Cited by 1,633Prostate Cancer Treatment and ResearchProstate Cancer Diagnosis and TreatmentBone health and treatments

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Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer

Davis, Ian D., Martin, Andrew J., Stockler, Martin R., Begbie, Stephen, Chi, Kim N., Chowdhury, Simon, Coskinas, Xanthi, Frydenberg, Mark, Hague, Wendy E., Horvath, Lisa G., Joshua, Anthony M., Lawrence, Nicola J., Marx, Gavin, McCaffrey, John, McDermott, Ray, McJannett, Margaret, North, Scott A., Parnis, Francis, Parulekar, Wendy, Pook, David W., Reaume, M. Neil, Sandhu, Shahneen K., Tan, Alvin, Tan, T. Hsiang, Thomson, Alastair, Tu, Emily, Vera-Badillo, Francisco, Williams, Scott G., Yip, Sonia, Zhang, Alison Y., Zielinski, Robert R., Sweeney, Christopher J.·2019·New England Journal of Medicine

DOI 10.1056/nejmoa1903835

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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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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
DOI: 10.1056/nejmoa1903835
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
Licence: www.nejmgroup.org/legal/terms-of-use.htm (vor)
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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Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer

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