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, Tomasz (Tom) Beer, B. Tombal, S. Holmstrom

    Research output: Contribution to journalArticle

    11 Citations (Scopus)

    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

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    Castration
    Spinal Cord Compression
    Prostatic Neoplasms
    Quality of Life
    Confidence Intervals
    Placebos
    Radiation
    Bone and Bones
    Therapeutics

    ASJC Scopus subject areas

    • Oncology
    • Urology
    • Cancer Research

    Cite this

    Skeletal-related events significantly impact health-related quality of life in metastatic castration-resistant prostate cancer : Data from PREVAIL and AFFIRM trials. / Saad, F.; Ivanescu, C.; Phung, D.; Loriot, Y.; Abhyankar, S.; Beer, Tomasz (Tom); Tombal, B.; Holmstrom, S.

    In: Prostate Cancer and Prostatic Diseases, Vol. 20, No. 1, 01.03.2017, p. 110-116.

    Research output: Contribution to journalArticle

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    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.",
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    T1 - Skeletal-related events significantly impact health-related quality of life in metastatic castration-resistant prostate cancer

    T2 - Data from PREVAIL and AFFIRM trials

    AU - Saad, F.

    AU - Ivanescu, C.

    AU - Phung, D.

    AU - Loriot, Y.

    AU - Abhyankar, S.

    AU - Beer, Tomasz (Tom)

    AU - Tombal, B.

    AU - Holmstrom, S.

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    N2 - 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.

    AB - 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.

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    DO - 10.1038/pcan.2016.62

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