Skeletal-related events significantly impact health-related quality of life in metastatic castration-resistant prostate cancer: data from PREVAIL and AFFIRM trials

Background:we investigated the impact of skeletal-related events (sres) on health-related quality of life (hrqol) in patients with metastatic castration-resistant prostate cancer (mcrpc) in phase iii trials of enzalutamide versus placebo.methods:patients with mcrpc experiencing at least one sre during affirm and prevail were assessed for trajectory-adjusted mean change in hrqol by first sre using functional assessment of cancer therapy-prostate (fact-p; affirm, three domains, and prevail, nine domains) and eq-5d (prevail) instruments.results:first sres caused hrqol deterioration in both trials. spinal cord compression had the largest impact, with clinically meaningful reductions in seven of nine fact-p domains in prevail and all three in affirm (mean (95% confidence interval (ci)) change in fact-p total score –16.95 (–26.47, –7.44) and –9.69 (–16.10, –3.27), respectively). in prevail, first sres caused clinically meaningful declines in eq-5d utility index, irrespective of category; spinal cord compression had the largest impact (mean (95% ci) change –0.24 (–0.39, –0.08)). in affirm, fact-p and fact-general total scores showed clinically meaningful declines after radiation/surgery to bone.conclusions:sres were associated with clinically meaningful functional declines in the daily lives of patients with mcrpc. spinal cord compression had the largest impact on hrqol.