Evaluation of the palliative benefit and toxicity of Ra-223 treatment of men with hormone refractory prostate cancer in a community setting.

Abstract

225 Background: The ALSYMCA (Alpharadin in Symptomatic Prostate Cancer) trial was a phase III, placebo controlled, randomized trial in which 921 men with bone metastasis from hormone refractory prostate cancer (HRPC) were randomly assigned to receive radium-223 (Ra-223) or placebo. Ra-223 produced a 30% survival benefit, with a median survival of 14.9 months compared to 11.3 months for patients treated with a placebo, which led to FDA approval in 2013. Methods: We identified through the nuclear medicine records 11 patients who started Ra-223 between March 15, 2013 and December 10, 2015. The Wilcoxon signed rank test was used to compare the published results of the ALSYMPCA patients with those from our institution. Results: The Hodges-Lehman estimate of the median survival of our patients from the date of the first Ra-223 infusion was 7.8 months. The 95% confidence interval (CI) was (2.8, 14.7; p = 0.0122) indicating our patients had a significantly shorter survival. Our patients did not have a statistically significant worse rate of anemia, neutropenia, or thrombocytopenia. Only 27.3% (95% CI: 6.0, 61.0%) of our patients completed all 6 planned infusions significantly less than 63% for the ALSYMPCA patients treated with Ra-223 (p = 0.0239), but not statistically different than the placebo patients (p = 0.236). The median survival from the last Ra-223 was 3.53 months. We used 3 measures of treatment effectiveness: (1) reduction in the pain scores, (2) reduction in the serum PSA, and (3) reduction in the alkaline phosphatase. Compared to the pre-treatment values, numerical reductions were seen at the last follow-up evaluation for both the pain scores and the alkaline phosphatase levels, but the reductions were not statistically significant. Conclusions: Not all patients with castration resistant prostate cancer benefit from Ra-223 to the same extent as the ALSYMPCA patients. It is important to identify patients with a sufficient life expectancy to benefit from this treatment.