Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy
Open accessAbstract
BACKGROUND: Enzalutamide (formerly called MDV3100) targets multiple steps in the androgen-receptor-signaling pathway, the major driver of prostate-cancer growth. We aimed to evaluate whether enzalutamide prolongs survival in men with castration-resistant prostate cancer after chemotherapy. METHODS: In our phase 3, double-blind, placebo-controlled trial, we stratified 1199 men with castration-resistant prostate cancer after chemotherapy according to the Eastern Cooperative Oncology Group performance-status score and pain intensity. We randomly assigned them, in a 2:1 ratio, to receive oral enzalutamide at a dose of 160 mg per day (800 patients) or placebo (399 patients). The primary end point was overall survival. RESULTS: The study was stopped after a planned interim analysis at the time of 520 deaths. The median overall survival was 18.4 months (95% confidence interval [CI], 17.3 to not yet reached) in the enzalutamide group versus 13.6 months (95% CI, 11.3 to 15.8) in the placebo group (hazard ratio for death in the enzalutamide group, 0.63; 95% CI, 0.53 to 0.75; P<0.001). The superiority of enzalutamide over placebo was shown with respect to all secondary end points: the proportion of patients with a reduction in the prostate-specific antigen (PSA) level by 50% or more (54% vs. 2%, P<0.001), the soft-tissue response rate (29% vs. 4%, P<0.001), the quality-of-life response rate (43% vs. 18%, P<0.001), the time to PSA progression (8.3 vs. 3.0 months; hazard ratio, 0.25; P<0.001), radiographic progression-free survival (8.3 vs. 2.9 months; hazard ratio, 0.40; P<0.001), and the time to the first skeletal-related event (16.7 vs. 13.3 months; hazard ratio, 0.69; P<0.001). Rates of fatigue, diarrhea, and hot flashes were higher in the enzalutamide group. Seizures were reported in five patients (0.6%) receiving enzalutamide. CONCLUSIONS: Enzalutamide significantly prolonged the survival of men with metastatic castration-resistant prostate cancer after chemotherapy. (Funded by Medivation and Astellas Pharma Global Development; AFFIRM ClinicalTrials.gov number, NCT00974311.).
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Approval of novel therapies for mCRPC has resulted in uncertainties on optimal treatment sequencing, and utilization of these treatments is limited, demonstrating the need for improved real-world treatment practices.
“Although improvements in clinical outcomes have been observed with novel therapies [20–31], their approval has resulted in uncertainties on optimal treatment sequencing, and utilization of these treatments is limited, demonstrating the need for improved real-world treatment practices.”
From Navigating therapeutic sequencing in the metastatic castration-resistant prostate cancer patient journey (2025) · cites this paper as [21]
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- Authors
- Scher, H. I., Fizazi, K., Saad, F., Taplin, M.-E., Sternberg, C. N., Miller, K., de Wit, R., Mulders, P., Chi, K. N., Shore, N. D., Armstrong, A. J., Flaig, T. W., Fléchon, A., Mainwaring, P., Fleming, M., Hainsworth, J. D., Hirmand, M., Selby, B., Seely, L., & de Bono, J. S.
- Affiliations
- Memorial Sloan Kettering Cancer Center (US)
- Université Paris-Sud (FR)
- Dana-Farber Cancer Institute (US)
- Azienda Ospedaliera San Camillo-Forlanini (IT)
- Charité – Universitätsmedizin Berlin (DE)
- Radboud University Medical Center (NL)
- BC Cancer Agency (CA)
- Carolina Urologic Research Center (US)
- Duke University (US)
- University of Colorado Cancer Center (US)
- Centre Léon Bérard (FR)
- Mater Private Hospital (AU)
- Virginia Oncology Associates (US)
- Medivation, Inc. (United States) (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2012-09-27
- Volume
- 367
- Issue
- 13
- Pages
- 1187-1197
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2148643283
- Cited by
- 4,586
- References
- 8
- Citations by year
- 2026: 142 · 2025: 197 · 2024: 235 · 2023: 283 · 2022: 322 · 2021: 374 · 2020: 363 · 2019: 364 · 2018: 362 · 2017: 355 · 2016: 405 · 2015: 371 · 2014: 424 · 2013: 325 · 2012: 51
- FWCI
- 302.63
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
- Radboud Repository (Radboud University) (submittedVersion)
- Radboud Repository (Radboud University) (submittedVersion, other-oa)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- RePub (Erasmus University Rotterdam) (submittedVersion, other-oa)
- Funders
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Teva Pharmaceutical Industries
- Celgene
- Memorial Sloan-Kettering Cancer Center
- Eisai
- Astellas Pharma
- Active Biotech
- Genentech
- Astellas Pharma Global Development
- Chugai Pharmaceutical
- Janssen Pharmaceuticals
- Cilag
- 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, castration-resistant prostate cancer, androgen receptor signaling, overall survival, PSA response, radiographic progression-free survival, skeletal-related events, quality of life, adverse events, fatigue, diarrhea, hot flashes, seizures, metastatic prostate cancer, pain intensity, performance status
- MeSH terms
- Docetaxel, Aged, Antineoplastic Agents, Benzamides, Double-Blind Method, Humans, Male, Middle Aged, Neoplasm Metastasis, Nitriles, Orchiectomy, Phenylthiohydantoin, Prostatic Neoplasms, Seizures, Signal Transduction, Multivariate Analysis, Disease-Free Survival, Taxoids, Kaplan-Meier Estimate, Androgen Receptor Antagonists
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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