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

 Tumour response evaluation:

1. Assessment of overall tumour burden and measurable disease

To assess the objective response or future progression, it is necessary to estimate the overall tumour burden at baseline and use this as a comparator for subsequent measurements. '

  • When primary endpoint=objective tumor response

Only patients with measurable disease at baseline should be included in protocols 

Measurable disease is defined by the presence of at least one measurable lesion.

  • When primary endpoint = tumour progression (either time to progression or proportion with progression at a fixed date)

The protocol must specify if entry is restricted to those with measurable disease or whether patients having non-measurable disease only are also eligible.


2. Baseline documentation of ‘target’ and ‘non-target’ lesions 

‘Target’ lesions :

  • When >1 measurable lesion is present at baseline all lesions up to a maximum of 5 lesions total (and <=2 lesions per organ) representative of all involved organs should be identified as target lesions and will be recorded and measured at baseline

Q: What are "Target lesions"

A: 1<number of all lesions <=5 measurable lesions, per organ with <=2 lesions >

 (this means in instances where patients have only one or two organ sites involved a maximum of two and four lesions respectively will be recorded). 


  • Target lesions should be selected on the basis of their size (lesions with the longest diameter), be representative of all involved organs, but in addition, should be those that lend themselves to reproducible repeated measurements.  

  • Lymph nodes - pathological nodes that are defined as measurable and may be identified as target lesions must meet the criterion of a short axis of >=15 mm by CT scan. Only the short axis of these nodes will contribute to the baseline sum.

<e.g.  an abdominal node which is reported as being 20mmx30mm has a short axis of 20mm and qualifies as a malignant, measurable node. In this example, 20 mm should be recorded as the node measurement. >

  • A sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) for all target lesions will be calculated and reported as the baseline sum diameters.  

 

‘Non-Target’ lesions :

  • All other lesions (or sites of disease) including pathological lymph nodes should be identified as non-target lesions and should also be recorded at baseline. 
  • Measurements are not required and these lesions should be followed as ‘present’, ‘absent’, or in rare cases ‘unequivocal progression’  
  • it is possible to record multiple non- target lesions involving the same organ as a single item on the case record form (e.g. ‘multiple enlarged pelvic lymph nodes’ or ‘multiple liver metastases). 

Reference:
RECIST guideline (version 1.1)

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