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INTERVENTIONAL ONCOLOGY

Clinical
evidence

20+ years of interventional oncology research

Our interventional oncology portfolio is backed by over 20 years of clinical research, driving the transition from palliative to curative intent, unlocking the potential of personalised dosimetry and exploring new indications for both TheraSphereTM Y-90 therapy and cryoablation

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$8M

Investment

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>3,000

Patients enrolled in IO clinical trials

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50

Global IO investigator-initiated research studies

In addition to the studies we initiate, we work with you to support your research and evidence generation to help advance the field of interventional oncology, expand technology applications and generate data on combination therapies. 

Our investment in research provides you with the evidence you need to be confident in recommending proven interventional oncology strategies to your peers and choose the best treatment for each patient.



Clinical evidence with TheraSphere in liver cancer

For over 20 years, we have been making significant investments in advancing clinical data for TheraSphere (Y-90 SIRT treatment).

With clinical studies enrolling more than 2,000 patients worldwide, we have been building robust evidence of the benefits it offers. From bridging and downstaging to lobectomy and segmentectomy, the versatility of TheraSphere has been proven in more than 50 publications, and more data is on its way.

Ochsner tumour dose analysis

Retrospective, single-centre analysis of solitary HCC patients (n=56) with TheraSphere Y-90 Glass Microspheres.

97%

Durable response at 2 years.

99%

Median target tumour necrosis*

*in 15 patients who received liver transplant

PROACTIF study: interim HCC and iCC data

PROACTIF is the largest, prospective, real-world, Y-90 study of primary liver cancer in 1,000+ patients.

In interim HCC analysis 873 patients across 32 sites TheraSphere Y-90 glass microspheres demonstrated positive results and builds on previously published landmark trials.

Interim data of 168 iCC patients across 32 sites demonstrated an overall survival of 18.1 months.

 21.1 months

Median overall survival for intermediate and advanced stage HCC patients

 18.1 months

Median overall survival for iCC patients

EPOCH clinical trial

EPOCH is the only positive Level-1, Phase III, randomised controlled trial using SIRT to treat colorectal liver metastases (CLM).

EPOCH showed significantly improved survival rates in patients treated with 2nd-line chemotherapy plus TheraSphere vs those treated with chemotherapy alone.

 31%

Risk reduction of overall progression or death

41%

Risk reduction of hepatic progression or death

DOSISPHERE-01 clinical trial

Level 1 evidence of benefits of using personalised multi-compartment dosimetry approach compared to a standard, single compartment dosimetry approach.

26.6 months

Overall survival in personalised dosimetry arm

10.7 months

Overall survival in standard dosimetry arm

LEGACY study

A robust multicentre study confirming TheraSphere as a neoadjuvant or standalone therapy in treating primary liver cancer (HCC).

100% 

Patients responded to TheraSphere

93% 

Objective response rate (with TAD predictive of response)

TARGET study

A global real-world retrospective study that confirms TheraSphere for HCC as safe and effective, demonstrating predictable clinical outcomes across a broad patient population in 8 countries.

20.3 months 

Median overall survival (with TAD* predictive of survival)

70.8%

Objective response rate (with TAD predictive of response)

* tumour-absorbed dose


Clinical evidence for cryoablation

We invest in exploring new cryoablation treatment options for our clinicians and patients in the fight against different types of cancer.

With decades of clinical evidence in urological cancers, cryotherapy has emerged as a versatile therapy for the treatment of renal cell carcinoma, pulmonary metastases, bone metastases ad palliation of non-oncologic pain.

MOTION multicentre study

A multicentre study showing that cryoablation offers effective palliation for painful bone metastases with a corresponding increase in quality of life.

92% of participants

Achieved pain palliation

Over 6 months 

Consistent improvement in quality of life

ECLIPSE multicentre study

A multicentre study showing that cryoablation offers long-term local disease control and favourable survival rates in patients with metastatic pulmonary tumours.. 

79.2% 

5-year local tumour control rate 

46.7% 

5-year overall survival


References:
PROACTIF: 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)

Garin E, Brenot-Rossi I, Tlili G et al. Abstract 222.4 Treatment of intrahepatic cholangiocarcinoma with Y-90 glass microspheres in the PROACTIF study. ECIO 2024 Book of Abstracts. Cardiovasc Intervent Radiol 47 (Suppl 4); 2024. p.60 https://doi.org/10.1007/s00270-024-03732-x

EPOCH:  Mulcahy, M. et al, Radioembolization With Chemotherapy for Colorectal Liver Metastases: A Randomized, Open-Label, International, Multicenter, Phase III Trial (EPOCH). Journal of Clinical Oncology, 20 Sept 2021.


DOSISPHERE: 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

LEGACY: Salem R et al. “3020.2: Yttrium-90 Glass Microspheres in the Treatment of Hepatocellular Carcinoma: The LEGACY Study,” CIRSE 2020 Virtual Summit, September 12-15, 2020.

TARGET: Lam, Marnix. A Global Study of Advanced Dosimetry in the Treatment of Hepatocellular Carcinoma with Yttrium-90 Glass Microspheres: Analyses from the TARGET Study. Presented at SIR. March 25, 2021

MOTION: Jack W. Jennings, MD, PhD et al. Cryoablation for Palliation of Painful Bone Metastases: the MOTION Multicenter Study. Radiology: Imaging Cancer 2021; 3(2):e200101, 

ECLIPSE: Thierry de Baère, MD et al. The ECLIPSE Study: Efficacy of Cryoablation on Metastatic Lung Tumors with a 5-Year Follow-up.  Journal of Thoracic Oncology • August 2021

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.