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dc.contributor.authorThürlimann, Beat
dc.contributor.authorKeshaviah, Aparna
dc.contributor.authorCoates, Alan S
dc.contributor.authorMouridsen, Henning
dc.contributor.authorMauriac, Louis
dc.contributor.authorForbes, John F
dc.contributor.authorParidaens, Robert
dc.contributor.authorCastiglione-Gertsch, Monica
dc.contributor.authorGelber, Richard D
dc.contributor.authorRabaglio, Manuela
dc.contributor.authorSmith, Ian
dc.contributor.authorWardley, Andrew M
dc.contributor.authorPrice, Karen N
dc.contributor.authorGoldhirsch, Aron
dc.date.accessioned2009-08-06T15:47:17Z
dc.date.available2009-08-06T15:47:17Z
dc.date.issued2005-12-29
dc.identifier.citationA comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. 2005, 353 (26):2747-57 N. Engl. J. Med.en
dc.identifier.issn1533-4406
dc.identifier.pmid16382061
dc.identifier.doi10.1056/NEJMoa052258
dc.identifier.urihttp://hdl.handle.net/10541/76602
dc.description.abstractBACKGROUND: The aromatase inhibitor letrozole is a more effective treatment for metastatic breast cancer and more effective in the neoadjuvant setting than tamoxifen. We compared letrozole with tamoxifen as adjuvant treatment for steroid-hormone-receptor-positive breast cancer in postmenopausal women. METHODS: The Breast International Group (BIG) 1-98 study is a randomized, phase 3, double-blind trial that compared five years of treatment with various adjuvant endocrine therapy regimens in postmenopausal women with hormone-receptor-positive breast cancer: letrozole, letrozole followed by tamoxifen, tamoxifen, and tamoxifen followed by letrozole. This analysis compares the two groups assigned to receive letrozole initially with the two groups assigned to receive tamoxifen initially; events and follow-up in the sequential-treatment groups were included up to the time that treatments were switched. RESULTS: A total of 8010 women with data that could be assessed were enrolled, 4003 in the letrozole group and 4007 in the tamoxifen group. After a median follow-up of 25.8 months, 351 events had occurred in the letrozole group and 428 events in the tamoxifen group, with five-year disease-free survival estimates of 84.0 percent and 81.4 percent, respectively. As compared with tamoxifen, letrozole significantly reduced the risk of an event ending a period of disease-free survival (hazard ratio, 0.81; 95 percent confidence interval, 0.70 to 0.93; P=0.003), especially the risk of distant recurrence (hazard ratio, 0.73; 95 percent confidence interval, 0.60 to 0.88; P=0.001). Thromboembolism, endometrial cancer, and vaginal bleeding were more common in the tamoxifen group. Women given letrozole had a higher incidence of skeletal and cardiac events and of hypercholesterolemia. CONCLUSIONS: In postmenopausal women with endocrine-responsive breast cancer, adjuvant treatment with letrozole, as compared with tamoxifen, reduced the risk of recurrent disease, especially at distant sites. (ClinicalTrials.gov number, NCT00004205.)
dc.language.isoenen
dc.subjectBreast Canceren
dc.subjectCanceren
dc.subjectOestrogen Receptorsen
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshAged, 80 and over
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.meshDrug Administration Schedule
dc.subject.meshFemale
dc.subject.meshHumans
dc.subject.meshMiddle Aged
dc.subject.meshNeoplasms, Hormone-Dependent
dc.subject.meshNeoplasms, Second Primary
dc.subject.meshNitriles
dc.subject.meshPostmenopause
dc.subject.meshProportional Hazards Models
dc.subject.meshReceptors, Estrogen
dc.subject.meshReceptors, Progesterone
dc.subject.meshRecurrence
dc.subject.meshSurvival Rate
dc.subject.meshTamoxifen
dc.subject.meshTriazoles
dc.titleA comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer.en
dc.typeArticleen
dc.contributor.departmentSenology Center of Eastern Switzerland, Kantonsspital, St. Gallen, and the Swiss Group for Clinical Cancer Research, Switzerland.en
dc.identifier.journalThe New England Journal of Medicineen
html.description.abstractBACKGROUND: The aromatase inhibitor letrozole is a more effective treatment for metastatic breast cancer and more effective in the neoadjuvant setting than tamoxifen. We compared letrozole with tamoxifen as adjuvant treatment for steroid-hormone-receptor-positive breast cancer in postmenopausal women. METHODS: The Breast International Group (BIG) 1-98 study is a randomized, phase 3, double-blind trial that compared five years of treatment with various adjuvant endocrine therapy regimens in postmenopausal women with hormone-receptor-positive breast cancer: letrozole, letrozole followed by tamoxifen, tamoxifen, and tamoxifen followed by letrozole. This analysis compares the two groups assigned to receive letrozole initially with the two groups assigned to receive tamoxifen initially; events and follow-up in the sequential-treatment groups were included up to the time that treatments were switched. RESULTS: A total of 8010 women with data that could be assessed were enrolled, 4003 in the letrozole group and 4007 in the tamoxifen group. After a median follow-up of 25.8 months, 351 events had occurred in the letrozole group and 428 events in the tamoxifen group, with five-year disease-free survival estimates of 84.0 percent and 81.4 percent, respectively. As compared with tamoxifen, letrozole significantly reduced the risk of an event ending a period of disease-free survival (hazard ratio, 0.81; 95 percent confidence interval, 0.70 to 0.93; P=0.003), especially the risk of distant recurrence (hazard ratio, 0.73; 95 percent confidence interval, 0.60 to 0.88; P=0.001). Thromboembolism, endometrial cancer, and vaginal bleeding were more common in the tamoxifen group. Women given letrozole had a higher incidence of skeletal and cardiac events and of hypercholesterolemia. CONCLUSIONS: In postmenopausal women with endocrine-responsive breast cancer, adjuvant treatment with letrozole, as compared with tamoxifen, reduced the risk of recurrent disease, especially at distant sites. (ClinicalTrials.gov number, NCT00004205.)


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