Long-term Efficacy and Safety of Enzalutamide Monotherapy in Hormone-naive Prostate Cancer: 1-and 2-Year Open-label Follow-up Results
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F15%3A10313328" target="_blank" >RIV/00216208:11110/15:10313328 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.1016/j.eururo.2015.01.027" target="_blank" >http://dx.doi.org/10.1016/j.eururo.2015.01.027</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.eururo.2015.01.027" target="_blank" >10.1016/j.eururo.2015.01.027</a>
Alternative languages
Result language
angličtina
Original language name
Long-term Efficacy and Safety of Enzalutamide Monotherapy in Hormone-naive Prostate Cancer: 1-and 2-Year Open-label Follow-up Results
Original language description
Background: Enzalutamide is an androgen receptor inhibitor with a demonstrated overall survival benefit in metastatic castration-resistant prostate cancer. A phase 2 study of enzalutamide monotherapy in patients with hormone-naive prostate cancer (HNPC)showed a high response rate for the prespecified primary endpoint (ie, prostate-specific antigen [PSA] response at week 25), regardless of metastases at baseline, and favorable tolerability. Objective: To determine the long-term efficacy and safety of enzalutamide monotherapy at 1 and 2 yr. Design, setting, and participants: Open-label, single-arm study in patients with HNPC and noncastrate testosterone (>= 230 ng/dl). Intervention: Oral enzalutamide 160 mg/d until disease progression or unacceptable toxicity. Outcome measurements and analysis: PSA response (>= 80% decline from baseline) assessed at 1 yr (49 wk) and 2 yr (97 wk). Results and limitations: The median (range) age was 73 (48-86) yr and 26 patients (39%) presented with metas
Czech name
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Czech description
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Classification
Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FJ - Surgery including transplantology
OECD FORD branch
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Result continuities
Project
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Continuities
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Others
Publication year
2015
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
European Urology
ISSN
0302-2838
e-ISSN
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Volume of the periodical
68
Issue of the periodical within the volume
5
Country of publishing house
NL - THE KINGDOM OF THE NETHERLANDS
Number of pages
8
Pages from-to
787-794
UT code for WoS article
000363475800019
EID of the result in the Scopus database
2-s2.0-84942983807