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Response Evaluation Criteria in Solid Tumors
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o RECIST 1.1 Rules & Definitions o RECIST Resources
o Protocol, Forms o Presentation slides o Example Case
o CT Scans, Forms o Background Article o Certificate
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o Introduction and definitions o Resources o Baseline Reporting o Follow-up Reporting o Multi-step studies o Special Circumstances o Wrap up
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ESPONSE
VALUATION
RITERIA
N
OLID
UMORS
RECIST- the criteria used to assess impact of a treatment on disease
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RECIST 1.0 vs. RECIST 1.1
http://www.ecog.org/ecoginst/Recist.html
For RECIST 1.0 criteria visit:
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Disease Definitions Target
Non-target
Response Definitions Complete Response
Partial Response
Progressive Disease
Stable Disease
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Measurable lesions
There are different rules for nodal
target lesions and non-nodal target
lesions.
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Non-nodal target lesions must be:
> 10 mm long axis when evaluated with CT Scan
> 20 mm long axis when evaluated with Chest X-ray
> 10 mm long axis with calipers
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Lymph Nodes:
> 15 mm short axis
for target
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Pathologic lesions too small to be considered target lesions
Lesions not qualifying as target lesions due to restrictions on the
number of target lesions from a single site or total number of target
lesions
Truly non-measurable lesions
Bone lesions
Pleural\pericardial effusion and ascites
Inflammatory breast disease
Lymphangitis cutis/pulmonis
Cystic lesions
Leptomeningeal disease
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Disappearance of all non-nodal target lesions
Reduction in short axis of all nodal target and nodal
non-target lesions to < 10mm
Disappearance of all non-nodal non-target lesions
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A 30% decrease in the Sum of Axes of Target Lesions
(SATL) when compared to the baseline sum
AND
A response of non-PD in non-target lesions
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A 20% increase in the (SATL) when compared to the
smallest SATL ever reported
AND
A > 5mm increase over that SATL
And/Or
Presence of new lesions*
* Specific requirements discussed later
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Criteria for CR,PR or PD are not met
Section 6.0 of the protocol defines the minimum time
frame required between the start of treatment and
follow-up scan for SD to be reported
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Disease Definitions
Target Lesions
• Nodal vs. non-nodal
Non-target Lesions
Response Definitions
Complete Response
Partial Response
Progressive Disease
Stable Disease
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Protocol Section 3.0, 6.0 and 7.0
Forms Packet Forms Submission Schedule
RECIST 1.1 Measurement Form
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Section 3.0
Section 6.0
Section 7.0
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Patient must have measurable or non-measureable
disease.
Baseline measurement and evaluation of all sites of
disease must be obtained < 4 weeks prior to
registration.
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Target lesion restrictions
2 target lesions per organ
5 target lesions in total
Lesions with longest axes and are suitable for
repeated measurements
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Stable disease minimum time
frame
6 weeks (42 days) from study
entry
Note: Be sure you know
whether the time frame start
from Baseline scans or Study
entry (registration)
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Forms Submission
Schedule
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Used when reviewing imaging studies to ensure target and non-target
lesions are followed consistently & to determine response
http://www.ecog.org/ecoginst/tools/RECIST_meas_form1_1.pdf
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The Purpose
Baseline Reminders
Determining what to report
How to report it
Cross checking forms
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Determine patient’s eligibility
Be sure all sites of disease are captured
Ensure follow-up will be done
consistently
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ALL sites of disease MUST be reported
(including suspicious sites)
Lesions must be scanned within 4 weeks
of registration
Check your protocol for acceptable
methods of evaluation
Lesions must be followed with the same
