www.OncologyEducation.ca Abiraterone acetate (AA) plus low dose prednisone (P) improves overall survival in patients with metastatic CRPCa who have progressed after docetaxel-based chemotherapy: Results of COU-AA- 301, a randomized placebo controlled phase III study. Authors: de Bono et al, ESMO, October 2010 Subgroup analysis update: Scher et al, GU ASCO, February 2011 Reviewed by: Dr. Lori Wood Abstract: ESMO LBA5, GU ASCO Abstract 4 Date posted: May 13, 2011
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Abiraterone acetate (AA) plus low dose prednisone (P) improves overall survival in patients with metastatic CRPCa who have progressed after docetaxel-based chemotherapy: Results of
COU-AA-301, a randomized placebo controlled phase III study.
Authors: de Bono et al, ESMO, October 2010
Subgroup analysis update: Scher et al, GU ASCO, February 2011
Reviewed by: Dr. Lori Wood
Abstract: ESMO LBA5, GU ASCO Abstract 4
Date posted: May 13, 2011
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Thank you for downloading this update. Please feel free to use it for educational purposes.
Please acknowledge OncologyEducation.ca and Dr. Wood when using these slides.
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BACKGROUND
• After patients with metastatic CRPCa fail docetaxel-based chemotherapy, there were no randomized trials showing a clinically significant benefit to any other agents. In Canada, we often treated patients with mitoxantrone based on phase II data.
• Studies show that CRPCa remains driven by ligand-dependent androgen receptor signaling.
• Abiraterone acetate (AA) is a potent selective inhibitor of CYP17 which is a key enzyme in androgen synthesis.
• Basic science and some clinical data suggest that some CRPCa’s remain dependent on androgen receptor signaling.
• All subgroups benefited– ECOG: 0-1 vs. 2– BPI: 4 vs. 4– Prior chemotherapy: 1 vs. 2– Progression: PSA only vs. radiological
PSA– LDH: low vs. high
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STUDY COMMENTARY
• Data reviewed at a pre-specified interim analysis and IDMC recommended study be unblinded.
• AA shows a 3.8m survival advantage over placebo post docetaxel-based chemotherapy in patients with metastatic CRPCa.
• Very well-tolerated.
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BOTTOM-LINE FOR CANADIAN MEDICAL ONCOLOGISTS
• This study will change practice.• Results from another post docetaxel phase III
trial (TROPIC: Cabazitaxel vs. Mitoxantrone) were reported at ASCO 2010. Median OS 15.1m vs. 12.7m
• Given the ease of administration and low toxicity, AA will likely become the standard of care post docetaxel-based chemotherapy in men with metastatic CRPCa.