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dc.contributor.authorColeman, Robert E.
dc.contributor.authorMarshall, Helen
dc.contributor.authorCameron, David
dc.contributor.authorDodwell, David
dc.contributor.authorBurkinshaw, Roger
dc.contributor.authorKeane, Maccon
dc.contributor.authorGil, Miguel
dc.contributor.authorHouston, Stephen J.
dc.contributor.authorGrieve, Robert J.
dc.contributor.authorBarrett-Lee, Peter J.
dc.contributor.authorRitchie, Diana
dc.contributor.authorPugh, Julia
dc.contributor.authorGaunt, Claire
dc.contributor.authorRea, Una
dc.contributor.authorPeterson, Jennifer
dc.contributor.authorDavies, Claire
dc.contributor.authorHiley, Victoria
dc.contributor.authorGregory, Walter
dc.contributor.authorBell, Richard
dc.date.accessioned2018-09-20T16:03:42Z
dc.date.available2018-09-20T16:03:42Z
dc.date.issued2011-10-13
dc.identifier.citationColeman, Robert E. Marshall, Helen; Cameron, David; Dodwell, David; Burkinshaw, Roger; Keane, Maccon; Gil, Miguel; Houston, Stephen J.; Grieve, Robert J.; Barrett-Lee, Peter J.; Ritchie, Diana; Pugh, Julia; Gaunt, Claire; Rea, Una; Peterson, Jennifer; Davies, Claire; Hiley, Victoria; Gregory, Walter; Bell, Richard (2011). Breast-cancer adjuvant therapy with zoledronic acid. New England Journal of Medicine 365 (15), 1396-1405
dc.identifier.issn0028-4793,1533-4406
dc.identifier.urihttp://hdl.handle.net/10379/10843
dc.description.abstractBACKGROUND 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. (Funded by Novartis Pharmaceuticals and the National Cancer Research Network; AZURE Current Controlled Trials number, ISRCTN79831382.)
dc.publisherNew England Journal of Medicine (NEJM/MMS)
dc.relation.ispartofNew England Journal of Medicine
dc.subjectoral clodronate
dc.subjectfollow-up
dc.subjectbone
dc.subjectpamidronate
dc.subjectdoxorubicin
dc.subjectprevention
dc.subjectsurvival
dc.subjectefficacy
dc.subjecttrials
dc.titleBreast-cancer adjuvant therapy with zoledronic acid
dc.typeArticle
dc.identifier.doi10.1056/nejmoa1105195
dc.local.publishedsourcehttp://eprints.whiterose.ac.uk/84229/1/AZURE%20first%20efficacy%20data%20NEJM%202011%20paper.pdf
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