| Characteristic | WHO | RECIST | RECIST 1.1 |
|---|---|---|---|
| Measurability of lesion at baseline | 1. Measurable, bidimensional* (product of LD and greatest perpendicular diameter) | 1. Measurable, unidimensional (LD only: size with conventional techniques ≥ 20 mm, with spiral CT ≥ 10 mm) | 1. Measurable, unidimensional (LD only: size with conventional techniques ≥ 20 mm, with spiral CT ≥ 10 mm; nodes: target short axis ± 15 mm, nontarget 10- to 15-mm nodes, normal < 10 mm) |
| 2. Nonmeasurable/evaluable (e.g., lymphangitic pulmonary metastases, abdominal masses) | 2. Nonmeasurable: all other lesions, including small lesions; evaluable is not recommended | 2. Nonmeasurable: all other lesions, including small lesions; evaluable is not recommended | |
| Objective response | 1. Measurable disease (change in sum of products of the LD and greatest perpendicular diameters, no maximal number of lesions specified): CR, disappearance of all known disease, confirmed at ≥4 wk; PR, ≥50% decrease from baseline, confirmed at ≥4 wk; PD, ≥25% increase of one or more lesions or appearance of new lesions; NC, neither PR nor PD criteria met | 1. Target lesions (change in sum of LD, maximum of 5 per organ up to 10 total [more than 1 organ]): 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 or appearance of new lesions; SD, neither PR nor PD criteria met | 1. Target lesions (change in sum of LDs, maximum of 2 per organ up to 5 total [more than 1 organ]): 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 and overall 5-mm net increase or appearance of new lesions; SD, neither PR nor PD criteria met |
| 2. Nonmeasurable disease: CR, disappearance of all known disease, confirmed at ≥4 wk; PR, estimated decrease of ≥50%, confirmed at 4 wk; PD, estimated increase of ≥25% in existent lesions or new lesions; NC, 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 | 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. Stably positive PET is not PD if it corresponds to anatomic non-PD | |
| Overall response | 1. Best response is recorded in measurable disease | 1. Best response is recorded in measurable disease from treatment start to disease progression or recurrence | 1. Best response is recorded in measurable disease from treatment start to disease progression or recurrence |
| 2. NC in nonmeasurable lesions will reduce CR in measurable lesions to overall PR | 2. Non-PD in nontarget lesions will reduce CR in target lesions to overall PR | 2. Non-PD in nontarget lesions will reduce CR in target lesions to overall PR | |
| 3. NC in nonmeasurable lesions will not reduce PR in measurable lesions | 3. Non-PD in nontarget lesions will not reduce PR in target lesions | 3. Non-PD in nontarget lesions will not reduce PR in target lesions | |
| 4. Unequivocal new lesions are PD regardless of response in target and nontarget lesions | 4. Unequivocal new lesions are PD regardless of response in target and nontarget lesions | ||
| Duration of response | 1. CR: from date CR criteria are first met to date PD is first noted | 1. Overall CR: from date CR criteria are first met to date recurrent disease is first noted | 1. Overall CR: from date CR criteria are first met to date recurrent disease is first noted |
| 2. Overall response: from date of treatment start to date PD is first noted | 2. Overall response: from date CR or PR criteria are first met (whichever status came first) to date recurrent disease is first noted | 2. Overall response: from date CR or PR criteria are first met (whichever status came first) to date recurrent disease is first noted | |
| 3. In patients who achieve only PR, only period of overall response should be recorded | 3. SD: from date of treatment start to date PD is first noted | 3. SD: from date of treatment start to date PD is first noted |
↵* Lesions that can be measured only unidimensionally are considered measurable (e.g., mediastinal adenopathy or malignant hepatomegaly).
LD = longest diameter; CR = complete response; PR = partial response; PD = progressive disease; SD = stable disease; NC = no change.