The PREVAIL Study: Primary Outcomes by Site and Extent of Baseline Disease for Enzalutamide-treated Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer.

Christopher P Evans; Celestia S Higano; Thomas Keane; Gerald Andriole; Fred Saad; Peter Iversen; Kurt Miller; Choung-Soo Kim; Go Kimura; Andrew J Armstrong; Cora N Sternberg; Yohann Loriot; Johann de Bono; Sarah B Noonberg; Hank Mansbach; Suman Bhattacharya; Frank Perabo; Tomasz M Beer; Bertrand Tombal

doi:10.1016/j.eururo.2016.03.017

The PREVAIL Study: Primary Outcomes by Site and Extent of Baseline Disease for Enzalutamide-treated Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer.

Christopher P Evans, Celestia S Higano, Thomas Keane, Gerald Andriole, Fred Saad, Peter Iversen, Kurt Miller, Choung-Soo Kim, Go Kimura, Andrew J Armstrong, Cora N Sternberg, Yohann Loriot, Johann de Bono, Sarah B Noonberg, Hank Mansbach, Suman Bhattacharya, Frank Perabo, Tomasz M Beer, Bertrand Tombal

77 Citations (Scopus)

Abstract

BACKGROUND: Enzalutamide, an oral androgen receptor inhibitor, significantly improved overall survival (OS) and radiographic progression-free survival (rPFS) versus placebo in the PREVAIL trial of men with chemotherapy-naïve metastatic castration-resistant prostate cancer.

OBJECTIVE: To assess the effects of enzalutamide versus placebo in patients from PREVAIL based on site and extent of baseline disease.

DESIGN, SETTING, AND PARTICIPANTS: One thousand seven hundred and seventeen asymptomatic or minimally symptomatic patients were randomized to enzalutamide (n=872) or placebo (n=845). Subgroup analyses included nonvisceral (only bone and/or nodal; n=1513), visceral (lung and/or liver; n=204), low-volume bone disease (<4 bone metastases; n=867), high-volume bone disease (≥4 bone metastases; n=850), lymph node only disease (n=195).

INTERVENTION: Oral enzalutamide (160mg) or placebo once daily while continuing androgen deprivation therapy.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Coprimary endpoints (rPFS, OS) were prospectively evaluated in nonvisceral and visceral subgroups. All other efficacy analyses were post hoc.

RESULTS AND LIMITATIONS: Enzalutamide improved rPFS versus placebo in patients with nonvisceral disease (hazard ratio [HR], 0.18; 95% confidence interval [CI], 0.14-0.22), visceral disease (HR, 0.28; 95% CI, 0.16-0.49), low- or high-volume bone disease (HR, 0.16; 95% CI, 0.11-0.22; HR, 0.22; 95% CI, 0.16-0.29, respectively), and lymph node only disease (HR, 0.09; 95% CI, 0.04-0.19). For OS, HRs favored enzalutamide (<1) across all disease subgroups, although 95% CI was >1 in patients with visceral disease (HR, 0.82; 95% CI, 0.55-1.23). Enzalutamide was well tolerated in patients with or without visceral disease.

CONCLUSIONS: Enzalutamide provided clinically significant benefits in men with chemotherapy-naïve metastatic castration-resistant prostate cancer, with or without visceral disease, low- or high-volume bone disease, or lymph node only disease.

PATIENT SUMMARY: Patients with metastatic castration-resistant prostate cancer-including those with or without visceral disease or widespread bone disease-benefitted from enzalutamide, an active well-tolerated therapy.

Original language	English
Journal	European Urology
Volume	70
Issue number	4
Pages (from-to)	675-683
ISSN	0302-2838
DOIs	https://doi.org/10.1016/j.eururo.2016.03.017
Publication status	Published - 2016

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Evans, C. P., Higano, C. S., Keane, T., Andriole, G., Saad, F., Iversen, P., Miller, K., Kim, C.-S., Kimura, G., Armstrong, A. J., Sternberg, C. N., Loriot, Y., de Bono, J., Noonberg, S. B., Mansbach, H., Bhattacharya, S., Perabo, F., Beer, T. M., & Tombal, B. (2016). The PREVAIL Study: Primary Outcomes by Site and Extent of Baseline Disease for Enzalutamide-treated Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer. European Urology, 70(4), 675-683. https://doi.org/10.1016/j.eururo.2016.03.017

The PREVAIL Study: Primary Outcomes by Site and Extent of Baseline Disease for Enzalutamide-treated Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer. / Evans, Christopher P; Higano, Celestia S; Keane, Thomas et al.
In: European Urology, Vol. 70, No. 4, 2016, p. 675-683.

