Long-Term Antitumor Activity and Safety of Enzalutamide Monotherapy in Hormone Naïve Prostate Cancer: 3-Year Open Label Followup Results
Abstract
PURPOSE: A phase 2 study of enzalutamide monotherapy in patients with hormone naïve 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 naïve 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 -0.1%). 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 naïve prostate cancer at 3 years. Overall bone mineral density, global health status and safety results were similar to those at 2 years.
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Similar increases in fat mass following bicalutamide and enzalutamide monotherapy have been reported.
“Similar increases in fat mass following bicalutamide 120 and enzalutamide 121 , 122 monotherapy have also been reported”
From The role of the androgen receptor in the pathogenesis of obesity and its utility as a target for obesity treatments (2022) · cites this paper as [122]
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- Authors
- Tombal, B., Borre, M., Rathenborg, P., Werbrouck, P., Van Poppel, H., Heidenreich, A., Iversen, P., Braeckman, J., Heracek, J., Baron, B., Krivoshik, A., Hirmand, M., & Smith, M. R.
- Affiliations
- Cliniques Universitaires Saint-Luc (BE)
- Aarhus University Hospital (DK)
- Herlev Hospital (DK)
- AZ Groeninge (BE)
- Universitair ziekenhuis Leuven, Leuven, Belgium
- University of Cologne (DE)
- University of Copenhagen (DK)
- Universitair Ziekenhuis Brussel (BE)
- Univerzita Karlova v Praze, Prague, Czech Republic
- Astellas Pharma, Inc., Leiden, The Netherlands
- Astellas Pharma (United States) (US)
- Medivation, Inc. (United States) (US)
- Massachusetts General Hospital (US)
- Venue
- Journal of Urology
- Published
- 2018-02
- Volume
- 199
- Issue
- 2
- Pages
- 459-464
- ISSN
- 0022-5347 (ISSN-L)
- 1527-3792
- OpenAlex
- W2753160869
- Cited by
- 26
- References
- 22
- Citations by year
- 2026: 2 · 2025: 5 · 2024: 4 · 2023: 1 · 2022: 4 · 2021: 2 · 2020: 3 · 2019: 3 · 2018: 2
- FWCI
- 1.81
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Urology (publishedVersion)
- PubMed (publishedVersion)
- Kölner Universitäts PublikationsServer (Universität zu Köln) (publishedVersion)
- DIAL (Catholic University of Leuven) (submittedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- VUBIR (Vrije Universiteit Brussel) (submittedVersion)
- Funders
- Pfizer
- Astellas Foundation for Research on Metabolic Disorders
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Treatment and Research
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Keywords
- enzalutamide, hormone-naive prostate cancer, androgen receptor antagonists, PSA response, bone mineral density, adverse events, gynecomastia, global health status, metastatic prostate cancer
- MeSH terms
- Administration, Oral, Aged, Aged, 80 and over, Antineoplastic Agents, Benzamides, Follow-Up Studies, Humans, Male, Middle Aged, Nitriles, Phenylthiohydantoin, Prostatic Neoplasms, Treatment Outcome
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