method of evaluation used at baseline
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E5508 S, J 1 2 3 4 5 Dr. Example
RUL lung #1 LLL lung
Pleural Eff
01/25/2012
54mm 25mm 19mm 16mm
01/25/2012
RUL lung #2
PTrach node 18mm 17mm
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1 2 3 4 5 LABEL 1
x
2
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1 R upper lobe lung #1 0 9 0 3 0 1 2 5 2 0 1 2 5 4
7 3
2 L lower lobe lung 0 9 0 3 0 1 2 5 2 0 1 2 1 9
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73 + 17 = 90mm
3 Paratracheal lymph node 1 0 0 3 0 1 2 5 2 0 1 2 1 7
1 7
9 0
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R upper lobe lung #2 0 9 0 3 Pleural Effusion 0 4 0 3 3
0 1 2 5 2 0 1 2
0 1 2 5 2 0 1 2
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1 R upper lobe lung #1
0 9 0 3 0 1 2 5 2 0 1 2 5 4
2 L lower lobe lung 0 9 0 3 0 1 2 5 2 0 1 2 1 9
3 Paratracheal lymph node 1 0 0 3 0 1 2 5 2 0 1 2 1 7
R upper lobe lung #2 0 9 0 3 Pleural Effusion 0 4 0 3 3
0 1 2 5 2 0 1 2
0 1 2 5 2 0 1 2
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0 2
0 2
0 1
0 2
0 2
0 1
0 1
0 1
0 1
0 1
0 1
0 1
0 2 Pleural effusion
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pt # 12345 S, J reg date: 02/01/2012
Step 1 Baseline 01/25/2012
SATL: 90mm
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pt # 12345 S, J reg date: 02/01/2012
Step 1 Baseline 01/25/2012
SATL: 90mm
SATL X 0.7 =
70% of SATL PR < 63.0mm
PD > 108.0mm 90mm X 0.7 = 63.0mm
SATL X 1.2 =
120% of SATL (20% increase over SATL)
90mm X 1.2 = 108.0mm
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pt # 12345 S, J reg date: 02/01/2012
Step 1 Baseline 01/25/2012
63.0mm
108.0mm
00 mm
SATL: 90mm PR < 63.0mm
PD > 108.0mm
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The Purpose
Follow-up Reminders
How to determine overall response
Reporting follow-up scans
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Step 1 Baseline
Scan
St 1 Reg
Step 1, Cycle 2 scan
Step 1, Cycle 4
scan
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Overall Response
Target Lesions
Non-target Lesions
New Lesions
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The lesions must be reported consistently
Same order, number, name and site code
The method of evaluation must be the
same as Baseline
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Stable disease minimum time frame must
be met
St 1 Reg
Step 1, Cycle 2 scan 1
2
3
4
5
6
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Are confirmation scans required?
E5508 = No confirmation scans
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Progression requires the patient to come
off study
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Progression exceptions and notes
PD in Effusion/Ascites
Positive cytology must be
obtained
PD in Non-targets only
Must document that the
progression represents the
patients overall disease
status change
PD in new Lymph
Node lesions
Subclinical LNs present
at baseline must
increase to > 15mm or
have pathological
confirmation of
disease in order to be
considered new lesions
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Step 1 Baseline
Scan
St 1 Reg
Step 1, Cycle 2 scan
Step 1, Cycle 4
scan
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E5508 S, J 1 2 3 4 5 Dr. Example
RUL lung #1 LLL lung
Pleural Eff
01/25/2012
54mm 25mm 19mm 16mm
01/25/2012
RUL lung #2
PTrach node 18mm 17mm
03/15/2012
49mm 19mm 17mm 13mm
03/15/2012
17mm 16mm
Stable Stable
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1 2 34 5 LABEL
1
x
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1 R upper lobe lung #1 0 9 0 3 0 3 1 5 2 0 1 2 4 9
6 6
2 L lower lobe lung 0 9 0 3 0 3 1 5 2 0 1 2 1 7
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66 + 16 = 82mm
3 Paratracheal lymph node 1 0 0 3 0 3 1 5 2 0 1 2 1 6
1 6
8 2
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R upper lobe lung #2 0 9 0 3 Pleural Effusion 0 4 0 3 3
0 3 1 5 2 0 1 2
0 3 1 5 2 0 1 2
2
2
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pt # 12345 S, J reg date: 02/01/2012
Step 1 Baseline 01/25/2012
Partial Response is a 30% decrease from the Baseline SATL Progression is a 20% increase from the smallest SATL ever reported
Step 1, Cycle 2 03/15/2012
SATL: 82mm
SATL: 90mm PR < 63.0mm
PD > 108.0mm
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pt # 12345 S, J reg date: 02/01/2012
Step 1 Baseline 01/25/2012
Step 1, Cycle 2 03/15/2012
SATL: 82mm
SATL: 90mm PR < 63.0mm
PD > 108.0mm
SATL X 0.7 =
70% of SATL
90mm X 0.7 = 63.0mm
SATL X 1.2 =
120% of SATL (20% increase over SATL)
90mm X 1.2 = 108.0mm
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63.0mm
108.0mm
00 mm
pt # 12345 S, J reg date: 02/01/2012
Step 1 Baseline 01/25/2012
Step 1, Cycle 2 03/15/2012
SATL: 82mm
SATL: 90mm PR < 63.0mm
PD > 108.0mm
