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
 
               
             
          |