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J Nucl Med. 2012; 53 (Supplement 1):222
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Oncology: Basic, Translational & Therapy

Radiopharmaceutical Therapy: Clinical

Radium-223 chloride: Radiation safety, tolerability, and survival gain in patients with castration-resistant prostate cancer (CRPC) and bone metastases

Valerie Lewington1, Roy Lamey2, Karin Staudacher3 and Nicholas Vogelzang2

1 Guy's and St Thomas' Hospital, London, United Kingdom 2 US Oncology Research, Comprehensive Cancer Centers of Nevada, Las Vegas, NV 3 Algeta ASA, Oslo, Norway

Abstract No. 222

Objectives: Radium-223 chloride (Ra-223) targets bone metastases with high LET, short range (<100μm) alpha-particles. The phase III, double-blind, randomized, international ALSYMPCA study compared Ra-223 plus best standard of care (BSC) vs placebo plus BSC in CRPC patients with bone metastases. The radiation safety and phase III clinical results using Ra-223 are described.

Methods: The physical properties of Ra-223 were assessed to establish radiation protection parameters for safe use. Eligible ALSYMPCA patients had confirmed CRPC with ≥2 bone metastases, no known visceral disease, and were post-docetaxel or unfit for docetaxel. The primary endpoint was overall survival (OS). After randomization (2:1), 922 pts (Ra-223, n=615; placebo, n=307) received 6 injections of Ra-223 (50 kBq/kg IV) every 4 weeks or matching placebo.

Results: The 11.4 day physical T1/2 of Ra-223 was sufficient for preparation, distribution, and administration. The short penetration of alpha radiation avoided requirements for complex shielding. Treatment was delivered on an outpatient basis. No specific radiation protection restrictions were required. Standard equipment was used for contamination monitoring. A planned interim analysis of ALSYMPCA (n=809) showed that Ra-223 improved median OS vs placebo (14.0 vs 11.2 mo, respectively; two-sided P=.00185; HR=.695; 95% CI, .552-.875). Safety and tolerability of Ra-223 were favorable, with low myelosuppression (1.8% vs 0.8% grade 3/4 neutropenia in Ra-223 and placebo groups, respectively).

Conclusions: Ra-223 is safe and straightforward to administer using conventional nuclear medicine equipment. Few radiation protection limitations are required post-therapy. ALSYMPCA demonstrated significantly improved OS and very low toxicity, suggesting that Ra-223 may provide a new standard of care for patients with CRPC and bone metastases.

Research Support: Algeta AS





This Article
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Google Scholar
Right arrow Articles by Lewington, V.
Right arrow Articles by Vogelzang, N.
PubMed
Right arrow Articles by Lewington, V.
Right arrow Articles by Vogelzang, N.