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Revised RECIST Guideline Version 1.1: What Oncologists Want To Know and What Radiologists Need To Know
Revised RECIST Guideline Version 1.1: What Oncologists Want To Know and What Radiologists Need To Know
Nishino et al.
Revised RECIST Guideline
Special Article
Pictorial Essay
O
bjective assessment of the change the new version compared with the original
in tumor burden is important to RECIST guideline; provide representative
evaluate tumor response to ther- cases in which application of the new RE-
apy. The Response Evaluation CIST guideline influences the response eval-
Criteria in Solid Tumors (RECIST) was in- uation; and discuss future directions.
troduced in 2000 by an International Work-
ing Party to standardize and simplify tumor Review of the Original RECIST
response criteria [1]. Key features of the Guideline
original RECIST, version 1.0, included defi- The original RECIST guideline, version
nitions of the minimum size of measurable 1.0, provided definitions for “measurable le-
lesions, instructions about how many lesions sion” and “nonmeasurable lesion” [1]. Mea-
to follow, and the use of unidimensional surable lesions must have a longest diameter
measures for evaluation of overall tumor bur- of ≥ 10 mm on CT with a slice thickness of
den [1]. RECIST has subsequently been ≤ 5 mm (or a longest diameter of ≥ 20 mm on
widely accepted as a standardized measure nonhelical CT with a slice thickness of > 10
of tumor response, particularly in oncologic mm) or a longest diameter of ≥ 20 mm on
clinical trials in which the primary endpoints chest radiography [1] (Fig. 1).
are objective response or time to progression Nonmeasurable lesions include other le-
Keywords: CT, oncologic imaging, response assessment, [2]. With rapid technical innovations in im- sions that do not meet the criteria as measur-
Response Evaluation Criteria in Solid Tumors, RECIST,
RECIST 1.1, tumor measurement
aging techniques including MDCT and PET able lesions, such as small lesions with a lon-
combined with CT (PET/CT), the limita- gest diameter of < 10 mm, skeletal metastases
DOI:10.2214/AJR.09.4110 tions of the original RECIST and the need without a soft-tissue component, ascites, pleu-
for revision have become clear [2]. ral effusion, lymphangitic spread of tumor,
Received December 11, 2009; accepted after revision
In January 2009, a revised RECIST guide- leptomeningeal disease, inflammatory breast
January 29, 2010.
line (version 1.1) based on a database consisting disease, cystic or necrotic lesions, lesions in
M. Nishino is supported by a 2009–2011 Agfa of more than 6,500 patients with greater than an irradiated area, and an abdominal mass not
Healthcare/RSNA research scholar grant. 18,000 target lesions was presented by the RE- confirmed by imaging [1] (Fig. 2).
1
CIST Working Group [2–5]. Some of the clini- After identifying measurable and non-
All authors: Department of Imaging, Dana-Farber
Cancer Institute, 44 Binney St., Boston, MA 02115.
cal trials at tertiary cancer centers have already measurable lesions according to the guide-
Address correspondence to M. Nishino started to use the revised guideline, RECIST line, target lesions are selected at baseline.
(Mizuki_Nishino@dfci.harvard.edu). 1.1, instead of the original RECIST 1.0. Aware- Target lesions include all measurable le-
ness and knowledge of the new criteria are es- sions—up to five per organ and 10 total—
AJR 2010; 195:281–289 sential for radiologists involved in imaging and and are recorded and measured at baseline
0361–803X/10/1952–281
response assessment of cancer patients. [1]. Target lesions are selected on the basis
In this article, we review the new RECIST of their size (i.e., longest diameter) and suit-
© American Roentgen Ray Society guideline, focusing on the major changes in ability for accurate repeated measurements
A B C
Fig. 1—Measurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST).
A, CT scan of chest in 64-year-old man with colon cancer. Lobulated nodule in left lower lobe representing metastasis measures 2.5 cm in longest diameter (arrow),
meeting criteria for measurable lesion on CT (longest diameter ≥ 10 mm).
B, CT scan of abdomen in 75-year-old woman with lung cancer shows metastatic lesion in liver that measures 2.1 cm in longest diameter (arrow), meeting criteria for
measurable lesion on CT (longest diameter ≥ 10 mm).
American Journal of Roentgenology 2010.195:281-289.
C, Frontal chest radiograph in 52-year-old woman shows mass with longest diameter of 4.2 cm (arrow) representing lung cancer, which meets criteria for measurable
lesion on chest radiography (longest diameter ≥ 20 mm).
