In the US, TheraSphere® is authorized by Federal Law 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. Humanitarian Device.1
Common adverse effects include fatigue, pain, and nausea. The majority of adverse effects were mild to moderate in severity and were manageable or resolved over time. For details on rare or more severe adverse effects, please refer to the TheraSphere® Package Insert. 1,3,5
Package Insert – TheraSphere® Yttrium-90 Glass Microspheres – Rev. 12. Biocompatibles UK Ltd, a BTG International group company.
Walrand S, Hesse M, Jamar F, et al. A hepatic dose-toxicity model opening the way toward individualized radioembolization planning. J Nucl Med 2014;55(8):1317–22.
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.
Kennedy A, Nag S, Salem R, et al. Recommendations for radioembolization of hepatic malignancies using yttrium-90 microsphere brachytherapy: a consensus panel report from the radioembolization brachytherapy oncology consortium. Int J Radiat Oncol Biol Phys 2007;68(1):13–23.
Merkel C, Montagnese S, Amodio P. Functional Anatomy of Liver Circulation. Functional Molecular Imaging In Hepatology. Ed. Keiding S, Sørensen M, Bentham Science, 2014.
Pellerin O, Lin M, Bhagat N, et al. Can C-arm cone-beam CT detect a micro-embolic effect after TheraSphere radioembolization of neuroendocrine and carcinoid liver metastasis? Cancer Biother Radiopharm 2013;28(6):459–65.
Kulik M, Carr B, Mulcahy M, et al. Safety and efficacy of Y90 radiotherapy for hepatocellular carcinoma with and without portal vein thrombosis. Hepatology 2008 47(1): 71-81.
Salem R, Lewandowski RJ, Mulcahy MF, et al. Radioembolization for hepatocellular carcinoma using Yttrium-90 microspheres: a comprehensive report of long-term outcomes. Gastroenterology 2010;138(1):52–64.
Llovet JM, Di Bisceglie AM, Bruix J, et al. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst 2008;100(10):698–711.
Reference Manual – TheraSphere® Yttrium-90 Glass Microspheres – Biocompatibles UK Ltd, a BTG International group company.
BTG, Data on File. June 02, 2015.
Salem R, Gilbertsen M, Butt Z, et al. Increased quality of life among hepatocellular carcinoma patients treated with radioembolization, compared with chemoembolization. Clin Gastroenterol Hepatol 2013;11(10):1358–65.
Steel J, Baum A, Carr B. Quality of life in patients diagnosed with primary hepatocellular carcinoma: hepatic arterial infusion of Cisplatin versus Yttrium-90 microspheres (Therasphere). Psycho-Oncology 2004;13(2):73–9.
Lambert B, Sturm E, Mertens J, et al. Intra-arterial treatment with Y90 microspheres for hepatocellular carcinoma: 4 years experience at the Ghent University Hospital. Eur J Nuc Mol Imaging 2011;38(1):2117-2124.
McCann J, Larkin A, Martino L, et al. Radiation emission from patients treated with selective hepatic readioembolization using yttrium-90 microspheres: are contact restrictions necessary? J Vasc Interv Radiol 2012; 23(1):661-667
GLOBOCAN website. http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx. Accessed on June 29, 2015.
American Cancer Society. Liver cancer. Available at www.cancer.org. Accessed June 29, 2015.
Chowdhury R, Satoskar R. Chapter 2: Surveillance for Hepatocellular Carcinoma. Primary Liver Cancer Surveillance, Diagnosis and Treatment. Humana Press; 2012
Kulik LM, Carr BI, Mulcahy MF, et al. Safety and efficacy of Y90 radiotherapy for hepatocellular carcinoma with and without portal vein thrombosis. Hepatology 2008;47(1):71–81.
Abdel-Misih SRZ, Bloomston M. Liver Anatomy. Surgical Clinics 2010;90(4):643–653
Dancygier H. Clinical Hepatology. Springer-Verlag Berlin Heidelberg; 2010.
Canadian Liver Foundation. Cirrhosis of the liver. Available at www.liver.ca. Accessed June 29, 2015.
Eipel C, Abshagen K, Vollmar B. Regulation of hepatic blood flow: The hepatic arterial buffer response revisited. World J Gastroenterol 2010;16(48):6046–6057.
Barrett K, Brooks H, Boitano S, et al. Ganong’s Review of Medical Physiology, 23rd edition. McGraw-Hill; 2012.
Canadian Cancer Society. Liver cancer. Available at www.cancer.ca. Accessed June 29, 2015.
Cancer Research UK. The liver. Available at www.cancerresearchuk.org. Accessed June 29, 2015
National Library of Medicine. How does the liver work. Available at www.ncbi.nlm.nih.gov/pubmedhealth/PMH0072577. Accessed June 29, 2015.
Cancer Research UK. Risks and causes of liver cancer. Available at www.cancerresearchuk.org. Accessed June 29, 2015.
American Cancer Society. What are the risk factors for liver cancer? Available at www.cancer.org. Accessed June 29, 2015.
Wei SJ. All about liver cancer. Available at www.oncolink.org. Accessed June 29, 2015.
Cancer Research UK. Symptoms of liver cancer. Available at www.cancerresearchuk.org. Accessed June 29, 2015.
American Society of Clinical Oncology. Liver cancer: symptoms and signs. Available at: www.cancer.net. Accessed June 29, 2015.
American Society of Clinical Oncology. Liver cancer: diagnosis. Available at: www.cancer.net. Accessed June 29, 2015.
Memorial Sloan Kettering Cancer Center. About liver metastases. Available at www.mskcc.org. Accessed June 29, 2015.
Cancer Research UK. TNM and number stages of bowel cancer. Available at www.cancerresearchuk.org. Accessed June 29, 2015.
American Cancer Society. How is colorectal cancer staged? Available at www.cancer.org. Accessed June 29, 2015.
Canadian Cancer Society. Metastatic cancer. Available at www.cancer.ca. Accessed June 29, 2015.
John Hopkins Medicine. Colorectal Cancer that has spread to the liver. Available at www.hopkinsmedicine.org/liver_tumor_center. Accessed June 29, 2015.
Beating Bowel Cancer. Targeted therapies. Available at www.beatingbowelcancer.org. Accessed June 29, 2015.
Vermaat JS, Nijman IJ, Koudijs MJ, et al. Primary colorectal cancers and their subsequent hepatic metastases are genetically different: implications for selection of patients for targeted treatment. Clin Cancer Res 2012;18(3):688–99.
Corporate and Regional Press Releases
Corporate press releases are selected from information communicated on www.btgplc.com and are selected because the information relates to BTG products available in various countries. The information is not being shared to advocate use of a product outside of its locally approved indication for use.