Universität zu Köln

Tombal, Bertrand, Borre, Michael, Rathenborg, Per, Werbrouck, Patrick, Van Poppel, Hendrik, Heidenreich, Axel, Iversen, Peter, Braeckman, Johan, Heracek, Jiri, Baron, Benoit, Krivoshik, Andrew, Section, Mohammad Hirmand and Smith, Matthew R. (2018). Long-Term Antitumor Activity and Safety of Enzalutamide Monotherapy in Hormone Naive Prostate Cancer: 3-Year Open Label Followup Results. J. Urol., 199 (2). S. 459 - 465. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1527-3792

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Abstract

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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Tombal, Bertrand UNSPECIFIED UNSPECIFIED UNSPECIFIED Borre, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Rathenborg, Per UNSPECIFIED UNSPECIFIED UNSPECIFIED Werbrouck, Patrick UNSPECIFIED UNSPECIFIED UNSPECIFIED Van Poppel, Hendrik UNSPECIFIED UNSPECIFIED UNSPECIFIED Heidenreich, Axel UNSPECIFIED UNSPECIFIED UNSPECIFIED Iversen, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Braeckman, Johan UNSPECIFIED UNSPECIFIED UNSPECIFIED Heracek, Jiri UNSPECIFIED UNSPECIFIED UNSPECIFIED Baron, Benoit UNSPECIFIED UNSPECIFIED UNSPECIFIED Krivoshik, Andrew UNSPECIFIED UNSPECIFIED UNSPECIFIED Section, Mohammad Hirmand UNSPECIFIED UNSPECIFIED UNSPECIFIED Smith, Matthew R. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-198308
DOI:	10.1016/j.juro.2017.08.103
Journal or Publication Title:	J. Urol.
Volume:	199
Number:	2
Page Range:	S. 459 - 465
Date:	2018
Publisher:	ELSEVIER SCIENCE INC
Place of Publication:	NEW YORK
ISSN:	1527-3792
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ANDROGEN-DEPRIVATION THERAPY; BONE-MINERAL DENSITY; BICALUTAMIDE MONOTHERAPY; BODY-COMPOSITION; MEN; CASTRATION; RISK; CHEMOTHERAPY; EFFICACY; FRACTURE Multiple languages Urology & Nephrology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/19830