The association between health-related quality-of-life scores and clinical outcomes in metastatic castration-resistant prostate cancer patients: Exploratory analyses of AFFIRM and PREVAIL studies

Tomasz (Tom) Beer, Kurt Miller, Bertrand Tombal, David Cella, De Phung, Stefan Holmstrom, Cristina Ivanescu, Konstantina Skaltsa, Shevani Naidoo

    Research output: Contribution to journalArticle

    11 Citations (Scopus)

    Abstract

    Background Our exploratory analysis examined the association between health-related quality of life (HRQoL) (baseline and change over time) and clinical outcomes (overall survival [OS]/radiographic progression-free survival [rPFS]) in metastatic castration-resistant prostate cancer (mCRPC). Methods HRQoL, OS and rPFS were assessed in phase III trials comparing enzalutamide with placebo in chemotherapy-naïve (PREVAIL; NCT01212991) or post-chemotherapy (AFFIRM; NCT00974311) mCRPC. HRQoL was assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P). Multivariate analyses evaluated the prognostic significance of baseline and time-dependent scores after adjusting for treatment and clinical/demographic variables. Hazard ratios (HRs) and 95% confidence intervals (CIs) represented the hazard of rPFS or OS per minimally important difference (MID) score change in HRQoL variables. Results In baseline and time-dependent multivariate analyses, OS was independently associated with multiple HRQoL measures across both studies. In time-dependent analyses, a 10-point (upper bound of MID range) increase (improvement) in FACT-P total score was associated with reductions in mortality risk of 19% in AFFIRM (HR 0.81 [95% CI 0.78–0.84]) and 21% in PREVAIL (HR 0.79 [0.76–0.83]). For baseline analyses, a 10-point increase in FACT-P total score was associated with reductions in mortality risk of 12% (HR 0.88 [0.84–0.93]) and 10% (HR 0.90 [0.86–0.95]) in AFFIRM and PREVAIL, respectively. rPFS was associated with a subset of HRQoL domains in both studies. Conclusion Several baseline HRQoL domains were prognostic for rPFS and OS in patients with mCRPC, and this association was maintained during treatment, indicating that changes in HRQoL are informative for patients' expected survival.

    Original languageEnglish (US)
    Pages (from-to)21-29
    Number of pages9
    JournalEuropean Journal of Cancer
    Volume87
    DOIs
    StatePublished - Dec 1 2017

    Fingerprint

    Castration
    Prostatic Neoplasms
    Quality of Life
    Disease-Free Survival
    Survival
    Multivariate Analysis
    Confidence Intervals
    Therapeutics
    Drug Therapy
    Mortality
    Placebos
    Demography

    Keywords

    • Castration-resistant prostate cancer
    • Enzalutamide
    • Health-related quality of life
    • Survival

    ASJC Scopus subject areas

    • Oncology
    • Cancer Research

    Cite this

    The association between health-related quality-of-life scores and clinical outcomes in metastatic castration-resistant prostate cancer patients : Exploratory analyses of AFFIRM and PREVAIL studies. / Beer, Tomasz (Tom); Miller, Kurt; Tombal, Bertrand; Cella, David; Phung, De; Holmstrom, Stefan; Ivanescu, Cristina; Skaltsa, Konstantina; Naidoo, Shevani.

    In: European Journal of Cancer, Vol. 87, 01.12.2017, p. 21-29.

    Research output: Contribution to journalArticle

    Beer, Tomasz (Tom) ; Miller, Kurt ; Tombal, Bertrand ; Cella, David ; Phung, De ; Holmstrom, Stefan ; Ivanescu, Cristina ; Skaltsa, Konstantina ; Naidoo, Shevani. / The association between health-related quality-of-life scores and clinical outcomes in metastatic castration-resistant prostate cancer patients : Exploratory analyses of AFFIRM and PREVAIL studies. In: European Journal of Cancer. 2017 ; Vol. 87. pp. 21-29.
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    title = "The association between health-related quality-of-life scores and clinical outcomes in metastatic castration-resistant prostate cancer patients: Exploratory analyses of AFFIRM and PREVAIL studies",
    abstract = "Background Our exploratory analysis examined the association between health-related quality of life (HRQoL) (baseline and change over time) and clinical outcomes (overall survival [OS]/radiographic progression-free survival [rPFS]) in metastatic castration-resistant prostate cancer (mCRPC). Methods HRQoL, OS and rPFS were assessed in phase III trials comparing enzalutamide with placebo in chemotherapy-na{\"i}ve (PREVAIL; NCT01212991) or post-chemotherapy (AFFIRM; NCT00974311) mCRPC. HRQoL was assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P). Multivariate analyses evaluated the prognostic significance of baseline and time-dependent scores after adjusting for treatment and clinical/demographic variables. Hazard ratios (HRs) and 95{\%} confidence intervals (CIs) represented the hazard of rPFS or OS per minimally important difference (MID) score change in HRQoL variables. Results In baseline and time-dependent multivariate analyses, OS was independently associated with multiple HRQoL measures across both studies. In time-dependent analyses, a 10-point (upper bound of MID range) increase (improvement) in FACT-P total score was associated with reductions in mortality risk of 19{\%} in AFFIRM (HR 0.81 [95{\%} CI 0.78–0.84]) and 21{\%} in PREVAIL (HR 0.79 [0.76–0.83]). For baseline analyses, a 10-point increase in FACT-P total score was associated with reductions in mortality risk of 12{\%} (HR 0.88 [0.84–0.93]) and 10{\%} (HR 0.90 [0.86–0.95]) in AFFIRM and PREVAIL, respectively. rPFS was associated with a subset of HRQoL domains in both studies. Conclusion Several baseline HRQoL domains were prognostic for rPFS and OS in patients with mCRPC, and this association was maintained during treatment, indicating that changes in HRQoL are informative for patients' expected survival.",
    keywords = "Castration-resistant prostate cancer, Enzalutamide, Health-related quality of life, Survival",
    author = "Beer, {Tomasz (Tom)} and Kurt Miller and Bertrand Tombal and David Cella and De Phung and Stefan Holmstrom and Cristina Ivanescu and Konstantina Skaltsa and Shevani Naidoo",
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    TY - JOUR

