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.

2.50
Hdl Handle:
http://hdl.handle.net/10541/78874
Title:
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.
Authors:
Rosen, Lee S; Gordon, David; Kaminski, Mary; Howell, Anthony ( 0000-0002-3879-5991 ) ; Belch, Andrew; Mackey, John R; Apffelstaedt, Justus; Hussein, Mohamad A; Coleman, Robert E; Reitsma, Dirk J; Chen, Bee-Lian; Seaman, John J
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.
Affiliation:
Developmental Therapeutics, Cancer Institute Medical Group, Santa Monica, California 90095, USA. RosenL@jwci.org
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
Issue Date:
15-Oct-2003
URI:
http://hdl.handle.net/10541/78874
DOI:
10.1002/cncr.11701
PubMed ID:
14534891
Type:
Article
Language:
en
ISSN:
0008-543X
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorRosen, Lee S-
dc.contributor.authorGordon, David-
dc.contributor.authorKaminski, Mary-
dc.contributor.authorHowell, Anthony-
dc.contributor.authorBelch, Andrew-
dc.contributor.authorMackey, John R-
dc.contributor.authorApffelstaedt, Justus-
dc.contributor.authorHussein, Mohamad A-
dc.contributor.authorColeman, Robert E-
dc.contributor.authorReitsma, Dirk J-
dc.contributor.authorChen, Bee-Lian-
dc.contributor.authorSeaman, John J-
dc.date.accessioned2009-08-27T11:10:07Z-
dc.date.available2009-08-27T11:10:07Z-
dc.date.issued2003-10-15-
dc.identifier.citationLong-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 Canceren
dc.identifier.issn0008-543X-
dc.identifier.pmid14534891-
dc.identifier.doi10.1002/cncr.11701-
dc.identifier.urihttp://hdl.handle.net/10541/78874-
dc.description.abstractBACKGROUND: 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.en
dc.language.isoenen
dc.subjectBone Canceren
dc.subjectBreast Canceren
dc.subject.meshBone Diseases-
dc.subject.meshBone Neoplasms-
dc.subject.meshBreast Neoplasms-
dc.subject.meshDiphosphonates-
dc.subject.meshDouble-Blind Method-
dc.subject.meshHumans-
dc.subject.meshImidazoles-
dc.subject.meshMiddle Aged-
dc.subject.meshMultiple Myeloma-
dc.titleLong-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.en
dc.typeArticleen
dc.contributor.departmentDevelopmental Therapeutics, Cancer Institute Medical Group, Santa Monica, California 90095, USA. RosenL@jwci.orgen
dc.identifier.journalCanceren

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