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Overall Response
Target Lesions
Non-target Lesions
New Lesions
sd
non no
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0 3
0 1
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Partial Response is a 30% decrease from the Baseline SATL Progression is a 20% increase from the smallest SATL ever reported
pt # 12345 S, J reg date: 02/01/2012
Step 1 Baseline 01/25/2012
Step 1, Cycle 2 03/15/2012
SATL: 82 mm Stable Disease
BASELINE: 90mm Step1/Cycle2: 82mm
PR < 63.0mm
PD > 108.0mm SATL: 90mm
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pt # 12345 S, J reg date: 02/01/2012
Step 1 Baseline 01/25/2012
Step 1, Cycle 2 03/15/2012
SATL: 82 mm Stable Disease
PR < 63.0mm
PD > 98.4mm
PR < 63.0mm
PD > 108.0mm
SATL X 1.2 =
120% of SATL (20% increase over SATL)
82mm X 1.2 = 98.4mm
SATL: 90mm
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pt # 12345 S, J reg date: 02/01/2012
Step 1 Baseline 01/25/2012
Step 1, Cycle 2 03/15/2012
SATL: 82 mm Stable Disease
PR < 63.0mm
PD > 98.4mm
63.0mm
98.4mm
00 mm
SATL: 90mm PR < 63.0mm
PD > 108.0mm
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Step 1 Baseline
Scan
St 1 Reg
Step 1, Cycle 2 scan
Step 1, Cycle 4
scan
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E5508 S, J 1 2 3 4 5 Dr. Example
RUL lung #1 LLL lung
Pleural Eff
01/25/2012
54mm 25mm 19mm 16mm
01/25/2012
RUL lung #2
PTrach node 18mm 17mm
03/15/2012
49mm 19mm 17mm 13mm
03/15/2012
17mm 16mm
Stable Stable
04/26/2012
34mm 15mm 11mm 9mm
04/26/2012
12mm 11mm
Resolved Stable
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1 2 34 5 LABEL
1
x
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1 R upper lobe lung #1 0 9 0 3 0 4 2 6 2 0 1 2 3 4
4 5
2 L lower lobe lung 0 9 0 3 0 4 2 6 2 0 1 2 1 1
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1 0 0 3 0 3 1 5 2 0 1 2 1 1
45 + 11 = 56mm
5 6
3 Paratracheal lymph node
1 1
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R upper lobe lung #2 0 9 0 3 0 4 2 6 2 0 1 2 1 Pleural Effusion 0 4 0 3 0 4 2 6 2 0 1 2 2 3
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pt # 12345 S, J reg date: 02/01/2012
Step 1 Baseline 01/25/2012
Step 1, Cycle 2 03/15/2012
SATL: 82 mm
SATL: 90mm PR < 63.0mm
PD > 108.0mm
Stable Disease
PR < 63.0mm
PD > 98.4mm
63.0mm
98.4mm
00 mm
Step 1, Cycle 4 04/26/2012
SATL: 56 mm
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Overall Response
Target Lesions
Non-target Lesions
New Lesions
pr
non no
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0 2
0 1
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pt # 12345 S, J reg date: 02/01/2012
Step 1 Baseline 01/25/2012
Partial Response
Step 1, Cycle 4 04/26/2012
SATL: 56 mm
Step 1, Cycle 2 03/15/2012
SATL: 82 mm
SATL: 90mm PR < 63.0mm
PD > 108.0mm
Stable Disease
PR < 63.0mm
PD > 98.4mm
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Step 2 Baseline
Step 2 Follow-up
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E5508 S, J 1 2 3 4 5 Dr. Example
RUL lung #1 LLL lung
Pleural Eff
01/25/2012
54mm 25mm 19mm 16mm
01/25/2012
RUL lung #2
PTrach node 18mm 17mm
03/15/2012
49mm 19mm 17mm 13mm
03/15/2012
17mm 16mm
Stable Stable
04/26/2012
34mm 15mm 11mm 9mm
4/26/2012
12mm 11mm
Resolved Stable
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E5508 S, J 1 2 3 4 5 Dr. Example
RUL lung #1 LLL lung
Pleural Eff
PTrach node
04/26/2012
34mm 15mm 11mm 9mm
04/26/2012
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1 R upper lobe lung #1
0 9 0 3 0 4 2 6 2 0 1 2 3 4
4 5
2 L lower lobe lung
0 9 0 3 0 4 2 6 2 0 1 2 1 1
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4 5
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Pleural Effusion 0 4 0 3 0 4 2 6 2 0 1 2 3
Paratracheal node 1 0 0 3 0 4 2 6 2 0 1 2
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1 R upper lobe lung #1
0 9 0 3 0 4 2 6 2 0 1 2 3 4
2 L lower lobe lung
0 9 0 3 0 4 2 6 2 0 1 2 1 1
Pleural Effusion 0 4 0 3 0 4 2 6 2 0 1 2 3 Paratracheal node 1 0 0 3 0 4 2 6 2 0 1 2
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Step 2, Cycle 2 scan
St 2 Reg
Step 1, Cycle 4 scan & Step 2
Baseline
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pt # 12345 S, J reg date: 04/27/2012
Step 2 Baseline 04/26/2012
SATL: 45mm
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pt # 12345 S, J reg date: 04/27/2012
Step 2 Baseline 04/26/2012
SATL: 45mm PR < 31.5mm
PD > 54.0mm
SATL X 0.7 =
70% of SATL
45mm X 0.7 = 31.5mm
SATL X 1.2 =
120% of SATL (20% increase over SATL)
45mm X 1.2 = 54.0mm
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31.5mm
54mm
00 mm
pt # 12345 S, J reg date: 04/27/2012
Step 2 Baseline 04/26/2012
SATL: 45mm PR < 31.5mm
PD > 54.0mm
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Step 2, Cycle 2 scan
St 2 Reg
Step 1, Cycle 4 scan & Step 2
