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Comparison of imRECIST with RECIST v1.1 and irRC

Comparison of imRECIST with RECIST v1.1 and irRC
Criterion RECIST v1.1 irRC imRECIST
Tumor burden Unidimensional Bidimensional per WHO Unidimensional, with other target lesion criteria (number, measurability) per RECIST v1.1
Up to five target lesions or two per organ Up to 10 target lesions or five per organ
New lesions Always represent PD New lesions do not categorically define PD New lesions do not categorically define PD
  Measurable new lesions incorporated into the total tumor burden Measurable new lesions incorporated into the total tumor burden
  Nonmeasurable new lesions preclude CR Nonmeasurable new lesions preclude CR
Nontarget lesions Can contribute to defining CR or PD (unequivocal progression) Nontarget progression does not define PD Nontarget progression does not define PD
Can only contribute to defining CR (complete disappearance required) Can only contribute to defining CR (complete disappearance required)
PD ≥20% increase in the SLD (RECIST) and ≥5 mm increase compared with nadir, unequivocal progression in nontarget lesions, and/or appearance of new lesions Determined only on the basis of measurable disease Determined only on the basis of measurable disease
  Negated by subsequent non-PD assessment ≥4 weeks from the date first documented (lack of confirmation) Negated by subsequent non-PD assessment ≥4 weeks from the date first documented (lack of confirmation)
  ≥25% increase in the SLD compared with baseline/nadir ≥20% increase in SLD (RECIST) compared with baseline/nadir
Confirmation of PD not required Best response may occur before confirmed PD Best response may occur after any number of PD assessments
imRECIST: immune-modified Response Evaluation Criteria In Solid Tumors; RECIST: Response Evaluation Criteria In Solid Tumors; irRC: immune-related response criteria; WHO: World Health Organization; PD: progressive disease; CR: complete response; SLD: sum of longest diameters.
From: Hodi FS, Ballinger M, Lyons B, et al. Immune-Modified Response Evaluation Criteria In Solid Tumors (imRECIST): Refining Guidelines to Assess the Clinical Benefit of Cancer Immunotherapy. J Clin Oncol 2018; 36:850. DOI: 10.1200/JCO.2017.75.1644. Copyright © 2018 American Society of Clinical Oncology. Reproduced with permission from Wolters Kluwer Health. Unauthorized reproduction of this material is prohibited.
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