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Authors: Fizazi K et al, ASCO 2010 Abstract: LBA4507 Reviewed by: Dr. Lori Wood

A randomized phase III trial of denosumab versus zoledronic acid in patients with bone metastases from castration-resistant prostate cancer (CRPC). Authors: Fizazi K et al, ASCO 2010 Abstract: LBA4507 Reviewed by: Dr. Lori Wood Date posted: Jun 18 2010.

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Authors: Fizazi K et al, ASCO 2010 Abstract: LBA4507 Reviewed by: Dr. Lori Wood

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  1. A randomized phase III trial of denosumab versus zoledronic acid in patients with bone metastases from castration-resistant prostate cancer (CRPC) Authors: Fizazi K et al, ASCO 2010 Abstract: LBA4507 Reviewed by: Dr. Lori Wood Date posted: Jun 18 2010

  2. 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.

  3. Bone metastases very common in Prostate Cancer RANK Ligand (RANKL) is a central mediator of bone destruction RANKL is overexpressed in PCa and stimulates the maturation and activation of osteoclasts Denosumab is a monoclonal antibody to RANKL To date, i.v. Zoledronic Acid is the only drug shown to decrease SRE in CRPC Safety profile of Denosumab shown to be good STUDY RATIONALE

  4. STUDY DESIGN Treatment A: Denosumab 120 mg sc q4wks Placebo N=950 R Treatment B: Zoledronic Acid 4 mg i.v. q4wks Placebo N=951 • - CRPCa • Metastases to bone • Also given Vit D/calcium • Statistics: • - designed with non- • inferiority and superiority • - Primary outcome: • - time to first SRE

  5. RESULTS

  6. STUDY COMMENTARY • Denosumab increased time to first SRE compared to Zoedronic Acid (20.7m vs. 17.1m) thus, meeting the primary endpoint of the study • Originally felt very little renal toxicity but 14.7% compared to 16.2%. This will have to be further defined. • Incidence of ONJ is not less (2.3% vs. 1.3%)

  7. BOTTOM-LINE FOR CANADIAN MEDICAL ONCOLOGISTS • There is now another class of drugs that affect SRE in CRPC • Denosumab: a monoclonal antibody to RANKL • The time to first SRE is longer with Denosumab compared to Zoledronic Acid • But will need further details on the number and types of SREs • Unfortunately, it still does have toxicity including renal and ONJ • We still do not have good predictors of who benefits the most from bone targeted agents (for example: urine bone turnover markers) and when patients should be started/continued/stopped • Hopefully this will come with more research • Hard to know at this point how much Canadian practice will change based on this study

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