response evaluation criteria in solid tumors · esponse valuation riteria n olid umors recist- the...

Response Evaluation Criteria in Solid Tumors

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

o Introduction and definitions o Resources o Baseline Reporting o Follow-up Reporting o Multi-step studies o Special Circumstances o Wrap up

ESPONSE

VALUATION

RITERIA

N

OLID

UMORS

RECIST- the criteria used to assess impact of a treatment on disease

RECIST 1.0 vs. RECIST 1.1

http://www.ecog.org/ecoginst/Recist.html

For RECIST 1.0 criteria visit:

Disease Definitions Target

Non-target

Response Definitions Complete Response

Partial Response

Progressive Disease

Stable Disease

Measurable lesions

There are different rules for nodal

target lesions and non-nodal target

lesions.

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

Lymph Nodes:

> 15 mm short axis

for target

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

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

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

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

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

Disease Definitions

Target Lesions

• Nodal vs. non-nodal

Non-target Lesions

Response Definitions

Complete Response

Partial Response

Progressive Disease

Stable Disease

Protocol Section 3.0, 6.0 and 7.0

Forms Packet Forms Submission Schedule

RECIST 1.1 Measurement Form

Section 3.0

Section 6.0

Section 7.0

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.

Target lesion restrictions

2 target lesions per organ

5 target lesions in total

Lesions with longest axes and are suitable for

repeated measurements

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)

Forms Submission

Schedule

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

The Purpose

Baseline Reminders

Determining what to report

How to report it

Cross checking forms

Determine patient’s eligibility

Be sure all sites of disease are captured

Ensure follow-up will be done

consistently

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

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

1 2 3 4 5 LABEL 1

x

2

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

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

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

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



0 1 2 5 2 0 1 2

0 1 2 5 2 0 1 2

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

pt # 12345 S, J reg date: 02/01/2012

Step 1 Baseline 01/25/2012

SATL: 90mm

pt # 12345 S, J reg date: 02/01/2012


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

pt # 12345 S, J reg date: 02/01/2012


63.0mm

108.0mm

00 mm

SATL: 90mm PR < 63.0mm

PD > 108.0mm

The Purpose

Follow-up Reminders

How to determine overall response

Reporting follow-up scans

Step 1 Baseline

Scan

St 1 Reg

Step 1, Cycle 2 scan

Step 1, Cycle 4

scan

Overall Response

Target Lesions

Non-target Lesions

New Lesions

The lesions must be reported consistently

Same order, number, name and site code

The method of evaluation must be the

same as Baseline

Stable disease minimum time frame must

be met

St 1 Reg

Step 1, Cycle 2 scan 1

2

3

4

5

6

Are confirmation scans required?

E5508 = No confirmation scans

Progression requires the patient to come

off study

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

Step 1 Baseline

Scan

St 1 Reg


Step 1, Cycle 4

scan

E5508 S, J 1 2 3 4 5 Dr. Example


Pleural Eff

01/25/2012

54mm 25mm 19mm 16mm

01/25/2012

RUL lung #2


03/15/2012

49mm 19mm 17mm 13mm

03/15/2012

17mm 16mm

Stable Stable

1 2 34 5 LABEL

1

x

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

66 + 16 = 82mm


1 6

8 2


0 3 1 5 2 0 1 2

0 3 1 5 2 0 1 2

2

2

pt # 12345 S, J reg date: 02/01/2012


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


PD > 108.0mm

pt # 12345 S, J reg date: 02/01/2012


Step 1, Cycle 2 03/15/2012

SATL: 82mm


PD > 108.0mm

SATL X 0.7 =

70% of SATL

90mm X 0.7 = 63.0mm

SATL X 1.2 =


90mm X 1.2 = 108.0mm

63.0mm

108.0mm

00 mm

pt # 12345 S, J reg date: 02/01/2012


Step 1, Cycle 2 03/15/2012

SATL: 82mm


PD > 108.0mm

Overall Response

Target Lesions

Non-target Lesions

New Lesions

sd

non no

0 3

0 1

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, Cycle 2 03/15/2012

SATL: 82 mm Stable Disease

BASELINE: 90mm Step1/Cycle2: 82mm

PR < 63.0mm

PD > 108.0mm SATL: 90mm

pt # 12345 S, J reg date: 02/01/2012


Step 1, Cycle 2 03/15/2012


PR < 63.0mm

PD > 98.4mm

PR < 63.0mm

PD > 108.0mm

SATL X 1.2 =


82mm X 1.2 = 98.4mm

SATL: 90mm

pt # 12345 S, J reg date: 02/01/2012


Step 1, Cycle 2 03/15/2012


PR < 63.0mm

PD > 98.4mm

63.0mm

98.4mm

00 mm


PD > 108.0mm

Step 1 Baseline

Scan

St 1 Reg


Step 1, Cycle 4

scan

E5508 S, J 1 2 3 4 5 Dr. Example


Pleural Eff

01/25/2012

54mm 25mm 19mm 16mm

01/25/2012

RUL lung #2


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

1 2 34 5 LABEL

1

x

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

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

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

pt # 12345 S, J reg date: 02/01/2012


Step 1, Cycle 2 03/15/2012

SATL: 82 mm


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

Overall Response

Target Lesions

Non-target Lesions

New Lesions

pr

non no

0 2

0 1

pt # 12345 S, J reg date: 02/01/2012


Partial Response

Step 1, Cycle 4 04/26/2012

SATL: 56 mm

Step 1, Cycle 2 03/15/2012

SATL: 82 mm


PD > 108.0mm

Stable Disease

PR < 63.0mm

PD > 98.4mm

Step 2 Baseline

Step 2 Follow-up

E5508 S, J 1 2 3 4 5 Dr. Example


Pleural Eff

01/25/2012

54mm 25mm 19mm 16mm

01/25/2012

RUL lung #2


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

E5508 S, J 1 2 3 4 5 Dr. Example


Pleural Eff

PTrach node

04/26/2012

34mm 15mm 11mm 9mm

04/26/2012


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

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


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


St 2 Reg

Step 1, Cycle 4 scan & Step 2

Baseline

pt # 12345 S, J reg date: 04/27/2012


SATL: 45mm

pt # 12345 S, J reg date: 04/27/2012



PD > 54.0mm

SATL X 0.7 =

70% of SATL

45mm X 0.7 = 31.5mm

SATL X 1.2 =


45mm X 1.2 = 54.0mm

31.5mm

54mm

00 mm

pt # 12345 S, J reg date: 04/27/2012



PD > 54.0mm


St 2 Reg

Step 1, Cycle 4 scan & Step 2

Baseline

E5508 S, J 1 2 3 4 5 Dr. Example


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

LABEL

x

1 2 34 5

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

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

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

31.5mm

54.0mm

00 mm

pt # 12345 S, J reg date: 04/27/2012


Step 2, Cycle 2 06/21/2012

SATL: 50mm


PD > 54.0mm

Overall Response

Target Lesions

Non-target Lesions

New Lesions

sd

non yes

0 4

0 2

0 6 2 1 2 0 1 2

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

◦ 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

Overall Response: PD

PD > 75.6

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

Overall Response: -1 = Insufficient Evaluation

PD > 75.6

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

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

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

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

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

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

If a lesion becomes too small to measure but has not disappeared, code it as 1 mm.

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”

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

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

Any Question?!

response evaluation criteria in solid tumors · esponse valuation riteria n olid umors recist- the...

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