RECIST Training Workshop Response Evaluation Criteria in Solid Tumors

RECIST Training Workshop Response Evaluation Criteria in Solid Tumors
Hello, my name is Gina Williams, I am a Data Manager with ECOG. I work with Melanoma Trials and Adverse Events. Today, I am going to discuss RECIST with you. This talk will focus on RECIST 1.0, however at the end of the talk I will cover some upcoming changes with the new RECIST 1.1.

RECIST Workshop Folder
Copy of the Presentation RECIST 1.0 and 1.1 Background Articles CRA Manual Example of Section 6.0 of a Protocol Practice Session-Example of Forms Quiz Evaluation of Presentation On your tables you will find a RECIST Workshop Folder which contains the following:

Demystifying RECIST! The first step of this talk is to what I call “demystifying” RECIST. RECIST has this reputation of being very abstract and strange. But I want to show you the tools to understand it fully.

RECIST In fact, the truth is RECIST is not so mysterious but actually a concrete criteria to assess disease response in patients.

Objectives RECIST 1.0 Introduction and Definitions ECOG RECIST tools
Baseline Reporting and Definitions Follow-up Reporting and Definitions Coding conventions for special circumstances Testing your knowledge Coming Soon: Updates on RECIST 1.1 Gina = Say you will cover 1.0 in this presentation, and briefly mention 1.1

RECIST Introduction We are going to start with a quick introduction about what RECIST really is. After each section I will pause to take questions. However, if you think of a question later on, I will be taking questions at the very end of the talk.

RECIST Introduction RECIST – Response Evaluation Criteria in Solid Tumors Criteria used to assess impact of treatment on disease The initials RECIST actually stand for Response Evaluation in Solid Tumors. And they are a guideline or criteria used to asses the impact of treatment on disease. It is important to note that not all ECOG studies use RECIST and be sure to check your protocol.

Definitions The next section we will cover is definitions you will need to know to understand RECIST.

Definitions Target Lesions Nontarget Lesions Responses:
Complete Response Partial Response Progressive Disease Stable Disease We will cover the definition of Target Lesions, Non Target Lesions, The different types of disease response such as -Complete Response -Partial Response -Progressive Disease -Stable Disease

Definition of Target Lesions
Measurable Lesions = Target Lesions Measurements based only on the longest diameter: ≥ 2.0 cm with conventional techniques*** ≥ 1.0 cm with spiral CT *** Conventional Techniques include: Non-spiral CT, MRI, CXR, Ultrasound, Clinical/Physical exam measurements and others *** You may read in the protocol or hear the term Measurable Lesion. A measurable lesion is a Target Lesion. To be considered a Target Lesion, the longest diameter must satisfy either Greater than or equal to 2.0cm using conventional techniques such as MRIs and Ultrasounds or The lesion must measure greater than or equal to 1.0cm with a Spiral CT

Definition of Nontarget Lesions
Non-Measurable Lesions = Nontarget Lesions Small lesions and all other lesions not qualifying as Target Lesions Truly non-measurable lesions: Bone lesions Leptomeningeal disease Pleural/pericardial effusion and Ascites Inflammatory breast disease Lymphangitis cutis/pulmonis Cystic lesions The term Non-measurable lesions means Non Target lesions. Non target lesions are lesions that are too small to be considered a target lesion and all other lesions that do not qualify as target lesions. There are some types of lesions that are always considered non target lesions if even they have a measurement that would qualify them as a target lesion such as Bone Lesions and Pleurel Effusions.

Response Definitions COMPLETE RESPONSE (CR)
Disappearance of all Target Lesions. Sum of Longest Diameters = 0 cm PARTIAL RESPONSE (PR) A ≥ 30% decrease in SLD when compared to Baseline Sum of Longest Diameters There are several different types of responses. The first we will cover is Complete Response meaning a complete disappearance of ALL target lesions. The sum of longest diameters would be reported as 0cm The next definition would be Partial Response. This is when the Sum of the Longest Diameter has a decrease of 30% or more from the Baseline Sum of Longest Diameters

Response Definitions PROGRESSIVE DISEASE (PD)
Must satisfy at least 1 of the following: A ≥ 20% increase in SLD when compared to Smallest Sum of Longest Diameters ever reported Unequivocal progression of Nontarget lesion(s) Presence of new lesions Progressive Disease is met when at least one of the following has been met: A 20% or more increase in the SLD from the smallest SLD ever reported. An Unequivocal Progression of Non-Target Lesions is reported Or the presence of any new lesions A patient can have progressive disease if one, two, or all three of these have occurred

Response Definitions STABLE DISEASE (SD)
Does not meet criteria for CR, PR or PD Refer to section 6.0 of the protocol for minimum week requirement before meeting SD criteria Stable disease occurs when the patient’s disease response has not met the definitions of complete response, partial response, or progressive disease. Be sure to check section 6.0 of the protocol to make sure the minimum week requirement is met for stable disease. I will show you an example of this later on in this talk.

ECOG RECIST Tools We have completed the Definitions section, are there any questions? Next we I will show you some RECIST tools that will help you understand RECIST and help you when reporting RECIST information on your CRFs.

ECOG RECIST Tools ECOG Protocol Guidelines
Section Selection of Patients Section Measurement of Effect Section Study Parameters Forms Packet – Forms Submission Schedule SOPs for coding RECIST I am going to show you the sections of the Protocol that you will need to check prior to filling out forms. These sections will guide you on the RECIST criteria for your particular study. This includes section 3.0 selection of patients or eligibility, section 6.0 Measurement of Effect, Section 7.0 Study Parameters, and Forms Packet and Forms Submission Schedule. You will also want to check the ECOG website for the SOPs which will explain how to code RECIST properly. These can be found at this link on the ECOG website.

ECOG Protocol Guidelines
Section 3.0- Selection of Patients Measurable Disease Requirements “Patients must have measurable disease as defined by RECIST (see section 6).” Timelines will also be stated: most likely within 4-8 weeks of registration. Non-measurable Disease Requirements The first section you want to check in the Protocol is Section 3.0 or Selection of Patients. Here you will find the Measurable Disease or Target Lesion requirements. For example it may state “Patients must have measurable disease as defined by RECIST” Having measureable disease means having at least 1 lesion qualifying as a target lesion. You will also find timelines for baseline measurements in this section. Each protocol is different but it is usually somewhere within 4-8 weeks of registration. Non measureable disease or non target lesion requirements will also be defined in this section

Section 6.0 – Measurement Of Effect Measurable Disease Requirements RECIST Criteria Definition of Stable Disease Non-measurable Disease Requirements You will also want to be sure and check Section 6.0 or Measurement of Effect. Within this section you will find the Measurable Disease and Non Measurable Disease Requirements based on RECIST criteria

RECIST criteria Here is an example of section 6.0. Be sure to pay attention to these sections. You will see here it states measurable disease is defined by at least one measurable lesion. That is, at least one lesions meeting the Target Lesion definition. It will also give you a timeline and as you see here Baseline measurements should be done within 4 weeks of study registration. And you will notice here it states “at baseline, tumor lesions will be characterized as either measurable or non-measurable, meaning that all tumors existing in the patients must be reported. If the lesions do not meet Target Lesions criteria, they are to be reported as non target lesions.

ECOG Protocol Guidelines Stable disease definition
Note: Make sure you know whether the time frame starts from Baseline scans or Study entry (registration) Section 6.0 also includes the definition of stable disease including the minimal timeline which must be met. In this example you can see that in order for the patient to be considered having stable disease, it must be reported 6 weeks from study entry. In this example, the SD minimum interval is 6 weeks from study entry, or registration. However some studies may be x amount of weeks from Baseline scans. So be sure to check your protocol carefully.

