Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2017 Mar;20(1):110-116.
doi: 10.1038/pcan.2016.62. Epub 2017 Jan 3.

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

F Saad  1 , C Ivanescu  2 , D Phung  3 , Y Loriot  4 , S Abhyankar  5 , T M Beer  6 , B Tombal  7 , S Holmstrom  8
Affiliations

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

F Saad et al. Prostate Cancer Prostatic Dis. 2017 Mar.

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.

PubMed Disclaimer

Conflict of interest statement

FS received grants for research, honoraria (speaker and consultant) and serves on the advisory boards of Astellas, Medivation and Janssen. DP and SH and are employees of Astellas Pharma. SA is an employee of Medivation. TMB received grants for research funding from Astellas Pharma, Janssen Research and Development and Medivation, personal (consultancy) fees from Astellas Pharma and Janssen Japan and payment from Research to Practice for participation in a Certified Nursing Education program, which was supported, in part, by Medivation and Astellas Pharma. BT received grants, personal fees and nonfinancial support from Astellas and personal fees from Medivation. YL received personal fees from Astellas (advisory board, speaker, honoraria and travel) and from Medivation (advisory board, speaker). CI is an employee of Quintiles, which received funding from Astellas to conduct the analyses reported here.

Figures

Figure 1
Figure 1
Proportion of patients who experienced any SRE or given category of SRE in AFFIRM and PREVAIL (ITT population). ITT, intent-to-treat; SRE, skeletal-related event.
Figure 2
Figure 2
Impact of SREs on HRQoL outcomes scores by SRE category in (a) PREVAIL and (b) AFFIRM. EWB, emotional wellbeing; FACT-G, Functional Assessment of Cancer Therapy-General; FACT-P, Functional Assessment of Cancer Therapy-Prostate; FAPSI, Functional Assessment of Cancer Therapy Advanced Prostate Symptom Index; FWB, functional wellbeing; HRQoL, health-related quality of life; PCS, prostate cancer subscale; PWB, physical wellbeing; SRE, skeletal-related event; SWB, social wellbeing; TOI, Trial Outcome Index.
See this image and copyright information in PMC

References

    1. Butoescu V, Tombal B. Practical guide to bone health in the spectrum of advanced prostate cancer. Can J Urol 2014; 21 (Suppl 1): 84–92. - PubMed
    1. Hotte SJ, Saad F. Current management of castrate-resistant prostate cancer. Curr Oncol 2010; 17 (Suppl 2): S72–S79. - PMC - PubMed
    1. Brown JE, Sim S. Evolving role of bone biomarkers in castration-resistant prostate cancer. Neoplasia 2010; 12: 685–696. - PMC - PubMed
    1. Saad F, Gleason DM, Murray R, Tchekmedyian S, Venner P, Lacombe L et alZoledronic Acid Prostate Cancer Study Group. Long-term efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormone-refractory prostate cancer. J Natl Cancer Inst 2004; 96: 879–882. - PubMed
    1. Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS et alPREVAIL Investigators.. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med 2014; 371: 424–433. - PMC - PubMed

MeSH terms