FAQs

 

Frequently Asked Questions

 

How is TheraSphere® administered?

TheraSphere® is injected into the hepatic artery through a catheter that is inserted in the upper leg.1 The tiny radioactive glass microspheres flow directly into the liver tumor and become permanently lodged in the small blood vessels of the tumor.11 The radiation destroys tumor cells from within the tumor, with minimal impact to the surrounding healthy liver tissue.4,11,12

How does TheraSphere® minimize unnecessary radiation exposure to healthcare professionals and patients?

Treatment with TheraSphere® has been optimized to minimize unnecessary radiation exposure through the packaging of the dose vial, use of the Administration Accessory Kit and the radiation dose delivery mechanism.

The TheraSphere® dose vial remains shielded by both acrylic and lead during shipping AND patient treatment.1 There is no manipulation of the dose vial needed during treatment preparation since the shipping vial and treatment vial are one and the same.1,9

During the TheraSphere® treatment process, acrylic shielding of the Administration Accessory Kit and the waste container provides 100% beta radiation protection.1,16 Additionally, the high delivery efficiency due to the minimally embolic effect results in less 90Y in the waste materials handled after treatment.9

The tiny radioactive glass microspheres of TheraSphere® flow directly into the liver tumor and become permanently lodged in the small blood vessels of the tumor.11 The radiation destroys tumor cells from within the tumor, with minimal impact to the surrounding healthy liver tissue.4,11,12 Although the microspheres will continue to emit radiation for some time after TheraSphere® treatment, radiation levels decrease to about 15% of initial levels after one week and to insignificant levels soon thereafter.1 There are no precautions required following patient discharge from hospital.

Are there any risks associated with TheraSphere® use?

TheraSphere® is suitable for patients in whom either the liver is the only site of disease or the liver is the major site of disease.1 The effects of TheraSphere® on tumors outside the liver has not yet been studied.

TheraSphere® treatment has some common side effects that may occur throughout the first week after treatment, including mild to moderate fatigue, pain and nausea.1,3,5,7 Physicians describe these symptoms as similar to those of the common flu. Some patients may experience loss of appetite and temporary changes in liver blood tests.1,3,5,7 Rare but more severe side effects are possible.1 For more information, please refer to the TheraSphere® Package Insert.1

A retrospective study of 121 patients from five clinical trials has shown that the following five Pre-treatment High-Risk Factors have been associated with at least 48% of all serious adverse events that were possibly related to use of the device and with 11 of the 12 deaths that were possibly related to use of the device:1

  • Infiltrative tumor type
  • "Bulk disease” (tumor volume >70% of the target liver volume, or tumor nodules too numerous to count)
  • AST or ALT >5 × ULN
  • Bilirubin >2 mg/dL
  • Tumor volume >50% combined with an albumin <3 g/dL

The physician should always take the above-noted Pre-treatment High-Risk Factors into consideration for each patient when making decisions regarding the use of TheraSphere® for treatment.

How do I get more information on TheraSphere®?

Call +1 866 363 3330 or e-mail TheraSphereCustomerSupport@btgplc.com.

Will insurers pay for TheraSphere® treatment?

TheraSphere® reimbursement is specific to your geographic region. Please consult Reimbursement for more information.

Who administers TheraSphere®

TheraSphere® is usually administered by an interventional radiologist under the supervision of a radiation oncologist, or nuclear medicine physician. These specialists are part of a multidisciplinary team that may also include a surgeon, hepatologist, and medical oncologist.

Can TheraSphere® treatment make a previously unresectable liver tumor operable?

TheraSphere® allows patients with unresectable liver cancer 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 transplant.7,8

What does treatment with TheraSphere® cost?

Treatment costs will vary based upon the number of treatments required and by the institution administering the treatment. Please contact BTG customer Services at +1-866-363-3330 for specific pricing information in your territory.

Where is TheraSphere® currently being used?

