Zoledronic acid versus pamidronate in the treatment of skeletal metastases in patients with breast cancer or osteolytic lesions of multiple myeloma: A phase III, double-blind, comparative trial

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dc.contributor.authorRosen L.S.
dc.contributor.authorGordon D.
dc.contributor.authorKaminski M.
dc.contributor.authorHowell A.
dc.contributor.authorBelch A.
dc.contributor.authorMackey J.
dc.contributor.authorApffelstaedt J.
dc.contributor.authorHussein M.
dc.contributor.authorColeman R.E.
dc.contributor.authorReitsma D.J.
dc.contributor.authorSeaman J.J.
dc.contributor.authorChen B.-L.
dc.contributor.authorAmbros Y.
dc.date.accessioned2011-05-15T16:15:52Z
dc.date.available2011-05-15T16:15:52Z
dc.date.issued2001
dc.description.abstractPURPOSE: Zoledronic acid, a new and more potent bisphosphonate, was compared with pamidronate, the current standard treatment for patients with osteolytic or mixed bone metastases/lesions. PATIENTS AND METHODS: A total of 1648 patients with either Durie-Salmon stage III multiple myeloma or advanced breast cancer and at least one bone lesion were randomly assigned to treatment with either 4 or 8 mg of zoledronic acid via 15-minute intravenous infusion or 90 mg of pamidronate via 2-hour intravenous infusion every 3 to 4 weeks for 12 months. The primary efficacy endpoint was the proportion of patients experiencing at least one skeletal-related event over 13 months. RESULTS: The proportion of patients with at least one skeletal-related event was similar in all treatment groups. Median time to the first skeletal-related event was approximately 1 year in each treatment group. The skeletal morbidity rate was slightly lower in patients treated with zoledronic acid than in those treated with pamidronate, and zoledronic acid (4 mg) significantly decreased the incidence and event rate for radiation therapy to bone, both overall and in breast cancer patients receiving hormonal therapy. Pain scores decreased in all treatment groups in the presence of stable or decreased analgesic use. Zoledronic acid (4 mg) and pamidronate were equally well tolerated; the most common adverse events were bone pain, nausea, fatigue, and fever and < 5% of serious adverse events were related to the study drug. The incidence of renal impairment among patients treated with 4 mg of zoledronic acid via 15-minute infusion was similar to that among patients treated with pamidronate. CONCLUSIONS: Zoledronic acid (4 mg) via 15-minute intravenous infusion was as effective and well tolerated as 90 mg of pamidronate in the treatment of osteolytic and mixed bone metastases/lesions in patients with advanced breast cancer or multiple myeloma. Copyright © 2001 Jones and Bartlett Publishers, Inc.
dc.description.versionArticle
dc.identifier.citationCancer Journal
dc.identifier.citation7
dc.identifier.citation5
dc.identifier.issn15289117
dc.identifier.urihttp://hdl.handle.net/10019.1/13523
dc.subjectanalgesic agent
dc.subjectantineoplastic agent
dc.subjectcalcium
dc.subjecthormone
dc.subjectmultivitamin
dc.subjectpamidronic acid
dc.subjectzoledronic acid
dc.subjectbisphosphonic acid derivative
dc.subjectimidazole derivative
dc.subjectadult
dc.subjectalopecia
dc.subjectanemia
dc.subjectanorexia
dc.subjectarthralgia
dc.subjectarticle
dc.subjectbone metastasis
dc.subjectbone pain
dc.subjectbreast cancer
dc.subjectcancer hormone therapy
dc.subjectcancer pain
dc.subjectcancer radiotherapy
dc.subjectcancer staging
dc.subjectclinical trial
dc.subjectconstipation
dc.subjectcontrolled clinical trial
dc.subjectcontrolled study
dc.subjectcoughing
dc.subjectdiarrhea
dc.subjectdouble blind procedure
dc.subjectdrug efficacy
dc.subjectdrug megadose
dc.subjectdrug safety
dc.subjectdrug tolerability
dc.subjectdyspnea
dc.subjectfatigue
dc.subjectfemale
dc.subjectfever
dc.subjectheadache
dc.subjecthuman
dc.subjectincidence
dc.subjectkidney disease
dc.subjectleg edema
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectmorbidity
dc.subjectmulticenter study
dc.subjectmultiple myeloma
dc.subjectmuscle weakness
dc.subjectmyalgia
dc.subjectnausea
dc.subjectosteolysis
dc.subjectpain assessment
dc.subjectphase 3 clinical trial
dc.subjectpriority journal
dc.subjectrandomized controlled trial
dc.subjectvomiting
dc.subjectbone tumor
dc.subjectbreast tumor
dc.subjectcomparative study
dc.subjectmetastasis
dc.subjectmiddle aged
dc.subjectpathology
dc.subjectAntineoplastic Agents
dc.subjectBone Neoplasms
dc.subjectBreast Neoplasms
dc.subjectDiphosphonates
dc.subjectDouble-Blind Method
dc.subjectFemale
dc.subjectHumans
dc.subjectImidazoles
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectMulticenter Studies
dc.subjectMultiple Myeloma
dc.titleZoledronic acid versus pamidronate in the treatment of skeletal metastases in patients with breast cancer or osteolytic lesions of multiple myeloma: A phase III, double-blind, comparative trial
dc.typeArticle
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