The aim of this study was to compare radio- and pathological changes and test the adjunct efficacy of sorafenib to yttrium-90 radioembolization (Y90) as a bridge to transplantation in HCC. We tested WHO, EASL, RECIST, mRECIST and apparent diffusion coefficient (ADC) values (DWI parameter) as surrogate markers of complete pathological response after randomization to Yttrium-90 AUY-922 research buy radioembolization (Y90) with or without Sorafenib. This is a detailed imaging analysis from a prospective, randomized study of Y90 radioembolization ± sorafenib in HCC patients being bridged to orthotopic liver transplant (OLT). Patients were randomized 1:1 to
Y90 alone (group A) or in combination with sorafenib (group B). The trial was approved by the Northwestern University Institutional Review Board (Chicago, IL), compliant with the Health Insurance Portability and Accountability Act, and has
been registered (NCT00846131). Clinical effects (adverse events, tolerability, and dose reductions) of combining Y90 with sorafenib are beyond the scope of this imaging analysis and are being reported in a separate article focused on clinical outcomes. Inclusion criteria for the study included HCC confirmed KU-57788 by American Association for the Study of Liver Diseases (AASLD) guidelines, Child-Pugh score ≤B8, and candidates for OLT (up to University of California San Francisco [UCSF] criteria). Patients with performance status >2, metastatic disease, tumor-related portal vein thrombosis (PVT), and/or biological or clinical abnormality contraindicating sorafenib or radioembolization were not study candidates. By protocol, patients receiving >2 Y90 treatments were withdrawn from the analysis. Despite being classified as advanced HCC by Barcelona staging (Barcelona Clinic Liver Cancer; BCLC), patients 上海皓元医药股份有限公司 with performance status >0, but with imaging findings of BCLC A, were still considered for transplantation. Between February 2009 and October 2012, 23 patients
(group A: N = 12; group B: N = 11) were enrolled in the study (study flow chart; Fig. 1). Two did not receive therapy: One patient from group A did not have confirmed angiographic hypervascularity at angiography (despite meeting diagnostic criteria), with a subsequent biopsy being negative for malignancy, and 1 from group B died before treatment (ruptured HCC). One patient from group A withdrew consent; that patient was treated off-study with Y90, followed by OLT. The 20 remaining patients comprise the intention-to-treat patient sample (group A: N = 10; group B: N = 10). The study was officially closed on February 7, 2013, when the last remaining patient in group A died of cardiac causes while awaiting transplantation.