dc.contributor.author | Evans, CP | |
dc.contributor.author | Higano, CS | |
dc.contributor.author | Keane, T | |
dc.contributor.author | Andriole, G | |
dc.contributor.author | Saad, F | |
dc.contributor.author | Iversen, P | |
dc.contributor.author | Miller, K | |
dc.contributor.author | Kim, C-S | |
dc.contributor.author | Kimura, G | |
dc.contributor.author | Armstrong, AJ | |
dc.contributor.author | Sternberg, CN | |
dc.contributor.author | Loriot, Y | |
dc.contributor.author | de Bono, J | |
dc.contributor.author | Noonberg, SB | |
dc.contributor.author | Mansbach, H | |
dc.contributor.author | Bhattacharya, S | |
dc.contributor.author | Perabo, F | |
dc.contributor.author | Beer, TM | |
dc.contributor.author | Tombal, B | |
dc.date.accessioned | 2017-03-01T15:43:21Z | |
dc.date.issued | 2016-10-01 | |
dc.identifier.citation | European urology, 2016, 70 (4), pp. 675 - 683 | |
dc.identifier.issn | 0302-2838 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/458 | |
dc.identifier.eissn | 1873-7560 | |
dc.identifier.doi | 10.1016/j.eururo.2016.03.017 | |
dc.description.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. | |
dc.format | Print-Electronic | |
dc.format.extent | 675 - 683 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | ELSEVIER SCIENCE BV | |
dc.rights.uri | https://www.rioxx.net/licenses/all-rights-reserved | |
dc.subject | Humans | |
dc.subject | Bone Neoplasms | |
dc.subject | Liver Neoplasms | |
dc.subject | Lung Neoplasms | |
dc.subject | Lymphatic Metastasis | |
dc.subject | Phenylthiohydantoin | |
dc.subject | Antineoplastic Agents | |
dc.subject | Disease-Free Survival | |
dc.subject | Tumor Burden | |
dc.subject | Survival Rate | |
dc.subject | Prospective Studies | |
dc.subject | Double-Blind Method | |
dc.subject | Aged | |
dc.subject | Male | |
dc.subject | Androgen Receptor Antagonists | |
dc.subject | Prostatic Neoplasms, Castration-Resistant | |
dc.title | The PREVAIL Study: Primary Outcomes by Site and Extent of Baseline Disease for Enzalutamide-treated Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2016-03-04 | |
rioxxterms.versionofrecord | 10.1016/j.eururo.2016.03.017 | |
rioxxterms.licenseref.uri | https://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2016-10 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | European urology | |
pubs.issue | 4 | |
pubs.notes | Not known | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Prostate Cancer Targeted Therapy Group | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Prostate Cancer Targeted Therapy Group | |
pubs.publication-status | Published | |
pubs.volume | 70 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Prostate Cancer Targeted Therapy Group | |
dc.contributor.icrauthor | De Bono, Johann | |