1. 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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Hendriks, Pim, Rietbergen, Daphne D. D., van Erkel, Arian R., Coenraad, Minneke J., Arntz, Mark J., Bennink, Roel J., Braat, Andries E., Crobach, Stijn, van Delden, Otto M., Dibbets-Schneider, Petra, van der Hulle, Tom, Klümpen, Heinz-Josef, van der Meer, Rutger W., Nijsen, J. Frank W., van Rijswijk, Catharina S. P., Roosen, Joey, Ruijter, Bastian N., Smit, Frits, Stam, Mette K., and Takkenberg, R. Bart
- Subjects
CATHETER ablation ,HEPATOCELLULAR carcinoma ,RADIOEMBOLIZATION ,ABSORBED dose ,WALKING speed - Abstract
Purpose: The aim of this study was to investigate the biodistribution of (super-)selective trans-arterial radioembolization (TARE) with holmium-166 microspheres (
166 Ho-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 of166 Ho-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) of166 Ho-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 of166 Ho-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) [ABSTRACT FROM AUTHOR]- Published
- 2024
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