    T1 - The association between health-related quality-of-life scores and clinical outcomes in metastatic castration-resistant prostate cancer patients

    T2 - Exploratory analyses of AFFIRM and PREVAIL studies

    AU - Beer, Tomasz (Tom)

    AU - Miller, Kurt

    AU - Tombal, Bertrand

    AU - Cella, David

    AU - Phung, De

    AU - Holmstrom, Stefan

    AU - Ivanescu, Cristina

    AU - Skaltsa, Konstantina

    AU - Naidoo, Shevani

    PY - 2017/12/1

    Y1 - 2017/12/1

    N2 - Background Our exploratory analysis examined the association between health-related quality of life (HRQoL) (baseline and change over time) and clinical outcomes (overall survival [OS]/radiographic progression-free survival [rPFS]) in metastatic castration-resistant prostate cancer (mCRPC). Methods HRQoL, OS and rPFS were assessed in phase III trials comparing enzalutamide with placebo in chemotherapy-naïve (PREVAIL; NCT01212991) or post-chemotherapy (AFFIRM; NCT00974311) mCRPC. HRQoL was assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P). Multivariate analyses evaluated the prognostic significance of baseline and time-dependent scores after adjusting for treatment and clinical/demographic variables. Hazard ratios (HRs) and 95% confidence intervals (CIs) represented the hazard of rPFS or OS per minimally important difference (MID) score change in HRQoL variables. Results In baseline and time-dependent multivariate analyses, OS was independently associated with multiple HRQoL measures across both studies. In time-dependent analyses, a 10-point (upper bound of MID range) increase (improvement) in FACT-P total score was associated with reductions in mortality risk of 19% in AFFIRM (HR 0.81 [95% CI 0.78–0.84]) and 21% in PREVAIL (HR 0.79 [0.76–0.83]). For baseline analyses, a 10-point increase in FACT-P total score was associated with reductions in mortality risk of 12% (HR 0.88 [0.84–0.93]) and 10% (HR 0.90 [0.86–0.95]) in AFFIRM and PREVAIL, respectively. rPFS was associated with a subset of HRQoL domains in both studies. Conclusion Several baseline HRQoL domains were prognostic for rPFS and OS in patients with mCRPC, and this association was maintained during treatment, indicating that changes in HRQoL are informative for patients' expected survival.

    AB - Background Our exploratory analysis examined the association between health-related quality of life (HRQoL) (baseline and change over time) and clinical outcomes (overall survival [OS]/radiographic progression-free survival [rPFS]) in metastatic castration-resistant prostate cancer (mCRPC). Methods HRQoL, OS and rPFS were assessed in phase III trials comparing enzalutamide with placebo in chemotherapy-naïve (PREVAIL; NCT01212991) or post-chemotherapy (AFFIRM; NCT00974311) mCRPC. HRQoL was assessed using the Functional Assessment of Cancer Therapy-Prostate (FACT-P). Multivariate analyses evaluated the prognostic significance of baseline and time-dependent scores after adjusting for treatment and clinical/demographic variables. Hazard ratios (HRs) and 95% confidence intervals (CIs) represented the hazard of rPFS or OS per minimally important difference (MID) score change in HRQoL variables. Results In baseline and time-dependent multivariate analyses, OS was independently associated with multiple HRQoL measures across both studies. In time-dependent analyses, a 10-point (upper bound of MID range) increase (improvement) in FACT-P total score was associated with reductions in mortality risk of 19% in AFFIRM (HR 0.81 [95% CI 0.78–0.84]) and 21% in PREVAIL (HR 0.79 [0.76–0.83]). For baseline analyses, a 10-point increase in FACT-P total score was associated with reductions in mortality risk of 12% (HR 0.88 [0.84–0.93]) and 10% (HR 0.90 [0.86–0.95]) in AFFIRM and PREVAIL, respectively. rPFS was associated with a subset of HRQoL domains in both studies. Conclusion Several baseline HRQoL domains were prognostic for rPFS and OS in patients with mCRPC, and this association was maintained during treatment, indicating that changes in HRQoL are informative for patients' expected survival.

    KW - Castration-resistant prostate cancer

    KW - Enzalutamide

    KW - Health-related quality of life

    KW - Survival

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