Adjuvant holmium-166 radioembolization after radiofrequency ablation in early-stage hepatocellular carcinoma patients: a dose-finding study (HORA EST HCC trial)

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2024年2月8日

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Pim Hendriks,
Daphne D. D. Rietbergen,
Arian R. van Erkel,
Minneke J. Coenraad,
Mark J. Arntz,
Roel J. Bennink,
Andries E. Braat,
Stijn Crobach,
Otto M. van Delden,
Petra Dibbets-Schneider,
Tom van der Hulle,
Heinz-Josef Klümpen,
Rutger W. van der Meer,
J. Frank W. Nijsen,
Catharina S. P. van Rijswijk,
Joey Roosen,
Bastian N. Ruijter,
Frits Smit,
Mette K. Stam,
R. Bart Takkenberg,
Maarten E. Tushuizen,
Floris H. P. van Velden,
Lioe-Fee de Geus-Oei,
Mark C. Burgmans

摘要

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. (registered: 19-02-2018)