The PREVAIL trial of enzalutamide in men with chemotherapy-naïve, metastatic castrationresistant prostate cancer: Post hoc analysis of Korean patients

Choung Soo Kim, Ad Theeuwes, Dong Deuk Kwon, Young Deuk Choi, Byung Ha Chung, Hyun Moo Lee, Kang Hyun Lee, Sang Eun Lee

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Purpose: This post hoc analysis evaluated treatment effects, safety, and pharmacokinetics of enzalutamide in Korean patients in the phase 3, double-blind, placebo-controlled PREVAIL trial. Materials and Methods: Asymptomatic or mildly symptomatic chemotherapy-naïve men with metastatic castration-resistant prostate cancer that progressed on androgen deprivation therapy received 160 mg/d oral enzalutamide or placebo (1:1) until death or discontinuation due to radiographic progression or skeletal-related event and initiation of subsequent therapy. Coprimary end points were centrally assessed radiographic progression-free survival (rPFS) and overall survival (OS). Secondary end points included investigator-assessed rPFS, time to initiation of chemotherapy, time to prostate-specific antigen (PSA) progression, PSA response (≥50% decline), and time to skeletal-related event. Results: Of 1,717 total patients, 78 patients were enrolled in Korea (enzalutamide, n=40; placebo, n=38). Hazard ratios (95% confidence interval) for enzalutamide versus placebo were 0.23 (0.02–2.24) for centrally assessed rPFS, 0.77 (0.28–2.15) for OS, 0.21 (0.08–0.51) for time to chemotherapy, and 0.31 (0.17–0.56) for time to PSA progression. A PSA response was observed in 70.0% of enzalutamide-treated and 10.5% of placebo-treated Korean patients. Adverse events of grade ≥3 occurred in 33% of enzalutamide- treated and 11% of placebo-treated Korean patients, with median treatment durations of 13.0 and 5.1 months, respectively. At 13 weeks, the plasma concentration of enzalutamide plus N-desmethyl enzalutamide was similar in Korean and non-Korean patients (geometric mean ratio, 1.04; 90% confidence interval, 0.97–1.10). Conclusions: In Korean patients, treatment effects and safety of enzalutamide were consistent with those observed in the overall PREVAIL study population.

Original languageEnglish
Pages (from-to)174-183
Number of pages10
JournalInvestigative and clinical urology
Volume57
Issue number3
DOIs
Publication statusPublished - 2016 May

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Prostatic Neoplasms
Drug Therapy
Placebos
Prostate-Specific Antigen
Disease-Free Survival
Confidence Intervals
Therapeutics
Safety
MDV 3100
Survival
Castration
Korea
Androgens
Pharmacokinetics
Research Personnel
Population

All Science Journal Classification (ASJC) codes

  • Urology

Cite this

@article{810e58654e1942d387c3d8ed02f419c6,
title = "The PREVAIL trial of enzalutamide in men with chemotherapy-na{\"i}ve, metastatic castrationresistant prostate cancer: Post hoc analysis of Korean patients",
abstract = "Purpose: This post hoc analysis evaluated treatment effects, safety, and pharmacokinetics of enzalutamide in Korean patients in the phase 3, double-blind, placebo-controlled PREVAIL trial. Materials and Methods: Asymptomatic or mildly symptomatic chemotherapy-na{\"i}ve men with metastatic castration-resistant prostate cancer that progressed on androgen deprivation therapy received 160 mg/d oral enzalutamide or placebo (1:1) until death or discontinuation due to radiographic progression or skeletal-related event and initiation of subsequent therapy. Coprimary end points were centrally assessed radiographic progression-free survival (rPFS) and overall survival (OS). Secondary end points included investigator-assessed rPFS, time to initiation of chemotherapy, time to prostate-specific antigen (PSA) progression, PSA response (≥50{\%} decline), and time to skeletal-related event. Results: Of 1,717 total patients, 78 patients were enrolled in Korea (enzalutamide, n=40; placebo, n=38). Hazard ratios (95{\%} confidence interval) for enzalutamide versus placebo were 0.23 (0.02–2.24) for centrally assessed rPFS, 0.77 (0.28–2.15) for OS, 0.21 (0.08–0.51) for time to chemotherapy, and 0.31 (0.17–0.56) for time to PSA progression. A PSA response was observed in 70.0{\%} of enzalutamide-treated and 10.5{\%} of placebo-treated Korean patients. Adverse events of grade ≥3 occurred in 33{\%} of enzalutamide- treated and 11{\%} of placebo-treated Korean patients, with median treatment durations of 13.0 and 5.1 months, respectively. At 13 weeks, the plasma concentration of enzalutamide plus N-desmethyl enzalutamide was similar in Korean and non-Korean patients (geometric mean ratio, 1.04; 90{\%} confidence interval, 0.97–1.10). Conclusions: In Korean patients, treatment effects and safety of enzalutamide were consistent with those observed in the overall PREVAIL study population.",
author = "Kim, {Choung Soo} and Ad Theeuwes and Kwon, {Dong Deuk} and Choi, {Young Deuk} and Chung, {Byung Ha} and Lee, {Hyun Moo} and Lee, {Kang Hyun} and Lee, {Sang Eun}",
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language = "English",
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pages = "174--183",
journal = "Investigative and Clinical Urology",
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The PREVAIL trial of enzalutamide in men with chemotherapy-naïve, metastatic castrationresistant prostate cancer : Post hoc analysis of Korean patients. / Kim, Choung Soo; Theeuwes, Ad; Kwon, Dong Deuk; Choi, Young Deuk; Chung, Byung Ha; Lee, Hyun Moo; Lee, Kang Hyun; Lee, Sang Eun.

