Transarterial Radioembolization Versus Drug-Eluting Beads Chemoembolization For Treatment Of Inoperable Early And Intermediate Hepatocellular Carcinoma: Interim Results Of The Randomized Controlled Trace Trial

to compare the efficacy of Y90 radioembolization (TARE) with drug-eluting beads chemoembolization (DEB-TACE) for early and intermediate hepatocellular carcinoma (HCC), not amenable to curative treatment modalities. Patients with HCC in an early or intermediate Barcelona Clinic Liver Cancer (BCLC) stage A-B, extended to patients with ECOG 1 performance status and/or segmental portal vein thrombosis (PVT), and not eligible for surgery or thermo-ablation were included in a randomized controlled trial comparing TARE with DEB-TACE. Exclusion criteria were: prior tumor treatment in the same segment, > 50% tumor involvement, main and lobar PVT, a Child-Pugh score > 7 and ECOG ≥ 2. DEB-TACE was performed as selective as possible with 100-300 μm and 300-500 μm DEB loaded with a total of 150 mg doxorubicin. DEB-TACE could be repeated up to 3 times per lesion. TARE, using Y90 glass microspheres, was administered lobar or more selective if possible. Bilobar disease was treated with a 30-45 days interval. The administered activity was calculated to deliver an 80-150 Gy dose in the targeted area. The primary endpoint was time to progression (TTP) at 2 years and was assessed by blinded, non-chronological central review according modified Response Evaluation Criteria In Solid Tumors (mRECIST). Secondary endpoints were time to local tumor progression (TLP) in the treated liver volume at 2 years, safety (adverse events and 30-day mortality) and overall survival. Adverse events were recorded according to the Common Terminology Criteria for Adverse Events (CTCAE). 73 patients were included. Five patients were post-hoc excluded. 31 patients received TARE and 37 patients DEB-TACE. Median TTP in the TARE group was 392 days versus 299 days in the DEB-TACE group (P = 0.004). Median TLP for TARE was 497 days versus 350 days for DEB-TACE (P = 0.018). Adverse events CTCAE grade ≥3 (P = 0.3) and 30-day mortality (P = 0.2) were similar in both treatment groups. Median survival in the TARE group was 912 days versus 489 days in the DEB-TACE group (P = 0.008). In the selected BCLC stage A and B HCC patients, TARE was superior to DEB-TACE for tumor control and survival. Safety was similar for both groups.