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Zoledronic acid significantly reduces skeletal complications compared with placebo in Japanese women with bone metastases from breast cancer: a randomized, placebo-controlled trial.
J Clin Oncol. 2005 May 20; 23(15):3314-21.JC

Abstract

PURPOSE

To investigate the efficacy and safety of zoledronic acid for the treatment of bone metastases from breast cancer.

PATIENTS AND METHODS

Women with bone metastases (N = 228) were randomly assigned to receive 4 mg zoledronic acid (n = 114) or placebo (n = 114) via 15-minute infusions every 4 weeks for 1 year. The primary efficacy end point was the skeletal-related event (SRE) rate ratio between treatment groups. An SRE was defined as pathologic fracture, spinal cord compression, and radiation or surgery to bone. Secondary end points included percentage of patients with at least one SRE, time-to-first SRE, and Andersen-Gill multiple-event analysis.

RESULTS

The SRE rate ratio at 1 year (excluding HCM and adjusted for prior fracture) was 0.61 (permutation test; P = .027), indicating that zoledronic acid reduced the rate of SRE by 39% compared with placebo. The percentage of patients with at least one SRE (excluding HCM) was significantly reduced by 20% by zoledronic acid (29.8% v 49.6% for placebo; P = .003). Zoledronic acid significantly delayed time-to-first SRE (median not reached v 364 days; Cox regression; P = .007) and reduced the risk of SREs by 41% in multiple event analysis (risk ratio = 0.59; P = .019) compared with placebo. Zoledronic acid was well tolerated with a safety profile similar to placebo. No patient treated with zoledronic acid had grade 3 or 4 serum creatinine increase.

CONCLUSION

Zoledronic acid significantly reduced skeletal complications compared with placebo across multiple end points in Japanese women with bone metastases from breast cancer.

Authors+Show Affiliations

Department of Surgery, Hyogo Medical Center for Adults, 13-70 Kitaojicho Akashi 673-0021, Japan. norio@tiger.interq.or.jpNo 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

Language

eng

PubMed ID

15738536

Citation

Kohno, Norio, et al. "Zoledronic Acid Significantly Reduces Skeletal Complications Compared With Placebo in Japanese Women With Bone Metastases From Breast Cancer: a Randomized, Placebo-controlled Trial." Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 23, no. 15, 2005, pp. 3314-21.
Kohno N, Aogi K, Minami H, et al. Zoledronic acid significantly reduces skeletal complications compared with placebo in Japanese women with bone metastases from breast cancer: a randomized, placebo-controlled trial. J Clin Oncol. 2005;23(15):3314-21.
Kohno, N., Aogi, K., Minami, H., Nakamura, S., Asaga, T., Iino, Y., Watanabe, T., Goessl, C., Ohashi, Y., & Takashima, S. (2005). Zoledronic acid significantly reduces skeletal complications compared with placebo in Japanese women with bone metastases from breast cancer: a randomized, placebo-controlled trial. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 23(15), 3314-21.
Kohno N, et al. Zoledronic Acid Significantly Reduces Skeletal Complications Compared With Placebo in Japanese Women With Bone Metastases From Breast Cancer: a Randomized, Placebo-controlled Trial. J Clin Oncol. 2005 May 20;23(15):3314-21. PubMed PMID: 15738536.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Zoledronic acid significantly reduces skeletal complications compared with placebo in Japanese women with bone metastases from breast cancer: a randomized, placebo-controlled trial. AU - Kohno,Norio, AU - Aogi,Kenjiro, AU - Minami,Hironobu, AU - Nakamura,Seigo, AU - Asaga,Taro, AU - Iino,Yuichi, AU - Watanabe,Toru, AU - Goessl,Carsten, AU - Ohashi,Yasuo, AU - Takashima,Shigemitsu, Y1 - 2005/02/28/ PY - 2005/3/2/pubmed PY - 2005/6/25/medline PY - 2005/3/2/entrez SP - 3314 EP - 21 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JO - J Clin Oncol VL - 23 IS - 15 N2 - PURPOSE: To investigate the efficacy and safety of zoledronic acid for the treatment of bone metastases from breast cancer. PATIENTS AND METHODS: Women with bone metastases (N = 228) were randomly assigned to receive 4 mg zoledronic acid (n = 114) or placebo (n = 114) via 15-minute infusions every 4 weeks for 1 year. The primary efficacy end point was the skeletal-related event (SRE) rate ratio between treatment groups. An SRE was defined as pathologic fracture, spinal cord compression, and radiation or surgery to bone. Secondary end points included percentage of patients with at least one SRE, time-to-first SRE, and Andersen-Gill multiple-event analysis. RESULTS: The SRE rate ratio at 1 year (excluding HCM and adjusted for prior fracture) was 0.61 (permutation test; P = .027), indicating that zoledronic acid reduced the rate of SRE by 39% compared with placebo. The percentage of patients with at least one SRE (excluding HCM) was significantly reduced by 20% by zoledronic acid (29.8% v 49.6% for placebo; P = .003). Zoledronic acid significantly delayed time-to-first SRE (median not reached v 364 days; Cox regression; P = .007) and reduced the risk of SREs by 41% in multiple event analysis (risk ratio = 0.59; P = .019) compared with placebo. Zoledronic acid was well tolerated with a safety profile similar to placebo. No patient treated with zoledronic acid had grade 3 or 4 serum creatinine increase. CONCLUSION: Zoledronic acid significantly reduced skeletal complications compared with placebo across multiple end points in Japanese women with bone metastases from breast cancer. SN - 0732-183X UR - https://www.unboundmedicine.com/medline/citation/15738536/Zoledronic_acid_significantly_reduces_skeletal_complications_compared_with_placebo_in_Japanese_women_with_bone_metastases_from_breast_cancer:_a_randomized_placebo_controlled_trial_ DB - PRIME DP - Unbound Medicine ER -