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

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Tumor Measurement Criteria milestones - 1981 & 2000

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Tumor Measurement Criteriamilestones -1981 & 2000


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


WHO Handbook for Reporting Results of Cancer Treatment

World Health Organization Offset Publication No. 48Geneva, Switzerland, 1979


Reporting Results of Cancer Treatment

AB Miller, B Hogestraeten, M Staquet, A Winkler

Cancer 47:207–14, 1981

WHO bi-linear measurement


8 Weeks

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 criteria

CR = 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 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%)

24 weeks (PR confirmed - 52%)

52 weeks (- 74%)

metastatic renal cell


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


  • 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’

Lung nodule volume growth

Time Difference = 130 days

linear dimension increased 8 mm -> 11 mm in 4 months

A.P.Reeves, Cornell University, 1999

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



  • MR spectroscopy

  • CT density and contrast dynamics

  • Future:

    • Other PET ligands

    • Macromolecular MR agents

    • Optical methods

PET, CT, hybrid PET/CT forGIST response to imatinib (Gleevec)


7 wks post rx

G. W. Goerres et al, Univ Hosp Zurich

Visual: subjectiveStandardized Uptake Value (SUV): semi-quantitativeKinetic 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 & MRS

1 wk


76 cc

Day 1

AC x1

79 cc

Day 42

AC x3

26 cc

Day 70

AC x4

25 cc

Day 112

taxol x2

11 cc

Day 178

taxol x4

6 cc







partial response to AC, regrowth on taxol

final pathology - viable IDC and extensive DCIS

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 specificCAD 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:

  • Increase imaging studies, using standardized acquisition protocols, in NCI-funded therapy trials

  • Collate imaging data from all NCI-funded trials, e.g., in Cancer Centers, Cooperative Groups, CCR, etc.

  • Engage FDA through Inter Organization Task Force

  • Develop cadre of oncology imaging specialists in Cancer Centers

  • Develop functional imaging committees in all Cooperative Groups

  • Develop volumetric and functional “RECIST” criteria

CIP Near Term Goals: Data CollectionDevelop 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

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