Section 7.0 – Study Parameters Outline the frequency of assessments Forms Packet Forms Submission Schedule Within Section 7.0 Study Parameters and the Forms Packet you will find timelines of the frequency of assessments and how often to submit RECIST forms.

Section 7 of Protocol This is an example of Section 7.0 of the protocol You can see on the left hand side it lists “Imaging studies,” meaning assessments. As you can see with the X marked, these should be done at Baseline and then every other cycle.

Forms Submission Schedule In the Forms Submission Schedule you will find a schedule of when the forms should be submitted. So you can see in this case the RECIST forms should be submitted every other cycle such as Cycle 2, 4, 6 etc.

SOPs for Coding RECIST The final tool I’ll show you is the SOPs for coding RECIST. You will find these on the ECOG Website under the RECIST tab

SOPs for Coding RECIST Once you are in the RECIST section of the website you will see SOPs explaining Baseline RECIST Forms as well as Follow Up, Non Target Supplemental and Multi-step Studies. The SOPs are great guidelines to use to help you define and report disease response.

Source Document for RECIST Measurement Form
Also under the RECIST section of our website you will find the Source Documentation for RECIST Measurement Form. This Worksheet is helpful guide for your use only and should not be submitted to ECOG. This will help you keep your RECIST information organized and in one location. As you can see you report the target lesions in the first column, the Baseline date and measurements and then each of the follow up dates and measurements. This will make it easier to compare each assessment and define the patient’s response. Worksheet can be used when reviewing imaging studies to ensure Target and Nontarget lesions are followed consistently and to determine response.

Source Document for RECIST Measurement Form
This worksheet also includes non target lesions. You will want to fill this out just as you did the target lesions so you can compare baseline reports to each assessment. You will also want to have your PI or Radiologist look each assessment over and sign the bottom. Worksheet can be used when reviewing imaging studies to ensure Target and Nontarget lesions are followed consistently and to determine response.

How to translate a radiology report into a measurement!
From Report to RECIST How to translate a radiology report into a measurement! Are there any questions on the RECIST tools I have shown you? Next we will cover How to translate a radiology report to a measurement which you report on the CRFs

From Report to RECIST Use the scan reports
Involve your MD in the process Use a RECIST Measurement worksheet Complete the RECIST Forms In order to translate a scan to a reportable measurement you will want to follow these guidelines: Be sure you use the correct scan reports. Make sure to involve your MD or PI in the process Use that RECIST Measurement Worksheet I just showed you And be sure and complete all necessary RECIST forms

Schedule a MD Review of Scans
Purpose: Determine patient’s eligibility for study prior to registration To capture all sites of disease that will be reported throughout the study Helpful for your MD review: CT report and the CT films Patient’s chart with history and physical Source Document for RECIST Measurement Form Protocol (Section 3.0 and Section 6.0) On-Study Form Baseline Disease Evaluation Form (RECIST) Before filling out the RECIST Forms it’s a good idea to schedule a review with your MD or PI You will want to do this to be sure the patient is eligible for the study before registering them and to be sure you have captured all sites of disease that are to be reported throughout the study. Make sure to bring with you the following items

MD Review of Scans Source Document for RECIST Measurement Form
The MD needs to sign and date the Source Document for RECIST Measurement Form It is important to have a Source Document for RECIST Measurement Form to use as a working document if the scan reports are not clear Include slice numbers or anatomic landmarks The Source Document for RECIST Measurement Form is highly helpful when meeting with you rMD or PI Make sure he or she signs and dates the worksheet This is a working document that will help you keep things clear Also be sure to add any slice numbers or anatomic landmarks that may be included

Baseline Reporting and Definitions
Gina = When beginning this section, tell them to refer to their folder to follow along if they want

Purpose of Baseline Evaluation
Provide a basis of comparison to assess disease response to treatment

Baseline RECIST Form

Definition of Target Lesions
Measurable Lesions = Target Lesions Measurements based only on the longest diameter: ≥ 2.0 cm with conventional techniques*** ≥ 1.0 cm with spiral CT *** Conventional Techniques include: Non-spiral CT, MRI, CXR, Ultrasound, Clinical/Physical exam measurements and others ***

Method of Evaluation Baseline measurement ≤ 4 weeks prior to registration Select the single most reliable Baseline Method of Evaluation Follow-up measurements should be made by the same method of evaluation used at Baseline Occasionally, the method can be different at follow-up, but it’s protocol-specific. In the event that this happens, contact the ECC

Baseline Evaluation – Target Lesions
Identify Target Lesions No more than 5 lesions per organ No more than 10 total Target Lesions Lesions with longest diameter and suitable for repeated measurements Calculate Sum of Longest Diameter (SLD)

Definition of Nontarget Lesions
Non-Measurable Lesions = Nontarget Lesions Small lesions and all other lesions not qualifying as Target Lesions Truly non-measurable lesions: Bone lesions Leptomeningeal disease Pleural/pericardial effusion and Ascites Inflammatory breast disease Lymphangitis cutis/pulmonis Cystic lesions

Bone and Effusion/Ascites
Site codes = 01 [Bone] and 04 [Effusion/Ascites] should always be reported as Nontarget lesions even if reports provide associated measurements (such as for lytic bone lesions)

Baseline RECIST Form Fill in Protocol number, Patient ID and step number Place a label on the form

Baseline RECIST Form Complete ONLY if there are more than 10 Nontarget lesions. Do NOT submit blank forms.

On-Study Form and Baseline RECIST
1 Sites of involvement on the On-Study Form must be reported on the Baseline Disease Evaluation Form (RECIST) 1 1 2 2 Gina = Say that sometimes it will say Metastatic sites or something else. It also might be good to mention that all sites of disease that are present at baseline MUST be reported on the RECIST forms, because I query on that ALL the time 1 1 1 1 2

Follow-up Reporting and Response Criteria
Gina = When beginning this section, tell them to refer to their folder to follow along if they want

Important Tips Each lesion listed at Baseline must be listed on all Follow-up Forms in the same order with the same: Lesion Number Site of Lesion Site Code Method of Evaluation Baseline Longest Diameter of lesion (For Target Lesions)

Response of Target Lesions
Response is based on the “Sum of the Longest Diameters” (SLD) regardless of an increase or decrease in any one site

Calculating Response Baseline RECIST CRF

Calculating Partial Response
Sum x 0.7 = 70% of Sum of the longest diameter 5.9 x 0.7= 4.13 4.1cm OR Sum x 0.3 Sum - 30% = 30% reduction 5.9 x 0.3 = 1.77 = 4.13 4.1cm Gina = Mention that round to the tenths place

Calculating Progressive Disease
Sum x 1.2 = 120% of Sum of the longest diameter (or 20% increase over sum) 5.9 x 1.2 = 7.08 7.1 cm OR Sum x 0.20 Sum + 20% = 20% increase over sum 5.9 x 0.2 = 1.18 = 7.08 7.1cm

Calculating Response Baseline RECIST CRF 5.9 x 0.7= 4.1 PR < 4.1 cm
PD > 7.1 cm

Calculated from Baseline
Follow-up RECIST Form Cycle 02 Follow-up RECIST CRF 5.9 x 0.7= 4.1 PR < 4.1 cm 5.9 x 1.2 = 7.1 PD > 7.1 cm Calculated from Baseline

Follow-up RECIST Form Cycle 02 Follow-up RECIST CRF

Response of Nontarget Lesions
COMPLETE RESPONSE (CR) Disappearance of all Nontarget Lesions INCOMPLETE RESPONSE/STABLE DISEASE (SD) Persistence of 1 or more Nontarget Lesions PROGRESSIVE DISEASE (PD) Unequivocal progression of Nontarget lesions Nontarget Lesions can not have a PR

COMPLETE RESPONSE (CR) Disappearance of all Target Lesions. Sum of Longest Diameters = 0 cm PARTIAL RESPONSE (PR) A ≥ 30% decrease in SLD when compared to Baseline Sum of Longest Diameters

