64937B RECIST 1.
1 Criteria REV 4 11/9/10 4:12 PM Page 1
RECIST 1.1
Criteria Handout
64937B RECIST 1.1 Criteria REV 4 11/9/10 4:12 PM Page 2
Table of Contents:
Basic Paradigm .............................................................................................................. 3
Image Acquisition............................................................................................................ 4
Measurable Lesions ........................................................................................................ 5
Non-Measurable Lesions ................................................................................................ 6
Special Lesion Types ...................................................................................................... 7
Baseline Lesion Burden .................................................................................................. 8
Target Lesions ................................................................................................................ 9
Baseline Documentation ................................................................................................10
Lesions with Prior Local Treatment ................................................................................11
Evaluating Response at Each Timepoint........................................................................12
Target Lesion Evaluation ..........................................................................................1314
Non-Target Lesion Evaluation ........................................................................................15
New Lesions ..................................................................................................................16
FDG-PET ......................................................................................................................17
Missing Assessments and Non-evaluable Designation ....................................................18
Recurrence of Lesions ..................................................................................................19
Evaluation of Overall Timepoint Response for Patients with
Measurable Disease at Baseline ..................................................................................20
Evaluation of Overall Timepoint Response for Patients without
Measurable Disease at Baseline ..................................................................................21
Confirmation ..................................................................................................................22
What Has Changed: RECIST 1.0 RECIST 1.1 ............................................................23
Modifications and Variants ............................................................................................24
References ....................................................................................................................25
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64937B RECIST 1.1 Criteria REV 4 11/9/10 4:12 PM Page 3
Basic Paradigm
Assess at baseline
Look for measurable lesions
Select target and non-target lesions
Measure target lesions
Add up to get tumor burden
Treat patient
Follow-up evaluation
Measure target lesions
Assess non-target lesions and look for new lesions
Calculate timepoint response
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Image Acquisition
CT
Slice thickness 5mm if possible, contiguous
IV and oral contrast used (3-phase liver if appropriate)
Field of view adjusted to body habitus (include the whole body, out to the skin)
MRI
Axial T1 and T2, axial T1 post contrast
5mm contiguous slices if possible
Use the same machine for all timepoints
PET/CT
Not required, but may be useful for assessment of new lesions on
future timepoints (see page 18)
CT portion of PET/CT is usually of lower quality, and should not be used
instead of dedicated diagnostic CT. If the CT is of high quality, with oral and
IV contrast, use with caution. Additional information from PET may bias CT
assessment.
Use the same machine for all timepoints
Calipers Hard to use reproducibly
Include ruler in photograph for skin lesions
Chest x-ray (CXR) Use CT instead (if possible)
Ultrasound Not reproducible
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Measurable Lesions
Tumor 10 mm in longest diameter (LD) on an axial image on CT or MRI
with 5 mm reconstruction interval
If slice thickness >5 mm, LD must be at least 2 times the thickness
Tumor 20 mm LD by chest x-ray (if clearly defined & surrounded by
aerated lung); CT is preferred (even without contrast)
Tumor 10 mm LD on clinical evaluation (photo) with electronic calipers;
skin photos should include ruler
Lesions which cannot be accurately measured with calipers should be
recorded as non-measurable
(CT
Lymph nodes 15 mm in short axis on CT
slice thickness no more than 5 mm)
Ultrasound cannot be used to measure lesions
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Non-Measurable Lesions
All other definite tumor lesions
Masses <10 mm
Lymph nodes 10-14 mm in short axis
Leptomeningeal disease
Ascites, pleural or pericardial effusion
Inflammatory breast disease
Lymphangitic involvement of skin or lung
Abdominal masses or organomegaly identified by physical exam which
cannot be measured by reproducible imaging techniques
Benign findings are NEVER included. Also, do not include equivocal (cannot
exclude) findings
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Special Lesion Types
Bone Lesions
NMBS, PET scans & plain films can be used to confirm the presence or
disappearance of bone lesions, but NOT for measurement
Bone lesions with identifiable soft tissue components seen on CT or MR
can be measurable if the soft tissue component meets the definition above
Blastic bone lesions are unmeasurable
Cystic Lesions
Simple cysts are not included as lesions
Cystic metastases may be selected, but prefer to use non-cystic lesions
as target
Clarify with sponsor as to their acceptability before study start
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Baseline Lesion Burden
Lesions
Measurable Non-measurable
Measurable
lesions not
selected
as target
Target Non-target
Followed quantitatively Followed qualitatively
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Target Lesions
Choose up to 5 lesions
Up to 2 per organ
Add up longest diameters (LD) of non-nodal lesions (axial plane)
Add short axis diameters of nodes
This is the sum of the longest diameters (SLD)
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Baseline Documentation
Only patients with measurable disease at baseline should be included in
protocols where objective tumor response is the primary endpoint.
Target Lesions
A maximum of five (5) target lesions in total (up to two (2) per organ)
Select largest reproducibly measurable lesions
If the largest lesion cannot be measured reproducibly, select the
next largest lesion which can be
Non-Target Lesions
It is possible to record multiple non-target lesions involving the same
organ as a single item on the eCRF (e.g. multiple enlarged pelvic lymph
nodes or multiple liver metastases)
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Lesions with Prior Local Treatment
Lesions in previously irradiated areas (or areas treated with local therapy)
should not be selected as target lesions, unless there has been
demonstrated progression in the lesion
Conditions in which these lesions would be considered target lesions
should be defined in study protocols
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Evaluating Response at Each Timepoint
Measure previously chosen target lesions
Even if they are no longer the largest
Evaluate all previously identified non-target lesions
Look for new definite cancer lesions
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Target Lesion Evaluation
Measure LD (axial plane) for each target lesion
Measure short axis for target lymph nodes
Add these measurements to get the SLD
IfIf too small to measure, a default value of 5 mm is assigned.
the lesion disappears completely, the measurement is
recorded as 0 mm.
