NICE RECOMMENDS BOSTON SCIENTIFIC THERASPHERE™ Y-90 GLASS MICROSPHERES FOR THE TREATMENT OF HEPATOCELLULAR CARCINOMA
LONDON, UK (26 February 2021)
The National Institute for Health and Care Excellence (NICE) has issued guidance recommending the use of TheraSphere™ Y-90 Glass Microspheres for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer with more than 6,400 cases diagnosed annually, through the NHS in England, Wales and Northern Ireland.1
The outcomes of more than 100 clinical studies demonstrate the effectiveness of TheraSphere in improving tumour response across all stages of liver cancer, and in extending and improving the quality of life for patients globally.2 – 9 TheraSphere is a medical device consisting of radioactive yttrium-90 (Y-90) glass microspheres, which are delivered directly to liver tumours via a catheter, resulting in an increased tumour response while preserving surrounding healthy tissue. This targeted treatment is commonly known as selective internal radiation therapy (SIRT).
TheraSphere can be used as an outpatient procedure and typically does not require lengthy hospitalisation, with the potential to alleviate pressure on the NHS. Recent statistics from University College London suggest there could be an additional 18,000 cancer deaths in England due to the COVID-19 pandemic, further highlighting the importance for physicians and patients to have access to new options, such as TheraSphere.10
“Outpatient treatment options are important for patients diagnosed with liver cancer as they are especially vulnerable to complications from COVID-19 and the use of TheraSphere can help avoid risk of exposure to infection in the healthcare setting.” said Jane Healy, vice president Peripheral Interventions, EMEA at Boston Scientific. “We look forward to bringing this proven treatment option to a greater number of patients with hepatocellular carcinoma, to improve their chance of survival against this disease in today’s challenging healthcare landscape and for many years to come.”
Globally, more than 70,000 patients have been treated with TheraSphere, which has been approved for use as an HCC treatment option in 16 other countries. TheraSphere is also indicated for the treatment of metastatic colorectal cancer (mCRC) in patients who have failed second line treatment in the UK. The company plans to further investigate TheraSphere as a treatment for different cancer segments, including prostate and brain cancers.
For information on the NICE Final Appraisal Documnt and guidance, visit link.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.eu and connect on Twitter and Facebook.
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- Globocan https://gco.iarc.fr/ Bray F, Ferlay J, Soerjomataram I, Siegel R, Torre L, Jemal A. Global cancer statistics 2018
- Hilgard P, Hamami M, Fouly AE, et al. Radioembolization with yttrium-90 glass microspheres in hepatocellular carcinoma: European experience on safety and long-term survival. Hepatology 2010;52(5):1741–9
- Riaz A, Gates VL, Atassi B, et al. Radiation segmentectomy: a novel approach to increase safety and efficacy of radioembolization. Int J Radiat Oncol Biol Phys 2011;79(1):163–71
- Mazzaferro V, Sposito C, Bhoori S, et al. Yttrium-90 radioembolization for intermediate-advanced hepatocellular carcinoma: a phase 2 study. Hepatology 2013;57(5):1826–37
- Vouche M, Habib A, Ward TJ, et al. Unresectable solitary hepatocellular carcinoma not amenable to radiofrequency ablation: multicenter radiology-pathology correlation and survival of radiation segmentectomy. Hepatology 2014;60(1):192–201
- Salem R, Lewandowski RJ, Kulik L, et al. Radioembolization results in longer time-to-progression and reduced toxicity compared with chemoembolization in patients with hepatocellular carcinoma. Gastroenterology 2011;140(2):497–507
- Lewandowski RJ, Kulik LM, Riaz A, et al. A comparative analysis of transarterial downstaging for hepatocellular carcinoma: chemoembolization versus radioembolization. Am J Transplant 2009;9(8):1920–8
- Salem R, Gabr A, Riaz A, et al. Institutional decision to adopt Y-90 as primary treatment for HCC informed by a 1,000-patient 15-year experience.Hepatology. 2017 Dec 1
- Garin et al, J Clin Oncol 38, 2020 (suppl 4; abstr 516)
- UCL Cancer Institute - https://www.ucl.ac.uk/cancer/news/2021/feb/cancer-time-covid-keeping-vital-research-and-treatment-track