Confirmation of Complete (CR) or Partial (PR) Response
Requires a confirmation assessment no less than 4 weeks after the criteria are first met

PROGRESSIVE DISEASE (PD) A ≥ 20% increase in SLD when compared to Smallest Sum of Longest Diameters ever reported Unequivocal progression of Nontarget lesion(s) Presence of new lesions

Appearance of New Lesions
*Exception* If a New Lesion has a site code of [04] = Effusion/Ascites, a positive cytology must be obtained to constitute Progressive Disease

STABLE DISEASE (SD) Does not meet criteria for CR, PR or PD Refer to section 6.0 of the protocol for minimum week requirement before meeting SD criteria

Follow-up RECIST Form Cycle 02 Follow-up RECIST CRF 5.9 x 0.7= 4.1 PR < 4.1 cm 5.9 x 1.2 = 7.1 PD > 7.1 cm Calculated from Baseline

Determining Response PR PD SD 3.6 4.1 5 6 7.1 SLD (cm) C2 SLD = 3.6 cm

Follow-up RECIST Form Cycle 02 Follow-up RECIST CRF C2 SLD = 3.6 cm 5.9 x 0.7= 4.1 PR < 4.1 cm 5.9 x 1.2 = 7.1 PD > 7.1 cm Calculated from Baseline

Overall Response Overall Response Target Lesions
All targets must be assessed each time to determine response (except if PD criteria have been met) Overall Response Gina = When you talk about how all target lesions must be assessed to determine response, note that not all Nontarget lesions need to be assessed, and even though our 1 Nontarget lesion wasn’t assessed, we can still code the response Nontarget Lesions New Lesions

Determining Overall Response
Target Nontarget New Lesions? Overall Response CR No Non-PD PR SD PD Any Yes or No Yes

Follow-up RECIST Form Page 4

Re-Calculating Progressive Disease
Cycle 02 Follow-up RECIST CRF

Re-calculating Progressive Disease
IMPORTANT PD is calculated from the Smallest Sum of Longest Diameters since Baseline Baseline: SLD = 5.9 cm C2: SLD = 3.6 cm

Sum x 1.2 = 120% of Sum of the longest diameter (or 20% increase over sum) 3.6 x 1.2 = 4.32 4.3 cm OR Sum x 0.20 Sum + 20% = 20% increase over sum 3.6 x 0.2 = 0.72 = 4.32 4.3 cm

Calculated from BL & Cycle 2
Follow-up RECIST Form Cycle 04 Follow-up RECIST CRF 5.9 x 0.7= 4.1 PR < 4.1 cm 3.6 x 1.2 = 4.3 PD > 4.3 cm Calculated from BL & Cycle 2

Follow-up RECIST Form Cycle 04 Follow-up RECIST CRF C4 SLD = 2.0 cm 5.9 x 0.7= 4.1 PR < 4.1 cm 3.6 x 1.2 = 4.3 PD > 4.3 cm Calculated from BL & Cycle 2

Overall Response Overall Response Target Lesions Nontarget Lesions
New Lesions 76

Target Nontarget New Lesions? Overall Response CR No Non-PD PR SD PD Any Yes or No Yes 77

Confirmation of Complete (CR) or Partial (PR) Response
Requires a confirmation assessment no less than 4 weeks after the criteria are first met 78

Follow-up RECIST Form Page 4

Cycle 04 Follow-up RECIST CRF Now, again we need to recalculate for PD, since the SLD has decreased

IMPORTANT PD is calculated from the Smallest Sum of Longest Diameters since Baseline Baseline: SLD = 5.9 cm C2: SLD = 3.6 cm C4: SLD = 2.0 cm Again, an important reminder that PD is calculated from the smallest SLD, and since the cycle 4 SLD decreased to 2.0 cm, we will need to recalculate.

Sum x 1.2 = 120% of Sum of the longest diameter (or 20% increase over sum) 2.0 x 1.2 = 2.4 2.4 cm OR Sum x 0.20 Sum + 20% = 20% increase over sum 2.0 x 0.2 = 0.4 = 2.4 2.4cm Again, like I showed you before, you can either multiply the SLD by 1.2, to get 120% of the SLD, or a 20% increase, and that would give you 2.4 cm. Or you can multiply the SLD by .2, to get 20% of the SLD, and then add it to the SLD, which also gives you 2.4 cm.

Follow-up RECIST Form Cycle 06 Follow-up RECIST CRF So now let’s look at the cycle 6 Follow-up RECSIST form. The SLD is 3.7 for this scan. Below are the calculations that we completed earlier. Remember, the response would be considered PD if the SLD is greater than or equal to 2.4 cm. In this case, the SLD is 3.7 cm, which is, in fact, larger than 2.4 cm. So we just met criteria for PD. 5.9 x 0.7= 4.1 PR < 4.1 cm 2.0 x 1.2 = 2.4 PD > 2.4 cm Calculated from BL & Cycle 4

Follow-up RECIST Form Cycle 06 Follow-up RECIST CRF
Now let’s look further down the form at the Nontarget lesions section. You will notice that the Follow-up Status of Lesion(s) for our only Nontarget lesion is coded as PD. Now it’s important that you note that when PD is coded for a Nontarget lesion, you must explain the unequivocal progression at the bottom of the section. If you look next at the top of the Follow-up status of lesion(s) column, 4=PD has 2 asterisks next to it. At the bottom of this section next to 2 asterisks, it says “Unequivocal progressive disease in nontarget lesions is based on (description required):”, and there’s a line where you should specify the progression. In this case, the explanation is “Reaccumulation ascites – paracentesis 1500 cc + cytology”. So far on the cycle 6 scan, we saw PD in the Target lesions and also PD in the Nontarget lesions.

Now let’s move on to the new lesions section. You will notice that the question “Was the appearance of any new lesions documented” was answered “2=yes”. Below, a liver lesion was reported. Be sure that when you report new lesions, that you provide a site code, a method of evaluation, and a date of evaluation. You should only report a cytology result if the new lesion is a site of effusion or ascites. Since a new lesion was found on this scan, another criterion for PD has been met.

Follow-up RECIST Form Cycle 06 Follow-up RECIST CRF C6 SLD = 3.7 cm So if we move on to the response of target lesions section, we need to report PD. Remember, our SLD on this scan was 3.7 cm, and according to our calculation, if the SLD is 2.4 or higher, than the patient has PD in the Target lesions. So in this section, report PD, and be sure to report a “Progressive Disease Observed Date (Target Lesion)”, which would be the date that the PD scan took place. 5.9 x 0.7= 4.1 PR < 4.1 cm 2.0 x 1.2 = 2.4 PD > 2.4 cm Calculated from BL & Cycle 4

Overall Response Overall Response Target Lesions Nontarget Lesions
Now remember, in order to assess overall response, we must look at the response of the target lesions, the response of nontarget lesions, and whether or not new lesions were found. On this particular scan, all 3 criteria for PD was found: PD was found in Target lesions, since the SLD increased by over 20%; there was unequivocal progression in our Nontarget lesion; and there was a new lesion reported. Nontarget Lesions New Lesions 87

Target Nontarget New Lesions? Overall Response CR No Non-PD PR SD PD Any Yes or No Yes In this situation, the overall response would be considered PD. As you can see from this chart, an overall response of PD would be coded if 1, 2 or all of the 3 criteria for PD were met, so remember that you do not need to satisfy all of the 3 criteria in order to code PD. 88

So if we jump to the Overall response section, we must be sure to report that yes, the response has changed, and the overall response status at this assessment would be 04=PD. Also, make sure that you remember to code the progressive disease observed date, which would be the date that the PD scan took place.

