Topic 12 | Section 4.3.4

Change 12: Definition of Unequivocal Progression


  • …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]).


  • 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
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