Splitting or coalescent lesions
If a target lesion fragments into multiple smaller lesions, the LDs of
all fragmented portions are added to the sum
If target lesions coalesce, the LD of the resulting coalescent lesion is
added to the sum
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Target Lesion Evaluation
Response Definition
Complete Disappearance of all extranodal target lesions. All pathological lymph
Response (CR) nodes must have decreased to <10 mm in short axis.
Partial At least a 30% decrease in the SLD of target lesions, taking as
Response (PR) reference the baseline sum diameters
Progressive SLD increased by at least 20% from the smallest value on study
Disease (PD) (including baseline, if that is the smallest)
The SLD must also demonstrate an absolute increase of at least 5 mm.
(Two lesions increasing from 2 mm to 3 mm, for example, does not
qualify)
Stable Disease Neither sufficient shrinkage to qualify for PR nor sufficient increase
(SD) to qualify for PD
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Non-Target Lesion Evaluation
Response Definition
Complete Disappearance of all extranodal non-target lesions
Response (CR) All lymph nodes must be non-pathological in size (<10 mm short axis).
Normalization of tumor marker level
Non CR/Non PD Persistence of one or more non-target lesion(s) and/or maintenance of
tumor marker level above the normal limits
Progressive Unequivocal progression of existing non-target lesions. (Subjective
Disease (PD) judgement by experienced reader)
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New Lesions
Should be unequivocal and not attributable to differences in scanning
technique or findings which may not be a tumor
Does not have to meet criteria to be measurable
If a new lesion is equivocal, continue to next timepoint. If confirmed then,
PD is assessed at the date when the lesion was first seen.
Lesions identified in anatomic locations not scanned at baseline are
considered new
New lesions on US should be confirmed on CT/MRI
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FDG-PET
New lesions can be assessed using FDG-PET
A positive FDG-PET scan lesion means one with uptake greater than
twice that of the surrounding tissue on the attenuation corrected image
(-) PET at baseline and (+) PET at follow-up:
Progressive Disease (PD) based on a new lesion
No PET at baseline and (+) PET at follow-up: PD if the new lesion is
confirmed on CT. If a subsequent CT confirms the new lesion, the date
of PD is the date of the initial PET scan.
No PET at baseline and (+) PET at follow-up corresponding to a
pre-existing lesion on CT that is not progressing is not PD
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Missing Assessments and Non-evaluable Designation
If all lesions cannot be evaluated due to missing data or poor image quality the
patient is not evaluable (NE) at that time point
If only a subset of lesions can be evaluated at an assessment, the visit is also
considered NE, unless a convincing argument can be made that the contribution of
the individual missing lesion(s) would not change the assigned time point response
E.g. PD based on other findings
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Recurrence of Lesions
For a patient with Stable Disease (SD)/Partial Response (PR), a lesion which
disappears and then reappears will continue to be measured and added to the sum
Response will depend on the status of the other lesions
For a patient with Complete Response (CR), reappearance of a lesion would be
considered Progressive Disease (PD)
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Evaluation of Overall Timepoint Response for Patients with
Measurable Disease at Baseline
Non-Target Overall
Target Lesions New Lesions
Lesions Response
CR CR No CR
CR Non-CR/Non-PD No PR
CR NE No PR
PR Non-PD or NE No PR
SD Non-PD or NE No SD
Not all evaluated Non-PD No NE
PD Any Yes or No PD
Any PD Yes or No PD
Any Any Yes PD
CR = Complete Response, PR = Partial Response, SD = Stable Disease,
PD = Progressive Disease, NE = Not Evaluable
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Evaluation of Overall Timepoint Response for Patients without
Measurable Disease at Baseline
Overall
Non-Target New Response
CR No CR
Non-CR/Non-PD No Non-CR/Non-PD
Not all evaluated No NE
Unequivocal Progression Yes or No PD
Any Yes PD
CR = Complete Response,
PD = Progressive Disease, NE = Not Evaluable
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Confirmation
Confirmation of Partial Response (PR)/Complete Response (CR) is only required
for non-randomized trials where response is the primary endpoint
In these trials, subsequent confirmation of PR with one interim time point of
Stable Disease (SD) is acceptable
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What Has Changed: RECIST 1.0 RECIST 1.1
RECIST 1.0 RECIST 1.1
10 Targets 5 Targets
Tumor Burden
(5 per organ) (2 per organ)
Measure like any Measure short axis
Lymph Nodes other lesion Defined normal size
20% increase in 20% increase in SLD
PD Definition
SLD 5 mm absolute increase
More details
Non-measurable PD Unequivocal
and examples
Required in non-randomized
Required for
Confirmation trial with response
PR and CR as 1 endpoint
New Lesions Section on FDG-PET
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Modifications and Variants
RECIST is not set in stone
Modifications for specific disease processes have been documented
Modifications may be made to meet the needs of individual trials
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References
Print Version:
Response assessment in solid tumours (RECIST): Version 1.1 and Supporting Papers.
European Journal of Cancer, Volume 45, Issue 2 Jan. 2009: 225-310. Print.
Online Version: http://www.eortc.be/Recist/Default.htm
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