Follow-up RECIST Form Complete this section Add comments as needed
Now before we move on from our example section, I just want to remind you to be sure to fill out the Symptomatic Deterioration section that is found on page 4 of the RECIST form in front of you. This is the section where you would report whether or not the patient had a decline in health that warranted the patient’s removal from treatment. In this situation, PD may not have occurred per RECIST, but the patient’s health has declined so much that the Dr decided to take the patient off treatment anyways. You should only complete this section if the patient’s health is so bad that they cannot continue on treatment. You should not report any AE’s that may have occurred but did not warrant the patient to come off Treatment. Be sure that if you report yes to the question “Is there symptomatic deterioration of the patient’s health status requiring discontinuation of treatment (this reporting period)?”, you should specify the symptomatic deterioration on the lines provided and include a symptomatic deterioration date, which would be the date that the patient’s health status declined so much that it forced the patient to come off treatment. Complete this section Add comments as needed

Reminder: Objective Progressive Disease
ECOG follows all patients until objective progressive disease Remember to submit RECIST forms if Protocol therapy discontinued early Begins a Non-Protocol Therapy regimen Experiences Symptomatic Deterioration OK, so moving on a little bit. I just want to remind you that you need to submit RECIST forms, even if the patient came off treatment, began NPT, or experienced symptomatic deterioration. ECOG follows all patients until they have had objective PD, so be sure that you continue to send these forms to us until the patient has PD per RECIST.

ECC Response Coding Internal Response Coding
Internal worksheet completed by Data Mgt Abstract data from RECIST forms and Treatment Forms Updated on an ongoing basis During treatment Until progression or death At the ECC, we data managers report each patient’s response internally. We have an internal worksheet, called the Internal Response form, where we report all of the important response information for each patient. We obtain this information from treatment and RECIST forms. We continue to update this form until either the patient has PD or the patient passes away. Therefore, it’s important that you’re sending these forms to us until one of these two scenarios occurs.

08 = Unevaluable ECC Response Coding Internal Response Coding
Common Reasons Pt did not start treatment Pt died before first assessment Method of Evaluation changed between Baseline and first Follow-up assessment Minimal time interval (Section 6.0) for stable disease not met on 1st assessment but 2nd assessment reveals PD There are some situations where, internally, we need to code the patient’s response as “08=Unevaluable”. This may occur for several reasons. First, if the patient never started treatment, 08 would be coded. If the patient died before the first follow-up disease assessment was obtained, we would have no response information, so the best overall response would be unevaluable. Also, if the method of evaluation changed between the baseline assessment and the first follow-up assessment, this would be considered unevaluable. For example, if the patient’s baseline scan was a spiral CT, and their first and only follow-up scan was an MRI, his/her overall response would be considered unevaluable. The final example of a reason why a patient’s best overall response would be unevaluable would be if the minimum time interval for SD, as defined in section 6 of the protocol, was not met on the first assessment, and the next assessment showed PD. For example, let’s say the minimum time interval for SD was 6 weeks, and the first scan was done 5 weeks post registration. On this scan, it would appear that the patient had SD, but SD cannot be coded as the response, since the scan was only done 5 weeks post-reg. If the next follow-up scan was done 11 weeks post-reg, and that scan showed PD, the patient’s best overall response would be unevaluable.

Coding Conventions for Special Circumstances
Now the next section I’m going to go over is coding conventions for special circumstances. These are all certain situations that may occur when you are using RECIST to evaluate one of your patient’s disease status, and I’ll show you what to do in these situations.

Coding Conventions for Special Circumstances
What to do if any lesions are not evaluated How to code response if minimum time requirement for SD is not met How to code if: Curative resection occurs Lesions have merged One lesion has split into two Target lesion still present, but too small to measure First, I’ll go over what to do if any lesions are not evaluated, whether it be Target or Nontarget lesions. I will tell you how to report the SLD and how to code response in these situations. Next, I’ll show you how to code response if the minimum time requirement for SD is not met but the patient has satisfied all other SD criteria. Then, I’ll show you how to code lesions if the patient receives a curative resection, 2 or more lesions have merged, one lesions has split into two, or a target lesions is still present, but too small to measure.

How to Report Lesions When They Are Not Evaluated
If one or more Target Lesions are not evaluated during an assessment: Code Method of Evaluation as 08=Not Evaluated and do not provide a Date of Evaluation or Longest Diameter Remember to still provide Baseline Longest Diameter If one or more Nontarget Lesions are not evaluated during an assessment: Code Method of Evaluation as 08=Not Evaluated and do not provide a Date of Evaluation, Follow Up Status, or Cytology Result OK, so first, what to do if a lesions is not evaluated. If one or more target lesions are not evaluated, make sure that you report the method of evaluation as 08=not evaluated. In this situation, the date of evaluation and longest diameter of lesion columns should be left blank, but make sure that you still provide the baseline longest diameter. If one or more nontarget lesions are not evaluated, make sure that you report the method of evaluation as 08=not evaluated. In this situation, the date of evaluation, follow-up status and cytology result should be left blank.

How to Code SLD When One or More Target Lesions Are Not Evaluated
If SLD of evaluated lesions shows > 20% increase in smallest SLD reported since Baseline Provide the SLD on the form If SLD of evaluated lesions shows < 20% increase in smallest SLD reported since Baseline Leave SLD blank Now back to one or more target lesions not being evaluated. How would you report the SLD. So, if the SLD of the evaluated lesions has increased by 20% or more over the smallest SLD ever reported, than you would provide this SLD on the form, since the target lesions showed PD, even without diameter of the unevaluated lesions. If the SLD of the evaluated lesions shows less than a 20% increase over the smallest SLD ever reported, than you would NOT report a SLD. This SLD should be left blank.

How to Code Response When One or More Target Lesions Are Not Evaluated
If SLD has > 20% increase and is reported on the form Target Lesion Response: PD Overall Response: PD If SLD has < 20% increase and is not reported on the form Target Lesion Response: -1 = Insufficient Overall Response: -1 = Insufficient Unless PD in Non Target or appearance of New Lesions is reported; Code as PD In the case where the SLD has increased by 20% or more, the SLD is reported on the form (like I said before), and both the response of target lesions and the overall response would be coded as PD. In the case where the SLD did not increase by 20% or more, the SLD is NOT reported on the form (like I said before), and both the response of target lesions and the overall response would be coded as -1=Insufficient evaluation to determine response. However, make a note that if this situation occurs, but there is PD in the Nontarget lesions or new lesions were found, than the response of target lesions would still be reported as -1=insufficient evaluation to determine response, but the overall response would be coded as PD.

Example of When One or More Target Lesions Are Not Evaluated
PD > 7.1 So here’s an example. In this situation, Target lesion #1 was not evaluated. The SLD of the other 2 evaluated lesions is 2.0 cm. PD is seen if the SLD is 7.1 cm or higher. Since the SLD of the 2 evaluated lesions is only 2.0 cm, and did not meet PD criteria, the SLD of all target lesions on this form should be left blank. The response of target lesions would be -1=insufficient evaluation to determine response, and the overall response would also be -1, unless there was PD in Nontarget lesions or new lesions were found. Response of Target Lesions: -1 = Insufficient Evaluation Overall Response: -1 = Insufficient Evaluation

Example of When One or More Target Lesions Are Not Evaluated
PD > 7.1 In this example, target lesion #1 wasn’t evaluated again. The SLD of the remaining 2 evaluated lesions is 7.7 cm. PD is found if the SLD is greater than or equal to 7.1 cm. Since the SLD of the 2 evaluated lesions would satisfy PD criteria, you would report the SLD of all target lesions, and the response of target lesions and overall response would be coded as PD. Response of Target Lesions: PD Overall Response: PD

SD Minimal Timeline If the Sum of Longest Diameters meets Stable Disease criteria, be sure minimal timeline is met (section 6.0) Section 6.0 stated “***** 6 weeks” If interval not met. This should be coded as -1 OK, next, we are going to talk about what to do if criteria for SD are met, but the minimum time requirement, as specified in section 6 of the protocol, isn’t met. So let’s say that our protocol requires at least 6 weeks. On the first follow-up scan that occurred 5 weeks post registration, let’s say that the target and nontarget lesions remained the same, and there were no new lesions. You would think that you could report SD, yet you cannot. Since the minimum time requirement wasn’t met, you cannot code SD, and you’d have to report “-1=Insufficient evaluation to determine response”.

