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3.2 General Points on Representation of Data within the Oncology Disease Response Domains for RECIST 1.1

In RECIST 1.1, a subject's tumors are identified as target tumors, non-target tumors and new tumors. At a specific disease assessment timepoint, the overall response in RECIST 1.1 is based on measurements of target tumors (target response), qualitative assessments of non-target tumors (non-target response) and the appearance of appearance of new tumors. Subjects with at least one target tumor can have overall response of CR (Complete Response (CR), PR (Partial Response), SD (Stable Disease), PD (Progressive Disease) and NE (Not Evaluable). Subjects with only non-measurable disease (i.e., no target tumors) can have overall response of CR (Complete Response), NonNON-CR/NonNON-PD, PD (Progressive Disease) and NE (Not Evaluable).

Target tumors are measured in the longest diameter except when the location is a lymph node, then they are measured in the longest perpendicular. The examples in this disease response supplement use TRTESTCD = "LDIAM" (Longest Diameter) for measurements of non-lymph node target tumors and TRTESTCD = "LPERP" (Longest Perpendicular) for measurements in the longest perpendicular of lymph node target tumors. The SDTMIG examples have previously used TRTESTCD = "DIAMETER" (Diameter) for measurements of both lymph nodes and non-lymph nodes. Either representation is acceptable for RECIST 1.1. The latter approach requires looking at the anatomical location in conjunction with the TRTESTCD to know whether the diameter was measured in the longest diameter or the longest perpendicular. The "LDIAM" and "LPERP" tests provide more specificity in the TRTESTCD itself and does not required looking to the anatomical location. In addition, "LDIAM" and "LPERP" are tests used in other disease response criteria so the use of these two tests provides standardization that work across criteria for the same measurement. Some sponsors prefer the approach used within this disease response supplement due to these reasons. 

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RECIST 1.1 recommends a standardized value of 5 mm is used in the calculation of sum of diameters when a target tumor is too small to measure. Note that this imputation should only be done when the lesion diameter is too small to measure.  When a numerical value is given for the lesion diameter, then that value will be used even if the diameter is less than 5 mm. The original or collected value "TOO SMALL TO MEASURE" should be represented in the TRORRES variable and the standardized value should be represented in the TRSTRESC and TRSTRESN variables. For absent non-lymph node target tumors, 0 mm is used in the calculation of the target sum. The longest perpendicular measurements of lymph node target tumors which are pathological (>= 10 mm) or non-pathological (< = 10 mm) are included in the target sum. 

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In TR, the TRDTC is populated with the date of tumor/lesion assessment/measurement, i.e., the date of the scan, image, or physical exam.  The In the examples, the summary results (e.g., Sum of Diameter) do not have TRMETHOD and TRDTC associated with them.  However, if an appropriate TRDTC is available, it can be populated. Also, scans which are not performed do not have a TRDTC populated. Symptomatic c deterioration may be collected in studies using RECIST 1.1 but it is not part of an objective RECIST 1.1 response.  See example 4.3 for a detailed example for representing these data.

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4 Examples for the Oncology Disease Response Domains Model for RECIST 1.1

4.1 Example 1: RECIST 1.1 example to show investigator response (RS) data and the underlying tumor identification (TU), tumor results (TR),

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and procedure (PR

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) data.

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  The example shows the case where lymph nodes are selected as target lesions. The tumor identifier is in TULNKID and matches TRLNKIDs in the TR Domain. The image identifiers are in TUREFID and TRREFID in the TU and TR domains, respectively, and they match the image identifiers in PRREFID in the PR Domain.

4.1.1 RS Domain Model

The rs.xpt table below shows the terminology used to implement RECIST 1.1 in the RS domain. This example shows the data for one subject collected at the week 6, week 12 and subsequent 8-week follow-up visits.

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The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for one subject at screening and at weeks 36 and 44 where new lesions are identified. In this example, lymph nodes are selected as target tumors.  In RECIST 1.1, target lymph node tumors are measured in the longest perpendicular (TRTESTCD = "LPERP" and TRTEST = "Longest Perpendicular") in the TR domain. The image identifier is in TUREFID and matches a PRREFID in the PR Domain.

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This example shows a situation where the Investigator provided the summary values for Target lesions as a group (TRGRPID = "TARGET"). The TRTESTCD = "SUMDIAMDIAM" is used for the assessments. Note that the sponsor should not derived these values if they were not part of the data capture.

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The supprs.xpt table below shows the data on the reason that the response was NE (Not Evaluable (NE) (QNAM = "REASNE") in the case where it is collected.

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The supprs.xpt table below shows the data on the reason that the response was NE (Not Evaluable (NE) (QNAM = "REASNE") in the case where it is collected.

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The supprs.xpt table below shows the data on the reason that the response was NE (Not Evaluable (NE) (QNAM = "REASNE") in the case where the reason is collected.

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The tu.xpt table below shows the terminology used to implement RECIST 1.1 in the TU domain. This example shows the data for one subject at screening and at weeks 36 and 44 where new lesions are identified. In this example, lymph nodes are selected as target tumors.  In RECIST 1.1, target lymph node tumors are measured in the longest perpendicular (TRTESTCD = "LPERP" and TRTEST = "Longest Perpendicular"). The image identifier is in TUREFID and matches a PRREFID in the PR Domain.

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