Adding radium-223 to abiraterone or enzalutamide is safe and may prolong overall survival for patients with metastatic castration-resistant prostate cancer (mCRPC), a study published in The Lancet Oncology has shown.1
For this international, open-label, single-arm, phase 3b study, researchers enrolled 839 patients with progressive bone-predominant mCRPC and with 2 or more skeletal metastases on imaging.
Of enrolled patients, 696 received 1 or more doses of radium-223 and 403 completed all 6 planned injections. Use of other concomitant therapies, such as abiraterone, enzalutamide, and denosumab, were permitted.
Median overall survival was longer in patients who received radium-223 plus abiraterone, enzalutamide, or both, compared with those who did not receive abiraterone or enzalutamide (median, not reached versus 13 months).
Patients who received radium-223 with denosumab had a longer overall survival than those who received radium-223 with denosumab (median, not reached versus 13 months).
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Median overall survival was longer for men with: a baseline alkaline phosphatase concentration less than the upper limit of normal, a baseline hemoglobin level of 10 g/dL or greater, a baseline ECOG performance status of 0, and no reported baseline pain.
A total of 35% of patients reported any grade of serious adverse events. Treatment-emergent adverse events of any grade occurred for 75% of patients.
- Saad F, Carles J, Gillessen S, et al. Radium-223 and concomitant therapies in patients with metastatic castration-resistant prostate cancer: an international, early access, open-label, single-arm phase 3b trial. Lancet Oncol. 2016 Jul 26. doi: 10.1016/S1470-2045(16)30173-5 [Epub ahead of print]