December 11, 2017
Institutional Decision to Adopt Y90 TARE with TheraSphere® as first-line treatment for HCC

London, UK, 11 December 2017

Based on experience with 1000 patients over 15 years, the largest single-centre, prospective centre cohort of patients with HCC treated with Y90 glass microspheres

BTG plc (LSE: BTG), a global specialist healthcare company, announced a study detailing the positive results of a 15-year experience between 2003 and 2017 with TheraSphere®, and an institution’s decision to adopt Y90 transarterial radioembolisation (TARE) with TheraSphere® as their primary transarterial loco-regional therapy (LRT) for patients with hepatocellular carcinoma (HCC) limited to the liver.1
 
HCC is considered to be the most common primary liver cancer and represents the second most common cause of cancer mortality worldwide.2 The institution’s decision to adopt TARE with TheraSphere® as a first-line transarterial LRT for patients with HCC was informed by data prospectively collected and incrementally reported, demonstrating outcomes as expected by the BCLC algorithm for stages A-D, applied as either neoadjuvant or definitive treatment. Compared with TACE, the data confirm that outpatient TARE allows for fewer treatments, better quality of life, longer time to progression and versatile application as neoadjuvant LRT combined with either resection or orthotopic liver transplantation.1
 
“Patients are looking for treatments that are safe, efficacious, have minimal detrimental effects on their quality of life and as pain free as possible,” said Dr Riad Salem, Chief, Section of Vascular & Interventional Radiology, Department of Radiology at Northwestern University and lead author of the paper “Institutional Decision to Adopt Y90 as Primary Treatment for HCC Informed by a 1,000-patient 15-year Experience” recently accepted for publication in Hepatology.1 “The benefit of Y90 TARE with TheraSphere® include meeting all of these patient needs, enabling outpatient treatment, permitting discharge on the same day, reducing the need for lengthy hospitalisations and minimising impact on daily life. We recognize the many approaches to establishing a new standard of care. In our case, we are proud of the controlled, prospective studies we completed over the last decade, each addressing a specific question, and each getting us closer to the unanimous, multidisciplinary adoption of Y90 as first-line. We are hopeful that when colleagues and peers review the study, the long-term survival outcomes, our rationale and the strength of the evidence, many will follow suit.” 
Peter Pattison, BTG General Manager Interventional Oncology, commented, “We are delighted that Y90 TARE with TheraSphere® has been adopted by these physicians as first line trans-arterial LRT for patients with HCC. Being the first centre to treat 1000 patients represents a major milestone and we are proud to partner with healthcare professionals to deliver improved treatment options for patients.”
 
Since TARE Y90 was FDA approved in 1999 and made available for clinical use in early 2000, radiation therapy has become widely available as an effective option to treat HCC.2  Treatment with Y90 TARE infuses TheraSphere® Y90 glass microspheres into the arteries that feed liver tumours. The microspheres deliver a targeted radiation dose to the tumour, minimising exposure to healthy tissue and can be adapted for each patient, allowing for a personalised treatment approach.
-ENDS-

About BTG Interventional Oncology
BTG Interventional Oncology is transforming the way cancer is treated with wide-ranging solutions consisting of minimally-invasive, highly targeted therapies that can be personalised to each patient’s needs. Our products are used to treat or provide symptomatic relief for people with cancer and benign tumors. To learn more about BTG Interventional Oncology, please follow @BTGIO on twitter or visit:  https://www.btg-im.com.

About TheraSphere®
TheraSphere® Y90 glass microspheres are specifically engineered to carry far greater power than any other Y90 liver-directed cancer therapy, delivering high doses of radiation to liver tumours while sparing normal tissue. The result is a powerful, targeted and well-tolerated therapy that may lead to patients becoming eligible for curative therapies.  In the EU, Singapore, South Korea and Canada, TheraSphere® is approved for the treatment of hepatic neoplasia. In the US, TheraSphere® is approved under a Humanitarian Device Exemption (HDE) for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) who can have placement of appropriately positioned hepatic arterial catheters. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion, when clinical evaluation warrants the treatment. The effectiveness of this device for this use has not been demonstrated. For full instructions for use and important safety information, please visit www.therasphere.com.

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1Salem R et al. Hepatology 2017; Accepted for publication
2 Tanguturi S K et al. The Oncologist 2014; http://theoncologist.alphamedpress.org/content/19/8/868.full Last accessed 6  December 2017   
Disclosure: Dr Riad Salem is an advisor to BTG.