111IN - Statistician - The basis of RECIST1.1

Date 29 September 2012
Event ESMO Congress 2012
Session ESMO-EANM-ESR Joint symposium: Imaging biomarkers in the era of targeted therapies
Topics Imaging, Diagnosis and Staging
Presenter Jan Bogaerts
Authors J. Bogaerts
  • Statistics Dept, EORTC, 1200 - Brussels/BE


Since its first publication in 2000 (Therasse et al., JNCI 2000) RECIST has become a widely applied method to assess solid tumor response and tumor progression. Advantages include its relative simplicity, the assurance that comparisons between trials can be reasonably applied, and the acceptance of its use in submitted data by regulators. Disadvantages include the difficulty to apply it in several tumor types and the generality of the method which does not have tumor type dependent adjustments.

In 2009 (Eisenhauer et al, EJC 2009) version 1.1 of RECIST was published, with as key updates the restriction of the number of targets to a maximum of five, special considerations for lymph nodes, a minimum increase in the sum of target diameters by 5 mm as an added requirement for progressive disease and a host of further specifications and clarifications. A first limited inclusion of FDG-PET data was also made, but still requiring CT scan confirmation.

Today work on RECIST continues, with extensive statistical analysis ongoing on the existing EORTC RECIST database, as well as efforts to collect FDG-PET data for evaluation of FDG-PET into the methodology. An overview of this work will be presented. Also, many questions exist in the community that may all have an impact on how RECIST should be modified: 3D imaging, the relatively new phenomenon of flare progression caused by some drugs, the extensive use of (RECIST based) progression free survival as a Phase III primary endpoint, the use of some new drugs beyond progression and the multitude of various imaging techniques in various stages of development.

We will also report on the outcomes of an ongoing survey that queries the community for what are seen as the most important items to be addressed by future versions of RECIST.


The author has declared no conflicts of interest.