RECIST 11 Criteria Handout Basic Paradigm Assess at baseline Look for measurable lesions Select target and nontarget lesions Measure target lesions Followup evaluation Measure target lesions ID: 775001
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Slide1
Response Evaluation Criteria in Solid TumorsRECIST 1.1
Criteria Handout
Slide2Basic Paradigm
Assess at baseline
Look for measurable lesions
Select target and non-target lesions
Measure target lesions
Follow-up evaluation
Measure target lesions
Assess non-target lesions and look for new lesions
Calculate
timepoint
response
Slide3Measurable Lesions
Tumor ≥10 mm in longest diameter (LD) on an axial image on CT or MRI
Lymph nodes ≥15 mm in short axis on CT
Lymph node measurements: specific instructions:
short axis ≥15 mm is measurable
10-14 mm is abnormal (recorded as non-target)
<10 mm is considered normal
Ultrasound cannot be used to measure lesions
Slide4Non-Measurable Lesions
All other definite tumor lesions
Masses <10 mm
Lymph nodes 10-14 mm in short axis
Leptomeningeal
disease
Ascites
, pleural or pericardial effusion
Inflammatory breast disease
Lymphangitic
involvement of skin or lung
Slide5Special Lesion Types
Bone Lesions
Bone lesions with identifiable soft tissue components seen on CT or MR can be measurable if the soft tissue component meets the definition above
Blastic
bone lesions are
unmeasurable
Slide6Special Lesion Types
Cystic Lesions
Simple cysts are not included as lesions
Cystic metastases may be selected, but prefer to use non-cystic lesions as “target”
Slide7Baseline Lesion Burden
Slide8Target Lesions
Record a maximum of five (5) target lesions in total
Up to two (2) per organ
Any combination of organ masses or lymph nodes, but representative of all involved organs
Select largest reproducibly measurable lesions
If the largest lesion cannot be measured reproducibly, select the next largest lesion which can be
Slide9Reproducible Target Lesion
Slide10Reproducible Target Lesion
Slide11Lymph Node Measurements
Measure short axis≥15 mm is measurable (may be recorded as target)10-14 mm is abnormal (recorded as non-target)<10 mm is considered normal
Slide12Non-Target Lesions
It is possible to record multiple non-target lesions involving the same organ as a single item (e.g. “multiple enlarged pelvic lymph nodes” or “multiple liver metastases”)
Slide13Evaluation on Follow-up
Measure previously chosen target lesions
Even if they are no longer the largest
If a target lesion fragments into multiple smaller lesions, the LDs of all fragmented portions are measured
If target lesions coalesce, the LD of the resulting coalescent lesion is measured
Evaluate all previously identified non-target lesions
Look for new definite cancer lesions
Slide14Non-Target Lesions
Slide15Non-Target Lesions
Slide16New Lesions
Should be unequivocal and not attributable to differences in scanning technique or findings which may not be a tumor
Does not have to meet criteria to be “measurable”
Lesions identified in anatomic locations not scanned at baseline are considered new
New lesions on US should be confirmed on CT/MRI