1. 90Y Radioembolization versus Drug-eluting Bead Chemoembolization for Unresectable Hepatocellular Carcinoma: Results from the TRACE Phase II Randomized Controlled Trial
- Author
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Elisabeth Dhondt, Bieke Lambert, Laurens Hermie, Lynn Huyck, Peter Vanlangenhove, Anja Geerts, Xavier Verhelst, Maridi Aerts, Aude Vanlander, Frederik Berrevoet, Roberto Ivan Troisi, Hans Van Vlierberghe, Luc Defreyne, Supporting clinical sciences, and Gastroenterology
- Subjects
DOUBLE-BLIND ,INTERNAL RADIATION-THERAPY ,YTTRIUM 90 ,MRECIST ,TRANSARTERIAL CHEMOEMBOLIZATION ,Medicine and Health Sciences ,MULTICENTER ,SURVIVAL ,CONVENTIONAL CHEMOEMBOLIZATION ,Radiology, Nuclear Medicine and imaging ,OPEN-LABEL ,ARTERIAL CHEMOEMBOLIZATION - Abstract
Background: Transarterial chemoembolization (TACE) is the recommended treatment for intermediate hepatocellular carcinoma (HCC) according to the Barcelona Clinic Liver Cancer guidelines. Prospective uncontrolled studies suggest that yttrium 90 (Y-90) transarterial radioembolization (TARE) is a safe and effective alternative. Purpose: To compare the efficacy and safety of TARE with TACE for unresectable HCC. Materials and Methods: In this single-center prospective randomized controlled trial (TRACE), Y-90 glass TARE was compared with doxorubicin drug-eluting bead (DEB) TACE in participants with intermediate-stage HCC, extended to Eastern Cooperative Oncology Group performance status 1 and those with early-stage HCC not eligible for surgery or thermoablation. Participants were recruited between September 2011 and March 2018. The primary end point was time to overall tumor progression (TTP) (Kaplan-Meier analysis) in the intention-to-treat (ITT) and per-protocol (PP) groups. Results: At interim analysis, 38 participants (median age, 67 years; IQR, 63-72 years; 33 men) were randomized to the TARE arm and 34 (median age, 68 years; IQR, 61-71 years; 30 men) to the DEB-TACE arm (ITT group). Median TTP was 17.1 months in the TARE arm versus 9.5 months in the DEB-TACE arm (ITT group hazard ratio [HR], 0.36; 95% CI: 0.18, 0.70; P =.002) (PP group, 32 and 34 participants, respectively, in each arm; HR, 0.29; 95% CI: 0.14, 0.60; P
- Published
- 2022
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