After a Curative Resection
Continue to submit Follow-up RECIST forms Resected Target Lesion should be reported as 00.0cm at each cycle Resected Nontarget 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 OK, so what do you do if the patient has a curative resection of one of their lesions. You would continue to submit FU RECIST forms as required. If the resected lesion was a Target lesion, report the SLD as 00.0 cm at each cycle. If the resected lesion was a nontarget lesion, you should report a follow-up status of 1=CR at each cycle. You would continue to code the overall response until PD is found. Be sure that if this situation occurs, you explain it in the comments section at the end of each follow-up RECIST form.

Merged Target Lesions Continue to report all target lesions in the same order as reported at Baseline—even if merged. Find Longest Diameter of merged lesion; divide Longest Diameter by # of original lesions Report this calculation as the Longest Diameter for each original lesion Be sure to add comment In the next example, what should you do if one or more target lesions merged. In this case, you would continue to report all target lesions in the same order as they were reported at baseline, using the same site name and site coded, even if the lesions have merged. Next, you would take the longest diameter of the merged lesions. You would divide this longest diameter by the number of original lesions. This calculation would be reported as the longest diameter for each of the original lesions. Be sure that if this situation occurs, you explain it in the comments section at the end of each follow-up RECIST form.

Merged Target Lesions Example: Cycle 2: TL #1: 3.0 cm TL #2: 2.0 cm
These lesions have merged to one lesion measuring 6.0 cm 6.0 / 2 (# of original lesions) = 3.0 cm On the form report: TL#1: 3.0 cm TL #2: 3.0 cm Let’s look at an example. Let’s say that on the cycle 2 scan, target lesion #1 had a diameter of 3.0 cm and target lesion #2 had a diameter of 2.0 cm. In cycle 4, these 2 lesions have merged into 1 lesion. You would find the longest diameter of this merged lesion, which in our situation is 6.0 cm. Then, you would divide 6 by the # of original lesions, which in this example is 2. You would get 3.0 cm. So, on this cycle 4 form, you would still report target lesion #1 and #2 separately, and report their longest diameter of lesions as 3.0 cm.

One Lesion Splitting into two
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 Diameters of both lesions and report this sum as the Longest Diameter of the original lesion. Be sure to add comment Now, I’ll tell you what to do if one lesion has split into 2. In this case, continue to report the original target lesion as it was reported at baseline. Do not report the split lesions separately, and do NOT report in the new lesions section. Find the longest diameter of each of the split lesions, and add those together. Report this sum as the longest diameter of the original lesion. Be sure that if this situation occurs, you explain it in the comments section at the end of each follow-up RECIST form.

One Lesion Splitting into two
Example: Cycle 2: TL #1: 5.0 cm Cycle 4: This lesion has split into two lesions, one measuring 2.0 cm and the other 1.0 cm = 3.0 cm On the form report: TL#1: 3.0 cm So for example, on the cycle 2 RECIST form, target lesion #1 has a diameter of 5.0 cm. On the cycle 4 scan, the lesion split into 2 different lesions, one measuring 2 cm and one measuring 1 cm. What you would do is add these 2 diameters together. On the cycle 4 RECIST form, you would still report target lesion #1 the same was as at baseline, and you would report the longest diameter as 3.0 cm.

Target Lesion Still Present but Too Small to Measure
If a lesion becomes too small to measure but has not disappeared, code the longest diameter as 0.1 cm. In our final example: if a lesion is too small to measure, but hasn’t disappeared, code the longest diameter as .1 cm.

Take a Break! OK, time to take a break

Test your RECIST Strength
QUIZ TIME! While on your break, you should complete the quiz that’s in your binder. When we are done with the break, Julianne will go over the quiz, and then you guys will correct the answers you reported. Whoever gets the best score gets a prize, so let’s see what you guys can do. Test your RECIST Strength Julianne Burns Data Associate Lung Studies

Which of the following are Target Lesions?
RECIST Quiz #1 Which of the following are Target Lesions? Bone lesion Liver lesion measuring 1.9 x 1.5 cm on Spiral CT Lung lesion measuring 1.8 x 1.7 cm on MRI Lymph node measuring 2.1 x 2.3 cm on CT First question: Which of the following are Target Lesions?

Which of the following are Target Lesions?
RECIST Quiz #1 Which of the following are Target Lesions? Bone lesion Liver lesion measuring 1.9 x 1.5 cm on Spiral CT Lung lesion measuring 1.8 x 1.7 cm on MRI Lymph node measuring 2.1 x 2.3 cm on CT Correct, both B and C are target lesions. B is correct because its longest diameter is > or = 1.0 cm when spiral CT was used. D is correct because its longest diameter is > or = 2.0 cm with conventional CT. A is incorrect because it is a truly non-measurable lesion, and thus must always be reported as a Nontarget lesion. C is incorrect because its longest diameter is less than 2 cm using conventional scanning, the MRI.

Which of the following are Nontarget Lesions?
RECIST Quiz #2 Which of the following are Nontarget Lesions? Bone lesion Lung lesion measuring 1.9 x 1.5 cm on Spiral CT Pericardial effusion with no cytology Lymph node measuring 3.7 x 2.3 cm on MRI Next question: Which of the following are Nontarget Lesions?

Which of the following are Nontarget Lesions?
RECIST Quiz #2 Which of the following are Nontarget Lesions? Bone lesion Lung lesion measuring 1.9 x 1.5 cm on Spiral CT Pericardial effusion with no cytology Lymph node measuring 3.7 x 2.3 cm on MRI Correct, A and C. These are both lesions that are considered to be truly non-measurable, and thus would have to be reported as nontarget lesions. B would be considered a Target lesion, since its longest diameter is over 1 cm using spiral CT, and D would also be considered a target lesion, since its longest diameter is over 2 cm using MRI.

Where is stable disease defined in the protocol?
RECIST Quiz #3 Where is stable disease defined in the protocol? Section 3.0 Selection of Patients Section 6.0 Measurement of Effect Section 7.0 Study Parameters Section Records to Be Kept Next question: Where is stable disease defined in the protocol?

Where is stable disease defined in the protocol?
RECIST Quiz #3 Where is stable disease defined in the protocol? Section 3.0 Selection of Patients Section 6.0 Measurement of Effect Section 7.0 Study Parameters Section Records to Be Kept B is correct, section 6 is the measurement of effect section. Here is where you would find RECIST criteria and response definitions. Be sure you are familiar with this section.

Stable disease requires a confirmation scan.
RECIST Quiz #4 Stable disease requires a confirmation scan. True False Next question: Stable disease requires a confirmation scan, T or F?

Stable disease requires a confirmation scan.
RECIST Quiz #4 Stable disease requires a confirmation scan. True False PR and CR require a confirmation scan, at least 4 weeks after the first observed date Correct, this is false. SD does not require a confirmation scan. Both PR and CR require a confirmation scan at least 4 weeks after the first observed date.

