Efficacy and safety of enzalutamide in patients 75 years or older with chemotherapy-naive metastatic castration-resistant prostate cancer: results from PREVAIL

J N Graff; G Baciarello; A J Armstrong; C S Higano; P Iversen; T W Flaig; D Forer; T Parli; D Phung; B Tombal; T M Beer; C N Sternberg

doi:10.1093/annonc/mdv542

Efficacy and safety of enzalutamide in patients 75 years or older with chemotherapy-naive metastatic castration-resistant prostate cancer: results from PREVAIL

J N Graff, G Baciarello, A J Armstrong, C S Higano, P Iversen, T W Flaig, D Forer, T Parli, D Phung, B Tombal, T M Beer, C N Sternberg

103 Citationer (Scopus)

Abstract

BACKGROUND: Prostate cancer disproportionately affects older men. Because age affects treatment decisions, it is important to understand the efficacy and tolerability of therapies for advanced prostate cancer in elderly men. This analysis describes efficacy and safety outcomes in men aged ≥75 years who received enzalutamide, an androgen receptor inhibitor, in the phase III PREVAIL trial.

PATIENTS AND METHODS: PREVAIL was a randomised, double-blind, multinational study of oral enzalutamide 160 mg/day (N = 872) versus placebo (N = 845) in chemotherapy-naive men with metastatic castration-resistant prostate cancer. Overall survival (OS) and radiographic progression-free survival (rPFS) were coprimary end points. Subgroup analysis of men aged ≥75 years (elderly) and men aged <75 years was pre-specified for the coprimary end points and adverse events (AEs).

RESULTS: Among 609 elderly patients (35%) who participated in PREVAIL, median treatment duration was 16.6 and 5.0 months in the enzalutamide and placebo arms, respectively. In the elderly subgroup, OS was greater with enzalutamide than with placebo [32.4 months (95% confidence interval (CI) 27.7-not yet reached] versus 25.1 months (95% CI 22.6-28.0); hazard ratio (HR) = 0.61 (95% CI 0.47-0.79); P = 0.0001], as was rPFS [not yet reached (95% CI 12.3-not yet reached) versus 3.7 months (95% CI 3.6-5.3); HR = 0.17 (95% CI 0.12-0.24); P < 0.0001]. Irrespective of treatment assignment, incidence of AEs was similar between the two age groups, except for an overall higher incidence of falls among elderly patients than younger patients [84/609 (13.8%) versus 62/1106 (5.6%)] and among elderly patients receiving enzalutamide than those receiving placebo [61/317 (19.2%) versus 23/292 (7.9%)].

CONCLUSIONS: Elderly men benefited from treatment with enzalutamide in terms of OS and rPFS. Enzalutamide was well tolerated in the elderly subgroup and those aged <75 years. Age and enzalutamide treatment were associated with a higher incidence of falls.

CLINICAL TRIAL IDENTIFIER: NCT01212991, ClinicalTrials.gov.

Originalsprog	Engelsk
Tidsskrift	Annals of oncology : official journal of the European Society for Medical Oncology / ESMO
Vol/bind	27
Udgave nummer	2
Sider (fra-til)	286-94
Antal sider	9
ISSN	0923-7534
DOI	https://doi.org/10.1093/annonc/mdv542
Status	Udgivet - feb. 2016

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10.1093/annonc/mdv542

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Graff, J. N., Baciarello, G., Armstrong, A. J., Higano, C. S., Iversen, P., Flaig, T. W., Forer, D., Parli, T., Phung, D., Tombal, B., Beer, T. M., & Sternberg, C. N. (2016). Efficacy and safety of enzalutamide in patients 75 years or older with chemotherapy-naive metastatic castration-resistant prostate cancer: results from PREVAIL. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, 27(2), 286-94. https://doi.org/10.1093/annonc/mdv542

Efficacy and safety of enzalutamide in patients 75 years or older with chemotherapy-naive metastatic castration-resistant prostate cancer: results from PREVAIL. / Graff, J N; Baciarello, G; Armstrong, A J et al.
I: Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, Bind 27, Nr. 2, 02.2016, s. 286-94.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Graff, JN, Baciarello, G, Armstrong, AJ, Higano, CS, Iversen, P, Flaig, TW, Forer, D, Parli, T, Phung, D, Tombal, B, Beer, TM & Sternberg, CN 2016, 'Efficacy and safety of enzalutamide in patients 75 years or older with chemotherapy-naive metastatic castration-resistant prostate cancer: results from PREVAIL', Annals of oncology : official journal of the European Society for Medical Oncology / ESMO, bind 27, nr. 2, s. 286-94. https://doi.org/10.1093/annonc/mdv542

