HCC data overview
PROACTIF: A prospective, real-world, Y-90 study with TheraSphere for the treatment of liver malignancies: interim analysis of 873 hepatocellular carcinoma (HCC) patients.
TheraSphere Y-90 glass microspheres demonstrated high overall survival in intermediate and advanced HCC patients in PROACTIF, the largest, prospective, real-world, Y-90 study of primary liver cancer in 1,000+ patients.
Interim HCC analysis*
870+ patients across 30+ sites demonstrated positive results and builds on previously published landmark trials.
High overall survival for intermediate & advanced stage HCC patients
Subgroup analysis demonstrated prolonged survival in patients who received selective treatment, were ALBI Grade 1, or had Unilobar disease*
Data from 30+ sites used contemporary techniques and dosing*
Real-word treatment scenarios span curative to palliative intent
Majority of patients were intermediate / advanced stage with index lesions > 5cm*
Patient demographics and disease characteristics
Conclusion
Interim analysis of 873 HCC patients across 32 sites demonstrated high overall survival in intermediate and advanced HCC patients. Data builds on evidence from previously published landmark trials such as DOSISPHERE-01 and TARGET.
*Interim data presented at SIR 2024. Data collection as of 12/30/2023. Final results are expected in 2025
** Based on mITT population.
- Garin E, Tselikas L, Guiu B et al. Personalized versus standard dosimetry approach of selective internal radiation therapy in patients with locally advanced hepatocellular carcinoma (DOSISPHERE-01): a randomised, multicentre, open-label phase 2 trial. Lancet Gastroenterol Hepatol. 2021, 6: 17-29.
- Lam, M., Garin, E., Maccauro, M. et al. A global evaluation of advanced dosimetry in transarterial radioembolization of hepatocellular carcinoma with Yttrium-90: the TARGET study. Eur J Nucl Med Mol Imaging (2022). https://doi.org/10.1007/s00259-022-05774-0.
- Garin E, Tselikas L, Guiu B, et al. Long-Term Overall Survival After Selective Internal Radiation Therapy for Locally Advanced Hepatocellular Carcinomas: Updated Analysis of DOSISPHERE-01 Trial. J Nucl Med. 2024;65(2):264-269. Published 2024 Feb 1. doi:10.2967/jnumed.123.266211
Garin E, Bailly C, Letang A et al. Abstract No. 257 • Featured Abstract The PROACTIF French Registry Study of Y-90 Glass Microspheres for the Treatment of Liver Malignancies: Interim Analysis of 670 Hepatocellular Carcinoma (HCC) Patients. J Vasc Interv Radiol. 2024 Mar 35(3):S113 doi: https://doi.org/10.1016/j.jvir.2023.12.295 (updated dataset for oral presentation at SIR March 2024)
TheraSphere is a registered trademark of Theragenics Corporation used under license by Boston Scientific Medical Device Limited, a wholly owned indirect subsidiary of Boston Scientific Corporation.
Caution:
The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.