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. 2013 Mar;11(1):20-6.
doi: 10.1016/j.clgc.2012.07.002. Epub 2012 Sep 26.

Two-year Survival Follow-Up of the Randomized, Double-Blind, Placebo-Controlled Phase II Study of radium-223 Chloride in Patients With Castration-Resistant Prostate Cancer and Bone Metastases

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Two-year Survival Follow-Up of the Randomized, Double-Blind, Placebo-Controlled Phase II Study of radium-223 Chloride in Patients With Castration-Resistant Prostate Cancer and Bone Metastases

Sten Nilsson et al. Clin Genitourin Cancer. .

Abstract

Background: This phase II randomized, placebo-controlled study was conducted to evaluate efficacy and safety of radium-223 in patients with castration-resistant prostate cancer (CRPC) and painful bone metastases. Twelve- and 18-month survival results were reported previously. Here we report 24-month overall survival (OS) and safety data from the period 12 to 24 months after the first injection of study medication.

Methods: Patients with CRPC and bone pain were randomized 1:1 to receive 4 injections of radium-223 (50 kBq/kg [n = 33]) or placebo (n = 31) after external-beam radiotherapy; each injection was given every 4 weeks. Endpoints for this report were 24-month OS, long-term safety, and treatment-related adverse events (AEs) occurring in the 12- to 24-month period.

Results: After 24 months, 10 (30%) patients were alive in the radium-223 group compared with 4 patients (13%) in the placebo group. Patients who received at least 1 dose of study medication had a median OS of 65 weeks in the radium-223 group vs. 46 weeks in the placebo group (log-rank P = .056). The hazard ratio (HR) for OS, adjusted for baseline covariates, was 0.476 (95% confidence interval [CI], 0.258-0.877; Cox regression P = .017). The most frequent cause of death for both arms was disease progression. There were no reports of treatment-related AEs or long-term hematologic toxicity during the 12- to 24-month follow-up.

Conclusion: Radium-223 had a highly favorable safety profile, with no evidence of second malignancies at 24-month follow-up. The significant improvement in OS observed in patients receiving radium-223 vs. placebo suggests that treatment of bone disease with radium-223 has survival benefits.

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