Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: An in-depth post hoc analysis of EQ-5D data from the PREVAIL trial

Nancy Devlin, Michael Herdman, Marco Pavesi, De Phung, Shevani Naidoo, Tomasz (Tom) Beer, Bertrand Tombal, Yohann Loriot, Cristina Ivanescu, Teresa Parli, Mark Balk, Stefan Holmstrom

    Research output: Contribution to journalArticle

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    Abstract

    Background: The effect of enzalutamide on health-related quality of life (HRQoL) in the PREVAIL trial in chemotherapy-naïve men with metastatic castration-resistant prostate cancer was analyzed using the generic EQ-5D instrument. Methods: Patients received oral enzalutamide 160 mg/day (n = 872) or placebo (n = 845). EQ-5D index and EQ-5D visual analogue scale (EQ-5D VAS) scores were evaluated at baseline, week 13, and every 12 weeks until week 61 due to sample size reduction thereafter. Changes on individual dimensions were assessed, and Paretian Classification of Health Change (PCHC) and time-to-event analyses were conducted. Results: With enzalutamide, EQ-5D index and EQ-5D VAS scores declined more slowly versus placebo and time to diverge from full health was prolonged. Average decline in EQ-5D index (-0.042 vs. -0.070; P < .0001) and EQ-5D VAS (-1.3 vs. -4.4; P < .0001) was significantly smaller with enzalutamide. There were significant (P < .05) between-group differences favoring enzalutamide in Pain/Discomfort to week 37, Anxiety/Depression at week 13, and Usual Activities at week 25, but no significant differences for Mobility and Self-care. The PCHC analysis showed more enzalutamide patients reporting improvement than placebo patients at weeks 13, 25, and 49 (all P < .05) and week 37 (P = .0512). Enzalutamide was superior (P ≤ .0003) to placebo for time to diverge from full health and time to first deterioration on Pain/Discomfort and Anxiety/Depression dimensions. Conclusions: This in-depth post hoc analysis showed that enzalutamide delayed HRQoL deterioration and had beneficial effects on several HRQoL domains, including Pain/Discomfort and the proportion of patients in full health, compared with placebo, and may help to support future analyses of this type. Trial registration:NCT01212991.

    Original languageEnglish (US)
    Article number130
    JournalHealth and Quality of Life Outcomes
    Volume15
    Issue number1
    DOIs
    StatePublished - Jun 23 2017

    Fingerprint

    Castration
    Prostatic Neoplasms
    Quality of Life
    Placebos
    Visual Analog Scale
    Health
    Pain
    Anxiety
    Depression
    MDV 3100
    Self Care
    Sample Size
    Drug Therapy

    Keywords

    • Enzalutamide
    • Eq-5D
    • Metastatic castration-resistant prostate cancer
    • Quality of life

    ASJC Scopus subject areas

    • Public Health, Environmental and Occupational Health

    Cite this

    Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer : An in-depth post hoc analysis of EQ-5D data from the PREVAIL trial. / Devlin, Nancy; Herdman, Michael; Pavesi, Marco; Phung, De; Naidoo, Shevani; Beer, Tomasz (Tom); Tombal, Bertrand; Loriot, Yohann; Ivanescu, Cristina; Parli, Teresa; Balk, Mark; Holmstrom, Stefan.

    In: Health and Quality of Life Outcomes, Vol. 15, No. 1, 130, 23.06.2017.

    Research output: Contribution to journalArticle

    Devlin, Nancy ; Herdman, Michael ; Pavesi, Marco ; Phung, De ; Naidoo, Shevani ; Beer, Tomasz (Tom) ; Tombal, Bertrand ; Loriot, Yohann ; Ivanescu, Cristina ; Parli, Teresa ; Balk, Mark ; Holmstrom, Stefan. / Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer : An in-depth post hoc analysis of EQ-5D data from the PREVAIL trial. In: Health and Quality of Life Outcomes. 2017 ; Vol. 15, No. 1.
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    abstract = "Background: The effect of enzalutamide on health-related quality of life (HRQoL) in the PREVAIL trial in chemotherapy-na{\"i}ve men with metastatic castration-resistant prostate cancer was analyzed using the generic EQ-5D instrument. Methods: Patients received oral enzalutamide 160 mg/day (n = 872) or placebo (n = 845). EQ-5D index and EQ-5D visual analogue scale (EQ-5D VAS) scores were evaluated at baseline, week 13, and every 12 weeks until week 61 due to sample size reduction thereafter. Changes on individual dimensions were assessed, and Paretian Classification of Health Change (PCHC) and time-to-event analyses were conducted. Results: With enzalutamide, EQ-5D index and EQ-5D VAS scores declined more slowly versus placebo and time to diverge from full health was prolonged. Average decline in EQ-5D index (-0.042 vs. -0.070; P < .0001) and EQ-5D VAS (-1.3 vs. -4.4; P < .0001) was significantly smaller with enzalutamide. There were significant (P < .05) between-group differences favoring enzalutamide in Pain/Discomfort to week 37, Anxiety/Depression at week 13, and Usual Activities at week 25, but no significant differences for Mobility and Self-care. The PCHC analysis showed more enzalutamide patients reporting improvement than placebo patients at weeks 13, 25, and 49 (all P < .05) and week 37 (P = .0512). Enzalutamide was superior (P ≤ .0003) to placebo for time to diverge from full health and time to first deterioration on Pain/Discomfort and Anxiety/Depression dimensions. Conclusions: This in-depth post hoc analysis showed that enzalutamide delayed HRQoL deterioration and had beneficial effects on several HRQoL domains, including Pain/Discomfort and the proportion of patients in full health, compared with placebo, and may help to support future analyses of this type. Trial registration:NCT01212991.",
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    T1 - Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer

    T2 - An in-depth post hoc analysis of EQ-5D data from the PREVAIL trial

    AU - Devlin, Nancy

    AU - Herdman, Michael

    AU - Pavesi, Marco

    AU - Phung, De

    AU - Naidoo, Shevani

    AU - Beer, Tomasz (Tom)

    AU - Tombal, Bertrand

    AU - Loriot, Yohann

    AU - Ivanescu, Cristina

    AU - Parli, Teresa

    AU - Balk, Mark

    AU - Holmstrom, Stefan

    PY - 2017/6/23

    Y1 - 2017/6/23

    N2 - Background: The effect of enzalutamide on health-related quality of life (HRQoL) in the PREVAIL trial in chemotherapy-naïve men with metastatic castration-resistant prostate cancer was analyzed using the generic EQ-5D instrument. Methods: Patients received oral enzalutamide 160 mg/day (n = 872) or placebo (n = 845). EQ-5D index and EQ-5D visual analogue scale (EQ-5D VAS) scores were evaluated at baseline, week 13, and every 12 weeks until week 61 due to sample size reduction thereafter. Changes on individual dimensions were assessed, and Paretian Classification of Health Change (PCHC) and time-to-event analyses were conducted. Results: With enzalutamide, EQ-5D index and EQ-5D VAS scores declined more slowly versus placebo and time to diverge from full health was prolonged. Average decline in EQ-5D index (-0.042 vs. -0.070; P < .0001) and EQ-5D VAS (-1.3 vs. -4.4; P < .0001) was significantly smaller with enzalutamide. There were significant (P < .05) between-group differences favoring enzalutamide in Pain/Discomfort to week 37, Anxiety/Depression at week 13, and Usual Activities at week 25, but no significant differences for Mobility and Self-care. The PCHC analysis showed more enzalutamide patients reporting improvement than placebo patients at weeks 13, 25, and 49 (all P < .05) and week 37 (P = .0512). Enzalutamide was superior (P ≤ .0003) to placebo for time to diverge from full health and time to first deterioration on Pain/Discomfort and Anxiety/Depression dimensions. Conclusions: This in-depth post hoc analysis showed that enzalutamide delayed HRQoL deterioration and had beneficial effects on several HRQoL domains, including Pain/Discomfort and the proportion of patients in full health, compared with placebo, and may help to support future analyses of this type. Trial registration:NCT01212991.

    AB - Background: The effect of enzalutamide on health-related quality of life (HRQoL) in the PREVAIL trial in chemotherapy-naïve men with metastatic castration-resistant prostate cancer was analyzed using the generic EQ-5D instrument. Methods: Patients received oral enzalutamide 160 mg/day (n = 872) or placebo (n = 845). EQ-5D index and EQ-5D visual analogue scale (EQ-5D VAS) scores were evaluated at baseline, week 13, and every 12 weeks until week 61 due to sample size reduction thereafter. Changes on individual dimensions were assessed, and Paretian Classification of Health Change (PCHC) and time-to-event analyses were conducted. Results: With enzalutamide, EQ-5D index and EQ-5D VAS scores declined more slowly versus placebo and time to diverge from full health was prolonged. Average decline in EQ-5D index (-0.042 vs. -0.070; P < .0001) and EQ-5D VAS (-1.3 vs. -4.4; P < .0001) was significantly smaller with enzalutamide. There were significant (P < .05) between-group differences favoring enzalutamide in Pain/Discomfort to week 37, Anxiety/Depression at week 13, and Usual Activities at week 25, but no significant differences for Mobility and Self-care. The PCHC analysis showed more enzalutamide patients reporting improvement than placebo patients at weeks 13, 25, and 49 (all P < .05) and week 37 (P = .0512). Enzalutamide was superior (P ≤ .0003) to placebo for time to diverge from full health and time to first deterioration on Pain/Discomfort and Anxiety/Depression dimensions. Conclusions: This in-depth post hoc analysis showed that enzalutamide delayed HRQoL deterioration and had beneficial effects on several HRQoL domains, including Pain/Discomfort and the proportion of patients in full health, compared with placebo, and may help to support future analyses of this type. Trial registration:NCT01212991.

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    KW - Eq-5D

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    KW - Quality of life

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