Tags

Type your tag names separated by a space and hit enter

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.
Cancer. 2003 Oct 15; 98(8):1735-44.C

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.

Authors+Show Affiliations

Developmental Therapeutics, Cancer Institute Medical Group, Santa Monica, California 90095, USA. RosenL@jwci.orgNo 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
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14534891

Citation

Rosen, Lee S., et al. "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." Cancer, vol. 98, no. 8, 2003, pp. 1735-44.
Rosen LS, Gordon D, Kaminski M, et al. 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. Cancer. 2003;98(8):1735-44.
Rosen, L. S., Gordon, D., Kaminski, M., Howell, A., Belch, A., Mackey, J., Apffelstaedt, J., Hussein, M. A., Coleman, R. E., Reitsma, D. J., Chen, B. L., & Seaman, J. J. (2003). 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. Cancer, 98(8), 1735-44.
Rosen LS, et al. 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. Cancer. 2003 Oct 15;98(8):1735-44. PubMed PMID: 14534891.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Rosen,Lee S, AU - Gordon,David, AU - Kaminski,Mary, AU - Howell,Anthony, AU - Belch,Andrew, AU - Mackey,John, AU - Apffelstaedt,Justus, AU - Hussein,Mohamad A, AU - Coleman,Robert E, AU - Reitsma,Dirk J, AU - Chen,Bee-Lian, AU - Seaman,John J, PY - 2003/10/10/pubmed PY - 2003/10/31/medline PY - 2003/10/10/entrez SP - 1735 EP - 44 JF - Cancer JO - Cancer VL - 98 IS - 8 N2 - 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. SN - 0008-543X UR - https://www.unboundmedicine.com/medline/citation/14534891/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_ L2 - https://doi.org/10.1002/cncr.11701 DB - PRIME DP - Unbound Medicine ER -