Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: A randomised open-label trial

Johann Sebastian De Bono, Stephane Oudard, Mustafa Ozguroglu, Steinbjørn Hansen, Jean Pascal MacHiels, Ivo Kocak, Gwenaëlle Gravis, I. Bodrogi, Mary J. MacKenzie, Liji Shen, Martin Roessner, Sunil Gupta, A. Oliver Sartor

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Abstract

Background Cabazitaxel is a novel tubulin-binding taxane drug with antitumour activity in docetaxel-resistant cancers. We aimed to compare the efficacy and safety of cabazitaxel plus prednisone with those of mitoxantrone plus prednisone in men with metastatic castration-resistant prostate cancer with progressive disease after docetaxel-based treatment. Methods We undertook an open-label randomised phase 3 trial in men with metastatic castration-resistant prostate cancer who had received previous hormone therapy, but whose disease had progressed during or after treatment with a docetaxel-containing regimen. Participants were treated with 10 mg oral prednisone daily, and were randomly assigned to receive either 12 mg/m2 mitoxantrone intravenously over 15-30 min or 25 mg/m2 cabazitaxel intravenously over 1 h every 3 weeks. The random allocation schedule was computer-generated; patients and treating physicians were not masked to treatment allocation, but the study team was masked to the data analysis. The primary endpoint was overall survival. Secondary endpoints included progression-free survival and safety. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, NCT00417079. Findings 755 men were allocated to treatment groups (377 mitoxantrone, 378 cabazitaxel) and were included in the intention-to-treat analysis. At the cutoff for the final analysis (Sept 25, 2009), median survival was 15·1 months (95 CI 14·1-16·3) in the cabazitaxel group and 12·7 months (11·6-13·7) in the mitoxantrone group. The hazard ratio for death of men treated with cabazitaxel compared with those taking mitoxantrone was 0·70 (95 CI 0·59-0·83, p

Original languageEnglish
Pages (from-to)1147-1154
Number of pages8
JournalThe Lancet
Volume376
Issue number9747
DOIs
Publication statusPublished - Oct 2 2010

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docetaxel
Mitoxantrone
Castration
Prednisone
Prostatic Neoplasms
Intention to Treat Analysis
Therapeutics
Safety
Survival
Tubulin
Random Allocation
Antineoplastic Agents
Disease-Free Survival
cabazitaxel
Appointments and Schedules
Hormones
Physicians

ASJC Scopus subject areas

  • Medicine(all)

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Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment : A randomised open-label trial. / De Bono, Johann Sebastian; Oudard, Stephane; Ozguroglu, Mustafa; Hansen, Steinbjørn; MacHiels, Jean Pascal; Kocak, Ivo; Gravis, Gwenaëlle; Bodrogi, I.; MacKenzie, Mary J.; Shen, Liji; Roessner, Martin; Gupta, Sunil; Sartor, A. Oliver.

In: The Lancet, Vol. 376, No. 9747, 02.10.2010, p. 1147-1154.

Research output: Contribution to journalArticle

De Bono, JS, Oudard, S, Ozguroglu, M, Hansen, S, MacHiels, JP, Kocak, I, Gravis, G, Bodrogi, I, MacKenzie, MJ, Shen, L, Roessner, M, Gupta, S & Sartor, AO 2010, 'Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: A randomised open-label trial', The Lancet, vol. 376, no. 9747, pp. 1147-1154. https://doi.org/10.1016/S0140-6736(10)61389-X
De Bono, Johann Sebastian ; Oudard, Stephane ; Ozguroglu, Mustafa ; Hansen, Steinbjørn ; MacHiels, Jean Pascal ; Kocak, Ivo ; Gravis, Gwenaëlle ; Bodrogi, I. ; MacKenzie, Mary J. ; Shen, Liji ; Roessner, Martin ; Gupta, Sunil ; Sartor, A. Oliver. / Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment : A randomised open-label trial. In: The Lancet. 2010 ; Vol. 376, No. 9747. pp. 1147-1154.
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AU - De Bono, Johann Sebastian

AU - Oudard, Stephane

AU - Ozguroglu, Mustafa

AU - Hansen, Steinbjørn

AU - MacHiels, Jean Pascal

AU - Kocak, Ivo

AU - Gravis, Gwenaëlle

AU - Bodrogi, I.

AU - MacKenzie, Mary J.

AU - Shen, Liji

AU - Roessner, Martin

AU - Gupta, Sunil

AU - Sartor, A. Oliver

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N2 - Background Cabazitaxel is a novel tubulin-binding taxane drug with antitumour activity in docetaxel-resistant cancers. We aimed to compare the efficacy and safety of cabazitaxel plus prednisone with those of mitoxantrone plus prednisone in men with metastatic castration-resistant prostate cancer with progressive disease after docetaxel-based treatment. Methods We undertook an open-label randomised phase 3 trial in men with metastatic castration-resistant prostate cancer who had received previous hormone therapy, but whose disease had progressed during or after treatment with a docetaxel-containing regimen. Participants were treated with 10 mg oral prednisone daily, and were randomly assigned to receive either 12 mg/m2 mitoxantrone intravenously over 15-30 min or 25 mg/m2 cabazitaxel intravenously over 1 h every 3 weeks. The random allocation schedule was computer-generated; patients and treating physicians were not masked to treatment allocation, but the study team was masked to the data analysis. The primary endpoint was overall survival. Secondary endpoints included progression-free survival and safety. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, NCT00417079. Findings 755 men were allocated to treatment groups (377 mitoxantrone, 378 cabazitaxel) and were included in the intention-to-treat analysis. At the cutoff for the final analysis (Sept 25, 2009), median survival was 15·1 months (95 CI 14·1-16·3) in the cabazitaxel group and 12·7 months (11·6-13·7) in the mitoxantrone group. The hazard ratio for death of men treated with cabazitaxel compared with those taking mitoxantrone was 0·70 (95 CI 0·59-0·83, p

AB - Background Cabazitaxel is a novel tubulin-binding taxane drug with antitumour activity in docetaxel-resistant cancers. We aimed to compare the efficacy and safety of cabazitaxel plus prednisone with those of mitoxantrone plus prednisone in men with metastatic castration-resistant prostate cancer with progressive disease after docetaxel-based treatment. Methods We undertook an open-label randomised phase 3 trial in men with metastatic castration-resistant prostate cancer who had received previous hormone therapy, but whose disease had progressed during or after treatment with a docetaxel-containing regimen. Participants were treated with 10 mg oral prednisone daily, and were randomly assigned to receive either 12 mg/m2 mitoxantrone intravenously over 15-30 min or 25 mg/m2 cabazitaxel intravenously over 1 h every 3 weeks. The random allocation schedule was computer-generated; patients and treating physicians were not masked to treatment allocation, but the study team was masked to the data analysis. The primary endpoint was overall survival. Secondary endpoints included progression-free survival and safety. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, NCT00417079. Findings 755 men were allocated to treatment groups (377 mitoxantrone, 378 cabazitaxel) and were included in the intention-to-treat analysis. At the cutoff for the final analysis (Sept 25, 2009), median survival was 15·1 months (95 CI 14·1-16·3) in the cabazitaxel group and 12·7 months (11·6-13·7) in the mitoxantrone group. The hazard ratio for death of men treated with cabazitaxel compared with those taking mitoxantrone was 0·70 (95 CI 0·59-0·83, p

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