NICE recommends selective internal radiation therapies for the treatment of hepatocellular carcinoma

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The National Institute for Health and Care Excellence (NICE) has issued guidance recommending the use of selective internal radiation therapy (SIRT) for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer, with more than 6,400 cases diagnosed annually through the National Health Service (NHS) in England, Wales, and Northern Ireland. 

The NICE website states: “After considering the feedback from consultation, the Appraisal Committee has prepared a Final Appraisal Determination (FAD) on Selective internal radiation therapies (SIRT) for treating hepatocellular carcinoma [ID1276] and submitted it to the Institute.”

This document includes recommendations for SIR-Spheres (Sirtex) and TheraSphere Y-90 glass microspheres (Boston Scientific).

Specifically, it reads:

“The SIRT SIR-Spheres is recommended as an option for treating unresectable advanced hepatocellular carcinoma (HCC) in adults, only if:

  • used for people with Child-Pugh grade A liver impairment when conventional transarterial therapies are inappropriate, and
  • the company provides SIR-Spheres according to the commercial arrangement.

“The SIRT TheraSphere is recommended as an option for treating unresectable advanced hepatocellular carcinoma (HCC) in adults, only if:

  • used for people with Child-Pugh grade A liver impairment when conventional transarterial therapies are inappropriate, and
  • the company provides TheraSphere according to the commercial arrangement.”

The SIRT QuiremSpheres (Terumo) is not recommended, within its CE marking, for treating unresectable advanced HCC in adults.

SIRT can be used performed an outpatient procedure and typically does not require lengthy hospitalisation, with the potential to alleviate pressure on the NHS. Recent statistics from University College London suggest there could be an additional 18,000 cancer deaths in England due to the COVID-19 pandemic, which Boston Scientific and Sirtex say further highlights the importance for physicians and patients having access to new options.

At the virtual 2020 meeting of the Cardiovascular and Interventional Radiological Society of Europe (12–15 September, online), positive results from the largest European-wide observational study on the treatment of primary and metastatic liver tumours with SIR-Spheres microspheres were presented, demonstrating the product’s safety and showing good overall survival from its 1,027-patient cohort for the first time.

“It is excellent news that NICE has recommended SIRT for the treatment of HCC,” comments Paul Ross, consultant medical oncologist at Guy’s & St. Thomas’ NHS Foundation Trust and clinical lead for HCC at King’s College Hospital (both London, UK). “The expanded options will advance the quality of life for patients and provide meaningful alternatives to existing treatments.”

“The British Liver Trust is delighted that NICE has now approved the use of SIRT as an option for treating unresectable advanced HCC in adults,” says Pamela Healy OBE, chief executive of the British Liver Trust. “HCC is the most common form of liver cancer. It is particularly aggressive and a diagnosis is devastating for patients, carers and their families. Treatment options for patients with advanced liver cancer have been very limited and this decision will make this innovative treatment more easily available and improve options for patients. Evidence shows that outcomes for people with advanced liver cancer are particularly poor so this is a very important step.”

As stated in a Boston Scientific press release, the outcomes of more than 100 clinical studies demonstrate the effectiveness of TheraSphere in improving tumour response across all stages of liver cancer, and in extending and improving the quality of life for patients globally. TheraSphere is a medical device consisting of radioactive yttrium-90 (Y-90) glass microspheres, which are delivered directly to liver tumours via a catheter, resulting in an increased tumour response while preserving surrounding healthy tissue.

Globally, more than 70,000 patients have been treated with TheraSphere, which has been approved for use as an HCC treatment option in 16 other countries. TheraSphere is also indicated for the treatment of metastatic colorectal cancer (mCRC) in patients who have failed second line treatment in the UK . The company plans to further investigate TheraSphere as a treatment for different cancer segments, including prostate and brain cancers.


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