Research output: Contribution to journal › Journal article › Research › peer-review

Evans, CP, Higano, CS, Keane, T, Andriole, G, Saad, F, Iversen, P, Miller, K, Kim, C-S, Kimura, G, Armstrong, AJ, Sternberg, CN, Loriot, Y, de Bono, J, Noonberg, SB, Mansbach, H, Bhattacharya, S, Perabo, F, Beer, TM & Tombal, B 2016, 'The PREVAIL Study: Primary Outcomes by Site and Extent of Baseline Disease for Enzalutamide-treated Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer.', European Urology, vol. 70, no. 4, pp. 675-683. https://doi.org/10.1016/j.eururo.2016.03.017

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title = "The PREVAIL Study: Primary Outcomes by Site and Extent of Baseline Disease for Enzalutamide-treated Men with Chemotherapy-na{\"i}ve Metastatic Castration-resistant Prostate Cancer.",

abstract = "BACKGROUND: Enzalutamide, an oral androgen receptor inhibitor, significantly improved overall survival (OS) and radiographic progression-free survival (rPFS) versus placebo in the PREVAIL trial of men with chemotherapy-na{\"i}ve metastatic castration-resistant prostate cancer.OBJECTIVE: To assess the effects of enzalutamide versus placebo in patients from PREVAIL based on site and extent of baseline disease.DESIGN, SETTING, AND PARTICIPANTS: One thousand seven hundred and seventeen asymptomatic or minimally symptomatic patients were randomized to enzalutamide (n=872) or placebo (n=845). Subgroup analyses included nonvisceral (only bone and/or nodal; n=1513), visceral (lung and/or liver; n=204), low-volume bone disease (<4 bone metastases; n=867), high-volume bone disease (≥4 bone metastases; n=850), lymph node only disease (n=195).INTERVENTION: Oral enzalutamide (160mg) or placebo once daily while continuing androgen deprivation therapy.OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Coprimary endpoints (rPFS, OS) were prospectively evaluated in nonvisceral and visceral subgroups. All other efficacy analyses were post hoc.RESULTS AND LIMITATIONS: Enzalutamide improved rPFS versus placebo in patients with nonvisceral disease (hazard ratio [HR], 0.18; 95% confidence interval [CI], 0.14-0.22), visceral disease (HR, 0.28; 95% CI, 0.16-0.49), low- or high-volume bone disease (HR, 0.16; 95% CI, 0.11-0.22; HR, 0.22; 95% CI, 0.16-0.29, respectively), and lymph node only disease (HR, 0.09; 95% CI, 0.04-0.19). For OS, HRs favored enzalutamide (<1) across all disease subgroups, although 95% CI was >1 in patients with visceral disease (HR, 0.82; 95% CI, 0.55-1.23). Enzalutamide was well tolerated in patients with or without visceral disease.CONCLUSIONS: Enzalutamide provided clinically significant benefits in men with chemotherapy-na{\"i}ve metastatic castration-resistant prostate cancer, with or without visceral disease, low- or high-volume bone disease, or lymph node only disease.PATIENT SUMMARY: Patients with metastatic castration-resistant prostate cancer-including those with or without visceral disease or widespread bone disease-benefitted from enzalutamide, an active well-tolerated therapy.",

author = "Evans, {Christopher P} and Higano, {Celestia S} and Thomas Keane and Gerald Andriole and Fred Saad and Peter Iversen and Kurt Miller and Choung-Soo Kim and Go Kimura and Armstrong, {Andrew J} and Sternberg, {Cora N} and Yohann Loriot and {de Bono}, Johann and Noonberg, {Sarah B} and Hank Mansbach and Suman Bhattacharya and Frank Perabo and Beer, {Tomasz M} and Bertrand Tombal",

year = "2016",

doi = "10.1016/j.eururo.2016.03.017",

language = "English",

volume = "70",

pages = "675--683",

journal = "European Urology",

issn = "0302-2838",

publisher = "Elsevier BV",

number = "4",

}

TY - JOUR

T1 - The PREVAIL Study: Primary Outcomes by Site and Extent of Baseline Disease for Enzalutamide-treated Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer.

