Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): Results from a randomised, phase 3 trial

Yohann Loriot, Kurt Miller, Cora N. Sternberg, Karim Fizazi, Johann S. De Bono, Simon Chowdhury, Celestia S. Higano, Sarah Noonberg, Stefan Holmstrom, Harry Mansbach, Frank G. Perabo, De Phung, Cristina Ivanescu, Konstantina Skaltsa, Tomasz (Tom) Beer, Bertrand Tombal

    Research output: Contribution to journalArticle

    105 Citations (Scopus)

    Abstract

    Background: Enzalutamide significantly increased overall survival and radiographic progression-free survival compared with placebo in the PREVAIL trial of asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer. We report the effect of enzalutamide on health-related quality of life (HRQoL), pain, and skeletal-related events observed during this trial. Methods: In this phase 3, double-blind trial, patients were randomly assigned (1:1) to receive enzalutamide 160 mg/day (n=872) or placebo (n=845) orally. HRQoL was assessed at baseline and during treatment using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EQ-5D questionnaires. Pain status was assessed at screening, baseline, week 13, and week 25 with the Brief Pain Inventory Short Form (BPI-SF). The primary analysis of HRQoL data used a mixed-effects model to test the difference between least square means change from baseline at week 61. We assessed change from baseline, percentage improvement, and time to deterioration in HRQoL and pain, the proportion of patients with a skeletal-related event, and time to first skeletal-related event. Analysis was done on the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01212991. Findings: Median treatment duration was 16·6 months (IQR 10·1-21·1) in the enzalutamide group and 4·6 months (2·8-9·7) in the placebo group. The mixed-effects model analyses showed significant treatment differences in change from baseline to week 61 with enzalutamide compared with placebo for most FACT-P endpoints and EQ-5D visual analogue scale. Median time to deterioration in FACT-P total score was 11·3 months (95% CI 11·1-13·9) in the enzalutamide group and 5·6 months (5·5-5·6) in the placebo groups (hazard ratio [HR] 0·62 [95% CI 0·54-0·72]; p

    Original languageEnglish (US)
    Pages (from-to)509-521
    Number of pages13
    JournalThe Lancet Oncology
    Volume16
    Issue number5
    DOIs
    StatePublished - 2015

    Fingerprint

    Castration
    Prostatic Neoplasms
    Quality of Life
    Drug Therapy
    Pain
    Placebos
    Therapeutics
    Least-Squares Analysis
    Visual Analog Scale
    Disease-Free Survival
    MDV 3100
    Equipment and Supplies
    Survival
    Population

    ASJC Scopus subject areas

    • Oncology

    Cite this

    Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL) : Results from a randomised, phase 3 trial. / Loriot, Yohann; Miller, Kurt; Sternberg, Cora N.; Fizazi, Karim; De Bono, Johann S.; Chowdhury, Simon; Higano, Celestia S.; Noonberg, Sarah; Holmstrom, Stefan; Mansbach, Harry; Perabo, Frank G.; Phung, De; Ivanescu, Cristina; Skaltsa, Konstantina; Beer, Tomasz (Tom); Tombal, Bertrand.

    In: The Lancet Oncology, Vol. 16, No. 5, 2015, p. 509-521.

    Research output: Contribution to journalArticle

    Loriot, Yohann ; Miller, Kurt ; Sternberg, Cora N. ; Fizazi, Karim ; De Bono, Johann S. ; Chowdhury, Simon ; Higano, Celestia S. ; Noonberg, Sarah ; Holmstrom, Stefan ; Mansbach, Harry ; Perabo, Frank G. ; Phung, De ; Ivanescu, Cristina ; Skaltsa, Konstantina ; Beer, Tomasz (Tom) ; Tombal, Bertrand. / Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL) : Results from a randomised, phase 3 trial. In: The Lancet Oncology. 2015 ; Vol. 16, No. 5. pp. 509-521.
    @article{518db69549e64ed981236a72f7c2a188,
    title = "Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): Results from a randomised, phase 3 trial",
    abstract = "Background: Enzalutamide significantly increased overall survival and radiographic progression-free survival compared with placebo in the PREVAIL trial of asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer. We report the effect of enzalutamide on health-related quality of life (HRQoL), pain, and skeletal-related events observed during this trial. Methods: In this phase 3, double-blind trial, patients were randomly assigned (1:1) to receive enzalutamide 160 mg/day (n=872) or placebo (n=845) orally. HRQoL was assessed at baseline and during treatment using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EQ-5D questionnaires. Pain status was assessed at screening, baseline, week 13, and week 25 with the Brief Pain Inventory Short Form (BPI-SF). The primary analysis of HRQoL data used a mixed-effects model to test the difference between least square means change from baseline at week 61. We assessed change from baseline, percentage improvement, and time to deterioration in HRQoL and pain, the proportion of patients with a skeletal-related event, and time to first skeletal-related event. Analysis was done on the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01212991. Findings: Median treatment duration was 16·6 months (IQR 10·1-21·1) in the enzalutamide group and 4·6 months (2·8-9·7) in the placebo group. The mixed-effects model analyses showed significant treatment differences in change from baseline to week 61 with enzalutamide compared with placebo for most FACT-P endpoints and EQ-5D visual analogue scale. Median time to deterioration in FACT-P total score was 11·3 months (95{\%} CI 11·1-13·9) in the enzalutamide group and 5·6 months (5·5-5·6) in the placebo groups (hazard ratio [HR] 0·62 [95{\%} CI 0·54-0·72]; p",
    author = "Yohann Loriot and Kurt Miller and Sternberg, {Cora N.} and Karim Fizazi and {De Bono}, {Johann S.} and Simon Chowdhury and Higano, {Celestia S.} and Sarah Noonberg and Stefan Holmstrom and Harry Mansbach and Perabo, {Frank G.} and De Phung and Cristina Ivanescu and Konstantina Skaltsa and Beer, {Tomasz (Tom)} and Bertrand Tombal",
    year = "2015",
    doi = "10.1016/S1470-2045(15)70113-0",
    language = "English (US)",
    volume = "16",
    pages = "509--521",
    journal = "The Lancet Oncology",
    issn = "1470-2045",
    publisher = "Lancet Publishing Group",
    number = "5",

