A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer


Coombes, RC; Hall, E; Gibson, LJ; Paridaens, R; Jassem, J; Delozier, T; Jones, SE; Alvarez, I; Bertelli, G; Ortmann, O; Coates, AS; Bajetta, E; Dodwell, D; Coleman, RE; Fallowfield, LJ; Mickiewicz, E; Andersen, J; Lønning, PE; Cocconi, G; Stewart, A; Stuart, N; Snowdon, CF; Carpentieri, M; Massimini, G; Bliss, JM; van de Velde, C; Intergroup Exemestane Study, ; (2004) A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. The New England journal of medicine, 350 (11). pp. 1081-92. ISSN 0028-4793 DOI: https://doi.org/10.1056/NEJMoa040331

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Abstract

: Tamoxifen, taken for five years, is the standard adjuvant treatment for postmenopausal women with primary, estrogen-receptor-positive breast cancer. Despite this treatment, however, some patients have a relapse.<br/> : We conducted a double-blind, randomized trial to test whether, after two to three years of tamoxifen therapy, switching to exemestane was more effective than continuing tamoxifen therapy for the remainder of the five years of treatment. The primary end point was disease-free survival.<br/> : Of the 4742 patients enrolled, 2362 were randomly assigned to switch to exemestane, and 2380 to continue to receive tamoxifen. After a median follow-up of 30.6 months, 449 first events (local or metastatic recurrence, contralateral breast cancer, or death) were reported--183 in the exemestane group and 266 in the tamoxifen group. The unadjusted hazard ratio in the exemestane group as compared with the tamoxifen group was 0.68 (95 percent confidence interval, 0.56 to 0.82; P<0.001 by the log-rank test), representing a 32 percent reduction in risk and corresponding to an absolute benefit in terms of disease-free survival of 4.7 percent (95 percent confidence interval, 2.6 to 6.8) at three years after randomization. Overall survival was not significantly different in the two groups, with 93 deaths occurring in the exemestane group and 106 in the tamoxifen group. Severe toxic effects of exemestane were rare. Contralateral breast cancer occurred in 20 patients in the tamoxifen group and 9 in the exemestane group (P=0.04).<br/> : Exemestane therapy after two to three years of tamoxifen therapy significantly improved disease-free survival as compared with the standard five years of tamoxifen treatment.<br/>

Item Type: Article
Keywords: Administration, Oral, Aged, Androstadienes, Antineoplastic Agents, Hormonal, Aromatase, Breast Neoplasms, Chemotherapy, Adjuvant, Comparative Study, Disease-Free Survival, Double-Blind Method, Estrogen Antagonists, Female, Human, Middle Aged, Neoplasms, Hormone-Dependent, Postmenopause, Receptors, Estrogen, Support, Non-U.S. Gov't, Tamoxifen, Administration, Oral, Aged, Androstadienes, adverse effects, therapeutic use, Antineoplastic Agents, Hormonal, adverse effects, therapeutic use, Aromatase, antagonists & inhibitors, Breast Neoplasms, drug therapy, mortality, surgery, Chemotherapy, Adjuvant, Comparative Study, Disease-Free Survival, Double-Blind Method, Estrogen Antagonists, adverse effects, therapeutic use, Female, Human, Middle Aged, Neoplasms, Hormone-Dependent, drug therapy, Postmenopause, Receptors, Estrogen, analysis, Support, Non-U.S. Gov't, Tamoxifen, adverse effects, therapeutic use
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology
PubMed ID: 15014181
Web of Science ID: 220110100005
URI: http://researchonline.lshtm.ac.uk/id/eprint/14755

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