Abstract
177 Background: Radium-223 improved overall survival (OS) with meaningful improvements vs placebo in health-related quality of life (HRQoL) in phase 3 ALSYMPCA (Parker NEJM 2013; Nilsson Ann Oncol 2016). We examined the relationship of OS to HRQoL scores at baseline or change from baseline. Methods: HRQoL in ALSYMPCA was assessed by FACT-P questionnaire at baseline, during treatment (wk 16, 24), and follow-up. Cox proportional hazards model for OS was fitted using HRQoL baseline scores and included previously identified covariates: treatment (radium-223 vs placebo); log10 baseline LDH, ALP, and PSA; age; baseline ECOG-PS; and albumin. A time-dependent model also included change from baseline HRQoL scores. Results: Analysis includedbetween 810-836 patients with baseline HRQoL scores for various FACT-P metrics. Significant associations were seen between OS and FACT-P total score at baseline or change from baseline. Every 10-point increase in FACT-P total score (ie, improvement) was associated with 7% decreased risk of death (Table). Results for FACT-P subscales were similar, except social well-being. Conclusions: This analysis of ALSYMPCA data shows that baseline HRQoL and changes in HRQoL are prognostic of OS in mCRPC. Clinical trial information: NCT00699751. [Table: see text]
Published Version
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