Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer
- PMID: 15470214
- DOI: 10.1056/NEJMoa041318
Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer
Abstract
Background: Mitoxantrone-based chemotherapy palliates pain without extending survival in men with progressive androgen-independent prostate cancer. We compared docetaxel plus estramustine with mitoxantrone plus prednisone in men with metastatic, hormone-independent prostate cancer.
Methods: We randomly assigned 770 men to one of two treatments, each given in 21-day cycles: 280 mg of estramustine three times daily on days 1 through 5, 60 mg of docetaxel per square meter of body-surface area on day 2, and 60 mg of dexamethasone in three divided doses before docetaxel, or 12 mg of mitoxantrone per square meter on day 1 plus 5 mg of prednisone twice daily. The primary end point was overall survival; secondary end points were progression-free survival, objective response rates, and post-treatment declines of at least 50 percent in serum prostate-specific antigen (PSA) levels.
Results: Of 674 eligible patients, 338 were assigned to receive docetaxel and estramustine and 336 to receive mitoxantrone and prednisone. In an intention-to-treat analysis, the median overall survival was longer in the group given docetaxel and estramustine than in the group given mitoxantrone and prednisone (17.5 months vs. 15.6 months, P=0.02 by the log-rank test), and the corresponding hazard ratio for death was 0.80 (95 percent confidence interval, 0.67 to 0.97). The median time to progression was 6.3 months in the group given docetaxel and estramustine and 3.2 months in the group given mitoxantrone and prednisone (P<0.001 by the log-rank test). PSA declines of at least 50 percent occurred in 50 percent and 27 percent of patients, respectively (P<0.001), and objective tumor responses were observed in 17 percent and 11 percent of patients with bidimensionally measurable disease, respectively (P=0.30). Grade 3 or 4 neutropenic fevers (P=0.01), nausea and vomiting (P<0.001), and cardiovascular events (P=0.001) were more common among patients receiving docetaxel and estramustine than among those receiving mitoxantrone and prednisone. Pain relief was similar in both groups.
Conclusions: The improvement in median survival of nearly two months with docetaxel and estramustine, as compared with mitoxantrone and prednisone, provides support for this approach in men with metastatic, androgen-independent prostate cancer.
Copyright 2004 Massachusetts Medical Society.
Comment in
-
Mechanisms of androgen-refractory prostate cancer.N Engl J Med. 2004 Oct 7;351(15):1488-90. doi: 10.1056/NEJMp048178. N Engl J Med. 2004. PMID: 15470210 No abstract available.
-
Chemotherapy for advanced prostate cancer.N Engl J Med. 2005 Jan 13;352(2):200-1; author reply 200-1. doi: 10.1056/NEJM200501133520218. N Engl J Med. 2005. PMID: 15647586 No abstract available.
-
Docetaxel-based chemotherapy trials in androgen-independent prostate cancer: first demonstration of a survival benefit.Curr Oncol Rep. 2005 May;7(3):205-6. doi: 10.1007/s11912-005-0074-1. Curr Oncol Rep. 2005. PMID: 15847711 No abstract available.
Similar articles
-
Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer.N Engl J Med. 2004 Oct 7;351(15):1502-12. doi: 10.1056/NEJMoa040720. N Engl J Med. 2004. PMID: 15470213 Clinical Trial.
-
Multicenter randomized phase II study of two schedules of docetaxel, estramustine, and prednisone versus mitoxantrone plus prednisone in patients with metastatic hormone-refractory prostate cancer.J Clin Oncol. 2005 May 20;23(15):3343-51. doi: 10.1200/JCO.2005.12.187. Epub 2005 Feb 28. J Clin Oncol. 2005. PMID: 15738542 Clinical Trial.
-
Docetaxel, estramustine and prednisone for hormone-refractory prostate cancer: a single-center experience.Anticancer Res. 2005 Nov-Dec;25(6C):4481-6. Anticancer Res. 2005. PMID: 16334130 Clinical Trial.
-
Future directions in the treatment of androgen-independent prostate cancer.Urology. 2005 Jun;65(6 Suppl):8-12. doi: 10.1016/j.urology.2005.04.020. Urology. 2005. PMID: 15939077 Review.
-
Recent docetaxel studies establish a new standard of care in hormone refractory prostate cancer.Can J Urol. 2005 Feb;12 Suppl 1:81-5. Can J Urol. 2005. PMID: 15780173 Review.
Cited by
-
Therapeutic options in docetaxel-refractory metastatic castration-resistant prostate cancer: a cost-effectiveness analysis.PLoS One. 2013 May 22;8(5):e64275. doi: 10.1371/journal.pone.0064275. Print 2013. PLoS One. 2013. PMID: 23717582 Free PMC article.
