Jonathan Reuning-Scherer

Patient-reported quality-of-life analysis of radium-223 dichloride from the phase III ALSYMPCA study

In the phase III randomized ALSYMPCA trial of radium-223 in patients with castration-resistant prostate cancer and bone metastases, improved survival with radium-223 is accompanied by significant quality of life benefits, measured by EQ-5D and FACT-P, including a higher percentage of patients with meaningful improvement in quality of life and a slower decline in quality of life over time.

Effects of radium-223 dichloride (Ra-223) on risk for hospitalization and health care resource use in the phase 3 ALSYMPCA trial.

21 Background: Ra-223 is a first-in-class alpha-emitter approved for treatment (tx) of patients (pts) with castration-resistant prostate cancer and symptomatic bone metastases. In ALSYMPCA, Ra-223 significantly improved overall survival by 3.6 months vs placebo (pbo) (HR = 0.70; 95% CI, 0.58-0.83; P < 0.001) and was well tolerated. To understand whether the tx benefit corresponds to differences in utilization, hospitalization and other types of health care resource use were evaluated. METHODS Data on hospitalization, nursing home visits, home health care and adult day care services use, and physician visits were captured for each pt. Tx groups were compared, based on percentage needing each type of health care resource, using Fishers exact test. To account for differences in each pt resource use in ALSYMPCA, the number of encounters (eg, office visits) and duration of encounters (eg, days hospitalized) were divided by observation time. The mean number and duration of encounters were compared using analysis of variance. To compare tx groups based on the rate of use per year, incidence rates and ratios were calculated using a generalized estimating equation (GEE) regression model. RESULTS The mean follow-up time in months for Ra-223 vs pbo was 10.0 vs 8.6. The incidence rate for Ra-223 vs pbo was 1.1 vs 1.4 (incidence rate ratio = 0.77; 95% CI, 0.62-0.95; P = 0.013). The mean number of hospitalizations and hospitalization days per year for Ra-223 vs pbo were 1.3 vs 1.7 (P = 0.020) and 8.1 vs 14.6 (P < 0.001), respectively. The percentage of pts that required hospitalization was nominally lower for Ra-223 vs pbo (42.3% vs 49.0%, P = 0.062). Among pts who experienced at least one hospitalization, the mean number of hospitalization days per year for Ra-223 vs pbo pts was 19.4 vs 30.4 (P < 0.001). No significant differences were found between tx groups in terms of visits or durations of time in nursing homes per year, amount of adult day care and home health care services utilized per year, and number of physician visits per year. CONCLUSIONS Compared with pbo, Ra-223 tx resulted in a 23% reduction in incidence of hospitalizations per year and about 6.5 fewer hospitalization days per pt per year. CLINICAL TRIAL INFORMATION NCT00699751.