RESIST Chest ConXP

8/14/2019 RESIST Chest ConXP

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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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Time point response








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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Time point response








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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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


> Not present

> Present

Overall

assessment


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Assessment of

non target lesion

New lesion

Over all

response

> Complete response

> Non CR/ Non PD


> Not present

> Present

Over all

assessment


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Conclusion Diagram


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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