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    Breast-cancer adjuvant therapy with zoledronic acid

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    Date
    2011-10-13
    Author
    Coleman, 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
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    Cited 373 times in Scopus (view citations)
    
    Recommended Citation
    Coleman, 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
    Published Version
    http://eprints.whiterose.ac.uk/84229/1/AZURE%20first%20efficacy%20data%20NEJM%202011%20paper.pdf
    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. (Funded by Novartis Pharmaceuticals and the National Cancer Research Network; AZURE Current Controlled Trials number, ISRCTN79831382.)
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    http://hdl.handle.net/10379/10843
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