PAREXEL
Topic 

Overview: RECIST vs. RECIST 1.1

  RECIST RECIST 1.1
Measurable Disease at BL Required, MTLS

When required then MTLS, Pats. with non-measurable disease only are allowed

Minimum Target Lesion Size ≥10 mm (Spiral CT)
≥20 mm (Conventional CT, MRI)
≥10 mm (CT + MRI)
≥15 mm Lymph nodes
≥20 mm Chest X-Ray
No. of measurable Lesions, per organ 1-10
5
1-5
2
Measurement

Uni-Dimensional

Uni-Dimensional
Lymph nodes = short axis

PD

20 % increase in SLD from Nadir 20 % increase in SOD
+ min. 5mm increase from Nadir

Confirmation of CR and PR

After at least 28 days

Only required, if response is primary endpoint and not randomized

Non Measurable Assessment

Unequivocal progression

… substantial worsening,
… tumor burden has increased sufficiently

Lymph node Measurements

None Specific instructions
≥15mm, 10-14mm, <10mm

PET

Not available

May be considered to support CT;
for PD and confirmation of CR