RECIST Quiz #5 Partial response is recalculated each time the Sum of the longest diameters changes. True False Next question: Partial response is recalculated each time the Sum of the longest diameters changes, T or F

RECIST Quiz #5 Partial response is recalculated each time the Sum of the longest diameters changes. True False PR = based on the Baseline SLD PD = based on the Smallest SLD ever measured, and is recalculated each time the SLD decreases Correct, this is false! PR is based on the Baseline SLD, and only needs to be calculated once at baseline. PD, on the other hand, needs to be recalculated each time the SLD decreases. So, for example, if the SLD at baseline is 5.0 cm, you would calculate for PR and PD. If at the next scan, the SLD decreases to 2.0 cm, you would NOT need to recalculate for PR, but you would need to recalculate for PD.

Which of the following are considered PD?
RECIST Quiz #6 Which of the following are considered PD? New pleural effusion with negative cytology Increase of a single target lesion > 20 % over baseline diameter Unequivocal progression of a Nontarget lesion Increase in the sum of the longest diameters > 20 % over smallest diameter ever measured Next question: Which of the following are considered PD?

Which of the following are considered PD?
RECIST Quiz #6 Which of the following are considered PD? New pleural effusion with negative cytology Increase of a single target lesion > 20 % over baseline diameter Unequivocal progression of a Nontarget lesion Increase in the sum of the longest diameters > 20 % over smallest diameter ever measured Correct, C and D. If there is unequivocal progression of Nontarget lesions and/or an increase in the SLD of > or = 20% over the smallest SLD ever recorded, the overall response would be PD. Remember that another criterion for PD is that a new lesion is found. If 1, 2 or 3 of these criteria are met, than you would code PD. In choice A, new pleural effusion with a negative cytology would not constitute PD. This is an exception to the “new lesions equals PD” rule. If a pleural effusion is found with a negative cytology, that would not constitute PD. In choice B, an increase in just one single lesion over 20% would not constitute PD because we need to look at the SLD. We can’t just base PD on the increase of one target lesion, we need to look at the sum.

Which of the following lesions are considered truly Non-measurable?
RECIST Quiz #7 Which of the following lesions are considered truly Non-measurable? Pleural/pericardial effusion Bone Lesion Inflammatory breast disease Ascites Next question: Which of the following lesions are considered truly Non-measurable?

Which of the following lesions are considered truly Non-measurable?
RECIST Quiz #7 Which of the following lesions are considered truly Non-measurable? Pleural/pericardial effusion Bone Lesion Inflammatory breast disease Ascites Correct, all of these are considered truly non-measurable, and would all need to be reported as Nontarget lesions.

RECIST Quiz #8 Target lesions must be > 20 mm if imaged by anything other than a spiral CT scan. True False Next question: Target lesions must be > 20 mm if imaged by anything other than a spiral CT scan.

RECIST Quiz #8 Target lesions must be > 20 mm if imaged by anything other than a spiral CT scan. True - lesion must be > 2 cm (or 20 mm) if conventional imaging methods are used. False Correct, this is true. Lesions must be 2 cm or more if conventional imaging methods are used.

RECIST Quiz #9 All Target and Nontarget lesions must be assessed to determine response. True False Next question: All Target and Nontarget lesions must be assessed to determine response.

RECIST Quiz #9 All Target and Nontarget lesions must be assessed to determine response. True False All Target lesions must be assessed to determine a response, unless a criterion for PD has been met All Nontarget lesions do NOT need to be assessed to determine a response Correct, this is false. Yes, it’s true that all target lesions must be assessed to determine response, unless a criterion for PD has been met. However, all Nontarget lesions do not need to be assessed to determine response.

Which of the following scans would be considered PD?
RECIST Quiz #10 Which of the following scans would be considered PD? Baseline SLD 2.0 cm; 6 week scan SLD 2.3 cm Baseline SLD 2.0 cm; 6 week scan SLD 2.5 cm Baseline SLD 2.0 cm; 6 week scan SLD 2.1 cm Baseline SLD 2.0 cm; 6 week scan SLD 2.4 cm Next question: Which of the following scans would be considered PD?

Which of the following scans would be considered PD?
RECIST Quiz #10 Which of the following scans would be considered PD? Baseline SLD 2.0 cm; 6 week scan SLD 2.3 cm Baseline SLD 2.0 cm; 6 week scan SLD 2.5 cm Baseline SLD 2.0 cm; 6 week scan SLD 2.1 cm Baseline SLD 2.0 cm; 6 week scan SLD 2.4 cm 2.0 cm x 1.2 = 2.4 cm PD > 2.4 cm Correct, B and D are correct. So at baseline, the SLD is 2.0 cm. In order to see which scans show PD, we need to do a calculation. Since PD is a > or = 20% increase in the smallest SLD, we would multiply the baseline SLD by 1.2 (to get 120% of the baseline sum). This gives us So, B and D satisfy the criteria for PD. In both A and C, the SLD has less than a 20% increase, which is too small to code as PD.

How would this response be coded? Baseline scans = 9/1/08
RECIST Quiz #11 How would this response be coded? Baseline scans = 9/1/08 Registration = 9/2/08 SD minimal interval 42 days (6 weeks) after registration 42 days after registration = 10/14/08 All scans were spiral CT Next question: How would this response be coded? The baseline scan was done on 9/1, and the patient was registered on 9/2. The SD minimum interval was 42 days after registration, which in this situation would be 10/14. All scans, baseline and follow-up, used spiral CT

How would this response be coded?
RECIST Quiz #11 How would this response be coded? Baseline Scan Cycle 2 Scan Lesion BL Date BL Diameter Date Diameter Liver#1 9/1/08 2.5 cm 10/18/08 1.9 cm Lung #1 1.5 cm 1.7 cm Lung #2 1.0 cm LN #1 2.7 cm 2.1 cm LN #2 1.8 cm 1. 0 cm Sum 10.0 cm 7.7 cm Here, you can see that there are 5 lesions listed. The baseline SLD is reported to be 10 cm. On the cycle 2 scan that occurred on 10/18, the SLD is 7.7 cm. So how would we code this response.

Response Calculations
RECIST Quiz #11 Response Calculations Baseline SLD = 10.0 cm PR calculation: 10.0 cm x .7 = 7.0 cm PR ≤ 7.0 cm PD calculation: 10.0 cm x 1.2 = 12.0 cm PD ≥ 12.0 cm C2 SLD = 7.7 cm First, we need to make some calculations. Our baseline SLD is 10.0 cm, like I said before. First, let’s calculate PR. We multiply 10 by .7, and get 7.0 cm, so the patient will have PR if the SLD is < or = 7.0 cm. To calculate PD, we multiply 10 by 1.2 and get 12.0 cm. So the patient will have PD if the SLD is > or = 12.0 cm. Now if you remember, the cycle 2 SLD is 7.7 cm. This SLD does not satisfy PR, since it is greater than 7.0, and it does not satisfy PD, since it is less than So it appears that this patient has SD. Let’s make sure.

STABLE DISEASE (SD) Does not meet criteria Refer to section 6.0 of
RECIST Quiz #11 STABLE DISEASE (SD) Does not meet criteria for CR, PR or PD Refer to section 6.0 of the protocol for minimum week requirement before meeting SD criteria Here’s the definition for SD from before. Let’s see…does this patient meet criteria for CR, PR or PD? No, so we satisfy that criterion. Next, did we meet the minimum time interval to code SD? Let’s see, the minimum time requirement is 42 days post registration, which would be 10/14 in our example. Our cycle 2 follow-up scan occurred on 10/18. Therefore, we did meet the minimum time interval. 42 days after registration = 10/14/08 C2 scan date = 10/18/08

RECIST Quiz #11 How would this response be coded? Baseline Scan Cycle 2 Scan Lesion BL Date BL Diameter Date Diameter Liver#1 9/1/08 2.5 cm 10/18/08 1.9 cm Lung #1 1.5 cm 1.7 cm Lung #2 1.0 cm LN #1 2.7 cm 2.1 cm LN #2 1.8 cm 1. 0 cm Sum 10.0 cm 7.7 cm So this patient’s overall response would be SD! Response = SD

How would this response be coded? Baseline scans = 9/1/08
RECIST Quiz #12 How would this response be coded? Baseline scans = 9/1/08 Registration = 9/2/08 SD minimal interval 42 days (6 weeks) after registration 42 days after registration = 10/14/08 All scans were spiral CT OK, in the next example, how would this response be coded. Again, the baseline scan was on 9/1 and the patient was registered on 9/2. The SD minimal time interval is, again, 42 days, which would be 10/14. All scans, baseline and follow-up, are spiral CT.

