When required then MTLS patients with nonmeasurable disease only are allowed
Minimum target lesion size
≥10 mm (Spiral CT) ≥20 mm (Conventional CT, MRI) Lymph node: not mentioned ≥20 mm (clinical)
≥10 mm (CT + MRI) ≥15 mm lymph nodes ≥20 mm chest X-ray ≥10 mm (clinical)
No. of measurable lesions
1–10 (5 per organ)
1–5 (2 per organ)
Measurement
Unidimensional
Unidimensional Lymph nodes = short axis
PD
20% increase in SLD from Nadir
20% increase in SOD + min. 5 mm increase from Nadir
Confirmation of CR and PR
After at least 28 days CR lymph node not mentioned
Only required, if response is primary endpoint and not randomized
Nonmeasurable assessment
Unequivocal progression considered as PD
(i) substantial worsening, (ii) tumour burden has increased sufficiently
Lymph node measurements
None
Specific instructions ≥15 mm, 10–14 mm, <10 mm CR lymph nodes must be <10 mm short axis
PET
Not available
May be considered to support CT, for PD and confirmation of CR
MTLS: Minimum Target Lesion Size. The size a lesion needs to be selected as a measurable target lesion at Baseline. SLD: old RECIST 1.0 sum of longest diameters for all measured target lesions' diameters to be added up at each time point. SOD: new RECIST 1.1 sum of diameters which are the longest of nonnodal lesions plus the longest of the short axis diameters of lymph nodes for measured target lesions' diameters to be added up at each time point.
