Perceptive
Topic 12 | Section 4.3.4

Change 12: Definition of Unequivocal Progression

RECIST 1.0:

  • …progressive disease –unequivocal progression of existing nontarget lesions.

    (Note: Although a clear progression of non-target lesions only is exceptional, in such circumstances, the opinion of the treating physician should prevail and the progression status should be confirmed later by the review panel [or study chair]).

RECIST 1.1:

  • Unequivocal progression of existing non-target lesions defined as:
    • Overall level of substantial worsening in non-target disease such that, even in presence of SD or PR in target disease, the overall tumor burden has increased sufficiently to merit discontinuation of therapy
    • In the absence of measurable disease, change in non-measurable disease comparable in magnitude to the increase that would be required to declare PD for measurable disease.
    • Examples include an increase in a pleural effusion from ‘trace’ to ‘large’, an increase in lymphangitic disease from localized to widespread

Visit Perceptive Imaging to learn how we leverage our extensive oncology imaging experience to help your trial succeed.

echo $homepage;?>