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

F. Saad, C. Ivanescu, D. Phung, Y. Loriot, S. Abhyankar, T. M. Beer, B. Tombal, S. Holmstrom

Research output: Contribution to journalArticlepeer-review

35 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)110-116
Number of pages7
JournalProstate Cancer and Prostatic Diseases
Volume20
Issue number1
DOIs
StatePublished - Mar 1 2017

ASJC Scopus subject areas

  • Oncology
  • Urology
  • Cancer Research

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