AU - Evans, Christopher P

AU - Higano, Celestia S

AU - Keane, Thomas

AU - Andriole, Gerald

AU - Saad, Fred

AU - Iversen, Peter

AU - Miller, Kurt

AU - Kim, Choung-Soo

AU - Kimura, Go

AU - Armstrong, Andrew J

AU - Sternberg, Cora N

AU - Loriot, Yohann

AU - de Bono, Johann

AU - Noonberg, Sarah B

AU - Mansbach, Hank

AU - Bhattacharya, Suman

AU - Perabo, Frank

AU - Beer, Tomasz M

AU - Tombal, Bertrand

PY - 2016

Y1 - 2016

N2 - BACKGROUND: Enzalutamide, an oral androgen receptor inhibitor, significantly improved overall survival (OS) and radiographic progression-free survival (rPFS) versus placebo in the PREVAIL trial of men with chemotherapy-naïve metastatic castration-resistant prostate cancer.OBJECTIVE: To assess the effects of enzalutamide versus placebo in patients from PREVAIL based on site and extent of baseline disease.DESIGN, SETTING, AND PARTICIPANTS: One thousand seven hundred and seventeen asymptomatic or minimally symptomatic patients were randomized to enzalutamide (n=872) or placebo (n=845). Subgroup analyses included nonvisceral (only bone and/or nodal; n=1513), visceral (lung and/or liver; n=204), low-volume bone disease (<4 bone metastases; n=867), high-volume bone disease (≥4 bone metastases; n=850), lymph node only disease (n=195).INTERVENTION: Oral enzalutamide (160mg) or placebo once daily while continuing androgen deprivation therapy.OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Coprimary endpoints (rPFS, OS) were prospectively evaluated in nonvisceral and visceral subgroups. All other efficacy analyses were post hoc.RESULTS AND LIMITATIONS: Enzalutamide improved rPFS versus placebo in patients with nonvisceral disease (hazard ratio [HR], 0.18; 95% confidence interval [CI], 0.14-0.22), visceral disease (HR, 0.28; 95% CI, 0.16-0.49), low- or high-volume bone disease (HR, 0.16; 95% CI, 0.11-0.22; HR, 0.22; 95% CI, 0.16-0.29, respectively), and lymph node only disease (HR, 0.09; 95% CI, 0.04-0.19). For OS, HRs favored enzalutamide (<1) across all disease subgroups, although 95% CI was >1 in patients with visceral disease (HR, 0.82; 95% CI, 0.55-1.23). Enzalutamide was well tolerated in patients with or without visceral disease.CONCLUSIONS: Enzalutamide provided clinically significant benefits in men with chemotherapy-naïve metastatic castration-resistant prostate cancer, with or without visceral disease, low- or high-volume bone disease, or lymph node only disease.PATIENT SUMMARY: Patients with metastatic castration-resistant prostate cancer-including those with or without visceral disease or widespread bone disease-benefitted from enzalutamide, an active well-tolerated therapy.

AB - BACKGROUND: Enzalutamide, an oral androgen receptor inhibitor, significantly improved overall survival (OS) and radiographic progression-free survival (rPFS) versus placebo in the PREVAIL trial of men with chemotherapy-naïve metastatic castration-resistant prostate cancer.OBJECTIVE: To assess the effects of enzalutamide versus placebo in patients from PREVAIL based on site and extent of baseline disease.DESIGN, SETTING, AND PARTICIPANTS: One thousand seven hundred and seventeen asymptomatic or minimally symptomatic patients were randomized to enzalutamide (n=872) or placebo (n=845). Subgroup analyses included nonvisceral (only bone and/or nodal; n=1513), visceral (lung and/or liver; n=204), low-volume bone disease (<4 bone metastases; n=867), high-volume bone disease (≥4 bone metastases; n=850), lymph node only disease (n=195).INTERVENTION: Oral enzalutamide (160mg) or placebo once daily while continuing androgen deprivation therapy.OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Coprimary endpoints (rPFS, OS) were prospectively evaluated in nonvisceral and visceral subgroups. All other efficacy analyses were post hoc.RESULTS AND LIMITATIONS: Enzalutamide improved rPFS versus placebo in patients with nonvisceral disease (hazard ratio [HR], 0.18; 95% confidence interval [CI], 0.14-0.22), visceral disease (HR, 0.28; 95% CI, 0.16-0.49), low- or high-volume bone disease (HR, 0.16; 95% CI, 0.11-0.22; HR, 0.22; 95% CI, 0.16-0.29, respectively), and lymph node only disease (HR, 0.09; 95% CI, 0.04-0.19). For OS, HRs favored enzalutamide (<1) across all disease subgroups, although 95% CI was >1 in patients with visceral disease (HR, 0.82; 95% CI, 0.55-1.23). Enzalutamide was well tolerated in patients with or without visceral disease.CONCLUSIONS: Enzalutamide provided clinically significant benefits in men with chemotherapy-naïve metastatic castration-resistant prostate cancer, with or without visceral disease, low- or high-volume bone disease, or lymph node only disease.PATIENT SUMMARY: Patients with metastatic castration-resistant prostate cancer-including those with or without visceral disease or widespread bone disease-benefitted from enzalutamide, an active well-tolerated therapy.

U2 - 10.1016/j.eururo.2016.03.017

DO - 10.1016/j.eururo.2016.03.017

M3 - Journal article

C2 - 27006332

SN - 0302-2838

VL - 70

SP - 675

EP - 683

JO - European Urology

JF - European Urology

IS - 4

ER -

The PREVAIL Study: Primary Outcomes by Site and Extent of Baseline Disease for Enzalutamide-treated Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer.

Abstract

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