[1]. The sum of the longest diameters for all should be noted at baseline and follow-up ex- sions are summarized in Table 1 with a case
target lesions is recorded and used for objec- aminations [1]. example in Figure 4. Assessment of overall
tive tumor response assessment [1] (Fig. 3). RECIST assigns four categories of re- response is based on the evaluations of target
Nontarget lesions include all other lesions sponse: complete response (CR), partial re- and nontarget lesions at each follow-up time
or sites of disease. Measurements of non- sponse (PR), stable disease (SD), and progres- point. The measurements and response as-
target lesions are not required; however, the sive disease (PD) [1]. The criteria of response sessment are often recorded using tumor mea-
presence or absence of each nontarget lesion evaluation of target lesions and nontarget le- surement tables [6] (Fig. 5).
A B C
Fig. 2—Nonmeasurable lesions according to Response Evaluation Criteria in Solid Tumors (RECIST).
A, CT scan of chest in 52-year-old woman with lung cancer shows multiple small nodules in lungs measuring
less than 10 mm; these nodules are miliary metastases.
B, CT scan at level of lung bases in 59-year-old woman with breast cancer shows sclerotic osseous
metastasis (arrow).
C, CT scan of abdomen in 45-year-old man with gastric cancer shows large amount of ascites. Cytology of fluid
was positive for malignant cells, confirming malignant nature of fluid.
D, CT scan of chest in 70-year-old woman with lung cancer shows irregular thickening of interlobular septum and
bronchovascular bundles in lower lobes; these findings are consistent with lymphangitic spread of lung cancer.
D
TABLE 1: Evaluation of Target and Nontarget Lesions by Response Evaluation Criteria in Solid Tumors
(RECIST), Version 1.0
Response Assessment RECIST Guideline, Version 1.0
Evaluation of target lesions
CR Disappearance of all target lesions
PR ≥ 30% decrease in the sum of the longest diameters of target lesions compared with baseline
PD ≥ 20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest
diameter recorded or the appearance of one or more new lesions
SD Neither PR or PD
Evaluation of nontarget lesions
CR Disappearance of all nontarget lesions and normalization of tumor marker level
Incomplete response, SD Persistence of one or more nontarget lesions and/or the maintenance of tumor marker level above the normal limits
PD Appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions
Note—CR = complete response, PR = partial response, PD = progressive disease, SD = stable disease.
American Journal of Roentgenology 2010.195:281-289.
A B C
Fig. 3—Target lesions and their measurement.
A–C, CT images of abdomen in 49-year-old woman with metastatic ovarian cancer show three measurable lesions (liver lesion, peritoneal implant, and enlarged iliac
lymph node) that are selected as target lesions. Measurements of target lesions are 1.9 cm (A), 1.6 cm (B), and 3.1 cm (C), totaling 6.0 cm.
A B
A B
Fig. 5—Screen shots show tumor measurement record of 46-year-old woman with lung cancer.
A, Tumor measurement record lists target lesions with series and image numbers and measurements at baseline and on follow-up CT scans (red square). Nontarget
lesions (yellow square) are also listed. Sum of longest diameters of all target lesions (blue square) is recorded. Percent changes compared with baseline and nadir
(smallest diameter since baseline, pink square) provide response assessment at each follow-up scan.
American Journal of Roentgenology 2010.195:281-289.
B, Graph shows chronologic changes of longest diameters of each target lesion and sum of longest diameters of all target lesions (red line).
Major Imaging-Related Changes in gan and from a maximum of 10 target lesions 5]. Lymph nodes with a short axis of ≥ 15 mm
Revised RECIST Guideline total to a maximum of five total [2] (Figs. 6 are considered measurable and assessable as
Major changes in RECIST 1.1 related and 7). The change is based on the analysis target lesions, and the short-axis measurement
to imaging include the following: first, the of a large prospective database from 16 clini- should be included in the sum of target lesion
number of target lesions; second, assessment cal trials that showed that assessment of five measurements in the calculation of tumor re-
of pathologic lymph nodes; third, clarifica- lesions per patient did not influence the over- sponse as opposed to the longest axis used for
tion of disease progression; fourth, clarifica- all response rate and only minimally affected measurements of other target lesions. Lymph
tion of unequivocal progression of nontarget progression-free survival [3]. nodes with a short axis of < 10 mm are de-
lesions; and, fifth, inclusion of 18F-FDG PET fined as “nonpathologic” (Fig. 8A). All other
in the detection of new lesions [2]. Assessment of Pathologic Lymph Nodes pathologic nodes—that is, those with a short
In RECIST 1.0, there was no clear guide- axis of ≥ 10 mm but < 15 mm—should be
Number of Target Lesions line for lymph node measurement. In RECIST considered nontarget lesions [2] (Fig. 8B).
