Response Evaluation Criteria in Solid Tumors (RECIST v 1.1). Selected sections from the Response Evaluation Criteria in Solid Tumors (RECIST) (Xxxxxxxxxx EA et al), Version 1.1 are presented below, with slight modifications and the addition of explanatory text as needed for clarity. At baseline, tumor lesions/lymph nodes will be categorized measurable or non-measurable as follows. • 10 mm by computed tomography (CT) or magnetic resonance imaging (MRI) scan (CT/MRI scan slice thickness/interval no greater than 5 mm) • 10-mm caliper measurement by clinical examination (lesions that cannot be accurately measured with calipers should be recorded as non-measurable) • 20 mm by chest X-ray At baseline and in follow-up, only the short axis will be measured and followed. See also notes below on “Baseline Documentation of Target and Non-Target Lesions” for information on lymph node measurement. Non-measurable tumor lesions encompass small lesions (longest diameter < 10 mm or pathological lymph nodes with ≥ 10 to < 15 mm short axis), as well as truly non-measurable lesions. Lesions considered truly non-measurable include leptomeningeal disease, ascites, pleural or pericardial effusion, inflammatory breast disease, lymphangitic involvement of skin or lung, peritoneal spread, and abdominal masses/abdominal organomegaly identified by physical examination that is not measurable by reproducible imaging techniques. Bone lesions, cystic lesions, and lesions previously treated with local therapy require particular comment, as outlined below.
