tumor measurement criteria milestones - 1981 & 2000
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Tumor Measurement Criteria milestones - 1981 & 2000. RESPONSE EVALUATION CRITERIA IN SOLID TUMORS (RECIST) New Guidelines to Evaluate the Response to Treatment in Solid Tumors - PowerPoint PPT PresentationTRANSCRIPT
RESPONSE EVALUATION CRITERIA IN SOLID TUMORS
(RECIST)
New Guidelines to Evaluate the Response to Treatment in Solid Tumors
P Therasse, SG Arbuck, EA Eisenhauer,J Wanders, RS Kaplan, L Rubinstein,
J Verweij, M Van Glabbeke, AT van Oosterom, MC Christian, SG Gwyther
Journal of the National Cancer Institute
92: 205-216, 2000
TUMOR RESPONSE CRITERIA WORLD HEALTH ORGANIZATION
(WHO)
WHO Handbook for Reporting Results of Cancer Treatment
World Health Organization Offset Publication No. 48
Geneva, Switzerland, 1979————————————————————————————
Reporting Results of Cancer Treatment
AB Miller, B Hogestraeten, M Staquet, A Winkler
Cancer 47:207–14, 1981
Tumor Measurement Criteria
milestones - 1981 & 2000
Baseline 8 Weeks
WHO bi-linear measurement
RECIST CriteriaResponse Evaluation Criteria In Solid Tumors
• Simplification of former methods• 4 response categories (CR, PR, PD, SD)
• Based on linear 1-D being as good as 2-D• Least effort, conservative, for widest acceptance
RECIST Criteria • CR = disappearance of all target lesions• PR = 30% decrease in the sum of the longest
diameter of target lesions• PD = 20% increase in the sum of the longest
diameter of target lesions• SD = small changes that don’t meet above
criteriaCR = complete response
PR = partial response
PD = progressive disease
SD = stable disease
RECIST criteria
‘Target’ lesions
• All measurable lesions up to a maximum of five lesions per organ, and 10 lesions in total
• Sum of the longest diameter of all of the target lesions
RECIST
• RECIST criteria may be employed by NCI-funded cooperative groups which are encouraged, but not required, to use
• RECIST criteria are a voluntary, international standard, and not an NCI standard
• That doesn’t mean Clinical Trial groups are satisfied with it
20 weeks (PR at - 39%)baseline
24 weeks (PR confirmed - 52%) 52 weeks (- 74%)
metastatic renal cell
baseline 13 wks (– 7 %)
27 wks (PR – 43 %)
metastatic renal cell
FDA reform plans
The Value of Image Data
Validated image data could lead to:
• Smaller clinical trials with fewer patients
• Earlier go/no decisions on compounds
• Faster regulatory approval
• Shorter time to market
Biomarker• a measurable characteristic that predicts a clinical
endpoint• “surrogate marker” is a biomarker that substitutes for a
clinical endpoint– “surrogate marker” is a special case biomarker, i.e,
not just a predictor of a clinical endpoint, but a reliable substitute for a clinical endpoint
• the distinction has regulatory implications
• Outcome data is needed to establish validity of a surrogate marker
First steps
• Appropriate, disease-sensitive imaging
• Uniformly acquired with objective QA
• Quantitatively assessed
• Centrally accessible with metadata
Image Processing ‘validation’
Time Difference = 130 dayslinear dimension increased 8 mm -> 11 mm in 4 months
A.P.Reeves, Cornell University, 1999
Lung nodule volume growth
Why not calculate volumes?
• No fully automatic, objective methods
• Semi-automatic methods are time-consuming, labor-intensive, and/or not user-friendly.
Inhomogeneity problem
“Non-cytoreductive”(i.e. functional) measures
• FDG-PET• DCE-MRI• MR spectroscopy• CT density and contrast dynamics• Future:
– Other PET ligands– Macromolecular MR agents– Optical methods
G. W. Goerres et al, Univ Hosp Zurich
PET, CT, hybrid PET/CT forGIST response to imatinib (Gleevec)
baseline7 wks post rx
Visual: subjective
Standardized Uptake Value (SUV): semi-quantitative
Kinetic analysis: quantitative
Concerns about assessing 18FDG uptake in malignant tissue:
DCE MRI VEGF Inhibition time after contrast bolus (PTK/ZK TK inhibitor oral dose results on colon mets)
Morgan B et al, JCO 2003
Chemotherapy Response by MRI & MRS1 wk
pre-Tx76 cc
Day 1 AC x179 cc
Day 42AC x326 cc
Day 70AC x425 cc
Day 112taxol x2
11 cc
Day 178taxol x4
6 cc
partial response to AC, regrowth on taxolfinal pathology - viable IDC and extensive DCIS
593 486 267 79 481 595
Univ. of Minnesota
NCI-FDA Interagency Oncology Task Force
• Imaging Science Development for Oncologic Applications – Work in Progress– Develop volumetric anatomical imaging for oncology
e.g. revise (RECIST)– Develop standard dynamic (contrast) imaging
techniques for oncologic drug development and as surrogate endpoint for drug approvals
– Validate FDG-PET for oncologic drug development and as a surrogate endpoint for drug approvals
– Develop a pathway for accelerating molecular imaging including ‘first in human’ studies in diagnosed cancer patients
Foci on imaging
• NCI: Development and optimization of cancer specific CAD methods
• NIBIB: Development of advanced algorithms and generic image processing methods, code documentation, open source software.
• NLM: Open source software and related data processing platforms.
• NSF: Advanced algorithm development, specialized hardware, GRID computing resources.
• FDA: Development of standards for database development and
• NIST: Measurement of performance of application specific software.
Imaging methods validated as cancer biomarkers.
Objectives:1. Increase imaging studies, using standardized
acquisition protocols, in NCI-funded therapy trials2. Collate imaging data from all NCI-funded trials,
e.g., in Cancer Centers, Cooperative Groups, CCR, etc.
3. Engage FDA through Inter Organization Task Force4. Develop cadre of oncology imaging specialists in
Cancer Centers5. Develop functional imaging committees in all
Cooperative Groups6. Develop volumetric and functional “RECIST”
criteria
CIP Near Term Goals: Data Collection
Develop validated data collections:
• Lung nodules (FNIH Demonstration Project)– for Detection, Classification, rx. Response
• Liver mets - rx response• Colon polyps - screening detection,
classification• Breast digital mammo - detection,
classification
Clinical Imaging Concerns• Only 2% of all cancer patients are in formal
clinical trials• Unless genetics is found to be deterministic, (all)
cancer therapy will continue to be experimental• Conventional diagnostic imaging provides
(barely quantitative) information when following a course of therapy