33:
216:– all other lesions, including small lesions (longest diameter <20 mm with conventional techniques or <10 mm with spiral CT scan), i.e., bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusion, inflammatory breast disease, lymphangitis cutis/pulmonis, cystic lesions, and also abdominal masses that are not confirmed and followed by imaging techniques.
697:
424:
All of the patients who met the eligibility criteria should be included in the main analysis of the response rate. Patients in response categories 4-9 should be considered as failing to respond to treatment (disease progression). Thus, an incorrect treatment schedule or drug administration does not
420:
All patients included in the study must be assessed for response to treatment, even if there are major protocol treatment deviations or if they are ineligible. Each patient will be assigned one of the following categories: 1) complete response, 2) partial response, 3) stable disease, 4) progressive
245:
When the primary endpoint of the study is objective response evaluation, ultrasound (US) should not be used to measure tumor lesions. It is, however, a possible alternative to clinical measurements of superficial palpable lymph nodes, subcutaneous lesions and thyroid nodules. US might also be useful
464:
published the first tumour response criteria in 1981. However the specification documents were unclear which led to criteria adjustments and inconsistent conclusions. In the mid-1990s, an
International Working Party was created to simplify and standardize response criteria; it then published RECIST
431:
Subanalyses may then be performed on the basis of a subset of patients, excluding those for whom major protocol deviations have been identified (e.g., early death due to other reasons, early discontinuation of treatment, major protocol violations, etc.). However, these subanalyses may not serve as
352:
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement
171:
meant to determine whether patients have improved or not, as these are tumor-centric, not patient centric criteria. This distinction must be made by both the treating physicians and the cancer patients themselves. Many oncologists in their daily clinical practice follow their patients' malignant
249:
The utilization of endoscopy and laparoscopy for objective tumor evaluation has not yet been fully and widely validated. Their uses in this specific context require sophisticated equipment and a high level of expertise that may only be available in some centers. Therefore, the utilization of such
238:
CT and MRI are the best currently available and reproducible methods to measure target lesions selected for response assessment. Conventional CT and MRI should be performed with cuts of 10 mm or less in slice thickness contiguously. Spiral CT should be performed using a 5 mm contiguous
661:
E.A. Eisenhauer; P. Therasse; J. Bogaerts; L.H. Schwartz; D. Sargent; R. Ford; J. Dancey; S. Arbuck; S. Gwyther; M. Mooney; L. Rubinstein; L. Shankar; L. Dodd; R. Kaplan; D. Lacombe; J. Verweij (2009), "New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)",
402:
The clinical relevance of the duration of SD varies for different tumor types and grades. Therefore, it is highly recommended that the protocol specify the minimal time interval required between two measurements for determination of SD. This time interval should take into account the expected
357:
Patients with a global deterioration of health status requiring discontinuation of treatment without objective evidence of disease progression at that time should be classified as having “symptomatic deterioration”. Every effort should be made to document the objective progression even after
172:
disease by means of repeated imaging studies and make decisions about continuing therapy on the basis of both objective and symptomatic criteria. It is not intended that these RECIST guidelines play a role in that decision making, except if determined appropriate by the treating oncologist.
388:
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever status is recorded first) until the first date that recurrence or PD is objectively documented, taking as reference for PD the smallest measurements recorded since the treatment
361:
In some circumstances it may be difficult to distinguish residual disease from normal tissue. When the evaluation of complete response depends on this determination, it is recommended that the residual lesion be investigated (fine needle aspirate/biopsy) to confirm the complete response
411:
For trials where the response rate is the primary endpoint it is strongly recommended that all responses be reviewed by an expert(s) independent of the study at the study's completion. Simultaneous review of the patients’ files and radiological images is the best
376:
To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. Longer intervals as determined by the study protocol may also be
372:
The main goal of confirmation of objective response is to avoid overestimating the response rate observed. In cases where confirmation of response is not feasible, it should be made clear when reporting the outcome of such studies that the responses are not
227:
Clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes). For the case of skin lesions, documentation by color photography, including a ruler to estimate the size of the lesion, is
220:
All measurements should be taken and recorded in metric notation, using a ruler or calipers. All baseline evaluations should be performed as closely as possible to the beginning of treatment and never more than 4 weeks before the beginning of
281:
All other lesions (or sites of disease) should be identified as non-target lesions and should also be recorded at baseline. Measurements of these lesions are not required, but the presence or absence of each should be noted throughout
564:
Michaeli DT, Michaeli T (2022). "Overall
Survival, Progression-Free Survival, and Tumor Response Benefit Supporting Initial US Food and Drug Administration Approval and Indication Extension of New Cancer Drugs, 2003-2021".
250:
techniques for objective tumor response should be restricted to validation purposes in specialized centers. However, such techniques can be useful in confirming complete pathological response when biopsies are obtained.
253:
Tumor markers alone cannot be used to assess response. If markers are initially above the upper normal limit, they must normalize for a patient to be considered in complete clinical response when all lesions have
277:
A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference by which to characterize the objective tumor
271:
All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs should be identified as target lesions and recorded and measured at baseline.
380:
In the case of SD, follow-up measurements must have met the SD criteria at least once after study entry at a minimum interval (in general, not less than 6–8 weeks) that is defined in the study protocol
274:
Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically).
