Originally published as JCO Early Release 10.1200/JCO.2008.16.9524 on September 15 2008

This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Machiels, J.-P. Articles by Kerger, J. Search for Related Content PubMed PubMed Citation Articles by Machiels, J.-P. Articles by Kerger, J. Pubmed/NCBI databases Compound via MeSH Substance via MeSH Hazardous Substances DB DOCETAXEL PREDNISONE Medline Plus Health Information Prostate Cancer Related Articles Related Correspondence Social Bookmarking                            What's this?

Prospective Randomized Study Comparing Docetaxel, Estramustine, and Prednisone With Docetaxel and Prednisone in Metastatic Hormone-Refractory Prostate Cancer

Jean-Pascal Machiels, Filomena Mazzeo, Marylene Clausse, Bertrand Filleul, Luc Marcelis, Brigitte Honhon, Lionel D’Hondt, Catherine Dopchie, Vincent Verschaeve, Lionel Duck, Didier Verhoeven, Peter Jousten, Marie-Alix Bonny, Anne-Marie Moxhon, Bertrand Tombal, Joseph Kerger

From the Departments of Medical Oncology and Urology, Centre du Cancer, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain; Department of Medical Oncology, Centre Hospitalier Interrégional Edith Cavell Site Parc Leopold, Brussels; Department of Medical Oncology, Clinique Saint-Luc, Bouge; Department of Medical Oncology, Hôpital de Jolimont, Haine-St Paul; Department of Medical Oncology, Hôpital St-Joseph, Gilly; Department of Medical Oncology, Clinique Notre Dame, Charleroi; Department of Medical Oncology, Clinique Notre Dame, Tournai; Department of Medical Oncology, Clinique Notre Dame de Grâce, Gosselies; Department of Medical Oncology, Clinique St-Pierre, Ottignies; Department of Medical Oncology, AZ Klina, Brasschaat; Department of Medical Oncology, St Nikolaus-Hospital, Eupen; and Department of Medical Oncology, Université Catholique de Louvain, Mont-Godinne and Saint-Elisabeth, Yvoir and Namur, Belgium

Corresponding author: Jean-Pascal Machiels, MD, PhD, Medical Oncology Unit, Université Catholique de Louvain, Cliniques Universitaires Saint-Luc, Avenue Hippocrate 10, 1200 Brussels, Belgium; e-mail: Jean-pascal.Machiels{at}uclouvain.be

Purpose To assess the efficacy and toxicity of the addition of estramustine to docetaxel (D) for the treatment of metastatic hormone-refractory prostate cancer.

Patients and Methods One hundred fifty patients were randomly assigned to D alone (35 mg/m² on days 2 and 9, every 3 weeks) or D in combination with estramustine (D/E; 280 mg orally three times a day on days 1 to 5 and 8 to 12, every 3 weeks). All patients received prednisone (10 mg/d). The primary end point was prostate-specific antigen (PSA) response rate, which was defined as a decrease in PSA 50% from baseline. The study was powered to test the hypothesis that D/E would improve the PSA response rate by 25%.

Results The PSA response rate was not statistically different between the two groups. PSA of less than 4 ng/mL occurred in 29 (41%) of 71 patients receiving D/E and in 17 (25%) of 69 patients receiving D (P = .05). No significant differences were found for median time to PSA progression (D/E, 6.9 months; D, 7.3 months) or median overall survival time (D/E, 19.3 months; D, 21 months). More patients had at least one grade 3 or 4 toxicity with D/E (45%) compared with D (21%; P = .005), mainly as a result of grade 3 or 4 GI toxicity (P = .05). Serious adverse events were more frequent with D/E (n = 20) than with D (n = 9; P = .04).

Conclusion The addition of estramustine to weekly D does not provide any clinically relevant advantage. Both regimens are well tolerated, although the toxicity profile favors D without estramustine.

published online ahead of print at www.jco.org on September 15, 2008.

Supported by an educational grant from Sanofi-Aventis, Brussels, Belgium.

Preliminary results were presented at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00541281 [ClinicalTrials.gov] .

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

Related Correspondence

• Combining Docetaxel With Estramustine: Back to the Future?
  Stéphane Oudard, Jean Christophe Eymard, and Karim Fizazi
  JCO 2009 27: 1148-1149 [Full Text]

This article has been cited by other articles:

				M. M. Regan, E. K. O'Donnell, W. K. Kelly, S. Halabi, W. Berry, S. Urakami, N. Kikuno, and W. K. Oh Efficacy of carboplatin-taxane combinations in the management of castration-resistant prostate cancer: a pooled analysis of seven prospective clinical trials Ann. Onc., July 24, 2009; (2009) mdp308v1. [Abstract] [Full Text] [PDF]

				S. Oudard, J. C. Eymard, and K. Fizazi Combining Docetaxel With Estramustine: Back to the Future? J. Clin. Oncol., March 1, 2009; 27(7): 1148 - 1149. [Full Text] [PDF]

				J.-P. Machiels In Reply J. Clin. Oncol., March 1, 2009; 27(7): 1149 - 1150. [Full Text] [PDF]