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http://hdl.handle.net/2445/126613
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DC Field | Value | Language |
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dc.contributor.author | Coleman, Robert E. | - |
dc.contributor.author | Marshall, Helen | - |
dc.contributor.author | Cameron, David | - |
dc.contributor.author | Dodwell, David | - |
dc.contributor.author | Burkinshaw, Roger | - |
dc.contributor.author | Keane, Maccon | - |
dc.contributor.author | Gil Gil, Miguel | - |
dc.contributor.author | Houston, Stephen J. | - |
dc.contributor.author | Grieve, Robert J. | - |
dc.contributor.author | Barrett-Lee, Peter J. | - |
dc.contributor.author | Ritchie, Diana | - |
dc.contributor.author | Pugh, Julia | - |
dc.contributor.author | Gaunt, Claire | - |
dc.contributor.author | Rea, Una | - |
dc.contributor.author | Peterson, Jennifer | - |
dc.contributor.author | Davies, Claire | - |
dc.contributor.author | Hiley, Victoria | - |
dc.contributor.author | Gregory, Walter | - |
dc.contributor.author | Bell, Richard | - |
dc.date.accessioned | 2018-11-30T10:08:18Z | - |
dc.date.available | 2018-11-30T10:08:18Z | - |
dc.date.issued | 2011-10-13 | - |
dc.identifier.uri | http://hdl.handle.net/2445/126613 | - |
dc.description.abstract | BACKGROUND: Data suggest that the adjuvant use of bisphosphonates reduces rates of recurrence and death in patients with early-stage breast cancer. We conducted a study to determine whether treatment with zoledronic acid, in addition to standard adjuvant therapy, would improve disease outcomes in such patients. METHODS: In this open-label phase 3 study, we randomly assigned 3360 patients to receive standard adjuvant systemic therapy either with or without zoledronic acid. The zoledronic acid was administered every 3 to 4 weeks for 6 doses and then every 3 to 6 months to complete 5 years of treatment. The primary end point of the study was disease-free survival. A second interim analysis revealed that a prespecified boundary for lack of benefit had been crossed. RESULTS: At a median follow-up of 59 months, there was no significant between-group difference in the primary end point, with a rate of disease-free survival of 77% in each group (adjusted hazard ratio in the zoledronic acid group, 0.98; 95% confidence interval [CI], 0.85 to 1.13; P = 0.79). Disease recurrence or death occurred in 377 patients in the zoledronic acid group and 375 of those in the control group. The numbers of deaths - 243 in the zoledronic acid group and 276 in the control group - were also similar, resulting in rates of overall survival of 85.4% in the zoledronic acid group and 83.1% in the control group (adjusted hazard ratio, 0.85; 95% CI, 0.72 to 1.01; P = 0.07). In the zoledronic acid group, there were 17 confirmed cases of osteonecrosis of the jaw (cumulative incidence, 1.1%; 95% CI, 0.6 to 1.7; P < 0.001) and 9 suspected cases; there were no cases in the control group. Rates of other adverse effects were similar in the two study groups. CONCLUSIONS: These findings do not support the routine use of zoledronic acid in the adjuvant management of breast cancer. | - |
dc.format.extent | 10 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Massachusetts Medical Society | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1105195 | - |
dc.relation.ispartof | New England Journal of Medicine, 2011, vol. 365, num. 15, p. 1396-1405 | - |
dc.relation.uri | https://doi.org/10.1056/NEJMoa1105195 | - |
dc.rights | (c) (c) Massachusetts Medical Society, 2011 | - |
dc.source | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) | - |
dc.subject.classification | Càncer de mama | - |
dc.subject.classification | Tractament adjuvant del càncer | - |
dc.subject.other | Breast cancer | - |
dc.subject.other | Cancer adjuvant treatment | - |
dc.title | Breast-cancer Adjuvant Therapy With Zoledronic Acid | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.date.updated | 2018-07-24T12:58:55Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
Files in This Item:
File | Description | Size | Format | |
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ColemanRE.pdf | 866.67 kB | Adobe PDF | View/Open |
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