RECIST Quiz #12 How would this response be coded? Baseline Scan Cycle 2 Scan Lesion BL Date BL Diameter Date Diameter Liver#1 9/1/08 2.5 cm 10/10/08 1.9 cm Lung #1 1.5 cm 1.7 cm Lung #2 1.0 cm LN #1 2.7 cm 2.1 cm LN #2 1.8 cm 1. 0 cm Sum 10.0 cm 7.7 cm So let’s take a look. The baseline SLD is the same, 10 cm. The cycle 2 Follow-up SLD is the same, 7.7 cm, but the scan date is 8 days earlier, on 10/10

Response Calculations
RECIST Quiz #12 Response Calculations Baseline SLD = 10.0 cm PR calculation: 10.0 cm x .7 = 7.0 cm PR ≤ 7.0 cm PD calculation: 10.0 cm x 1.2 = 12.0 cm PD ≥ 12.0 cm C2 SLD = 7.7 cm So let’s take a look back at our calculations for PR and PD. So PR is < or = 7 cm and PD is > or = 12.0 cm. The C2 SLD is 7.7 cm, which satisfies neither of these responses, so it would appear that this patient has SD. Let’s check and make sure.

RECIST Quiz #12 STABLE DISEASE (SD) Does not meet criteria
for CR, PR or PD Refer to section 6.0 of the protocol for minimum week requirement before meeting SD criteria So here’s our response definition for SD. Does our patient meet criteria for CR, PR or PD? No, so we satisfy that criterion. Does this scan satisfy the minimum time requirement for SD? Let’s see. The minimum time requirement is 42 days post registration, or 10/14. Our follow-up scan was on 10/10, so no, we don’t satisfy this criterion, and we would not be able to code SD for this patient. 42 days after registration = 10/14/08 C2 scan date = 10/10/08

Response: -1 = Insufficient Evaluation
RECIST Quiz #12 How would this response be coded? Baseline Scan Cycle 2 Scan Lesion BL Date BL Diameter Date Diameter Liver#1 9/1/08 2.5 cm 10/10/08 1.9 cm Lung #1 1.5 cm 1.7 cm Lung #2 1.0 cm LN #1 2.7 cm 2.1 cm LN #2 1.8 cm 1. 0 cm Sum 10.0 cm 7.7 cm In this case, since SD cannot be coded, we would report the response as “-1=insufficient evaluation to determine response”. Response: -1 = Insufficient Evaluation

Is this Sum of the Longest Diameters correct?
RECIST Quiz #13 Is this Sum of the Longest Diameters correct? Baseline Scan Cycle 2 Scan Lesion BL Date BL Diameter Date Diameter Liver#1 9/1/08 2.5 cm 10/18/08 1.9 cm Lung #1 1.5 cm Not Measured Lung #2 1.0 cm LN #1 2.7 cm 2.1 cm LN #2 1.8 cm 1. 0 cm Sum 10.0 cm 6.0 cm Next question, Is this Sum of the Longest Diameters correct? Let’s see, notice that lung lesion #1 was not evaluated. Our SLD was reported to be 6.0 cm. Is this correct? If you remember from before, you should only report the SLD of all target lesions if the sum of the evaluated lesions is > or = a 20% increase in the smallest SLD reported since baseline. So, let’s see if this is a 20% or higher increase.

Progressive Disease Calculation
RECIST Quiz #13 Progressive Disease Calculation Baseline SLD = 10.0 cm PD calculation: 10.0 cm x 1.2 = 12.0 cm PD ≥ 12.0 cm Here, I calculated the PD threshold by multiplying the baseline SLD by 1.2, which gives us 12.0 cm. So the patient would have PD if the SLD is > or = 12.0 cm. The reported SLD in this example is 6.0 cm. Reported SLD = 6.0 cm

RECIST Quiz #13 Is this Sum of the Longest Diameters correct? Baseline Scan Cycle 2 Scan Lesion BL Date BL Diameter Date Diameter Liver#1 9/1/08 2.5 cm 10/18/08 1.9 cm Lung #1 1.5 cm Not Measured Lung #2 1.0 cm LN #1 2.7 cm 2.1 cm LN #2 1.8 cm 1. 0 cm Sum 10.0 cm So in this case, the SLD should be left blank, since there wasn’t a 20% or higher increase in the SLD of the evaluated target lesions. The Sum should be left blank if a lesion cannot be measured or is not evaluated AND PD not met!

RECIST Quiz #14 Is this Sum of the Longest Diameters correct? Baseline Scan Cycle 2 Scan Lesion BL Date BL Diameter Date Diameter Liver#1 9/1/08 2.5 cm 10/18/08 7.3 cm Lung #1 1.5 cm Not Measured Lung #2 LN #1 2.7 cm 2.1 cm LN #2 1.8 cm 3. 0 cm Sum 10.0 cm 12.4 cm In the next example, Is this Sum of the Longest Diameters correct? You will notice that lung lesions #1 and #2 were not evaluated, but our SLD was reported as 12.4 cm. Is this a 20% or more increase in the smallest SLD? Let’s see.

Progressive Disease Calculation
RECIST Quiz #14 Progressive Disease Calculation Baseline SLD = 10.0 cm PD calculation: 10.0 cm x 1.2 = 12.0 cm PD ≥ 12.0 cm Here’s that same PD calculation, so PD occurs when the SLD is > or = 12.0 cm. Our reported SLD is 12.4 cm, so yes, we did meet this PD criteria. Reported SLD = 12.4 cm

Target Lesion response = PD, so can record SLD
RECIST Quiz #14 Is this Sum of the Longest Diameters correct? Baseline Scan Cycle 2 Scan Lesion BL Date BL Diameter Date Diameter Liver#1 9/1/08 2.5 cm 10/18/08 7.3 cm Lung #1 1.5 cm Not Measured Lung #2 LN #1 2.7 cm 2.1 cm LN #2 1.8 cm 3. 0 cm Sum 10.0 cm 12.4 cm So therefore, we would report the SLD, and the response would be reported as PD. Target Lesion response = PD, so can record SLD

Can this response be coded?
RECIST Quiz #15 Can this response be coded? Baseline Scan Cycle 2 Scan Lesion BL Date BL Diameter Date Diameter Liver#1 9/1/08 2.5 cm 10/18/08 1.9 cm Lung #1 1.5 cm 1.7 cm Lung #2 1.0 cm LN #1 2.7 cm 2.1 cm LN #2 1.8 cm 1. 0 cm Sum 10.0 cm 7.7 cm Our final question: can this response be coded? At baseline, the SLD is 10 cm, and the cycle 2 scan is 7.7 cm. However, a spiral CT was done at baseline and an MRI was done at follow-up Spiral CT MRI

RECIST Quiz #15 Can this response be coded? No, method of evaluation must be consistent Baseline Scan Cycle 2 Scan Lesion BL Date BL Diameter Date Diameter Liver#1 9/1/08 2.5 cm 10/18/08 1.9 cm Lung #1 1.5 cm 1.7 cm Lung #2 1.0 cm LN #1 2.7 cm 2.1 cm LN #2 1.8 cm 1. 0 cm Sum 10.0 cm 7.7 cm Since the method of evaluation changed from baseline, the response cannot be coded at this follow-up, and would be reported as -1=insufficient evaluation to determine response. Spiral CT MRI

In what year was the first umbrella factory built in Baltimore?
Bonus Question! Baltimore, MD was the home of the nation’s FIRST Umbrella Factory! In what year was the first umbrella factory built in Baltimore? OK, so here’s the bonus. Did you know that Baltimore was the home of the nation’s first umbrella factory? Well it was. In what year was the first umbrella factory built? Yes, 1828 1828

Know the Protocol requirements Measurable vs. non-measurable disease
RECIST Reminders Know the Protocol requirements Measurable vs. non-measurable disease Assessment requirements Baseline During protocol therapy Stable disease timeline Determine target lesions Use worksheets Ok, let’s go over some RECIST reminders. First of all, it’s so important that you are familiar with your protocol and the RECIST requirements. Make sure you know the difference between measurable and non-measurable disease. Make sure you know the assessment requirements at baseline and during protocol treatment. Make sure that you also know the minimum SD time line. Also, be sure that you can determine which lesions are target lesions. Make sure you use the worksheet took to help you fill out your RECIST forms.

