Long-Term Antitumor Activity and Safety of Enzalutamide Monotherapy in Hormone Naive Prostate Cancer: 3-Year Open Label Followup Results

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F18%3A10387022" target="_blank" >RIV/00216208:11110/18:10387022 - isvavai.cz</a>

Result on the web

<a href="https://doi.org/10.1016/j.juro.2017.08.103" target="_blank" >https://doi.org/10.1016/j.juro.2017.08.103</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.juro.2017.08.103" target="_blank" >10.1016/j.juro.2017.08.103</a>

Result language

angličtina

Original language name

Long-Term Antitumor Activity and Safety of Enzalutamide Monotherapy in Hormone Naive Prostate Cancer: 3-Year Open Label Followup Results

Original language description

Purpose: A phase 2 study of enzalutamide monotherapy in patients with hormone naive prostate cancer demonstrated high prostate specific antigen response rates at 25 weeks, 1 year and 2 years with minimal effects on total body bone mineral density and favorable safety. In this followup analysis we evaluated enzalutamide antitumor activity and safety at 3 years. Materials and Methods: In a single arm analysis 67 patients with hormone na ive prostate cancer and noncastrate testosterone (230 ng/dl or greater) received enzalutamide 160 mg per day orally until disease progression or unacceptable toxicity. The primary end point was the prostate specific antigen response (80% or greater decline from baseline). Results: No patients discontinued treatment during year 3. Of 42 patients with prostate specific antigen assessments at 3 years 38 (90.5%, 95% CI 77.4-97.3) maintained a prostate specific antigen response. Of 26 patients with metastases at baseline 17 (65.4%) had a complete or partial response as the best overall response during 3 years. In patients who completed the 3-year visit minimal mean changes from baseline were observed in total body bone mineral density or bone mineral density of the femoral neck, trochanter, spine L1-L4 or forearm (range -2.7% to e0.1%). At 3 years total body fat had increased a mean of 16.5%, total lean body mass had decreased a mean of -6.5% and global health status had minimally decreased from baseline. Common adverse events were gynecomastia, fatigue, hot flush and nipple pain. Conclusions: Enzalutamide antitumor activity was maintained in patients with hormone naive prostate cancer at 3 years. Overall bone mineral density, global health status and safety results were similar to those at 2 years.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30217 - Urology and nephrology

Project

—

Continuities

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Publication year

2018

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Journal of Urology

ISSN

0022-5347

e-ISSN

—

Volume of the periodical

199

Issue of the periodical within the volume

2

Country of publishing house

US - UNITED STATES

Number of pages

6

Pages from-to

459-464

UT code for WoS article

000419581800080

EID of the result in the Scopus database

2-s2.0-85038941487