey J., Mansel R.E., Nabholtz J.M., Naglkalnai T., Nicolucci A., Nylen U., Sainsbury R., Sapunar F., Suarez-Mendez V.J., Tobias J.S., Friedlander M., Richardson G., Makar A., Neven P., Mention J., Distler D.W., Eiermann W., Mouritis M., Wamsteker, Campos O., Candeias O.R., Landers G., Llombart A., Menjon S., Repolles M., Lindahl B., Ingvar C., Bharbra K., Bjornsson S., Charnock F., Cutner A., De Bono M., Evans-Jones J., Glass M., Holt S., Kremer, and O'Donovan P.
- Abstract
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%). Conclusion(s): Fewer endometrial abnormalities occurred during 2 years treatment with anastrozole compared with tamoxifen although statistical significance was not reached in this sub-protocol analysis. © The Author 2005. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved.
- Published
- 2006