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90Y Radioembolization versus Drug-eluting Bead Chemoembolization for Unresectable Hepatocellular Carcinoma: Results from the TRACE Phase II Randomized Controlled Trial.

Authors
  • Dhondt, Elisabeth1
  • Lambert, Bieke1
  • Hermie, Laurens1
  • Huyck, Lynn1
  • Vanlangenhove, Peter1
  • Geerts, Anja1
  • Verhelst, Xavier1
  • Aerts, Maridi1
  • Vanlander, Aude1
  • Berrevoet, Frederik1
  • Troisi, Roberto Ivan1
  • Van Vlierberghe, Hans1
  • Defreyne, Luc1
  • 1 From the Departments of Vascular and Interventional Radiology (E.D., L. Hermie, L. Huyck, P.V., L.D.), Gastroenterology and Hepatology (A.G., X.V., M.A., H.V.V.), and General and HPB Surgery and Liver Transplantation (A.V., F.B.), Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent, Belgium; and the Departments of Diagnostic Sciences (B.L.) and Human Structure and Repair (R.I.T.), Ghent University, Ghent, Belgium. , (Belgium)
Type
Published Article
Journal
Radiology
Publisher
Radiological Society of North America
Publication Date
Jun 01, 2022
Volume
303
Issue
3
Pages
699–710
Identifiers
DOI: 10.1148/radiol.211806
PMID: 35258371
Source
Medline
Language
English
License
Unknown

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 (90Y) 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), 90Y 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 < .001). Median overall survival was 30.2 months after TARE and 15.6 months after DEB-TACE (ITT group HR, 0.48; 95% CI: 0.28, 0.82; P = .006). Serious adverse events grade 3 or higher (13 of 33 participants [39%] vs 19 of 36 [53%] after TARE and DEB-TACE, respectively; P = .47) and 30-day mortality (0 of 33 participants [0%] vs three of 36 [8.3%]; P = .24) were similar in the safety groups. At the interim, the HR for the primary end point, TTP, was less than 0.39, meeting the criteria to halt the study. Conclusion With similar safety profile, yttrium 90 radioembolization conferred superior tumor control and survival compared with chemoembolization using drug-eluting beads in selected participants with early or intermediate hepatocellular carcinoma. Clinical trial registration no. NCT01381211 © RSNA, 2022 Online supplemental material is available for this article.

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