Oral ibandronate for the treatment of metastatic bone disease in breast cancer: Efficacy and safety results from a randomized, double-blind, placebo-controlled trial

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dc.contributor.authorTripathy, D.
dc.contributor.authorLichinitzer, M.
dc.contributor.authorLazarev, A.
dc.contributor.authorMacLachlan, S. A.
dc.contributor.authorApffelstaedt, J.
dc.contributor.authorBudde, M.
dc.contributor.authorBergstrom, B.
dc.contributor.authorAbdi, E.
dc.contributor.authorAbramson, N.
dc.contributor.authorBaker, T. M.
dc.contributor.authorKirkegaard, L. W.
dc.contributor.authorSchmidt, J. R.
dc.contributor.authorBell, D.
dc.contributor.authorBell, R.
dc.contributor.authorBelt, R. J.
dc.contributor.authorBernstein, J. I.
dc.contributor.authorJust, R. G.
dc.contributor.authorBurningham, R. A.
dc.contributor.authorTrafficante, B.
dc.contributor.authorCaggiano, V.
dc.contributor.authorCartwright, T.
dc.contributor.authorChernozemsky, I. N.
dc.contributor.authorClingan, P.
dc.contributor.authorConkling, P.
dc.contributor.authorCraig, J. B.
dc.contributor.authorGrosbach, A. B.
dc.contributor.authorDecker, D.
dc.contributor.authorDickman, E.
dc.contributor.authorDuga, Jr. W.
dc.contributor.authorDunlap, W.
dc.contributor.authorEisenberg, P. D.
dc.contributor.authorEllerton, J.
dc.contributor.authorEttinger, M.
dc.contributor.authorEy, F.
dc.contributor.authorFalkson, G.
dc.contributor.authorFalkson, C.
dc.contributor.authorFink, K.
dc.contributor.authorFleagle, J.
dc.contributor.authorForlenza, T.
dc.contributor.authorGorbunova, V. A.
dc.contributor.authorGross, G. E.
dc.contributor.authorGrotes, T.
dc.contributor.authorGrygiel, J.
dc.contributor.authorGudgeon, A.
dc.contributor.authorWerner, I. D.
dc.contributor.authorHacking, D.
dc.contributor.authorHarrer, G. W.
dc.contributor.authorHarvey, V.
dc.contributor.authorHirsch, R.
dc.contributor.authorKoletsky, A.
dc.contributor.authorJordaan, J. P.
dc.contributor.authorCash, D. K.
dc.contributor.authorKhasanov, R. Sh.
dc.contributor.authorLaFata, J. A.
dc.contributor.authorLafollette, S.
dc.contributor.authorKoshla, P.
dc.contributor.authorLanders, G.
dc.contributor.authorLebos, H. C.
dc.contributor.authorWade, J. L.
dc.contributor.authorLowenthal, T.
dc.contributor.authorLyons, R.
dc.contributor.authorMcLachlan, S. A.
dc.contributor.authorMurray, R.
dc.contributor.authorPerez, D.
dc.contributor.authorPhadke, K.
dc.contributor.authorRapoport, B.
dc.contributor.authorRausch, P. G.
dc.contributor.authorRobinson, B.
dc.contributor.authorSarna, G.
dc.contributor.authorSaven, A.
dc.contributor.authorSchwartz, M.
dc.contributor.authorSemiglazov, V. F.
dc.contributor.authorStewart, J.
dc.contributor.authorSunderland, K.
dc.contributor.authorThomas, L.
dc.contributor.authorVogel, C. L.
dc.contributor.authorMartinez Rio, M.
dc.contributor.authorVorobiof, D. A.
dc.contributor.authorWilks, S.
dc.contributor.authorWoolley, P.
dc.date.accessioned2011-05-15T16:15:30Z
dc.date.available2011-05-15T16:15:30Z
dc.date.issued2004
dc.description.abstractBackground: We report the first results of a randomized trial assessing a new oral aminobisphosphonate, ibandronate, in patients with bone metastases from breast cancer. Patients and methods: Patients (n = 435) received placebo, or oral ibandronate 20 mg or 50 mg once-daily for 96 weeks. The primary efficacy measure was the number of 12-week periods with new bone complications [skeletal morbidity period rate (SMPR)]. Multivariate Poisson regression analysis assessed the relative risk reduction of skeletal-related events. Secondary efficacy analyses included bone pain and analgesic use. Adverse events were monitored. Results: SMPR was significantly reduced with oral ibandronate [placebo 1.2, 20 mg group 0.97 (P = 0.024), 50 mg group 0.98 (P = 0.037)]. Ibandronate 50 mg significantly reduced the need for radiotherapy (P = 0.005 versus placebo). The relative risk of skeletal events was reduced by 38% (20 mg dose) and 39% (50 mg dose) versus placebo (P = 0.009 and P = 0.005). The tolerability profile of ibandronate was similar to placebo. Conclusions: Oral ibandronate is an effective and well-tolerated treatment for metastatic bone disease. The 50 mg dose is being further evaluated in clinical trials, and this dose was recently approved in the European Union for the prevention of skeletal events in patients with breast cancer and bone metastases. © 2004 European Society for Medical Oncology.
dc.description.versionArticle
dc.identifier.citationAnnals of Oncology
dc.identifier.citation15
dc.identifier.citation5
dc.identifier.issn09237534
dc.identifier.other10.1093/annonc/mdh173
dc.identifier.urihttp://hdl.handle.net/10019.1/13367
dc.subjectbisphosphonic acid derivative
dc.subjectcytotoxic agent
dc.subjectibandronic acid
dc.subjectnarcotic analgesic agent
dc.subjectplacebo
dc.subjectabdominal pain
dc.subjectadult
dc.subjectaged
dc.subjectarticle
dc.subjectbone disease
dc.subjectbone metastasis
dc.subjectbone pain
dc.subjectbreast cancer
dc.subjectcancer growth
dc.subjectcancer radiotherapy
dc.subjectclinical trial
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectdiarrhea
dc.subjectdose response
dc.subjectdouble blind procedure
dc.subjectdrug approval
dc.subjectdrug efficacy
dc.subjectdrug fatality
dc.subjectdrug safety
dc.subjectdrug tolerability
dc.subjectdrug use
dc.subjectdyspepsia
dc.subjectesophagitis
dc.subjectEuropean Union
dc.subjectfemale
dc.subjectflatulence
dc.subjectfracture
dc.subjecthuman
dc.subjecthypocalcemia
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmorbidity
dc.subjectmultivariate analysis
dc.subjectnausea
dc.subjectnausea and vomiting
dc.subjectnephrotoxicity
dc.subjectpathologic fracture
dc.subjectPoisson distribution
dc.subjectpriority journal
dc.subjectrandomized controlled trial
dc.subjectregression analysis
dc.subjectrisk assessment
dc.subjectrisk reduction
dc.subjecturemia
dc.subjectvertebra fracture
dc.subjectAdministration, Oral
dc.subjectAdult
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectAnalgesics
dc.subjectBone Neoplasms
dc.subjectBreast Neoplasms
dc.subjectDiphosphonates
dc.subjectDouble-Blind Method
dc.subjectDrug Administration Schedule
dc.subjectFemale
dc.subjectHumans
dc.subjectMiddle Aged
dc.subjectMorbidity
dc.subjectPain
dc.subjectPlacebos
dc.titleOral ibandronate for the treatment of metastatic bone disease in breast cancer: Efficacy and safety results from a randomized, double-blind, placebo-controlled trial
dc.typeArticle
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