Is Survival the Only Thing that Matters?

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Classification of Standard Cytotoxics Activity Large Small Toxicity Significant Trade-offs Attempt to manage toxicity Castaway Discontinue Development Modest Superstar May be approved on phase II data Incrementalist Take to phase III if treatment void
Classification of Targeted Therapies Toxicity Strong Evidence of Tumor Regression Modest activity, good pks Target inhibition Target inhibition No biological activity Significant Trade-offs ?Castaway Castaway Castaway Manage toxicity, consider phase III Consider phase back to phase I-II Modest Superstar Incrementalist Incrementalist Castaway May approved on phase II data Consider for phase III Consider for phase III if tx void
Page 1 and 2: Drug Development and Acceptance: Is
Page 3 and 4: Eschenbach, Plenary Presentation AA
Page 10 and 11: Oncology: What is changing? • Com
Page 12 and 13: Who cares about endpoints? • Indu
Page 14 and 15: Endpoints • Desired endpoints var
Page 16 and 17: What is a surrogate marker? • Def
Page 18 and 19: Correlative Studies • It is still
Page 20 and 21: Phase I Endpoints •The only reaso
Page 22 and 23: Phase II • The purpose of a phase
Page 26 and 27: Study Endpoints- Response Rates •
Page 28 and 29: Phase III Endpoints • The purpose
Page 30 and 31: Study Endpoints-Survival Total Mort
Page 32 and 33: Case #1 • Gemcitabine for the tre
Page 34: Conclusions • Targeted therapies

Is Survival the Only Thing that Matters?

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