The number of target lesions to be assessed 1.1, detailed instructions about how to mea- Given the changes made in the assessment
was reduced from five per organ to two per or- sure and assess lymph nodes are provided [2, of pathologic lymph nodes, CR by RECIST 1.1
A B
Fig. 6—Number of target lesions according to revised Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1, has been reduced to up to two target lesions
per organ.
A, CT scan of abdomen in 72-year-old woman with pancreatic cancer shows dominant pancreatic mass (single-headed black arrow) with multiple metastatic lesions in
liver. Using RECIST, version 1.0, up to five lesions per organ (white arrows) could be selected. Double-headed black arrows show longest diameter of each lesion.
B, Using RECIST, version 1.1, which allows only up to two lesions per organ, only two liver lesions should be selected as target lesions (white arrows). Double-headed
black arrows show longest diameter of each lesion.
A B
Fig. 8—Assessment of pathologic lymph nodes by Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
A, CT scan of patient with lung cancer. Subcarinal lymph node measures 12 mm in short axis (arrow) on chest CT, so it should be considered as nontarget lesion according
to RECIST 1.1.
B, CT scan of patient with lung cancer. Precarinal lymph node measures 7 mm in short axis (arrow). Given that short-axis diameter is less than 10 mm, lymph node is
nonpathologic according to RECIST 1.1.
American Journal of Roentgenology 2010.195:281-289.
Fig. 9—Clarification of disease progression. Target lesion at baseline (A) has longest
diameter of 3.0 cm. On follow-up study after initiation of therapy (B), lesion measures
1.0 cm—showing 67% decrease in size compared with baseline. This finding is
consistent with partial response. On further follow-up study (C), lesion has slightly
increased in size and measures 1.3 cm. Because 30% increase in size of lesion since
smallest diameter (nadir) of 1.0 cm, assessment category according to Response
Evaluation Criteria in Solid Tumors (RECIST) 1.0 would be progressive disease and
therapy would be terminated. However, using RECIST 1.1, which requires 5-mm
absolute increase in size in addition to > 20% increase, assessment would be stable
disease and therapy would be continued. If further follow-up showed increase to
diameter of 1.6 cm (D), then criteria for progressive disease according to RECIST 1.1
would be met—that is, > 5 mm absolute increase in size in addition to > 20% increase
compared with nadir.
A B
Fig. 12—FDG PET in detection of new lesions in 48-year-old woman with breast cancer who had negative FDG PET/CT findings at baseline.
A and B, Follow-up FDG PET/CT images show new FDG-avid liver lesion (arrows) representing metastasis. Finding meets criteria for progressive disease using Response
Evaluation Criteria in Solid Tumors 1.1 because new lesion has been detected on FDG PET.
A B
Fig. 13—CT attenuation decrease in gastrointestinal stromal tumor (GIST) treated with tyrosine kinase inhibitor imatinib.
A, CT scan of abdomen in 59-year-old man with gastric GIST shows circumferential mass involving gastric wall (white arrows) and multiple liver masses (black arrows)
representing metastases.
B, Follow-up CT scan of abdomen shows markedly decreased CT attenuation in both gastric and liver lesions (arrows). According to Choi criteria, these changes in CT
attenuation indicate response to imatinib therapy.
American Journal of Roentgenology 2010.195:281-289.
A B
C D
Fig. 14—Paradoxical increase in size of target lesions after targeted therapy in 69-year-old woman with melanoma.
A, Baseline CT scan of abdomen shows two metastatic lesions in liver.
B, Follow-up CT scan obtained after treatment with tyrosine kinase inhibitor, sorafenib, shows increase in size of metastatic liver lesions, measuring 3.9 cm at follow-up
compared with 2.8 cm at baseline and 2.9 cm compared with 1.7 cm at baseline. Note heterogeneous CT attenuation within liver lesions.
C and D, MR images of abdomen show central high signal intensity of lesions (arrows) with surrounding hypointense rim on unenhanced T1-weighted image (C) and
without enhancement on contrast-enhanced T1-weighted image (D).
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American Journal of Roentgenology 2010.195:281-289.
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