Graff JN, Baciarello G, Armstrong AJ, Higano CS, Iversen P, Flaig TW et al. Efficacy and safety of enzalutamide in patients 75 years or older with chemotherapy-naive metastatic castration-resistant prostate cancer: results from PREVAIL. Annals of oncology : official journal of the European Society for Medical Oncology / ESMO. 2016 feb.;27(2):286-94. doi: 10.1093/annonc/mdv542

@article{e197eb65b51b427693ef1eb6e747e105,

title = "Efficacy and safety of enzalutamide in patients 75 years or older with chemotherapy-naive metastatic castration-resistant prostate cancer: results from PREVAIL",

abstract = "BACKGROUND: Prostate cancer disproportionately affects older men. Because age affects treatment decisions, it is important to understand the efficacy and tolerability of therapies for advanced prostate cancer in elderly men. This analysis describes efficacy and safety outcomes in men aged ≥75 years who received enzalutamide, an androgen receptor inhibitor, in the phase III PREVAIL trial.PATIENTS AND METHODS: PREVAIL was a randomised, double-blind, multinational study of oral enzalutamide 160 mg/day (N = 872) versus placebo (N = 845) in chemotherapy-naive men with metastatic castration-resistant prostate cancer. Overall survival (OS) and radiographic progression-free survival (rPFS) were coprimary end points. Subgroup analysis of men aged ≥75 years (elderly) and men aged <75 years was pre-specified for the coprimary end points and adverse events (AEs).RESULTS: Among 609 elderly patients (35%) who participated in PREVAIL, median treatment duration was 16.6 and 5.0 months in the enzalutamide and placebo arms, respectively. In the elderly subgroup, OS was greater with enzalutamide than with placebo [32.4 months (95% confidence interval (CI) 27.7-not yet reached] versus 25.1 months (95% CI 22.6-28.0); hazard ratio (HR) = 0.61 (95% CI 0.47-0.79); P = 0.0001], as was rPFS [not yet reached (95% CI 12.3-not yet reached) versus 3.7 months (95% CI 3.6-5.3); HR = 0.17 (95% CI 0.12-0.24); P < 0.0001]. Irrespective of treatment assignment, incidence of AEs was similar between the two age groups, except for an overall higher incidence of falls among elderly patients than younger patients [84/609 (13.8%) versus 62/1106 (5.6%)] and among elderly patients receiving enzalutamide than those receiving placebo [61/317 (19.2%) versus 23/292 (7.9%)].CONCLUSIONS: Elderly men benefited from treatment with enzalutamide in terms of OS and rPFS. Enzalutamide was well tolerated in the elderly subgroup and those aged <75 years. Age and enzalutamide treatment were associated with a higher incidence of falls.CLINICAL TRIAL IDENTIFIER: NCT01212991, ClinicalTrials.gov.",

author = "Graff, {J N} and G Baciarello and Armstrong, {A J} and Higano, {C S} and P Iversen and Flaig, {T W} and D Forer and T Parli and D Phung and B Tombal and Beer, {T M} and Sternberg, {C N}",

note = "{\textcopyright} The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].",

year = "2016",

month = feb,

doi = "10.1093/annonc/mdv542",

language = "English",

volume = "27",

pages = "286--94",

journal = "Annals of oncology : official journal of the European Society for Medical Oncology / ESMO",

issn = "0923-7534",

publisher = "Oxford University Press",

number = "2",

}

TY - JOUR

T1 - Efficacy and safety of enzalutamide in patients 75 years or older with chemotherapy-naive metastatic castration-resistant prostate cancer