Baseline
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E5508 S, J 1 2 3 4 5 Dr. Example
RUL lung #1 LLL lung
Pleural Eff
PTrach node
04/26/2012
34mm 15mm 11mm 9mm
04/26/2012
06/21/2012
06/21/2012
37mm 19mm 13mm 12mm
Stable Stable
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LABEL
x
1 2 34 5
1
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1 R upper lobe lung #1
0 9 0 3 0 6 2 1 2 0 1 2 3 7
5 0
2 L lower lobe lung
0 9 0 3 0 6 2 1 2 0 1 2 1 3
5 0
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Paratracheal Node 1 0 0 3 0 6 2 1 2 0 1 2 2
3 Pleural Effusion 0 4 0 3 0 6 2 1 2 0 1 2 2
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Right upper lobe lung 0 9 0 3 0 6 2 1 2 0 1 2
2
Right lower lobe lung 0 9 0 3 0 6 2 1 2 0 1 2
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31.5mm
54.0mm
00 mm
pt # 12345 S, J reg date: 04/27/2012
Step 2 Baseline 04/26/2012
Step 2, Cycle 2 06/21/2012
SATL: 50mm
SATL: 45mm PR < 31.5mm
PD > 54.0mm
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Overall Response
Target Lesions
Non-target Lesions
New Lesions
sd
non yes
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0 4
0 2
0 6 2 1 2 0 1 2
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All lesions were not evaluated
Minimum SD time was not met
Patient had a resection
Two lesions merged into one
One lesion split
Lesion is too small to measure
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◦ If SATL of evaluated lesions shows > 20% increase in smallest SATL reported since baseline
Provide the SATL on the form
Target lesion response: PD
Overall response: PD
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Overall Response: PD
PD > 75.6
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If SATL of evaluated lesions shows < 20% increase in smallest SATL reported since baseline
◦ Do not report SATL on the form ◦ Overall response: -1 = Insufficient
Unless PD in non-target lesions or appearance of new lesions is reported then code PD
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Overall Response: -1 = Insufficient Evaluation
PD > 75.6
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If subject does not have a PR, CR or PD, be sure minimal timeline is met (section 6.0) before coding SD Section 6.0 stated “…6 weeks” If interval not met. This should be coded as -1
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Continue to submit Follow-up RECIST 1.1 forms
Resected target lesion should be reported as 0 mm at each cycle
Resected non-target lesions should have a follow-up status of [1] = CR at each cycle
Continue to code overall response until PD Be sure to add comment
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Continue to report all target lesions in the same order as reported at baseline—even if merged.
Find longest/shortest axis of merged lesion; divide measurement by # of original lesions
Report this calculation as the measurement for each original lesion
Be sure to add comment
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Example: Cycle 2: TL #1: 30 mm TL #2: 20 mm Cycle 4: These lesions have merged to one lesion
measuring 60 mm 60 / 2 (# of original lesions) = 30 mm On the form report: TL#1: 30 mm TL #2: 30 mm
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Continue to report the original target lesion as it was reported at baseline.
◦ Do not report them separately or as new lesions
Calculate the sum of the longest/shortest axes of both lesions and report this sum as the measurement for the original lesion.
Be sure to add comment
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Example: Cycle 2: TL #1: 50 mm Cycle 4: This lesion has split into two lesions, one
measuring 20 mm and the other 10 mm 20 + 10 = 30 mm On the form report: TL#1: 30 mm
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If a lesion becomes too small to measure but has not disappeared, code it as 1 mm.
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These 2 lesions merged
All lesions were not evaluated!
But the minimum time requirement for SD was not met!
What if the patient had a resection?
This lesion split into two! The lesion is too
small to measure
Common “special circumstances”
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Know the protocol requirement • Measurable vs. non-measurable • Assessment requirements
• Baseline • During protocol therapy
• Stable disease timeline
Use worksheets!! Work with the MD!!
RECIST 1.1 REMINDERS
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Follow all lesions consistently • Assess all lesions at each evaluation • Use the same method of evaluation from Baseline to Follow-Up • Record all lesions even if not evaluated
RECIST 1.1 REMINDERS
Call ECOG CC 617-632-3610
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Any Question?!