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    Long-term efficacy and safety of zoledronic acid compared with pamidronate disodium in the treatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma: a randomized, double-blind, multicenter, comparative trial.

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    Authors
    Rosen, Lee S
    Gordon, David
    Kaminski, Mary
    Howell, Anthony
    Belch, Andrew
    Mackey, John R
    Apffelstaedt, Justus
    Hussein, Mohamad A
    Coleman, Robert E
    Reitsma, Dirk J
    Chen, Bee-Lian
    Seaman, John J
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    Affiliation
    Developmental Therapeutics, Cancer Institute Medical Group, Santa Monica, California 90095, USA. RosenL@jwci.org
    Issue Date
    2003-10-15
    
    Metadata
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    Abstract
    BACKGROUND: The goal of the current study was to compare the long-term (25-month) safety and efficacy of zoledronic acid with pamidronate in patients with bone lesions secondary to advanced breast carcinoma or multiple myeloma. METHODS: Patients (n = 1648) were randomized to receive 4 mg or 8 mg (reduced to 4 mg) zoledronic acid as a 15-minute infusion or to receive 90 mg pamidronate as a 2-hour infusion every 3-4 weeks for 24 months. The primary endpoint was the proportion of patients with at least 1 skeletal-related event (SRE), defined as pathologic fracture, spinal cord compression, radiation therapy, or surgery to bone. Secondary analyses included time to first SRE, skeletal morbidity rate, and multiple-event analysis. Hypercalcemia of malignancy (HCM) was included as an SRE in some secondary analyses. RESULTS: After 25 months of follow-up, zoledronic acid reduced the overall proportion of patients with an SRE and reduced the skeletal morbidity rate similar to pamidronate. Compared with pamidronate, zoledronic acid (4 mg) reduced the overall risk of developing skeletal complications (including HCM) by an additional 16% (P = 0.030). In patients with breast carcinoma, zoledronic acid (4 mg) was significantly more effective than pamidronate, reducing the risk of SREs by an additional 20% (P = 0.025) compared with pamidronate and by an additional 30% in patients receiving hormonal therapy (P = 0.009). Zoledronic acid (4 mg) and pamidronate were tolerated equally well. The most common adverse events included bone pain, nausea, and fatigue. CONCLUSIONS: Long-term follow-up data confirm that zoledronic acid was more effective than pamidronate in reducing the risk of skeletal complications in patients with bone metastases from breast carcinoma and was of similar efficacy in patients with multiple myeloma.
    Citation
    Long-term efficacy and safety of zoledronic acid compared with pamidronate disodium in the treatment of skeletal complications in patients with advanced multiple myeloma or breast carcinoma: a randomized, double-blind, multicenter, comparative trial. 2003, 98 (8):1735-44 Cancer
    Journal
    Cancer
    URI
    http://hdl.handle.net/10541/78874
    DOI
    10.1002/cncr.11701
    PubMed ID
    14534891
    Type
    Article
    Language
    en
    ISSN
    0008-543X
    ae974a485f413a2113503eed53cd6c53
    10.1002/cncr.11701
    Scopus Count
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