Minimise toxicity and preserve liver function with Simplicit90Y personalised dosimetry2
Cancer care is multidisciplinary. TheraSphere Y90 Therapy harnesses Simplicit90Y personalised dosimetry to be a minimally invasive, well-tolerated interventional treatment for your patients with HCC. It is a proven and precise therapy that expands your capabilities to achieve tumour response while preserving future treatment options.1
Provide greater survival benefits
➣ Doubled overall survival in patients with unresectable locally advanced HCC following personalised TheraSphere Y90 Therapy vs standard dosimetry2
Survival benefits in the DOSISPHERE-01 trial2
- Overall survival
- Summary
- Study design
Overall survival in the intention-to-treat population
- 26.6 months median OS with personalised dosimetry
(95% CI: 11.7–not reached) - 10.7 months median OS in the standard dosimetry group
(95% CI: 6.0–16.8)
HR: 0.421 (95% CI: 0.215–0.826, P=0.0096)
23 months median OS for PVT patients in personalised arm vs 9.5 months in standard arm
16-month survival improvement
DOSISPHERE-01 trial (Garin et al. 2021)
• Phase II trial
• Randomised
• Multicentre (France)
• Open-label
Patients with unresectable locally advanced HCC
• ≥1 tumour ≥7 cm
• 90% BCLC C
Offer better response rates
➣ Doubled response rates in patients with unresectable locally advanced HCC following personalised TheraSphere Y90 Therapy vs standard dosimetry2
Response rates in the DOSISPHERE-01 trial2
Promote curative options
➣ 36% of patients with unresectable locally advanced HCC accessed liver resection following personalised TheraSphere Y90 Therapy vs standard dosimetry2
Downstaging data in the DOSISPHERE-01 trial2
➣ 44% of PVT patients with unresectable locally advanced HCC accessed liver resection following personalised TheraSphere Y90 Therapy vs standard dosimetry2
Downstaging data for PVT patients in the DOSISPHERE-01 trial2
Reduce the number of liver adverse events with personalised dosimetry compared to standard dosimetry2
| Liver adverse events (Grade ≥3) related to TheraSphere Y90 Therapy* | ||
| Personalised (n=35) | Standard (n=21) | |
| Patients with ≥ 1 AE | 3 (8.6%) | 3 (14.3%) |
| Death | 1 (2.9%) | 1 (4.8%) |
| Liver AEs | 4 (11.4%) | 5 (23.8%) |
| • Ascites | 1 (2.9%) | 2 (9.5%) |
| • Encephalopathy | 0 | 0 |
| • GI haemorrhage | 0 | 2 (9.5%) |
| • Bilirubin increase/jaundice | 1 (2.9%) | 2 (9.5%) |
| • Hepatic failure | 2 (5.7%) | 0 |
*Adverse events occurring in >5% of patients
References
1.Gabr A, al. Liver Transplantation Following Yttrium‐90 Radioembolization: 15‐year Experience in 207‐Patient Cohort. Hepatology 2021;73(3):998-1010.
2.DOSISPHERE-01: Garin E, et al. Personalised 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 Jan;6(1):17-29.
Abbreviations
AE, adverse event; BCLC, Barcelona Clinic Liver Cancer; CI, confidence interval; GI, gastrointestinal; HCC, hepatocellular carcinoma; HR, hazard ratio; mITT, modified intention-to-treat; ORR, objective response rate; PVT, portal vein thrombosis; Y90, yttrium-90.
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.
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.
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