Follow all lesions consistently Assess all lesions at each evaluation
RECIST Reminders Follow all lesions consistently Assess all lesions at each evaluation Use the same method of evaluation Report lesions consistently on the Baseline and Follow-Up CRF’s Record all lesions at each assessment even if not evaluated. Refer to RECIST form instructions for your Protocol Call ECOG Coordinating Center for questions Be sure that you follow all lesions consistently. All lesions must be assessed at each evaluation, and if not, be sure to report them anyways. Read the AE form instructions for your protocol’s AE form to find your protocol-specific instructions for what to do if a follow-up assessment wasn’t done. Make sure that for every lesion, you use the same method of evaluation that was used at baseline. Be sure that you report lesions consistently on the baseline and follow-up RECIST forms. Record all lesions at each assessment, even if they are not evaluated. And always remember that you can call us at the ECC if you have any questions. We would be happy to help!

New Guidelines to Evaluate the Response to Treatment in Solid Tumors…
So before we wrap it up, I want to give you a quick introduction of RECIST In this presentation, I explained the RECIST 1.0 version, which is the current version that is used in our protocols. RECIST 1.1 is the updated RECIST version that will be coming out very soon, so I want to tell you a little bit about it. New Guidelines to Evaluate the Response to Treatment in Solid Tumors…

RECIST Guidelines Version 1.1 Minimum size measurable lesions
Spiral CT: > 1.0cm All other methods: > 2.0cm RECIST 1.1 CT: > 10mm Chest X-Ray: > 20mm Clinical Exam: > 10 mm with calipers Lymph Nodes: >15 mm short axis for Target >10–<15 mm short axis for Nontarget <10 mm short axis is non-pathological So let’s look at some of the differences between RECIST 1.0 an If you recall, in the current RECIST 1.0, the minimum size requirement for measurable lesions is 1.0 cm for a spiral CT and 2.0 cm for all other conventional methods. In the new RECIST 1.1, there are some changes. The minimum size requirement for measurable lesions is 10 mm for a CT and 10 mm for a clinical exam that is assessed using calipers. The minimum size requirement for measurable lesions is 20 cm with a chest x-ray. Now here’s a major change regarding lymph nodes. Firstly, when assessing lymph nodes, the diameter that is reported on the RECIST forms will be from the shortest diameter measured form the short axis, not the longest diameter. In order to determine whether a lymph node is a target lesion, nontarget lesion, or not reportable, follow these rules. If the lymph node’s short axis is > or = 15 mm, you would report this node as a target lesion. If the lymph node’s short axis is > or = 10 mm, but less than 15 mm, you would report this node as a nontarget lesion. Finally, if the lymph node’s short axis is < 10 mm, than it would be considered non-pathological, and would not need to be reported on the RECIST forms.

RECIST Guidelines Version 1.1
Number of Allowable Target Lesions RECIST 1.0 Maximum Target Lesions: 10 Maximum Target Lesions per Organ: 5 RECIST 1.1 Maximum Target Lesions: 5 Maximum Target Lesions per Organ: 2 Another major difference between RECIST 1.0 and 1.1 is the number of allowable target lesions. In the current RECIST 1.0, there are a maximum of 10 target lesions that can be reported, and a maximum of 5 target lesions were organ. In the new RECIST 1.1, these numbers have decreased. Now, there is a maximum of only 5 target lesions that can be reported, and a maximum of 2 target lesions per organ.

NEW to Version 1.1 Diagnostic Scans No longer differentiate between Spiral CT and Non-spiral CT PET-CT is now allowable but documentation must be available of its identical diagnostic quality to a CT Must have IV and Oral contrast FDG-PET can be used to complement a CT when diagnosing Progressive Disease Next, here are some features that are new to RECIST First of all, the new RECIST 1.1 does not differentiate between spiral CT and non-spiral CT scans. There will only be one “CT” option. Also, a PET-CT is now allowable as a method of evaluation, HOWEVER, documentation MUST be available confirming its identical diagnostic quality to a CT. Also, this PET-CT must have IV and oral contrast. Another update to RECIST 1.1 is that an FDG-PET can be used to complement a CT when diagnosing Progressive Disease.

NEW to Version 1.1 Response Definitions Progressive Disease: Target Lesions - PD is 20% increase over smallest SLD. Now it also requires at least mm increase over the smallest SLD Nontarget Lesions – It must be representative of overall disease status change, not a single lesion increase PD in Nontarget lesions should not normally trump target lesion response status. Let’s look at some more features that are new to RECIST Firstly, in order for a patient to have PD, there are a couple new criteria that are different from the old RECIST The original rule remains the same: that in target lesions, PD occurs with a 20% increase in the smallest SLD ever reported. HOWEVER, there is an additional criterion…this increase also requires at least a 5 mm increase over the smallest SLD. So for example, if the patient’s SLD increased by over 20% but did not increase by 5 mm or more above the smallest SLD, you would not be able to code PD. The next difference is that for Nontarget lesions, if one or more Nontarget lesions show PD, in order to code an overall response of PD, the progression must be representative of the overall disease status change, NOT just a single lesion increase. If PD is found in Nontarget lesions, it should not normally trump the response of target lesions. If PD is found in Nontargets, it should only be considered PD if the doctor believes that the Nontarget lesion PD is representative of the overall disease status change, and this should be documented by the doctor.

NEW to Version 1.1 Response Definitions Complete Response - both Target and Nontarget Lymph Node lesions Any pathological lymph nodes must have reduction in short axis to < 10mm. Does not require complete disappearance as in Version 1.0. Here are some other response differences. In order for lymph node lesions to be determined to have a complete response, the lymph nodes must have decreased in the short axis to 10 mm or below. In the old RECIST 1.0 version, CR in lymph node lesions required complete disappearance. In the new 1.1 version, for both target and nontarget lesions, a lymph node will have CR if its short axis decreased to 10 mm or lower.

All current studies using RECIST 1.0 will not be changed to the new version. Studies activated after 01/2010 will be using RECIST 1.1. ALWAYS CHECK THE PROTOCOL!! So that was a brief introduction to RECIST We just want to let you know that all of our current studies that are using RECIST version 1.0, the current version, will continue to do so. They will not be changed. However, any studies that are activated after January of next year will use this new RECIST It’s always a good idea to check your protocol to make sure you know which version of RECIST is being used, and that you know protocol-specific requirements and guidelines.

Questions? So that’s it….any questions?

RECIST Training Workshop Response Evaluation Criteria in Solid Tumors

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RECIST Training Workshop Response Evaluation Criteria in Solid Tumors

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Presentation on theme: "RECIST Training Workshop Response Evaluation Criteria in Solid Tumors"— Presentation transcript:

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