Is Survival the Only Thing that Matters?

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Study Endpoints- Response Rates • Response rates (RR) – Based on tumor measurements from anatomical imaging – RR is the likelihood that the tumor will shrink or disappear based on observations in a significant group of patients. • Response Evaluation Criteria in Solid Tumors (RECIST)
RECIST Responses * Complete Response (CR): * Partial Response (PR): * Progressive Disease (PD): * Stable Disease (SD): Disappearance of all target lesions At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
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 24 and 25: Classification of Standard Cytotoxi
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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