- Measurability of Tumors at Baseline
- Non-measurable Lesions
- Assessment of Lymph Nodes
- Bone Lesion Measurability
- Cystic Lesions
- Prior Local Treatment of Lesions
- Presence of Measurable Disease at Baseline
- Baseline Documentation of Target Lesions
- Documentation of Non-target Lesions
- Definition of Complete Response (CR)
- Definition of Progressive Disease (LR)
- Definition of Unequivocal Progression
- Too Small to Measure
- Lesions that Split or Coalesce
- New Lesions
- PET
- Missing Assessments and Inevaluable Designation
- Overall Response Table, Subjects With Measurable Disease
- Overall Response Table, Subjects Without Measurable Disease
- Best Overall Response
- Confirmation Measurement / Duration of Response
- Lesion Reappearance
- Protocol Design Considerations: Study Endpoints
- Protocol Design Considerations: Imaging Modalities
Change 19: Overall Response Table, Subjects Without Measurable Disease
RECIST 1.0:
|
RECIST 1.1:
Non-CR/non-PD is preferred over “stable disease” for non-target disease since SD is increasingly used as an endpoint for assessment of efficacy in some trials so to assign this category when no lesions can be measured is not advised. |