Efficacy and safety of denosumab versus zoledronic acid in patients with bone metastases: a systematic review and meta-analysis.

Abstract

BACKGROUND:

Zoledronic acid (ZA) has been used as the standard treatment for patients with solid cancer or myeloma that has metastasized into bone. A new potential therapeutic strategy, denosumab, is being investigated in a variety of tumors. We conducted a systematic review with meta-analysis of randomized clinical trials assessing the efficacy and safety of denosumab in comparison with ZA in patients with bone metastases secondary to malignancy.

METHODS:

A systematic literature search of several electronic databases till July 2011 and a review of reference lists of relevant articles was conducted. Summary relative estimates and 95% confidence intervals (CIs) were calculated using a fixed-effects or random-effects model, depending on the heterogeneity of the included studies.

RESULTS:

Seven reports from 3 randomized controlled trials involving 5723 patients were identified. The pooled analysis showed that denosumab significantly delayed time to first on-study skeletal-related event [hazard ratio (HR) = 0.83; 95% CI, 0.76-0.90, P < 0.001], time to multiple skeletal-related events (HR = 0.83; 95% CI, 0.76-0.90, P < 0.001), and pain worsening (HR = 0.92; 95% CI, 0.86-0.99, P = 0.026) for patients with bone metastases compared with ZA. Similar results of the 2 groups were obtained with respect to overall survival (HR = 0.98; 95% CI, 0.91-1.06), disease progression (HR = 1.02; 95% CI, 0.96-1.09), and pain improvement. Summary of the adverse effects revealed similar safety profiles for the 2 drugs.

CONCLUSIONS:

Denosumab is superior to ZA in preventing complications for patients with bone metastases. However, further studies are still needed to assess longer-term safety and efficacy of denosumab.

• Authors: Lei Sun, Shiying Yu
• Journal: American journal of clinical oncology (Am J Clin Oncol) Vol. 36 Issue 4 Pg. 399-403 (Aug 2013) ISSN: 1537-453X [Electronic] United States
• PMID: 22772430 (Publication Type: Comparative Study, Journal Article, Meta-Analysis, Review, Systematic Review)

Chemical References

• Antibodies, Monoclonal, Humanized
• Bone Density Conservation Agents
• Diphosphonates
• Imidazoles
• Denosumab
• Zoledronic Acid

Topics

• Antibodies, Monoclonal, Humanized (adverse effects, therapeutic use)
• Bone Density Conservation Agents (adverse effects, therapeutic use)
• Bone Neoplasms (drug therapy, mortality, secondary)
• Denosumab
• Diphosphonates (adverse effects, therapeutic use)
• Female
• Humans
• Imidazoles (adverse effects, therapeutic use)
• Male
• Neoplasm Staging
• Patient Safety
• Prognosis
• Quality of Life
• Randomized Controlled Trials as Topic
• Risk Assessment
• Survival Analysis
• Treatment Outcome
• Zoledronic Acid