Transarterial Chemoembolization With Drug-Eluting Beads Versus Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma: Outcomes From a Multicenter, Randomized, Phase 2 Trial (the TRENDY Trial)

Alejandra Méndez Romero*, Bronno van der Holt, Francois E.J.A. Willemssen, Rob A. de Man, Ben J.M. Heijmen, Steven Habraken, Henrike Westerveld, Otto M. van Delden, Heinz Josef Klümpen, Eric T.T.L. Tjwa, Pètra M. Braam, Sjoerd F.M. Jenniskens, Thomas Vanwolleghem, Reinhilde Weytjens, Olivier d'Archambeau, Judith de Vos-Geelen, Jeroen Buijsen, Christiaan van der Leij, Wilhelm den Toom, Dave SprengersJan N.M. IJzermans, Adriaan Moelker

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Purpose: To compare transarterial chemoembolization delivered with drug eluting beads (TACE-DEB) with stereotactioc body radiation therapy (SBRT) in patients with hepatocellular carcinoma (HCC) in a multicenter randomized trial. Methods and Materials: Patients were included if they were eligible for TACE. They could also be recruited if they required treatment prior to liver transplantation. A maximum of four TACE-DEB procedures and ablation after incomplete TACE-DEB were both allowed. SBRT was delivered in six fractions of 8-9Gy. Primary end point was time to progression (TTP). Secondary endpoints were local control (LC), overall survival (OS), response rate (RR), toxicity, and quality of life (QoL). The calculated sample size was 100 patients. Results: Between May 2015 and April 2020, 30 patients were randomized to the study. Due to slow accrual the trial was closed prematurely. Two patients in the SBRT arm were considered ineligible leaving 16 patients in the TACE-DEB arm and 12 in the SBRT arm. Median follow-up was 28.1 months. Median TTP was 12 months for TACEDEB and 19 months for SBRT (p=0.15). Median LC was 12 months for TACE-DEB and >40 months (not reached) for SBRT (p=0.075). Median OS was 36.8 months for TACEDEB and 44.1 months for SBRT (p=0.36). A post-hoc analysis showed 100% for SBRT 1- and 2-year LC, and 54.4% and 43.6% for TACE-DEB (p=0.019). Both treatments resulted in RR>80%. Three episodes of possibly related toxicity grade ≥3 were observed after TACE-DEB. No episodes were observed after SBRT. QoL remained stable after both treatment arms. Conclusions: In this trial, TTP after TACE-DEB was not significantly improved by SBRT, while SBRT showed higher local antitumoral activity than TACE-DEB, without detrimental effects on OS, toxicity and QoL. To overcome poor accrual in randomized trials that include SBRT, and to generate evidence for including SBRT in treatment guidelines, international cooperation is needed.

Original languageEnglish
Pages (from-to)45-52
Number of pages8
JournalInternational Journal of Radiation Oncology Biology Physics
Volume117
Issue number1
Early online date8 Apr 2023
DOIs
Publication statusPublished - 1 Sept 2023

Bibliographical note

Funding Information:
This research was supported by the Dutch Cancer Society (grant reference: KWF-EMCR 2012 – 5527 ).

Publisher Copyright:
© 2023 The Author(s)

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