New response evaluation criteria

in solid tumours:
Revised RECIST guideline
(version 1.1)
E.A. Eisenhauera,*, P. Therasseb,

EUROPEAN JOURNAL OF CANCER 45(2009

Purpose of this guideline

• Standard approach objective assessment

of change in tumour size for use in adult a
nd paediatric cancer
Purpose of this guideline

• This guideline is not intended for use for studies of

malignant lymphoma since international guidelines
for 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
 General concept of guideline
Base line assessment
- Target lesion (measurable)

- Non target lesion.

(measurable+Non measurable lesion)

Time point response -

Assessment changed of
Target lesion and Non target
lesion
- Looking for New lesion
Best over all response
(Phase II trial - Phase III trial)
How to set target lesion

• Lesion within CT

– Measurable
Target lesion

– Non-measurable Non- target lesion

 Measurable lesion
• Accurately measured in at least one dimension
• Longest diameter minimum 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.
Measurable lesion
• Malignant lymph nodes: To be considered
pathologically enlarged and measurable, a
lymph node must be >15mm in short axis
when assessed by CT scan
Lymph node measurement
1 cm 1.5 cm

Short axis
size

Non specific node Pathological node

Non-measurable Measurable
Non-measurable

• All other lesions, including small lesions

• Small lesion.
– Longest diameter<10 mm or
– Pathological lymph nodes with > 10 to <15
mm short axis
Non-measurable

• Leptomeningeal disease,
• Ascites,
• Pleural or pericardial effusion,
• Inflammatory breast disease,
• Lymphangitic
• Involvement of skin or lung,
Special consideration

• Bone lesion
• Cystic lesion
• Lesions with prior local treatment
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.
Cystic lesions

• Simple cysts should not be considered

• Cystic metastases > considered as
measurable lesions,
• If noncystic lesions are present in the
same patient, these are preferred for selec
tion as target lesions.
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.
 General concept of guideline
Base line assessment
- Target lesion (measurable)

- Non target lesion.

(measurable+Non measurable lesion)

Time point response -

Assessment changed of
Target lesion and Non target
lesion
- Looking for New lesion
Best over all response
(Phase II trial - Phase III trial)
Target lesion
• Measurable lesion

Maximum of 5 lesions totally

Maximum of 2 lesions per organ

• Select on the basis of their size

(lesions with the longest diameter)
• Reproducible lesion ***
Target lesion
• Lymph nodes
• short axis of >= 15 mm by CT scan
• All other pathological nodes (those with
short axis >= 10 mm but < 15 mm) should
be considered non-target lesions
Lymph node measurement
1 cm 1.5 cm

Short axis
size

Non specific node Pathological node

Non-target Target lesion

lesion
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
 General concept of guideline
Base line assessment
- Target lesion (measurable)

- Non target lesion.

(measurable+Non measurable lesion)

Time point response -

Assessment changed of
Target lesion and Non target
lesion
- Looking for New lesion
Best over all response
(Phase II trial - Phase III trial)
 Concept of assessment

Assessment of Assessment of New

target lesion non target lesion lesion

•Complete response
Over all
•Partial response
response •Stable disease
•Progressive disease
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
Response criteria
• Complete response (CR)
• Partial response (PR)
• Progressive disease (PD)
• Stable disease (SD)
Response criteria

Complete Response(CR):
• Disappearance of all target lesions.
• All pathological lymph nodes <10 mm.
Response criteria
Partial Response (PR):
• At least a 30% decrease in the sum of
diameters of target lesions,
– Reference the baseline sum diameters
Response criteria
Progressive disease (PD)
• At least a 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.
Response criteria
Stable Disease (SD):
• Neither sufficient shrinkage to qualify for
PR nor sufficient increase to qualify for PD
 Conclusion of response criteria
Progressive disease

+20% Smallest sum

Stable disease
Baseline sum or
smallest sum

-30% Baseline sum

Partial response

Complete response
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 <10mm.
Special note
• If the lesion is believed to be present and
is faintly seen but too small to measure, a
default value of 5 mm should be assigned
• But if lesion likely disappeared record
volume as 0 mm
 Non target lesion
assessment

• Complete Response (CR)

• Progressive Disease (PD)
• Non-CR/Non-PD
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
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
assessment

Unequivocal overall worsening of

progression disease

Modest increase
of one lesion
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.
Unequivocal progression
Unequivocal progression
New lesion
• New lesion = Progressive disease
• If equivocal >> Follow up
• But if F/U confirm, the progression should
be declare the date at first sight
 Concept of assessment
Assessment of Assessment of New lesion
target lesion non target lesion
> Complete response > Complete response > Not present
> Partial response > Non CR/ Non PD > Present
> Stable disease > Progressive disease
> Progressive disease

Overall
assessment

Overall
response
Concept of assessment
Assessment of New lesion
non target lesion
> Complete response > Not present
> Non CR/ Non PD > Present
> Progressive disease

Over all
assessment

Over all
response
Conclusion Diagram

Base line assessment

>>Target lesion >> measurable lesion

>>Non-target lesion >> other measurable + all non measureable

Follow up after treatment

Assessment
Re evaluate target lesion
Re-evaluate non target lesion Time point response
Looking for new lesion
 Summary major change
• RECIST 1.0 • RECIST 1.1
– 10 lesion(5per organ) – 5 lesion(2per organ)
– Not mention lymphnode – CT: short axis
• >=15mm = TG
• >=10,<15 mm= non TG
• <10 mm non-patho
• PD 20% increase over – PD 20% increase over
smallest sum or new smallest sum on study
lesion and at least 5 mm
increase or new
lesion
 Summary major change
• RECIST 1.0 • RECIST 1.1
– CR not mention lymph – CR lymph node must
node be shorter than 10mm
short axis