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Radium Ra 223 dichloride safe, effective for prostate cancer bone metastases
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Radium Ra 223 dichloride reduced the time to a first symptomatic skeletal event compared with placebo in patients with castration-resistant prostate cancer and symptomatic bone metastases, according to results of a randomized, double blind, phase 3 study.
Researchers also determined radium Ra 223 dichloride (Xofigo, Bayer HealthCare) decreased use of external beam radiation therapy for bone pain and also decreased the need for spinal cord compression.
The trial included 921 patients with castration-resistant prostate cancer and bone metastases.
Oliver Sartor, MD, medical director at Tulane Cancer Center, and colleagues assigned patients in a 2:1 ratio to IV injections of 50 kg radium Ra 223 dichloride — administered every four weeks for six cycles — or placebo.
All patients had two or more bone metastases and no known visceral metastases. Metastases were either unsuitable for or previously treated with docetaxel. OS served as the primary endpoint.
During the 31-month study period, researchers identified 202 symptomatic skeletal events in the radium Ra 223 dichloride arm and 116 in the placebo arm. The median time to first symptomatic skeletal event was 15.6 months (95% CI, 13.5-18) in the radium Ra 223 dichloride arm and 9.8 months (95% CI, 7.3-23.7) in the placebo arm (HR=0.66; 95% CI, 0.52-0.83).
Patients treated with radium Ra 223 dichloride were less likely to require external beam radiation therapy for bone pain (HR=0.67; 95% CI, 0.53-0.85) or spinal cord compression (HR=0.52; 95% CI, 0.29-0.93).
However, treatment with radium Ra 223 dichloride did not significantly reduce the risk for symptomatic pathological bone fracture (HR=0.62; 95% CI, 0.35-1.09) or tumor-associated orthopedic surgical intervention (HR=0.72; 95% CI, 0.28-1.82).
Disclosure: The study was funded by Algeta and Bayer HealthCare Pharmaceuticals.
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