The Need for Quantitative Imaging in Oncology:在肿瘤的定量成像的需要-PPT文档.ppt
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1、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?,
2、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
3、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 coup
4、led with symptomatic improvement,Activity vs. Benefit,Dont 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
5、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 h
6、istory 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 measurable lesio
7、ns RECIST: PR is 30% decrease in the baseline sum of the longest diameters of target lesions Each represents a 65% decrease in volume Confirmation 4 weeks later required,Criteria for Progression,WHO: PD is 25% increase in the sum of the product of the perpendicular diameters of measurable lesions (4
8、0% increase in volume) RECIST: PD is 20% in the sum of the longest diameters of target lesions (73% increase in volume) RECIST is biased toward stable disease,What is Measurable?,Lesion measured in one dimension as 20 mm with conventional techniques or 10 mm with spiral CT (5 mm reconstruction) All
9、measurable lesions up to max. of 10 are considered “target” lesions All of this is completely arbitrary and observer/technology-dependent!,You have to see it before you can measure it!,CT helps in the removal of most structure noise,case ctn048, ctn008 - section 17,Vast Amount of Data,From S. Armato
10、,Erasmus, J. J. et al. J Clin Oncol; 21:2574-2582 2003,Measurable?,Erasmus, J. J. et al. J Clin Oncol; 21:2574-2582 2003,Measurable?,Is RR Predictive of Benefit?,For hematologic malignancies, CR generally associated with symptomatic improvement, reduced transfusion requirement, reduced infection rat
11、es Buyse et. al. (Lancet, 2000): meta analysis of 25 CRC trials with fluoropyrimidines: tumor response a highly significant predictor of survival, independent of PS,Is RR Predictive of Benefit?,Chen et. al. (JNCI, 2000): phase II response rates in patients with extensive SCLC did not correlate with
12、median survival in phase III trials of same regimen Irinotecan (15%); docetaxel (38%); capecitabine (18.5%); oxaliplatin (9%) all improved survival in randomized trials In many other studies, a significant improvement in RR does not result in improved survival,Is RR Predictive of Benefit?,RR is reas
13、onably likely to predict clinical benefit, at least for certain diseases and certain drugs Is there a minimum RR predictive of benefit and how is it best measured? Is another surrogate predictive for drugs that do not cause regression?,BAY 43-9006: RDT Trial Schema, 25% Tumor shrinkage,-25% to +25%
14、Tumor stabilization, 25% Tumor growth,BAY 43-9006 12 week run-in,BAY 43-9006: RDT Design,All patients initially receive BAY 43-9006 Enrichment of randomized population for endpoint of interest Distinguishes antiproliferative activity of drug vs. the natural history of disease Requires less overall s
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