Radium-223 dichloride (radium-223) improves overall survival in patients with castration-resistant prostate cancer (CRPC). In addition, patient-reported quality of life (QOL) is higher and decline in QOL over time is slower, according to QOL data from the ALSYMPCA trial reported in the Annals of Oncology.1
The phase 3 ALSYMPCA study demonstrated an overall survival benefit with radium-223, a first-in-class alpha-emitting radiopharmaceutical recommended in both predocetaxel and postdocetaxel settings in patients with CRPC and symptomatic bone metastases.
For this report, analyses of the health-related QOL data from the ALSYMPCA study were performed to determine the treatment effects of radium-223 plus standard of care (SOC) vs placebo plus SOC. ALSYMPCA used 2 validated instruments to measure health-related QOL: the general EuroQoL 5D (EQ-5D) and the disease-specific Functional Assessment of Cancer Therapy—Prostate (FACT-P). The data were assessed for percentage of patients experiencing improvement, percentage of patients experiencing worsening, and mean QOL scores during the study.
Patients were randomized to receive radium-223 (n=614) or placebo (n=307). Mean baseline scores were similar between the treatment groups.
Meaningful improvement in QOL was seen in a significantly higher percentage of patients receiving the treatment vs placebo on EQ-5D utility score (29.2% vs 18.5%, respectively; P=0.004; odds ratio [OR]=1.82 [95% CI 1.21-2.74]) and on FACT-P total score (24.6% vs 16.1%, respectively; P=.020; OR=1.70 [95% CI 1.08-2.65]). EQ-5D utility score and FACT-P total score measures showed a lower percentage of patients receiving radium-223 experienced meaningful worsening vs placebo.
Prior docetaxel use and current bisphosphonate use had no affect on the findings. However, treatment with radium-223 was associated with higher scores vs placebo in EQ-5D utility score (0.56 vs 0.50, respectively; P=.002) and FACT-P total score (99.08 vs 95.22; P=.004, respectively).
1. Nilsson S, Cislo P, Sartor O, et al. Patient-reported quality of life analysis of radium-223 dichloride from the phase 3 ALSYMPCA study [published online ahead of print February 23, 2016]. Ann Oncol. doi:10.1093/annonc/mdw065.