Table 1. Assessment of response by RECIST 1.0 and RECIST 1.1.

Criteria	RECIST 1.0	RECIST 1.1	Comment
Minimum target lesion diameter by CT or MRI at baseline	≥20 mm	≥10 mm	Entry was restricted to those with measurable disease
Measurable lesions	Up to five per organ and ten lesions in total, representative of all involved organs	Up to two per organ and maximum of five lesions in total, representative of all involved organs
Prior treatment	Tumor lesions that are situated in a previously irradiated area not considered measurable	Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, are usually not considered measurable unless there has been demonstrated progression in the lesion
Non-target lesions	All other lesions (or sites of disease) were identified as non-target lesions and recorded at baseline	Multiple non-target lesions involving the same organ were assessed as a single item on the case record form (e.g., “multiple enlarged pelvic lymph nodes” or “multiple liver metastases”)
Criteria for response (according to sum of target lesions diameters)			Confirmation of CR or PR after at least 28 days required for RECIST 1.0 only and for RECIST 1.1 if primary endpoint Both target and non-target lesions in the liver were assessed at follow-up Note: appearance of new lesion as indicator of progression is only relevant for overall response evaluation
CR	Disappearance of lesions	Disappearance of lesions
PR	≥30% decrease	≥30% decrease
SD	<30% decrease or <20% increase	<30% decrease or <20% increase
PD	Any increase	≥20% or ≥5 mm increase
PET	No specific recommendations	FDG-PET may be considered to complement CT scanning in assessment of progression and the confirmation of CR	Results from PET were not considered in this study

RECIST, Response Evaluation Criteria in Solid Tumors; CT, computed tomography; CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; PET, positron emission tomography.