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. Author manuscript; available in PMC: 2014 Apr 9.
Published in final edited form as: Minerva Endocrinol. 2012 Dec;37(4):335–356.

Table 2.

Summary of RECIST criteria versions 1.0 and 1.1 (adapted from Wahl et al91)

RECIST 1.0 RECIST 1.1
Measurability and selection of target lesions at baseline

  1. Measurable/target lesions:

    • unidimensional measurement

    • All target lesions: LD only: size with conventional techniques ≥20 mm, with spiral CT ≥10 mm

    • Maximum number of target lesions: 5 per organ up to 10 total [more than 1 organ])

  1. Measurable/target lesions:

    • unidimensional measurement

    • Tumor lesions: LD only: size with conventional techniques ≥ 20 mm, with spiral CT ≥10 mm; nodes: short axis ≥ 15 mm

    • Malignant lymph nodes: >15 mm in short axis

    • Cystic lesions thought to represent metastases can be considered measurable if they meet size criteria.

    • Lesions in a previously irradiated area can be considered measurable if progression is demonstrated and they meet size criteria.

    • Maximum number of target lesions: 2 per organ up to 5 total [more than 1 organ])
Selection of nontarget lesions Nontarget lesions: lesions < 1 cm, cystic lesions, bone lesions without soft tissue component, pleural and pericardial effusions, ascites, leptomeningeal disease, lesions in an irradiated area. Nontarget lesions: Lymph nodes: 10 to 15 mm nodes. Non-lymph nodes: lesions < 1 cm, bone lesions without soft tissue component, pleural and pericardial effusions, ascites, leptomeningeal disease.
Objective response

  1. Target lesions (change in sum of LD): CR, disappearance of all target lesions, confirmed at ≥4 wk; PR, ≥30% decrease from baseline, confirmed at 4 wk; PD, ≥20% increase over smallest sum observed (nadir) or appearance of new lesions; SD, neither PR nor PD criteria met

  2. Nontarget lesions: CR, disappearance of all nontarget lesions and normalization of tumor markers, confirmed at ≥4 wk; PD, unequivocal progression of nontarget lesions or appearance of new lesions; non-PD, persistence of one or more nontarget lesions or tumor markers above normal limits

  1. Target lesions (change in sum of LDs): CR, disappearance of all target lesions, confirmed at ≥4 wk; PR, ≥30% decrease from baseline, confirmed at 4 wk; PD, ≥20% increase over smallest sum observed (nadir) and overall 5-mm net increase or appearance of new lesions; SD, neither PR nor PD criteria met

  2. Nontarget lesions: CR, disappearance of all nontarget lesions and normalization of tumor markers, confirmed at ≥4 wk; PD, unequivocal progression of nontarget lesions or appearance of new lesions; non-PD: persistence of one or more nontarget lesions or tumor markers above normal limits; PD must be “unequivocal” in nontarget lesions (e.g., 75% increase in volume); PD can also be new “positive PET” scan with confirmed anatomic progression. Stable positive PET is not PD if it corresponds to anatomic non-PD
Overall Response

  1. Best response is recorded in measurable disease from treatment start to disease progression or recurrence

  2. Non-PD in nontarget lesions will reduce CR in target lesions to overall PR

  3. Unequivocal new lesions are PD regardless of response in target and nontarget lesions

  1. Best response is recorded in measurable disease from treatment start to disease progression or recurrence

  2. Non-PD in nontarget lesions will reduce CR in target lesions to overall PR

  3. Unequivocal new lesions are PD regardless of response in target and nontarget lesions