Clinical Benefits

TheraSphere® is specifically engineered to deliver high dose radiation directly to tumors and to maximize convenience for the user, resulting in multiple clinical benefits:1,2,47

  • May allow 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
  • Treatment option for patients with hepatic neoplasia who otherwise have limited choices, such as:
    • Patients with partial or branch PVT5,7,12,13
    • Patients with large tumors or multifocal disease13
    • Patients who are elderly13
    • Patients who have failed or are intolerant to other treatments, such as cTACE3,14
  • Favorable outcomes demonstrated in clinical trials
    • Extended OS in patients treated with TheraSphere® versus standard treatment3,5,7,8
    • Prolonged TTP in patients treated with TheraSphere® versus standard treatment3,5,7,8
    • Primarily transient and mild to moderate adverse effects, with low risk of vascular stasis and gastric ulceration, and extremely low incidence of postembolization syndrome3,5,7,13
  • Minimally embolic therapy11
    • Liver vasculature is preserved, allowing potential retreatment or alternative therapy5,7,11
    • Adequate oxygenation of tumor tissue enhances cell-killing effects of radiation11
    • Low toxicity3,7,11
  • Simple and convenient to use
    • Dose vials are supplied in a ready-to-use format, since the shipping vial and treatment vial are one and the same9,47
    • Efficient and rapid five-minute infusion protocol15,47
    • Standardized, reproducible, consistent, and predictable dosimetry with no adjustment needed for tumor volume9,47
    • Extended shelf life which maximizes dosing flexibility over two weeks15
    • Available in various dose sizes, enabling personalized patient treatment and dose adjustment15,47
  • Minimizes unnecessary radiation exposure to healthcare professionals
    • Dose vial remains shielded by both acrylic and lead during shipping AND patient treatment47
    • No manipulation of the dose vial is needed since the shipping vial and treatment vial are one and the same9,47
    • Acrylic shielding of Administration Accessory Kit as well as around the waste container provides 100% beta radiation protection16,47
    • High delivery efficiency due to minimally embolic effect means there is less 90Y in waste materials that need to be handled after treatment9


Glossary

cTACE = conventional transarterial chemoembolization; HCC = hepatocellular carcinoma; OS = overall survival; PVT = portal vein thrombosis; RFA = radiofrequency ablation; TTP = time to progression; 90Y = yttrium-90