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New response evaluation criteriain solid tumours:
Revised RECIST guideline
(version 1.1)
EUROPEAN JOURNAL OF CANCER 45(200
E.A. Eisenhauera,*, P. Therasseb,
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Purpose of this guideline
Standard approach objectiveassessment
of change in tumour size for use in adult a
nd paediatric cancer
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Purpose of this guideline
This guideline is not intended for use for studies of
malignant lymphoma since international guidelinesfor response assessment in lymphoma are publish
ed separately
Applied in malignant brain tumour studies, there
are also separate criteria published for response a
ssessment in that setting
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General concept of guideline
Base line assessment
Time point response
Best over all response
(Phase II trial - Phase III trial)
- Target lesion (measurable)
- Non target lesion.
(measurable+Non measurable lesion)
-Assessment changed of
Target lesion and Non target
lesion
- Looking for New lesion
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How to set target lesion
Lesion within CT
Measurable
Non-measurable
Target lesion
Non- target lesion
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Measurable lesion Accurately measured in at least one dimension
LLongest diameterong
est diameterminimum size of:
10 mm by CT scan (slice thickness < 5 mm) If slice thickness >5 mm, the lesion should be larger than
x2 of slice thickness.
10 mm caliper measurement by clinical exam
20 mm by chest X-ray.
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Measurable lesion
Malignant lymph nodes: To be considered
pathologically enlarged and measurable, alymph node must be >15mm in short axis
when assessed by CT scan
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Lymph node measurement
1 cm 1.5 cm
Short axis
size
Non specific node Pathological node
MeasurableNon-measurable
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Non-measurable
All other lesions, including small lesions
Small lesion.
Longest diameter 10 to
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Non-measurable
Leptomeningeal disease,
Ascites,
Pleural or pericardial effusion, Inflammatory breast disease,
Lymphangitic
Involvement of skin or lung,
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Special consideration
Bone lesion
Cystic lesion
Lesions with prior local treatment
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Bone lesions
Bone scan, PET scan or plain films are not
adequate
Identifiable soft tissue components, that
can be evaluated by cross sectional imagi
ng techniques such as CTor MRI.
Blastic bone lesions are non-measurable.
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Cystic lesions
Simple cysts should not be considered
Cystic metastases > considered asmeasurable lesions,
If noncystic lesions are present in the
same patient, these are preferred for selection as target lesions.
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Lesions with prior
local treatment
Previously irradiated area and loco-
regional therapy, are usually not considere
d measurable.
Unless there has been demonstrated
progression in the lesion.
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General concept of guideline
Base line assessment
Time point response
Best over all response
(Phase II trial - Phase III trial)
- Target lesion (measurable)
- Non target lesion.
(measurable+Non measurable lesion)
-Assessment changed of
Target lesion and Non target
lesion
- Looking for New lesion
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Target lesion
Measurable lesion
Maximum of 5 lesions totallyMaximum of 2 lesions per organ
Select on the basis of their size(lesions with the longest diameter)
Reproducible lesion ***
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Target lesion
Lymph nodes
short axis of >= 15 mm by CT scan
All other pathological nodes (those withshort axis >= 10 mm but < 15 mm) should
be considered non-target lesions
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Lymph node measurement
1 cm 1.5 cm
Short axis
size
Non specific node Pathological node
Target lesionNon-targetlesion
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Non-target lesion
All other lesion(or site of disease)
Include pathological lymph node.
Multiple involvement of same organ. Follow up as
Present
Absent Unequivocal progression
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General concept of guideline
Base line assessment
Time point response
Best over all response
(Phase II trial - Phase III trial)
- Target lesion (measurable)
- Non target lesion.
(measurable+Non measurable lesion)
-Assessment changed of
Target lesion and Non target
lesion
- Looking for New lesion
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Concept of assessment
Assessment of
target lesion
Assessment of
non target lesion
New
lesion
Over all
response
Complete response
Partial response
Stable disease
Progressive disease
A t f t t
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Assessment of target
lesion
A sum of the diameters for all target
lesions
Longest for non-nodal lesions,
Short axis for nodal lesions
Re-evaluate when F/U
Response criteria when follow up
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Response criteria
Complete response (CR)
Partial response (PR)
Progressive disease (PD) Stable disease (SD)
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Response criteria
Complete Response(CR):
Disappearance of all target lesions.
All pathological lymph nodes
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Response criteria
Partial Response (PR):
At least a 30%30% decrease in the sum of
diameters of target lesions, Reference the baseline sum diameters
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Response criteria
Progressive disease (PD)
At least a 20%20% increase in the sum of
diameters of target lesions, taking as Reference the smallest sum on study
Absolute increase of at least 5 mm.
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Response criteria
Stable Disease (SD):
Neither sufficient shrinkage to qualify for
PR nor sufficient increase to qualify for PD
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Conclusion of response criteria
-30%
+20%
Baseline sum or
smallest sum
Stable disease
Partial response
Complete response
Progressive disease
Smallest sum
Baseline sum
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Special note
Sum of lesions may not be zero
Even if complete response criteria are
met, since a normal lymph node is defined
as having a short axis of
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Special note
If the lesion is believed to be present and
is faintly seen but too small to measure, a
default value of
5mm should be assigned
But if lesion likely disappeared record
volume as 0 mm
Non target lesion
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Non target lesion
assessment
Complete Response (CR)
Progressive Disease (PD)
Non-CR/Non-PD
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Non target lesion assessment
Complete Response (CR):
Disappearance of all non-target lesions
and normalisation of tumour marker level.
All lymph nodes must be non-pathological
in size
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Non target lesion assessment
Progressive Disease (PD):
Unequivocal progression of existing non-
target lesions.
The appearance of one or more new
lesions is also considered progression.
Non target lesion
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Non target lesion
assessment
Unequivocal
progression
overall worsening of
disease
Modest increase
of one lesion
Non target lesion
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Non target lesion
assessment
Non-CR/Non-PD:
Persistence of one or more non-target
lesion(s) and/or maintenance of tumour m
arker level above the normal limits.
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Unequivocal progression
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Unequivocal progression
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New lesion
New lesion = Progressive disease
If equivocal >> Follow up
But if F/U confirm, the progression shouldbe declare the date at first sight
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Concept of assessment
Assessment of
target lesion
Assessment of
non target lesion
New lesion
Overall
response
> Complete response
> Partial response
> Stable disease
> Progressive disease
> Complete response
> Non CR/ Non PD
> Progressive disease
> Not present
> Present
Overall
assessment
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Concept of assessment
Assessment of
non target lesion
New lesion
Over all
response
> Complete response
> Non CR/ Non PD
> Progressive disease
> Not present
> Present
Over all
assessment
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Conclusion Diagram
Base line assessment
Time point response
>>Target lesion >> measurable lesion
>>Non-target lesion >> other measurable + all non measureable
Re evaluate target lesion
Re-evaluate non target lesion
Looking for new lesion
Assessment
Follow up after treatment
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Summary major change RECIST 1.0
10 lesion(5per organ)
Not mention lymphnode
PD 20% increase over
smallest sum or new
lesion
RECIST 1.1
5 lesion(2per organ)
CT: short axis
>=15mm = TG >=10,
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Summary major change RECIST 1.0
CR not mention lymph
node
RECIST 1.1
CR lymph node must
be shorter than 10mm
short axis
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