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COMBI RECIST 1.1 February 2013. Target Lesions:  123
Selection at Baseline Perform baseline evaluations as
close to treatment start as possible
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Presentation on theme: "COMBI RECIST 1.1 February 2013. Target Lesions: Selection at
Baseline Perform baseline evaluations as close to treatment start as possible (no more
than."— Presentation transcript:

1 COMBI RECIST 1.1 February 2013

2 Target Lesions: Selection at Baseline Perform baseline evaluations as close to treatment start as
possible (no more than 4 weeks prior) View all available imaging before selecting target lesions Select
up to 5 in total; maximum of 2 lesions per organ –Measure short axis of lymph nodes and longest
diameter of non lymph nodes Target selection should be based on: –Lesion size –Representation of all
organs –Likely reliability/reproducibility of repeated measurement Clinical evaluations: –Use calipers or
ruler and color photography –If a lesion can be evaluated via either imaging or clinical exam, use
imaging

3 Target Lesion: Selection at Baseline (continued) GSK recommends the following not be selected
 as target lesions when other suitable lesions are
available –Lymph nodes –Cystic lesions thought to
represent cystic metastases Measurable lesions
that have been previously irradiated and have not 
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been shown to be progressing following
irradiation should not be considered as target
lesions Note: Any lesions not selected as target
We think lesions
you have liked this
should presentation.
be reported as nonIf target
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lesions.

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4 Target Lesion: Follow-up Assessment
Buttons: Ensure consistent assessment modality across
visits (same equipment where possible, same
contrast timing, and same output medium, e.g.
electronic image) Target lymph nodes : –Continue
to collect actual measurement, even if7< 10 mm. –
Sum of lesion diameter may not be zero, yet CR is still possible because lymph nodes < 10mm are
considered non pathologic Lesions (Non Lymph nodes): –All baseline target lesions should have actual
follow-up measurements recorded, even if very small (e.g., 2 mm) –If truly too small to measure but not
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absent 5 mm should be recorded and should contribute to the sum of the diameters –If it is likely the
lesion has disappeared 0mm should be reported

5 Target Lesion: if all Lesions Identified at Baseline are Not Assessed? SUMLD cannot be calculated
for purposes of assessing CR, PR, or SD or for use as the nadir for future assessments. SUMLD of the
assessed lesions and the percent change from nadir should be calculated to ensure that progression
has not been documented. If an assessment of PD cannot be made, the response assessment should
be NE.

6 Non-Target Lesion: Selection at Baseline Includes: –All truly non-measurable lesions (bone,
effusions, etc.) –Lesions with Diameter <10 mm (or < 2x slice thickness) –Pathological Lymph Nodes with
short axis ≥10mm and <15mm –All remaining measurable lesions not reported as target
Measurements not required Record multiple non-target lesions involving the same organ as a single
item –Multiple liver metastases

7 Non-Target Lesion: Follow-up Assessment Present Absent Unequivocal progression –If patient
has measurable and non-measurable disease: Modest increase in one or more non-targets is not
usually sufficient to qualify as unequivocal PD Must exhibit worsening in tumor burden sufficient
enough to warrant treatment discontinuation even if targets are in PR or SD –If patient only has non-
measurable disease: Consider whether change is comparable in magnitude to change required for PD
in measurable disease –E.g., 73% increase in volume= 20% increase in Sum of Diameters –Pleural
effusion changing from “trace” to “large” Progression sufficient enough to warrant change in treatment
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8 New Lesions: Unequivocal New Lesions New malignancies denoting disease progression must be
unequivocal Not attributable to different scanning
We thinktechniques: –E.g. this
you have liked change in modality
presentation. If or
youimaging
wish to
parameters Not thought to represent something otherit,than
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please (e.g. some
recommend ‘new’
it to yourbone lesions
friends may
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be simply healing or flare of pre- existing lesions) Lesions identified at follow-up in an anatomical
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location that was not scanned at baseline should be considered new lesions –E.g., positive brain MRI
on study with no brain MRI at baseline
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