Originally published as JCO Early Release 10.1200/JCO.2005.12.187 on February 28 2005

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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

From the Department of Medical Oncology, Georges Pompidou European Hospital; Oncology Department, Curie Institute; Oncology Department, Val de Grce Hospital; Association pour la Recherche de Thérapeuthiques Innovantes en Cancérologie Group, Paris; Radiotherapy Department, Mantes Hospital, Mantes; Victor Hugo Clinic, Le Mans; Oncology Department, Armoricaine Clinic, Saint Brieuc; Oncology Department, Roseraie European Hospital, Aubervilliers; and Oncology Department, Bretonneau Hospital, Tours, France

Address reprint requests to Stéphane Oudard, MD, PhD, Department of Medical Oncology, Georges Pompidou European Hospital, 20 Rue Leblanc, 75908, Paris Cedex 15, France; e-mail: stephane.oudard{at}hop.egp.ap-hop-paris.fr

PURPOSE: Mitoxantrone-corticosteroid is currently the standard palliative treatment in hormone-refractory prostate cancer (HRPC) patients. Recent clinical trials documented the high activity of the docetaxel-estramustine combination. We conducted a randomized phase II study to evaluate prostate-specific antigen (PSA) response (primary end point) and safety of two docetaxel-estramustine-prednisone (DEP) regimens and mitoxantrone-prednisone (MP).

PATIENTS AND METHODS: One hundred thirty metastatic HRPC patients were randomly assigned to receive docetaxel (70 mg/m² on day 2 or 35 mg/m² on days 2 and 9 of each 21-day cycle) and estramustine (280 mg PO tid on days 1 through 5 and 8 through 12) or mitoxantrone 12 mg/m² every 3 weeks; all patients received prednisone (10 mg daily).

RESULTS: One hundred twenty-seven patients were assessable for PSA response and safety. A 50% PSA decline was found in a greater percentage of patients in the docetaxel arms (67% and 63%) compared with MP (18%; P = .0001). Median time to PSA progression was five times longer with DEP than with MP (8.8 and 9.3 v 1.7 months, respectively; P = .000001). Overall survival was better in the docetaxel arms (18.6 and 18.4 months) compared with the MP arm (13.4 months), but not significantly so (P = .3). Crossover rates differed significantly among treatment arms (16%, 10%, and 48% in arms A, B, and C, respectively; P = .00001). Treatment-related toxicities were mild and mainly hematologic.

CONCLUSION: The results of this randomized phase II study showed significantly higher PSA decline 50% and longer times to progression in HRPC patients receiving DEP-based chemotherapy than MP, and that DEP could be proposed in this setting.

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

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