Introduction

Radium-223 improved overall survival (OS) with meaningful improvements versus 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 baseline HRQoL scores or change from baseline by prior docetaxel subgroup.

Methods

HRQoL in ALSYMPCA was assessed by Functional Assessment of Cancer Therapy--Prostate (FACT-P) questionnaire at baseline, during treatment (wk 16, 24), and during 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 lactate dehydrogenase, alkaline phosphatase, and prostate-specific antigen; age; baseline Eastern Cooperative Oncology Group performance status; and albumin. A time-dependent model also included change from baseline HRQoL scores. Results are presented by prior docetaxel subgroup.

Results

The analysis included patients with baseline HRQoL scores: 466-485 patients with prior docetaxel and 354-362 with no prior docetaxel for various FACT-P metrics. Significant associations were seen between OS and FACT-P total score at baseline or change from baseline regardless of prior docetaxel use. Every 10-point increase in FACT-P total score from baseline (ie, improvement) was associated with an 18-21% decreased risk of death. FACT-P subscale results were similar, except social well-being. (Table).

Conclusions

Improvement in HRQoL was associated with better OS in ALSYMPCA patients with metastatic castration-resistant prostate cancer regardless of prior docetaxel treatment.

Funding

Bayer HealthCare