The Need for Quantitative Imaging in Ocology在肿瘤的定量成像的需要.pptVIP

The Need for Quantitative Imaging in Oncology Richard L. Schilsky, M.D. Professor of Medicine, Associate Dean for Clinical Research, University of Chicago Chairman, Cancer and Leukemia Group B The Role of Imaging in Oncology Detection Staging (assess prognosis) Treatment planning Assess response/progression (assess benefit) Monitor recurrence The Role of Imaging in Oncology Is a tumor present? Where is it? How big is it? How deep is it? What is it near? Is it growing/shrinking/spreading? Clinical Practice vs. Clinical Research Mostly a matter of precision Practice setting: information that impacts clinical management of an individual, e.g., when to start/change/stop treatment; assess extent of disease and cause of symptoms Research setting: information that assesses an intervention in a population, e.g., precise staging; accurate tumor dimensions; assessment of response/progression Clinical Benefit Improved survival compared to no treatment or to a known effective therapy Non-inferiority to a known effective therapy Improvement in TTP compared to known effective treatment coupled with symptomatic improvement Activity vs. Benefit Don’t confuse activity with benefit Activity is the effect on a surrogate or clinical endpoint of administering the drug Efficacy is the overall benefit (adjusted for risk) of prescribing the drug (for a specific indication) Activity is necessary – but not sufficient – for efficacy Survival Unambiguous endpoint that is not subject to investigator interpretation or bias from unblinded studies Assessed easily, frequently No tumor measurements required!! Response Rate Treatment is “entirely” responsible for tumor reduction; unlikely due to natural history Endpoint reached quickly Response criteria arbitrary %CR and duration of response important Classical endpoint to screen for activity; accepted surrogate for clinical benefit Response Criteria WHO: PR is 50% decrease in the sum of the product of the perpendicular diameters of measurabl