Cited by 860Prostate Cancer Treatment and ResearchProstate Cancer Diagnosis and TreatmentBone health and treatments

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Bilateral orchiectomy with or without flutamide for metastatic prostate cancer.

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Eisenberger, Mario A., Blumenstein, Brent A., Crawford, E. David, Miller, Gary, McLeod, David G., Loehrer, Patrick J., Wilding, George, Sears, Kathy, Culkin, Daniel J., Thompson, Ian M., Bueschen, Anton J., Lowe, Bruce A.·1998·New England Journal of Medicine

DOI 10.1056/nejm199810083391504

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Abstract

BACKGROUND: Combined androgen blockade for the treatment of metastatic prostate cancer consists of an antiandrogen drug plus castration. In a previous trial, we found that adding the antiandrogen flutamide to leuprolide acetate (a synthetic gonadotropin-releasing hormone that results in medical ablation of testicular function) significantly improved survival as compared with that achieved with placebo plus leuprolide acetate. In the current trial, we compared flutamide plus bilateral orchiectomy with placebo plus orchiectomy. METHODS: We randomly assigned patients who had never received antiandrogen therapy and who had distant metastases from adenocarcinoma of the prostate to treatment with bilateral orchiectomy and either flutamide or placebo. Patients were stratified according to the extent of disease and according to performance status. RESULTS: Of the 1387 patients who were enrolled in the trial, 700 were randomly assigned to the flutamide group and 687 to the placebo group. Overall, the incidence of toxic effects was minimal; the only notable differences between the groups were the greater rates of diarrhea and anemia with flutamide. There was no significant difference between the two groups in overall survival (P=0.14). The estimated risk of death (hazard ratio) for flutamide as compared with placebo was 0.91 (90 percent confidence interval, 0.81 to 1.01). Flutamide was not associated with enhanced benefit in patients with minimal disease. CONCLUSIONS: The addition of flutamide to bilateral orchiectomy does not result in a clinically meaningful improvement in survival among patients with metastatic prostate cancer.

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Authors: Eisenberger, M. A., Blumenstein, B. A., Crawford, E. D., Miller, G., McLeod, D. G., Loehrer, P. J., Wilding, G., Sears, K., Culkin, D. J., Thompson, I. M., Bueschen, A. J., & Lowe, B. A.
Affiliations: Johns Hopkins Hospital (US)
SWOG Cancer Research Network (US)
University of Colorado Denver (US)
Walter Reed National Military Medical Center (US)
University of Wisconsin–Madison (US)
University of Oklahoma Health Sciences Center (US)
University of Alabama at Birmingham (US)
Oregon Health & Science University (US)
ORCID: Eisenberger, Mario A.
Blumenstein, Brent A.
Crawford, E. David
McLeod, David G.
Loehrer, Patrick J.
Wilding, George
Culkin, Daniel J.
Thompson, Ian M.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 1998-10-08
Volume: 339
Issue: 15
Pages: 1036-1042
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejm199810083391504
OpenAlex: W2003985632
Cited by: 859
References: 25
Citations by year: 2026: 2 · 2025: 5 · 2024: 8 · 2023: 12 · 2022: 20 · 2021: 15 · 2020: 21 · 2019: 26 · 2018: 25 · 2017: 23 · 2016: 34 · 2015: 52 · 2014: 49 · 2013: 51 · 2012: 37
FWCI: 37.16
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Funders: National Institutes of Health (2u10ca038926-25)
National Cancer Institute (CA-32102, CA 42777, U10CA032102, U10CA042777, CA 38926)
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: metastatic prostate cancer, bilateral orchiectomy, flutamide, combined androgen blockade, leuprolide, antiandrogen therapy, overall survival, adverse effects, anemia, diarrhea
MeSH terms: Adenocarcinoma, Adult, Aged, Aged, 80 and over, Androgen Antagonists, Bone Neoplasms, Combined Modality Therapy, Double-Blind Method, Flutamide, Humans, Male, Middle Aged, Orchiectomy, Prostatic Neoplasms, Soft Tissue Neoplasms, Survival Analysis, Prostate-Specific Antigen

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Bilateral orchiectomy with or without flutamide for metastatic prostate cancer.

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