TheraSphere® is being used at a number of private and academic medical centers. Please refer to our Treatment Centers map to locate a center near you.

Can I use TheraSphere® at my medical facility?

For information about TheraSphere® for use in your facility please call BTG at +1 866 363 3330 or email TheraSphereCustomerSupport@btgplc.com. BTG will ship to facilities with the appropriate radioactive materials license. Please refer to the TheraSphere® Package Insert for additional information.


What is the primary mechanism of action of TheraSphere® and how does it differ from other radioembolisation products?

 

TheraSphere ® yttrium-90 glass microspheres have a high specific activity which means that fewer microspheres are administered to achieve the desired dose. As a result, TheraSphere® works predominantly through radiation, with a microembolic effect11,51 which allows the microspheres to lodge deeper inside the tumour, achieving a high absorbed dose.49 Other 90Y microspheres have a lower specific activity and their mechanism of action is a combination of embolisation with lower levels of radiation.

What is the primary mechanism of action of TheraSphere® and how does it differ from other radioembolisation products?

Phase III clinical trials with TheraSphere® include STOP-HCC and EPOCH. The STOP-HCC in intermediate and advanced HCC compares sorafenib to TheraSphere® + sorafenib. Recruitment is ongoing with over 360 patients required in each study. The EPOCH study compares standard of care chemotherapy to chemotherapy + TheraSphere® in second-line colorectal liver metastases patients. For further information on these trials, please go the TheraSphere® clinical trials website at www.theraspheretrials.com or consult www.clinicaltrials.gov under the name TheraSphere™ for official clinical trial information.

BTG is also conducting a retrospective TARGET study that incorporates the innovative Simplicit90Y® dosimetry software to interactively tailor the absorbed dose while improving and accelerating dosimetry workflow. The TARGET study (TheraSphere Advanced Dosimetry Retrospective Global Study Evaluation in Hepatocellular Carcinoma Treatment) is a multicentre global study evaluating dose to two compartments (normal tissue and tumour absorbed dose) in an effort towards a more personalised approach to 90Y SIRT. The ability of TheraSphere® to selectively deliver a high absorbed dose to the tumour, without compromising patient safety, is fundamental to achieving improved patient outcomes.

READ90Y (RadioEmbolisation for the ADvancement of 90Y Glass Microspheres) is a global registry to prospectively collect clinical practice data and answer data gaps beyond the phase III clinical trial program. It is a collaboration between BTG and SYNERGY. The READ90Y registry (integrating Simplicit90Y™ software) will create an environment for data collection, enabling timely information sharing of clinical outcomes to help identify the best candidate for TheraSphere™ therapy. With both the TARGET study and READ90Y registry, physicians will be better equipped to optimize dose to tumour, minimise dose to normal tissue and personalise 90Y SIRT for individual patient treatment needs.

What is the safety profile of TheraSphere®?

A systematic review of 25 published studies, involving 2,165 HCC or mCRC patients treated with TheraSphere® (the largest ever conducted for 90Y SIRT), demonstrated that the majority of adverse events are mild to moderate in severity and are manageable or resolve over time. 1,3,5,52,55 Common adverse effects include fatigue, pain, and nausea, and may occur throughout the first week after treatment.1,3,5,7 Physicians describe these symptoms as similar to those of the common flu. Some patients may experience loss of appetite and temporary changes in liver blood tests.1,3,5,7 Rare but more severe side effects are possible.1
For more information, please refer to the TheraSphere® Instructions For Use.

What are the risk factors to consider for patient selection?

The physician should always take the below-noted pre-treatment high-risk factors into consideration for each patient when making decisions regarding the use of TheraSphere® for treatment:

  • Infiltrative tumour type
  • Bulk disease” (tumour volume >70% of the target liver volume, or tumour nodules too numerous to count)
  • AST or ALT >5 × ULN
  • Bilirubin >2 mg/dL
  • Tumour volume >50% combined with an albumin <3 g/dL