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

2.50
Hdl Handle:
http://hdl.handle.net/10541/78100
Title:
A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer.
Authors:
Coombes, R Charles; Hall, Emma; Gibson, Lorna J; Paridaens, Robert; Jassem, Jacek; Delozier, Thierry; Jones, Stephen E; Alvarez-Tabares, Isabel; Bertelli, Gianfilippo; Ortmann, Olaf; Coates, Alan S; Bajetta, Emilio; Dodwell, David J; Coleman, Robert E; Fallowfield, Lesley J; Mickiewicz, Elizabeth; Andersen, Jorn; Lønning, Per E; Cocconi, Giorgio; Stewart, Alan L; Stuart, Nick; Snowdon, Claire F; Carpentieri, Marina; Massimini, Giorgio; Bliss, Judith M; Van de Velde, Cornelius
Abstract:
BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.
Affiliation:
Department of Cancer Medicine, Imperial College and Charing Cross Hospital, London, United Kingdom.
Citation:
A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. 2004, 350 (11):1081-92 N. Engl. J. Med.
Journal:
The New England Journal of Medicine
Issue Date:
11-Mar-2004
URI:
http://hdl.handle.net/10541/78100
DOI:
10.1056/NEJMoa040331
PubMed ID:
15014181
Type:
Article
Language:
en
ISSN:
1533-4406
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorCoombes, R Charles-
dc.contributor.authorHall, Emma-
dc.contributor.authorGibson, Lorna J-
dc.contributor.authorParidaens, Robert-
dc.contributor.authorJassem, Jacek-
dc.contributor.authorDelozier, Thierry-
dc.contributor.authorJones, Stephen E-
dc.contributor.authorAlvarez-Tabares, Isabel-
dc.contributor.authorBertelli, Gianfilippo-
dc.contributor.authorOrtmann, Olaf-
dc.contributor.authorCoates, Alan S-
dc.contributor.authorBajetta, Emilio-
dc.contributor.authorDodwell, David J-
dc.contributor.authorColeman, Robert E-
dc.contributor.authorFallowfield, Lesley J-
dc.contributor.authorMickiewicz, Elizabeth-
dc.contributor.authorAndersen, Jorn-
dc.contributor.authorLønning, Per E-
dc.contributor.authorCocconi, Giorgio-
dc.contributor.authorStewart, Alan L-
dc.contributor.authorStuart, Nick-
dc.contributor.authorSnowdon, Claire F-
dc.contributor.authorCarpentieri, Marina-
dc.contributor.authorMassimini, Giorgio-
dc.contributor.authorBliss, Judith M-
dc.contributor.authorVan de Velde, Cornelius-
dc.date.accessioned2009-08-21T09:13:09Z-
dc.date.available2009-08-21T09:13:09Z-
dc.date.issued2004-03-11-
dc.identifier.citationA randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. 2004, 350 (11):1081-92 N. Engl. J. Med.en
dc.identifier.issn1533-4406-
dc.identifier.pmid15014181-
dc.identifier.doi10.1056/NEJMoa040331-
dc.identifier.urihttp://hdl.handle.net/10541/78100-
dc.description.abstractBACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.en
dc.language.isoenen
dc.subjectBreast Canceren
dc.subjectCanceren
dc.subjectOestrogen Antagonistsen
dc.subjectOestrogen Receptorsen
dc.subject.meshAdministration, Oral-
dc.subject.meshAged-
dc.subject.meshAndrostadienes-
dc.subject.meshAntineoplastic Agents, Hormonal-
dc.subject.meshAromatase Inhibitors-
dc.subject.meshBreast Neoplasms-
dc.subject.meshChemotherapy, Adjuvant-
dc.subject.meshDisease-Free Survival-
dc.subject.meshDouble-Blind Method-
dc.subject.meshEstrogen Antagonists-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshMiddle Aged-
dc.subject.meshNeoplasms, Hormone-Dependent-
dc.subject.meshPostmenopause-
dc.subject.meshReceptors, Estrogen-
dc.subject.meshTamoxifen-
dc.titleA randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer.en
dc.typeArticleen
dc.contributor.departmentDepartment of Cancer Medicine, Imperial College and Charing Cross Hospital, London, United Kingdom.en
dc.identifier.journalThe New England Journal of Medicineen

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