    }

    TY - JOUR

    T1 - Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL)

    T2 - Results from a randomised, phase 3 trial

    AU - Loriot, Yohann

    AU - Miller, Kurt

    AU - Sternberg, Cora N.

    AU - Fizazi, Karim

    AU - De Bono, Johann S.

    AU - Chowdhury, Simon

    AU - Higano, Celestia S.

    AU - Noonberg, Sarah

    AU - Holmstrom, Stefan

    AU - Mansbach, Harry

    AU - Perabo, Frank G.

    AU - Phung, De

    AU - Ivanescu, Cristina

    AU - Skaltsa, Konstantina

    AU - Beer, Tomasz (Tom)

    AU - Tombal, Bertrand

    PY - 2015

    Y1 - 2015

    N2 - Background: Enzalutamide significantly increased overall survival and radiographic progression-free survival compared with placebo in the PREVAIL trial of asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer. We report the effect of enzalutamide on health-related quality of life (HRQoL), pain, and skeletal-related events observed during this trial. Methods: In this phase 3, double-blind trial, patients were randomly assigned (1:1) to receive enzalutamide 160 mg/day (n=872) or placebo (n=845) orally. HRQoL was assessed at baseline and during treatment using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EQ-5D questionnaires. Pain status was assessed at screening, baseline, week 13, and week 25 with the Brief Pain Inventory Short Form (BPI-SF). The primary analysis of HRQoL data used a mixed-effects model to test the difference between least square means change from baseline at week 61. We assessed change from baseline, percentage improvement, and time to deterioration in HRQoL and pain, the proportion of patients with a skeletal-related event, and time to first skeletal-related event. Analysis was done on the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01212991. Findings: Median treatment duration was 16·6 months (IQR 10·1-21·1) in the enzalutamide group and 4·6 months (2·8-9·7) in the placebo group. The mixed-effects model analyses showed significant treatment differences in change from baseline to week 61 with enzalutamide compared with placebo for most FACT-P endpoints and EQ-5D visual analogue scale. Median time to deterioration in FACT-P total score was 11·3 months (95% CI 11·1-13·9) in the enzalutamide group and 5·6 months (5·5-5·6) in the placebo groups (hazard ratio [HR] 0·62 [95% CI 0·54-0·72]; p

    AB - Background: Enzalutamide significantly increased overall survival and radiographic progression-free survival compared with placebo in the PREVAIL trial of asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer. We report the effect of enzalutamide on health-related quality of life (HRQoL), pain, and skeletal-related events observed during this trial. Methods: In this phase 3, double-blind trial, patients were randomly assigned (1:1) to receive enzalutamide 160 mg/day (n=872) or placebo (n=845) orally. HRQoL was assessed at baseline and during treatment using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EQ-5D questionnaires. Pain status was assessed at screening, baseline, week 13, and week 25 with the Brief Pain Inventory Short Form (BPI-SF). The primary analysis of HRQoL data used a mixed-effects model to test the difference between least square means change from baseline at week 61. We assessed change from baseline, percentage improvement, and time to deterioration in HRQoL and pain, the proportion of patients with a skeletal-related event, and time to first skeletal-related event. Analysis was done on the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01212991. Findings: Median treatment duration was 16·6 months (IQR 10·1-21·1) in the enzalutamide group and 4·6 months (2·8-9·7) in the placebo group. The mixed-effects model analyses showed significant treatment differences in change from baseline to week 61 with enzalutamide compared with placebo for most FACT-P endpoints and EQ-5D visual analogue scale. Median time to deterioration in FACT-P total score was 11·3 months (95% CI 11·1-13·9) in the enzalutamide group and 5·6 months (5·5-5·6) in the placebo groups (hazard ratio [HR] 0·62 [95% CI 0·54-0·72]; p

    UR - http://www.scopus.com/inward/record.url?scp=84933674851&partnerID=8YFLogxK

    UR - http://www.scopus.com/inward/citedby.url?scp=84933674851&partnerID=8YFLogxK

    U2 - 10.1016/S1470-2045(15)70113-0

    DO - 10.1016/S1470-2045(15)70113-0

    M3 - Article

    C2 - 25888263

    AN - SCOPUS:84933674851

    VL - 16

    SP - 509

    EP - 521

    JO - The Lancet Oncology

    JF - The Lancet Oncology

    SN - 1470-2045

    IS - 5

    ER -