Clinical Benefits


 
TheraSphere™ uses radiation as the primary mode of action to deliver high absorbed dose coverage to the tumour.1,2
  • Patients with PVT5,7,12,13
  • Patients with large tumours or multifocal disease13
  • Patients who are elderly13
  • Patients who have failed or are intolerant to other treatments, such as cTACE3,14
  • Allows patients with HCC who would otherwise be ineligible for potentially curative therapies (such as RFA, resection, or transplant) to, in some cases, become eligible through downstaging of disease or bridging to transplant7,8
  • Significantly predicted response with a threshold of 500 Gy to the tumour5
  • Extended OS3,5,7,8
  • More complete pathologic necrosis observed when the delivered dose is >190 Gy in ≤2 segments in patients resected for transplantation6
  • Prolonged TTP3,5,7,8
  • Primarily transient and mild to moderate adverse effects, with low risk of vascular stasis and gastric ulceration, and extremely low incidence of radioembolisation-induced liver disease and postembolisation syndrome3,5,7,13
  • Liver vasculature is preserved, allowing potential retreatment or alternative therapy5,7,11
  • Adequate oxygenation of tumour tissue enhances cell-killing effects of radiation11
  • Minimal exposure to normal tissue3,7,11
  • Systematic review of 24 published studies, involving 1,634 HCC patients treated with TheraSphere, demonstrated low incidence of common adverse effects and gastric ulceration1,52,55
  • Dose vials are supplied in a ready-to-use format, since the shipping vial and treatment vial are one and the same1,9
    • Six standard vial sizes: 3, 5, 7, 10, 15, and 20 GBq
    • Custom vial sizes available in 0.5 GBq increments, between 3 and 20 GBq
  • Efficient and rapid five-minute infusion protocol1,15
  • Standardised, reproducible, consistent, and predictable dosimetry with no adjustment needed for tumour volume1,9
  • Extended shelf life, which maximises dosing flexibility over two weeks15
  • Available in various dose sizes, enabling personalised patient treatment and dose adjustment1,15
  • Dose vial remains shielded by both acrylic and lead during shipping AND patient treatment1
  • No manipulation of the dose vial is needed since the shipping vial and treatment vial are one and the same1,9
  • Acrylic shielding of Administration Accessory Kit as well as around the waste container provides 100% beta radiation protection1,16
  • High delivery efficiency due to microembolic effect means there is less 90Y in waste materials that need to be handled after treatment9
 
Glossary
cTACE = conventional transarterial chemoembolisation; HCC = hepatocellular carcinoma; mCRC = metastatic colorectal cancer;
OS = overall survival; PVT = portal vein thrombosis; RFA = radiofrequency ablation; TTP = time to progression; 90Y = yttrium-90