50:
140:
patients improve ("respond"), stay the same ("stabilize"), or worsen ("progress") during treatment. The criteria were published in
February 2000 by an international collaboration including the
608:
Ladanie A, Schmitt AM, Speich B, Naudet F, Agarwal A, Pereira TV, Sclafani F, Herbrand AK, Briel M, Martin-Liberal J, Schmid T, Ewald H, Ioannidis JP, Bucher HC, Kasenda B, Hemkens LG (2020).
141:
318:: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
399:
SD is measured from the start of the treatment until the criteria for disease progression are met, taking as reference the smallest measurements recorded since the treatment started.
200:– the presence of at least one measurable lesion. If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology.
487:
164:
evaluating cancer treatments for objective response in solid tumors use RECIST. These criteria were developed and published in
February 2000, and subsequently updated in 2009.
421:
disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 9) unknown (not assessable, insufficient data).
239:
reconstruction algorithm. This applies to tumors of the chest, abdomen and pelvis. Head and neck tumors and those of extremities usually require specific protocols.
465:
in 2000. These new criteria have been widely adopted and embraced by the regulatory authorities. The mean response rate for new cancer drugs approved by the U.S.
312:: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
261:
in rare cases (e.g., after treatment to differentiate between residual benign lesions and residual malignant lesions in tumor types such as germ cell tumors).
180:
The RECIST specification establishes a minimum size for measurable lesions, limits the number of lesions to follow and standardizes unidimensional measures.
97:
224:
The same method of assessment and the same technique should be used to characterize each identified and reported lesion at baseline and during follow-up.
69:
206:– lesions that can be accurately measured in at least one dimension with longest diameter ≥20 mm using conventional techniques or ≥10 mm by
432:
the basis for drawing conclusions concerning treatment efficacy, and the reasons for excluding patients from the analysis should be clearly reported.
242:
Lesions on chest X-ray are acceptable as measurable lesions when they are clearly defined and surrounded by aerated lung. However, CT is preferable.
76:
83:
481:
523:
Wolchok JD; Hoos A; O'Day S; Weber JS; Hamid O; Lebbé C; Maio M; Binder M; Bohnsack O; Nichol G; Humphrey R; Hodi FS. (December 1, 2009).
65:
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116:
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result in exclusion from the analysis of the response rate. Precise definitions for categories 4-9 will be protocol specific.
610:"Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016"
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Only patients with measurable disease at baseline should be included in protocols where objective tumor response is the
337:: Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits
207:
43:
461:
149:
764:
525:"Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria"
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306:: At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD
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to confirm the complete disappearance of superficial lesions usually assessed by clinical examination.
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Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions
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743:. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).
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Guidelines and information from
European Organization for Research and Treatment in Cancer
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331:: Disappearance of all non-target lesions and normalization of tumor marker level
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clinical benefit that such a status may bring to the population under study.
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Response
Evaluation Criteria in Solid Tumors (RECIST) Quick Reference
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were developed and are used in some immunotherapy clinical trials.
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469:, expressed as relative risk, ranges between 1.38x and 2.37x.
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Cytology and histology can be used to differentiate between
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Baseline documentation of "target" and "non-target" lesions
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All conclusions should be based on all eligible patients.
136:) is a set of published rules that define when tumors in
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Full presentation of newer guideline (14.7 MB; .pdf)
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Surveillance, Epidemiology, and End
Results database
57:. Unsourced material may be challenged and removed.
435:The 95% confidence intervals should be provided.
353:of both measurement and confirmation criteria
160:Clinical Trials Group. Today, the majority of
66:"Response evaluation criteria in solid tumors"
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130:Response evaluation criteria in solid tumors
18:Response Evaluation Criteria in Solid Tumors
335:Incomplete response or stable disease (SD)
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444:The RECIST criteria present problems for
117:Learn how and when to remove this message
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735:Eur J Cancer. 2009 Jan;45(2):228-47.
482:PET response criteria in solid tumors
300:: Disappearance of all target lesions
7:
55:adding citations to reliable sources
348:Evaluation of best overall response
158:National Cancer Institute of Canada
626:10.1001/jamanetworkopen.2020.24406
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726:RECIST article published in JNCI
700: This article incorporates
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450:immune-related response criteria
323:Evaluation of non-target lesions
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42:needs additional citations for
167:The criteria are specifically
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713:National Institutes of Health
542:10.1158/1078-0432.CCR-09-1624
384:Duration of overall response
358:discontinuation of treatment.
567:Journal of Clinical Oncology
467:Food and Drug Administration
292:Evaluation of target lesions
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741:10.1016/j.ejca.2008.10.026
676:10.1016/j.ejca.2008.10.026
664:European Journal of Cancer
394:Duration of stable disease
341:Progressive disease (PD):
720:Citation / External links
462:World Health Organization
150:National Cancer Institute
745:Guidelines (version 1.1)
316:Progressive disease (PD)
702:public domain material
511:Eisenhauer et al. 2009
329:Complete response (CR)
298:Complete response (CR)
233:Methods of measurement
214:Non-measurable lesions
416:Reporting of results
304:Partial response (PR)
579:10.1200/JCO.22.00535
51:improve this article
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310:Stable disease (SD)
204:Measurable lesions
198:Measurable disease
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