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Benefits and Risks

Benefits and Risks. Eugenie Kleinerman, MD Professor and Head, Division of Pediatrics MD Anderson Cancer Center. 2074.01. Safety. Side effects reflect activity of MTP Flu-like symptoms; treated with acetaminophen No increase in chemo toxicity Optimal biologic dose < Maximum tolerated dose

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Benefits and Risks

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  1. Benefits and Risks Eugenie Kleinerman, MD Professor and Head, Division of PediatricsMD Anderson Cancer Center 2074.01

  2. Safety Side effects reflect activity of MTP Flu-like symptoms; treated with acetaminophen No increase in chemo toxicity Optimal biologic dose < Maximum tolerated dose Compliance rather than safety concerns 2078.01

  3. Consistency of Efficacy Results: ITT N Events N Events MTP 338 107 MTP 338 63 No MTP 340 133 No MTP 340 85 2519.01

  4. Consistency of Efficacy Results: Metastatic 2520.01

  5. Survival: 2006 ITT MTP No MTP 2521.01

  6. Summary • Over 20 years of data with MTP in young people • Phase 3 trial designed to determine efficacy • Phase 3 study is largest US trial in osteosarcoma • No new agents for osteosarcoma since MTX approved • Survival data translate into 50 more cures per year 2522.01

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