Supported by comparative Dosisphere data, a phase II multicentric randomised dosimetry trial
LONDON, July 23, 2019 /PRNewswire/ -- BTG plc (LSE: BTG), a global healthcare company, today announced consensus recommendations for personalised treatment for hepatocellular carcinoma (HCC) with TheraSphere™ have been published by an international multidisciplinary working group1. In addition, data from the Dosisphere phase II dosimetry trial supports MAA SPECT/CT based prospective personalised dosimetry2.
Prof Etienne Garin, Nuclear Medicine Physician, Cancer Centre Eugène Marquis, Rennes, France, received the gold medal at the Global Embolisation Oncology Symposium Technologies (GEST) 2019 meeting for his work on the Investigator Initiated Study (IIS) Dosisphere. This study compared the efficacy of TheraSphere in 56 patients with at least one lesion > 7cm, using a personalised approach with Simplicit90Y dosimetry software vs standard dosimetry. Higher response rates of 71% were seen in the personalised prospective dosimetry arm vs 36% with standard dosimetry. "The future for radioembolisation is personalised dosimetry," said Prof Garin, Principal Investigator of the study.
"The working group reached a consensus recommendation on simple, reproducible and evidence-based practice for personalised treatment of HCC patients with TheraSphere™. This publication significantly advances our knowledge of dosimetry and will help to improve clinical outcomes" said Prof Riad Salem, Chief of Interventional Radiology, Northwestern Memorial Hospital, Chicago. The paper1 combines conclusions from the peer-reviewed literature together with expert opinion and includes curative and palliative therapy, categorised into four clinical scenarios: radiation segmentectomy, lobectomy, multifocal unilobar or bilobar disease and HCC with macrovascular invasion. For each scenario, recommendations are provided on patient selection, treatment planning and dosimetry, treatment delivery and outcome assessment and degree of recommendation and the strength of consensus.
Peter Pattison, Head of Interventional Oncology at BTG commented "The consensus guidelines support the advantages of a personalised approach within loco-regional therapies in liver disease to drive better patient outcomes. We are committed to providing personalised solutions that make a real difference to physicians and their patients'.
References:
1. Salem R, Padia S, Lam M et al. Eur J Nucl Med Mol Imaging. 2019 May 16. doi: 10.1007/s00259-019-04340-5. [Epub ahead of print]
2. Garin E, Tselikas L, Guiu B et al. A multicentric randomised study demonstrating the impact of MAA based dosimetry on tumour response with Y90 loaded glass microsphere SIRT for HCC: interim analysis of IIS Dosisphere [Poster presentation ECIO 2019 & oral presentation GEST 2019]
About TheraSphere™
TheraSphere™ is a targeted therapy for the treatment of hepatic neoplasia that consists of millions of glass microspheres containing radioactive Y90. The microspheres are delivered directly to liver tumours through the hepatic artery via catheter and become permanently lodged there. Because the procedure delivers the treatment directly to the liver tumour, the radiation destroys the tumour cells with minimal impact to the surrounding healthy liver tissue. The microspheres continue to deliver radiation to the tumour over the course of several weeks after treatment. Over 30,000 patients worldwide have been treated with TheraSphere™. For full instructions for use and important safety information, please visit therasphere.com.
About Simplicit90Y™
Simplicit90Y™ is a standalone software device developed in collaboration with Mirada Medical Ltd. It is intended for use by Nuclear Medicine (NM) or Radiology practitioners for display, processing and reporting of data, including planar scans (Static, Whole Body) and tomographic scans acquired by gamma cameras or PET scanners. Physicians can use the system for viewing and assessing image data for general clinical diagnostic purposes with additional features and optimised workflow for Y90 dosimetry.
About BTG Interventional Oncology
BTG Interventional Oncology strives to develop ground-breaking technologies, administered using minimally-invasive, image-guided therapies. By specifically targeting diseased cells, we can limit the impact on healthy tissue and bring significant quality of life benefits to patients. Our portfolio of innovative products is used to treat and provide symptomatic relief for people with cancer and benign tumours. We provide high value patient-centric treatment options which include locally-applied embolisation, radiotherapy with Y90 glass microspheres and cryoablation. Modern medicine is evolving and at BTG Interventional Oncology, we believe that intelligent science is the way forward. Please follow @BTGIO on Twitter or visit btg-io.com
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