The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. For Patients with Measurable Disease (i.e., Target Disease) Target Non-Target New Overall Best Overall Response when Lesions Lesions Lesions Response Confirmation is Required* CR CR No CR >4 wks. Confirmation** CR No PR CR Not evaluated No PR >4 wks. Confirmation** PR No PR evaluated SD No SD Documented at least once >4 wks. from baseline** evaluated PD Any Yes or No PD Any PD*** Yes or No PD no SD, PR or CR Any Any Yes PD See RECIST 1.1 manuscript for further details on what is evidence of a new lesion. ** Only for non-randomized trials with response as primary endpoint. *** In exceptional circumstances, unequivocal progression in non-target lesions may be accepted as disease progression. Note: Patients with a global deterioration of health status requiring discontinuation of treatment without objective evidence of disease progression at that time should be reported as effort should be made to document the deterioration.” “symptomatic objective progression even after discontinuation of treatment. For Patients with Non-Measurable Disease (i.e., Non-Target Disease) Non-Target Lesions New Lesions Overall Response CR No CR Non-CR/non-PD No Non-CR/non-PD* Not all evaluated No not evaluated Unequivocal PD Yes or No PD Any Yes PD is preferred over disease’ for non-target disease since SD is ‘Non-CR/non-PD’ ‘stable increasingly used as an endpoint for assessment of efficacy in some trials so to assign this category when no lesions can be measured is not advised
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. For Patients with Measurable Disease (i.e., Target Disease) Target Lesions Non-Target Lesions New Lesions Overall Response Best Overall Response when Confirmation is Required* CR CR No CR >4 wks. Confirmation** CR No PR >4 wks. Confirmation** CR Not evaluated No PR PR evaluated No PR SD evaluated No SD Documented at least once >4 wks. from baseline** PD Any Yes or No PD no SD, PR or CR Any PD*** Yes or No PD Any Any Yes PD See RECIST 1.1 manuscript for further details on what is evidence of a new lesion. ** Only for non-randomized trials with response as primary endpoint. *** In exceptional circumstances, unequivocal progression in non-target lesions may be accepted as disease progression. Note: Patients with a global deterioration of health status requiring discontinuation of treatment without objective evidence of disease progression at that time should be reported as “symptomatic deterioration.” effort should be made to document the objective progression even after discontinuation of treatment. For Patients with Non-Measurable Disease (i.e., Non-Target Disease) Non-Target Lesions New Lesions Overall Response CR No CR Non-CR/non-PD No Non-CR/non-PD* Not all evaluated No not evaluated Unequivocal PD Yes or No PD Any Yes PD ‘Non-CR/non-PD’ is preferred over ‘stable disease’ for non-target disease since SD is increasingly used as an endpoint for assessment of efficacy in some trials so to assign this category when no lesions can be measured is not advised
CTEP_Organ_Dysfunction_Protocol_Template.docx