Adjuvant holmium-166 radioembolization after radiofrequency ablation in early-stage hepatocellular carcinoma patients

a dose-finding study (HORA EST HCC trial)

Journal article (2024)

Authors

P. Hendriks Leiden University Medical Center
Daphne D.D. Rietbergen Leiden University Medical Center
Arian R. van Erkel Leiden University Medical Center
Minneke J. Coenraad Leiden University Medical Center
E.M. Arntz Radboud University Medical Center
Roel J. Bennink Universiteit van Amsterdam
Andries E. Braat Leiden University Medical Center
L.F. de Geus-Oei RST/Radiation, Science and Technology , Leiden University Medical Center, University of Twente
M.C. Burgmans Leiden University Medical Center
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Department
RST/Radiation, Science and Technology
Copyright: © 2024 P. Hendriks, Daphne D.D. Rietbergen, Arian R. van Erkel, Minneke J. Coenraad, Mark J. Arntz, Roel J. Bennink, Andries E. Braat, L.F. de Geus-Oei, M.C. Burgmans, More Authors
DOI
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https://doi.org/10.1007/s00259-024-06630-z
Holmium-166 Hepatocellular carcinoma Adjuvant therapy Dose-escalation study Radiofrequency ablation Trans-arterial radioembolization
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Published Date

2024

Language

English

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Department

RST/Radiation, Science and Technology

Abstract

Purpose: The aim of this study was to investigate the biodistribution of (super-)selective trans-arterial radioembolization (TARE) with holmium-166 microspheres (166Ho-MS), when administered as adjuvant therapy after RFA of HCC 2–5 cm. The objective was to establish a treatment volume absorbed dose that results in an absorbed dose of ≥ 120 Gy on the hyperemic zone around the ablation necrosis (i.e., target volume). Methods: In this multicenter, prospective dose-escalation study in BCLC early stage HCC patients with lesions 2–5 cm, RFA was followed by (super-)selective infusion of 166Ho-MS on day 5–10 after RFA. Dose distribution within the treatment volume was based on SPECT-CT. Cohorts of up to 10 patients were treated with an incremental dose (60 Gy, 90 Gy, 120 Gy) of 166Ho-MS to the treatment volume. The primary endpoint was to obtain a target volume dose of ≥ 120 Gy in 9/10 patients within a cohort. Results: Twelve patients were treated (male 10; median age, 66.5 years (IQR, [64.3–71.7])) with a median tumor diameter of 2.7 cm (IQR, [2.1–4.0]). At a treatment volume absorbed dose of 90 Gy, the primary endpoint was met with a median absorbed target volume dose of 138 Gy (IQR, [127–145]). No local recurrences were found within 1-year follow-up. Conclusion: Adjuvant (super-)selective infusion of 166Ho-MS after RFA for the treatment of HCC can be administered safely at a dose of 90 Gy to the treatment volume while reaching a dose of ≥ 120 Gy to the target volume and may be a favorable adjuvant therapy for HCC lesions 2–5 cm. Trial registration: Clinicaltrials.gov NCT03437382.