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Enzalutamide monotherapy in hormone-naive prostate cancer: primary analysis of an open-label, single-arm, phase 2 study
B. Tombal, M. Borre, P. Rathenborg, P. Werbrouck, H. Van Poppel, A. Heidenreich, P. Iversen, J. Braeckman, J. Heracek, E. Baskin-Bey, T. Ouatas, F. Perabo, D. Phung, M. Hirmand, MR. Smith,
Language English Country England, Great Britain
Document type Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't
NLK
ProQuest Central
from 2000-09-01 to 2 months ago
Nursing & Allied Health Database (ProQuest)
from 2000-09-01 to 2 months ago
Health & Medicine (ProQuest)
from 2000-09-01 to 2 months ago
Public Health Database (ProQuest)
from 2000-09-01 to 2 months ago
- MeSH
- Adenocarcinoma blood drug therapy MeSH
- Androgen Antagonists therapeutic use MeSH
- Phenylthiohydantoin analogs & derivatives therapeutic use MeSH
- Middle Aged MeSH
- Humans MeSH
- Prostatic Neoplasms blood drug therapy MeSH
- Prostate-Specific Antigen blood MeSH
- Antineoplastic Agents therapeutic use MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Research Support, N.I.H., Extramural MeSH
BACKGROUND: The androgen receptor inhibitor enzalutamide is approved for the treatment of metastatic castration-resistant prostate cancer that has progressed on docetaxel. Our aim was to assess the activity and safety of enzalutamide monotherapy in men with hormone-naive prostate cancer. METHODS: This trial is an ongoing open-label, single-arm, phase 2 study, done across 12 European sites. Men aged over 18 years, with hormone-naive prostate cancer for whom hormone therapy was indicated, and who had non-castration levels of testosterone and prostate-specific antigen (PSA) of 2 ng/mL or greater at screening, and an Eastern Cooperative Oncology Group score of 0, received oral enzalutamide 160 mg/day. The primary outcome was the proportion of patients with an 80% or greater decline in PSA at week 25. All analyses included all patients who had received at least one dose of the study drug. This study is registered with ClinicalTrials.gov, number NCT01302041. FINDINGS: 67 men were enrolled into the study. 62 patients (92.5%, 95% CI 86.2-98.8) had a decline in PSA of 80% or greater at week 25. The most commonly reported treatment-emergent adverse events up to week 25 were gynaecomastia (n=24), fatigue (n=23), nipple pain (n=13), and hot flush (n=12), all of which were of mild to moderate severity. Nine patients had a treatment-emergent adverse event of grade 3 or higher, most of which were reported in one patient each, except for pneumonia (grade 3, two patients) and hypertension (grade 3, four patients). Five patients reported serious adverse events, none of which were deemed to be treatment related. INTERPRETATION: Our findings suggest that enzalutamide monotherapy in men with hormone-naive prostate cancer of varying severity provides a level of disease suppression, and was generally well tolerated. These findings provide a rationale for further investigation of clinical response and outcomes with enzalutamide in non-castrate men with prostate cancer.
Aarhus University Hospital Aarhus Denmark
Astellas Pharma Global Development Leiden Netherlands
Astellas Pharma Global Development Northbrook IL USA
AZ Groeninge Kortrijk Kortrijk Belgium
Herlev Hospital Herlev Denmark
Institut de Recherche Clinique Université Catholique de Louvain Brussels Belgium
Klinik und Poliklinik für Urologie RWTH University Aachen Aachen Germany
Massachusetts General Hospital Cancer Center Boston MA USA
Medivation Inc San Francisco CA USA
Rigshospitalet University of Copenhagen Copenhagen Denmark
References provided by Crossref.org
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