-
HPMA Copolymer-Conjugated Pirarubicin in Multimodal Treatment of a Patient with Stage IV Prostate Cancer and Extensive Lung and Bone Metastases.Target Oncol. 2016 Feb;11(1):101-6. doi: 10.1007/s11523-015-0379-4. Target Oncol. 2016. PMID: 26194363
-
Acquisition of paclitaxel resistance is associated with a more aggressive and invasive phenotype in prostate cancer.J Cell Biochem. 2013 Jun;114(6):1286-93. doi: 10.1002/jcb.24464. J Cell Biochem. 2013. PMID: 23192682 Free PMC article.
-
Immunotherapy of genitourinary malignancies.J Oncol. 2012;2012:397267. doi: 10.1155/2012/397267. Epub 2012 Mar 5. J Oncol. 2012. PMID: 22481927 Free PMC article.
-
Significance of docetaxel-based chemotherapy as treatment for metastatic castration-resistant prostate cancer in Japanese men over 75 years old.Int Urol Nephrol. 2012 Dec;44(6):1697-703. doi: 10.1007/s11255-012-0223-z. Epub 2012 Jun 24. Int Urol Nephrol. 2012. PMID: 22729777
Publication types
MeSH terms
Substances
Grants and funding
- CA03096/CA/NCI NIH HHS/United States
- CA04919/CA/NCI NIH HHS/United States
- CA11083/CA/NCI NIH HHS/United States
- CA12213/CA/NCI NIH HHS/United States
- CA12644/CA/NCI NIH HHS/United States
- CA13612/CA/NCI NIH HHS/United States
- CA14028/CA/NCI NIH HHS/United States
- CA16385/CA/NCI NIH HHS/United States
- CA20319/CA/NCI NIH HHS/United States
- CA22433/CA/NCI NIH HHS/United States
- CA25224/CA/NCI NIH HHS/United States
- CA27057/CA/NCI NIH HHS/United States
- CA32102/CA/NCI NIH HHS/United States
- CA35090/CA/NCI NIH HHS/United States
- CA35119/CA/NCI NIH HHS/United States
- CA35128/CA/NCI NIH HHS/United States
- CA35176/CA/NCI NIH HHS/United States
- CA35178/CA/NCI NIH HHS/United States
- CA35192/CA/NCI NIH HHS/United States
- CA35261/CA/NCI NIH HHS/United States
- CA35281/CA/NCI NIH HHS/United States
- CA35431/CA/NCI NIH HHS/United States
- CA35996/CA/NCI NIH HHS/United States
- CA37135/CA/NCI NIH HHS/United States
- CA37981/CA/NCI NIH HHS/United States
- CA38926/CA/NCI NIH HHS/United States
- CA42777/CA/NCI NIH HHS/United States
- CA45377/CA/NCI NIH HHS/United States
- CA45450/CA/NCI NIH HHS/United States
- CA45461/CA/NCI NIH HHS/United States
- CA45807/CA/NCI NIH HHS/United States
- CA45808/CA/NCI NIH HHS/United States
- CA46113/CA/NCI NIH HHS/United States
- CA46136/CA/NCI NIH HHS/United States
- CA46282/CA/NCI NIH HHS/United States
- CA46368/CA/NCI NIH HHS/United States
- CA46441/CA/NCI NIH HHS/United States
- CA46462/CA/NCI NIH HHS/United States
- CA58416/CA/NCI NIH HHS/United States
- CA58658/CA/NCI NIH HHS/United States
- CA58686/CA/NCI NIH HHS/United States
- CA58723/CA/NCI NIH HHS/United States
- CA58861/CA/NCI NIH HHS/United States
- CA58882/CA/NCI NIH HHS/United States
- CA63844/CA/NCI NIH HHS/United States
- CA63845/CA/NCI NIH HHS/United States
- CA63848/CA/NCI NIH HHS/United States
- CA63850/CA/NCI NIH HHS/United States
- CA67575/CA/NCI NIH HHS/United States
- CA67663/CA/NCI NIH HHS/United States
- CA68183/CA/NCI NIH HHS/United States
- CA74647/CA/NCI NIH HHS/United States
- CA74811/CA/NCI NIH HHS/United States
- CA76129/CA/NCI NIH HHS/United States
- CA76132/CA/NCI NIH HHS/United States
- CA76447/CA/NCI NIH HHS/United States
- CA86780/CA/NCI NIH HHS/United States
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical
Research Materials
Miscellaneous