T2 - results from PREVAIL

AU - Graff, J N

AU - Baciarello, G

AU - Armstrong, A J

AU - Higano, C S

AU - Iversen, P

AU - Flaig, T W

AU - Forer, D

AU - Parli, T

AU - Phung, D

AU - Tombal, B

AU - Beer, T M

AU - Sternberg, C N

PY - 2016/2

Y1 - 2016/2

N2 - BACKGROUND: Prostate cancer disproportionately affects older men. Because age affects treatment decisions, it is important to understand the efficacy and tolerability of therapies for advanced prostate cancer in elderly men. This analysis describes efficacy and safety outcomes in men aged ≥75 years who received enzalutamide, an androgen receptor inhibitor, in the phase III PREVAIL trial.PATIENTS AND METHODS: PREVAIL was a randomised, double-blind, multinational study of oral enzalutamide 160 mg/day (N = 872) versus placebo (N = 845) in chemotherapy-naive men with metastatic castration-resistant prostate cancer. Overall survival (OS) and radiographic progression-free survival (rPFS) were coprimary end points. Subgroup analysis of men aged ≥75 years (elderly) and men aged <75 years was pre-specified for the coprimary end points and adverse events (AEs).RESULTS: Among 609 elderly patients (35%) who participated in PREVAIL, median treatment duration was 16.6 and 5.0 months in the enzalutamide and placebo arms, respectively. In the elderly subgroup, OS was greater with enzalutamide than with placebo [32.4 months (95% confidence interval (CI) 27.7-not yet reached] versus 25.1 months (95% CI 22.6-28.0); hazard ratio (HR) = 0.61 (95% CI 0.47-0.79); P = 0.0001], as was rPFS [not yet reached (95% CI 12.3-not yet reached) versus 3.7 months (95% CI 3.6-5.3); HR = 0.17 (95% CI 0.12-0.24); P < 0.0001]. Irrespective of treatment assignment, incidence of AEs was similar between the two age groups, except for an overall higher incidence of falls among elderly patients than younger patients [84/609 (13.8%) versus 62/1106 (5.6%)] and among elderly patients receiving enzalutamide than those receiving placebo [61/317 (19.2%) versus 23/292 (7.9%)].CONCLUSIONS: Elderly men benefited from treatment with enzalutamide in terms of OS and rPFS. Enzalutamide was well tolerated in the elderly subgroup and those aged <75 years. Age and enzalutamide treatment were associated with a higher incidence of falls.CLINICAL TRIAL IDENTIFIER: NCT01212991, ClinicalTrials.gov.

AB - BACKGROUND: Prostate cancer disproportionately affects older men. Because age affects treatment decisions, it is important to understand the efficacy and tolerability of therapies for advanced prostate cancer in elderly men. This analysis describes efficacy and safety outcomes in men aged ≥75 years who received enzalutamide, an androgen receptor inhibitor, in the phase III PREVAIL trial.PATIENTS AND METHODS: PREVAIL was a randomised, double-blind, multinational study of oral enzalutamide 160 mg/day (N = 872) versus placebo (N = 845) in chemotherapy-naive men with metastatic castration-resistant prostate cancer. Overall survival (OS) and radiographic progression-free survival (rPFS) were coprimary end points. Subgroup analysis of men aged ≥75 years (elderly) and men aged <75 years was pre-specified for the coprimary end points and adverse events (AEs).RESULTS: Among 609 elderly patients (35%) who participated in PREVAIL, median treatment duration was 16.6 and 5.0 months in the enzalutamide and placebo arms, respectively. In the elderly subgroup, OS was greater with enzalutamide than with placebo [32.4 months (95% confidence interval (CI) 27.7-not yet reached] versus 25.1 months (95% CI 22.6-28.0); hazard ratio (HR) = 0.61 (95% CI 0.47-0.79); P = 0.0001], as was rPFS [not yet reached (95% CI 12.3-not yet reached) versus 3.7 months (95% CI 3.6-5.3); HR = 0.17 (95% CI 0.12-0.24); P < 0.0001]. Irrespective of treatment assignment, incidence of AEs was similar between the two age groups, except for an overall higher incidence of falls among elderly patients than younger patients [84/609 (13.8%) versus 62/1106 (5.6%)] and among elderly patients receiving enzalutamide than those receiving placebo [61/317 (19.2%) versus 23/292 (7.9%)].CONCLUSIONS: Elderly men benefited from treatment with enzalutamide in terms of OS and rPFS. Enzalutamide was well tolerated in the elderly subgroup and those aged <75 years. Age and enzalutamide treatment were associated with a higher incidence of falls.CLINICAL TRIAL IDENTIFIER: NCT01212991, ClinicalTrials.gov.

U2 - 10.1093/annonc/mdv542

DO - 10.1093/annonc/mdv542

M3 - Journal article

C2 - 26578735

SN - 0923-7534

VL - 27

SP - 286

EP - 294

JO - Annals of oncology : official journal of the European Society for Medical Oncology / ESMO

JF - Annals of oncology : official journal of the European Society for Medical Oncology / ESMO

IS - 2

ER -

Efficacy and safety of enzalutamide in patients 75 years or older with chemotherapy-naive metastatic castration-resistant prostate cancer: results from PREVAIL

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