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Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer
Abstract
BACKGROUND: Enzalutamide, an androgen-receptor inhibitor, has been associated with improved overall survival in men with castration-resistant prostate cancer. It is not known whether adding enzalutamide to testosterone suppression, with or without early docetaxel, will improve survival in men with metastatic, hormone-sensitive prostate cancer. METHODS: In this open-label, randomized, phase 3 trial, we assigned patients to receive testosterone suppression plus either open-label enzalutamide or a standard nonsteroidal antiandrogen therapy (standard-care group). The primary end point was overall survival. Secondary end points included progression-free survival as determined by the prostate-specific antigen (PSA) level, clinical progression-free survival, and adverse events. RESULTS: A total of 1125 men underwent randomization; the median follow-up was 34 months. There were 102 deaths in the enzalutamide group and 143 deaths in the standard-care group (hazard ratio, 0.67; 95% confidence interval [CI], 0.52 to 0.86; P = 0.002). Kaplan-Meier estimates of overall survival at 3 years were 80% (based on 94 events) in the enzalutamide group and 72% (based on 130 events) in the standard-care group. Better results with enzalutamide were also seen in PSA progression-free survival (174 and 333 events, respectively; hazard ratio, 0.39; P<0.001) and in clinical progression-free survival (167 and 320 events, respectively; hazard ratio, 0.40; P<0.001). Treatment discontinuation due to adverse events was more frequent in the enzalutamide group than in the standard-care group (33 events and 14 events, respectively). Fatigue was more common in the enzalutamide group; seizures occurred in 7 patients in the enzalutamide group (1%) and in no patients in the standard-care group. CONCLUSIONS: Enzalutamide was associated with significantly longer progression-free and overall survival than standard care in men with metastatic, hormone-sensitive prostate cancer receiving testosterone suppression. The enzalutamide group had a higher incidence of seizures and other toxic effects, especially among those treated with early docetaxel. (Funded by Astellas Scientific and Medical Affairs and others; ENZAMET (ANZUP 1304) ANZCTR number, ACTRN12614000110684; ClinicalTrials.gov number, NCT02446405; and EU Clinical Trials Register number, 2014-003190-42.).
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“Multiple phase 3 clinical trials have demonstrated the benefit of AR-targeted therapies on patient survival9–18.”
From Genome-scale CRISPR screens identify PTGES3 as a direct modulator of androgen receptor function in advanced prostate cancer (2025) · cites this paper as [15]
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Metadata
- Authors
- Davis, I. D., Martin, A. J., Stockler, M. R., Begbie, S., Chi, K. N., Chowdhury, S., Coskinas, X., Frydenberg, M., Hague, W. E., Horvath, L. G., Joshua, A. M., Lawrence, N. J., Marx, G., McCaffrey, J., McDermott, R., McJannett, M., North, S. A., Parnis, F., Parulekar, W., Pook, D. W., Reaume, M. N., Sandhu, S. K., Tan, A., Tan, T. H., Thomson, A., Tu, E., Vera-Badillo, F., Williams, S. G., Yip, S., Zhang, A. Y., Zielinski, R. R., & Sweeney, C. J.
- Affiliations
- The University of Sydney (AU)
- University College Dublin (IE)
- ORCID
- Davis, Ian D.
- Martin, Andrew J.
- Stockler, Martin R.
- Begbie, Stephen
- Chi, Kim N.
- Coskinas, Xanthi
- Frydenberg, Mark
- Horvath, Lisa G.
- Joshua, Anthony M.
- Lawrence, Nicola J.
- Marx, Gavin
- McCaffrey, John
- McDermott, Ray
- McJannett, Margaret
- North, Scott A.
- Parulekar, Wendy
- Pook, David W.
- Reaume, M. Neil
- Sandhu, Shahneen K.
- Thomson, Alastair
- Vera-Badillo, Francisco
- Williams, Scott G.
- Yip, Sonia
- Zhang, Alison Y.
- Zielinski, Robert R.
- Sweeney, Christopher J.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2019-07-11
- Volume
- 381
- Issue
- 2
- Pages
- 121-131
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2947893479
- Cited by
- 1,633
- References
- 25
- Citations by year
- 2026: 166 · 2025: 217 · 2024: 228 · 2023: 244 · 2022: 276 · 2021: 253 · 2020: 192 · 2019: 49
- FWCI
- 141.62
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion)
- Funders
- Canadian Cancer Society (704970)
- Cancer Australia (Support for Cancer Clinical Trials Program)
- National Health and Medical Research Council (Practitioner Fellowship APP1102604, Program Grants 1037786 and 1150467)
- Astellas Scientific and Medical Affairs
- Topics
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Prostate Cancer Treatment and Research
- Health Sciences › Medicine › Urology › Prostate Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › Bone health and treatments
- Keywords
- enzalutamide, metastatic hormone-sensitive prostate cancer, androgen receptor antagonists, testosterone suppression, docetaxel, nonsteroidal antiandrogens, overall survival, progression-free survival, prostate-specific antigen, seizures, fatigue, adverse events, first-line therapy, castration-resistant prostate cancer, metastatic castration-resistant prostate cancer
- MeSH terms
- Progression-Free Survival, Adenocarcinoma, Aged, Antineoplastic Combined Chemotherapy Protocols, Benzamides, Bone Neoplasms, Digestive System Neoplasms, Fatigue, Follow-Up Studies, Humans, Male, Middle Aged, Nitriles, Phenylthiohydantoin, Prostatic Neoplasms, Seizures, Kaplan-Meier Estimate, Androgen Receptor Antagonists
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