Imaging and tumour response

Due to the lack of specific criteria to assess solid tumor in hollow viscous we moved to a different diagnostic criteria adopting the 3D volume reduction, size attenuation, morphology and structural change on venous phase CT (MASS) [16], contrast enhanced during mod Choi [17] and RECIST criteria [18].

Using standard criteria, RECIST, was not felt to be accurate enough as this could have had underestimated the overall benefit of the treatment.

Since RECIST was published in 2000, many investigators have confirmed in prospective analyses the validity of substituting unidimensional for bi-dimensional based criteria (With rare exceptions (e.g. mesothelioma)). This makes very difficult to quantify the response of solid tumour in allow viscous. We have overcome this limitation by adopting the concept of steady mass through 3 different worldwide, accepted criteria for solid tumor evaluation: MASS that assesses the change in the attenuation patterns of contrast enhancement on contrast-enhanced CT (CECT); RECIST that is the traditional method of evaluating therapy response based on measurements of long-axis tumor size on axial CT according to the Response Evaluation Criteria in Solid Tumors and mChoi criteria that was initially conceived to assess tumor response in patients with advanced gastrointestinal stromal tumors who received treatment with imatinib, and the criteria were evaluated by computed tomography (CT) scans and validated based on progression-free survival.

Grading of the adverse events was determined using CTCAE version 4. Primary endpoints of the study were feasibility, safety and symptoms control Secondary endpoints were response rate (RR), defined as volume reduction of target lesion and overall survival (OS), defined as time from the last TACE-DEBIRI treatment to death.