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

 1. Background 

1.1. History of RECIST criteria

Important endpoints in cancer clinical trials: 
  • Tumor shrinkage (Objective response)
  • Time of the development of disease progression
which are useful only if based on widely accepted and readily applied standard criteria based on anatomical tumour burden. 

Key features of the original RECIST:

  • Definitions of the minimum size of measurable lesions
  • Instructions on how many lesions to follow (up to 10; a maximum five per organ site)
  • Use of unidimensional, rather than bidimensional, measures for the overall evaluation of tumour burden. 

1.2. Why update RECIST? 

To clarify those questions:

  • whether fewer than 10 lesions can be assessed without affecting the overall assigned response for patients (or the conclusion about activity in trials); 
  • how to apply RECIST in randomized phase III trials where progression, not response, is the primary endpoint particularly if not all patients have measurable disease; 
  • whether or how to utilize newer imaging technologies such as FDG-PET and MRI; 
  • how to handle assessment of lymph nodes; 
  • whether response confirmation is truly needed; 
  • the applicability of RECIST in trials of targeted non-cytotoxic drugs. 

2. Purpose 

This guideline describes a standard approach to solid tumour measurement and definitions for objective assessment of change in tumour size for use in adult and paediatric cancer clinical trials. 

There are also separate criteria published for response assessment in malignant brain tumour studies. This guideline is not in- tended for use for studies of malignant lymphoma since international guidelines for response assessment in lymphoma are published separately.

 3. Measurability of tumour at baseline (Measurable v.s. Non-measurable)

3.1.1 Measurable

Tumour lesions: 

Must be accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded) with a minimum size of:

  • 10 mm by CT scan (CT scan slice thickness no greater than 5 mm; see Appendix II on imaging guidance).

  • 10 mm caliper measurement by clinical exam (lesions which cannot be accurately measured with calipers should be recorded as non-measurable).

  • 20 mm by chest X-ray. 

Malignant lymph nodes: 

To be considered pathologically enlarged and measurable, a lymph node must be >=15 mm in short axis when assessed by CT scan. 

At baseline and in follow-up, only the short axis will be measured and followed.


3.1.2 Non-measurable

  • Small lesions (longest diameter <10 mm or pathological lymph nodes with P10 to <15 mm short axis) 
  • Truly non-measurable lesions. 

Lesions considered truly non-measurable include: leptomeningeal dis- ease, ascites, pleural or pericardial effusion, inflammatory breast disease, lymphangitic involvement of skin or lung, abdominal masses/abdominal organomegaly identified by a physical exam that is not measurable by reproducible imaging techniques. 

3.2. Specifications by methods of measurements 

3.2.1. Measurement of lesions 

All baseline evaluations should be performed as close as possible to the treatment start and never more than 4 weeks before the beginning of the treatment. (Baseline evaluations collected <=4 weeks before the treatment starts)
 

3.2.2. Method of assessment 

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.  

  • Clinical lesions: Clinical lesions will only be considered measurable when they are superficial and >=10 mm diameter as assessed using calipers  [Q: Choose "Imaging based evaluations" or "Clinical examinations" ?when lesions can be evaluated by both clinical exam and imaging, imaging evaluation should be undertaken since it is more objective and may also be reviewed at the end of the study. ]
  • Chest X-ray: Chest CT is preferred over chest X-ray, particularly when progression is an important endpoint since CT is more sensitive than X-ray, particularly in identifying new lesions. 
  • CT, MRI: CT is the best currently available and reproducible method to measure lesions selected for response assessment.
  • Ultrasound: If new lesions are identified by ultrasound in the course of the study, confirmation by CT or MRI is advised.  
Reference:

RECISTGuidelines

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