RECIST has been the standard for response evaluation in clinical trials and has supported myriad regulatory approvals in solid tumors. It has provided a methodology for the consistent and reproducible evaluation of imaging and clinical data as a surrogate endpoint for survival and quality of life based endpoints.
In immunotherapy treatments, however, RECIST may not consistently provide the most accurate correlation of overall survival with response by evaluation of tumor burden where a worsening tumor burden is an indicator of progression. The much anticipated 2017 publication of iRECIST provides an opportunity to standardize the approach established with RECIST 1.1 with the evolving therapeutic effects of immunotherapy agents.
In May 2017, Mint Medical was pleased to offer the iRECIST response evaluation template as part of our most recent software release. An important feature of the mintLesion™ platform is the opportunity to conduct multiple criteria analyses on the same imaging datasets. Sites in Europe, Asia, and the USA have already begun using mint Lesion RECIST 1.1 and iRECIST in tandem in the evaluation of clinical trials.