Purpose: To prospectively compare SIRT and DEB-TACE for treating hepatocellular carcinoma (HCC).
Methods: From 04/2010-07/2012, 24 patients with histologically proven unresectable N0, M0 HCCs were randomized 1:1 to receive SIRT or DEB-TACE. SIRT could be repeated once in case of recurrence; while, TACE was repeated every 6 weeks until no viable tumor tissue was detected by MRI or contraindications prohibited further treatment. Patients were followed-up by MRI every 3 months; the final evaluation was 05/2013.
Results: Both groups were comparable in demographics (SIRT: 8males/4females, mean age 72 ± 7 years; TACE: 10males/2females, mean age 71 ± 9 years), initial tumor load (1 patient ≥25 % in each group), and BCLC (Barcelona Clinic Liver Cancer) stage (SIRT: 12×B; TACE 1×A, 11×B). Median progression-free survival (PFS) was 180 days for SIRT versus 216 days for TACE patients (p = 0.6193) with a median TTP of 371 days versus 336 days, respectively (p = 0.5764). Median OS was 592 days for SIRT versus 788 days for TACE patients (p = 0.9271). Seven patients died in each group. Causes of death were liver failure (n = 4 SIRT group), tumor progression (n = 4 TACE group), cardiovascular events, and inconclusive (n = 1 in each group).
Conclusions: No significant differences were found in median PFS, OS, and TTP. The lower rate of tumor progression in the SIRT group was nullified by a greater incidence of liver failure. This pilot study is the first prospective randomized trial comparing SIRT and TACE for treating HCC, and results can be used for sample size calculations of future studies.