Drug updated on 4/24/2024
| Dosage Form | Injection (intravenous; 1,100 kBq/mL [30 microcurie/mL]) |
| Drug Class | Alpha particle-emitting radioactive therapeutic agents |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
Summary
- Radium Ra 223 dichloride (Xofigo) is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease. Its efficacy and safety were examined in a study, particularly focusing on its use in combination with new-generation hormonal agents (NHAs), such as abiraterone acetate plus prednisone or enzalutamide.
- One study was reviewed to gather information about Xofigo, specifically targeting patients suffering from bone metastatic castration-resistant prostate cancer without any known visceral metastatic disease.
- In terms of safety and effectiveness comparison, the incidence of fractures showed no significant difference between groups treated with Xofigo combined with NHAs versus those receiving Xofigo monotherapy. However, both these groups had a higher incidence of fractures compared to the NHA monotherapy group.
- When considering only randomized controlled trials within the study, it was found that there was a significantly higher incidence of fractures in the group receiving combination therapy (Xofigo + NHA) compared to those undergoing NHA monotherapy.
- There were no significant differences among all three groups - Xofigo + NHA combination therapy group, Xofigo monotherapy group, and NHA monotherapy group - when it came to Symptomatic Skeletal Events (SSEs), SSE-free survival rates, or common adverse events across all grades, including grade 3 adverse events.
- Despite having an increased risk for fractures compared to just using NHAs alone, combining radium Ra 223 dichloride (Xofigo) along with NHAs has been well-tolerated by patients according to this analysis, which also calls out the need for more evidence-based research to understand the balance between efficacy and safety, especially while using them together as part of the treatment regimen.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Xofigo (radium Ra 223 dichloride) Prescribing Information. | 2019 | Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| The safety of radium-223 combined with new-generation hormonal agents in bone metastatic castration-resistant prostate cancer: a systematic review and network meta-analysis. | 2023 | Asian Journal of Andrology |