First Summary for New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)


Highlights of revised RECIST 1.1:

Major changes include: 

1. Number of lesions to be assessed: the number of lesions required to assess tumor burden for response determination has been reduced from a maximum of 10 to a maximum of 5 total (and from five to two per organ, maximum). 

2. Assessment of pathological lymph nodes is now incorporated: nodes with a short axis of >=15 mm are considered measurable and assessable as target lesions. 

The short axis measurement should be included in the sum of lesions in the calculation of tumor response.  Nodes that shrink to <10 mm short axis are considered normal. 

3. Confirmation of response is required for trials with response primary endpoint but is no longer required in randomized studies since the control arm serves as appropriate means of interpretation of data. 

[What does "Confirmation of response " refer to?

  • 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 confirmed.
  • 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 appropriate.
  • 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 ]

4. Disease progression is clarified in several aspects: in addition to the previous definition of progression in target disease of 20% increase in sum, a 5 mm absolute increase is now required as well to guard against over-calling PD when the total sum is very small. 



Reference:

https://www.sciencedirect.com/science/article/pii/S0959804908008733?casa_token=c7j8C9hD2lAAAAAA:qZFeWfBZ_xePIB6I415QK0QpRK7hAXFDNK-NY5zXQ0cEwnVlECJ7ZpQMYtfM5pumtC5WnevF

https://en.wikipedia.org/wiki/Response_evaluation_criteria_in_solid_tumors#:~:text=complete%20response%20status.-,Confirmation,the%20responses%20are%20not%20confirmed.



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