Samar A Raslan MD, Presenter: Nothing to Disclose

Sophie Egels, Abstract Co-Author: Nothing to Disclose

Michele Lamuraglia MD, Abstract Co-Author: Nothing to Disclose

Stephane Oudard MD, PhD, Abstract Co-Author: Nothing to Disclose

Reza Thierry Elaidi, Abstract Co-Author: Nothing to Disclose

Olivier Lucidarme MD, Abstract Co-Author: Nothing to Disclose

We studied whether CHOI and modified CHOI (mCHOI) criterion might be valuable to assess everolimus efficacy.

We, retrospectively, reviewed the computed tomography (CT) of 105 mRCC patient enrolled in the French centers that participated to the randomized, double-blind, multicenter phase III study comparing Everolimus vs placebo (RECORD-1). In this trial, the primary endpoint was PFS, based on RECIST criteria assessed on CT performed at baseline and every two months. We investigated CT at baseline and two months according to CHOI criteria where partial response (PR) was defined as ≥10% decrease in tumor size OR ≥15% decrease in attenuation; and according to mCHOI criteria where partial response (PR) was defined as ≥10% decrease in tumor size AND ≥15% decrease in attenuation. Mean attenuations were measured on 2D ROI drawn on the targeted lesions on the CT sections where the largest diameter was measured and using 3D ROI of the whole target lesions using a specialized software.

24 patients were in the placebo arm and 48 treated by Everolimus. Median progression free survival (PFS) was 1.9 and 5.5 months (p<0,002), respectively. In the placebo group (mean size/volume variation at 2 months = +11%/+53%), Recist criteria identified 79% of SD and 21% of PD without differences for median PFS (2.3 vs 1.75 months). 2D CHOI criteria identified 25% of PR without differences for median PFS compared to non-responders (2.3 vs 1.8 months, respectively), while mCHOI criteria found 0% of PR. In the Everolimus group (mean size/volume = -1%/-4%), 2% and 98 % of patients were considered PR and SD, respectively with Recist criteria (median PFS=5.5 months for both). 48% of patients were considered PR with 2D CHOI criteria without differences for median PFS compared to non-responders (5.4 and 5.8 months) while mCHOI found 8 % PR without significant differences for PFS (5.4 and 4.6 months). Similar results were obtained using 3D assessment of the attenuation.

Neither Recist, CHOI nor mCHOI criteria could discriminate responders or non-responders patients in the group treated with Everolimus.

We evaluated Recist, Choi and modified Choi criteria to assess everolimus efficacy.In our study,in the group treated with everolimus,they could not discriminate responders from non-responders patients

Raslan, S, Egels, S, Lamuraglia, M, Oudard, S, Elaidi, R, Lucidarme, O, Metastatic Renal Cell Carcinomas Patients Treated with mTOR Inhibitor: Interest of CHOI and Modified CHOI Criterion for Evaluation of Tumor Response.  Radiological Society of North America 2012 Scientific Assembly and Annual Meeting, November 25 - November 30, 2012 ,Chicago IL. http://archive.rsna.org/2012/12032157.html