166Ho-RadioEmbolizaTiOn Using personalized prediCtive dosimetry in patients with Hepatocellular carcinoma: A prospective, single-centre study (RETOUCH)
Handling Editor: Alejandro Forner.
Abstract
Background and Aims
Holmium-166 (166Ho) radioembolization could offer a more individualized approach in terms of imaging and dosimetry. We aim to evaluate the feasibility and safety of 166Ho selective internal radiation therapy (SIRT) using a higher tumour dose than previously administered determined by 166Ho-scout as a surrogate marker in HCC patients.
Methods
This is an open-label, prospective, non-randomized, single-centre pilot study that included patients with HCC that received 166Ho-SIRT if the work-up using 166Ho-scout showed a tumour-absorbed dose ≥150 Gy, a non-tumoural liver absorbed dose less than 60 Gy and a lung absorbed dose less than 30 Gy. Primary endpoints were feasibility and safety–toxicity profiles at 24–48 h and 1 month. Overall response rates (ORR) at 3 months (mRECIST, RECIST 1.1 and metabolic response by FDG and choline PET CT) and time to progression (TTP) represented the secondary endpoints.
Results
Fifteen patients with large tumours (mean diameter 55.67 ± 28.42 mm) received 17 166Ho-SIRT treatments between July 2020 and June 2022. All the attempted treatments were accomplished. Mean administered tumour dose was 183.18 ± 71.71 Gy, while non-tumour liver dose was 30.29 ± 14.56 Gy. Median time of follow-up was 12 months (IQR 9–16). Only grade 1–2 clinical and biological AEs were observed. There were no liver decompensations. At 3 months, objective response was achieved for all target lesions (CR 78.57%, PR 21.43% according to mRECIST). Median TTP was 18.8 (range 2.9; n.e.) months.
Conclusion
Personalized 166Ho-SIRT with a tumour delivered dose ≥150 Gy was feasible and safe for HCC patients with promising response rates.
CONFLICT OF INTEREST STATEMENT
Ana-Maria Bucalau: no conflict of interest. Benoît Collette: no conflict of interest. Illario Tancredi: consultant for Terumo Europe NV and Boston Scientific. Irina Vierasu: no conflict of interest. Fadi Tannouri: no conflict of interest. Martina Pezzullo: no conflict of interest. Rodrigo Moreno-Reyes: no conflict of interest. Gontran Verset: consultant for Terumo/Quirem; speaker/advisory board for Roche, Astra Zeneca, Eisai, Bayer, Ipsen.
Open Research
DATA AVAILABILITY STATEMENT
All data generated or analysed during this study are included in this article. Further enquiries can be directed to the corresponding author.
