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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.
Cancer J. 2001 Sep-Oct; 7(5):377-87.CJ

Abstract

PURPOSE

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 1,648 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 eventwas 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. (Can-

Authors+Show Affiliations

Jonsson Cancer Center, University of California, Los Angeles 90095, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11693896

Citation

Rosen, L S., et al. "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." Cancer Journal (Sudbury, Mass.), vol. 7, no. 5, 2001, pp. 377-87.
Rosen LS, Gordon D, Kaminski M, et al. 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. Cancer J. 2001;7(5):377-87.
Rosen, L. S., Gordon, D., Kaminski, M., Howell, A., Belch, A., Mackey, J., Apffelstaedt, J., Hussein, M., Coleman, R. E., Reitsma, D. J., Seaman, J. J., Chen, B. L., & Ambros, Y. (2001). 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. Cancer Journal (Sudbury, Mass.), 7(5), 377-87.
Rosen LS, et al. 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. Cancer J. 2001 Sep-Oct;7(5):377-87. PubMed PMID: 11693896.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Rosen,L S, AU - Gordon,D, AU - Kaminski,M, AU - Howell,A, AU - Belch,A, AU - Mackey,J, AU - Apffelstaedt,J, AU - Hussein,M, AU - Coleman,R E, AU - Reitsma,D J, AU - Seaman,J J, AU - Chen,B L, AU - Ambros,Y, PY - 2001/11/6/pubmed PY - 2002/2/12/medline PY - 2001/11/6/entrez SP - 377 EP - 87 JF - Cancer journal (Sudbury, Mass.) JO - Cancer J VL - 7 IS - 5 N2 - PURPOSE: 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 1,648 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 eventwas 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. (Can- SN - 1528-9117 UR - https://www.unboundmedicine.com/medline/citation/11693896/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_ L2 - https://ClinicalTrials.gov/search/term=11693896 [PUBMED-IDS] DB - PRIME DP - Unbound Medicine ER -