In: Investigative and clinical urology, Vol. 57, No. 3, 05.2016, p. 174-183.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The PREVAIL trial of enzalutamide in men with chemotherapy-naïve, metastatic castrationresistant prostate cancer

T2 - Post hoc analysis of Korean patients

AU - Kim, Choung Soo

AU - Theeuwes, Ad

AU - Kwon, Dong Deuk

AU - Choi, Young Deuk

AU - Chung, Byung Ha

AU - Lee, Hyun Moo

AU - Lee, Kang Hyun

AU - Lee, Sang Eun

PY - 2016/5

Y1 - 2016/5

N2 - Purpose: This post hoc analysis evaluated treatment effects, safety, and pharmacokinetics of enzalutamide in Korean patients in the phase 3, double-blind, placebo-controlled PREVAIL trial. Materials and Methods: Asymptomatic or mildly symptomatic chemotherapy-naïve men with metastatic castration-resistant prostate cancer that progressed on androgen deprivation therapy received 160 mg/d oral enzalutamide or placebo (1:1) until death or discontinuation due to radiographic progression or skeletal-related event and initiation of subsequent therapy. Coprimary end points were centrally assessed radiographic progression-free survival (rPFS) and overall survival (OS). Secondary end points included investigator-assessed rPFS, time to initiation of chemotherapy, time to prostate-specific antigen (PSA) progression, PSA response (≥50% decline), and time to skeletal-related event. Results: Of 1,717 total patients, 78 patients were enrolled in Korea (enzalutamide, n=40; placebo, n=38). Hazard ratios (95% confidence interval) for enzalutamide versus placebo were 0.23 (0.02–2.24) for centrally assessed rPFS, 0.77 (0.28–2.15) for OS, 0.21 (0.08–0.51) for time to chemotherapy, and 0.31 (0.17–0.56) for time to PSA progression. A PSA response was observed in 70.0% of enzalutamide-treated and 10.5% of placebo-treated Korean patients. Adverse events of grade ≥3 occurred in 33% of enzalutamide- treated and 11% of placebo-treated Korean patients, with median treatment durations of 13.0 and 5.1 months, respectively. At 13 weeks, the plasma concentration of enzalutamide plus N-desmethyl enzalutamide was similar in Korean and non-Korean patients (geometric mean ratio, 1.04; 90% confidence interval, 0.97–1.10). Conclusions: In Korean patients, treatment effects and safety of enzalutamide were consistent with those observed in the overall PREVAIL study population.

AB - Purpose: This post hoc analysis evaluated treatment effects, safety, and pharmacokinetics of enzalutamide in Korean patients in the phase 3, double-blind, placebo-controlled PREVAIL trial. Materials and Methods: Asymptomatic or mildly symptomatic chemotherapy-naïve men with metastatic castration-resistant prostate cancer that progressed on androgen deprivation therapy received 160 mg/d oral enzalutamide or placebo (1:1) until death or discontinuation due to radiographic progression or skeletal-related event and initiation of subsequent therapy. Coprimary end points were centrally assessed radiographic progression-free survival (rPFS) and overall survival (OS). Secondary end points included investigator-assessed rPFS, time to initiation of chemotherapy, time to prostate-specific antigen (PSA) progression, PSA response (≥50% decline), and time to skeletal-related event. Results: Of 1,717 total patients, 78 patients were enrolled in Korea (enzalutamide, n=40; placebo, n=38). Hazard ratios (95% confidence interval) for enzalutamide versus placebo were 0.23 (0.02–2.24) for centrally assessed rPFS, 0.77 (0.28–2.15) for OS, 0.21 (0.08–0.51) for time to chemotherapy, and 0.31 (0.17–0.56) for time to PSA progression. A PSA response was observed in 70.0% of enzalutamide-treated and 10.5% of placebo-treated Korean patients. Adverse events of grade ≥3 occurred in 33% of enzalutamide- treated and 11% of placebo-treated Korean patients, with median treatment durations of 13.0 and 5.1 months, respectively. At 13 weeks, the plasma concentration of enzalutamide plus N-desmethyl enzalutamide was similar in Korean and non-Korean patients (geometric mean ratio, 1.04; 90% confidence interval, 0.97–1.10). Conclusions: In Korean patients, treatment effects and safety of enzalutamide were consistent with those observed in the overall PREVAIL study population.

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