| 英国国家卫生与临床优化研究所（National institute for Health and Care Excellence, NICE）起源于1999年成立的国家卫生与临床优化研究院，旨在减少国家医疗服务体系（NHS）提供的治疗护理服务在不同地区的可及性和质量差异。NICE于2005年与健康发展署合并，更为现名，开始为公众预防疾病，促进健康生活方式制订公众健康指导。2013年通过立法，NICE成为非政府公众组织。它出了名的吝啬鬼，严格审查英国上市的各类医疗服务以保证其功效性。这样一个组织竟然推荐SIRT或称为TARE的选择性放射微粒这一昂贵的栓塞疗法治疗肝癌（在大英帝国每年超过6400例肝癌）。
NICE网站指出：“在考虑了咨询意见的反馈后，评估委员会编写了一份关于选择性内放疗法(SIRT)治疗肝细胞癌的最终评估确定(FAD)，并提交给了研究所。” 本文件包括对SIR-spheres (Sirtex) 和Thera-sphere Y-90玻璃微球（Boston Scientific）。
“ 建议将SIRT SIR-Sphere 和 TheraSphere 作为治疗成人无法切除的晚期肝细胞癌(HCC)的一种选择，但条件是：
SIRT QuiremSphere微球 (Terumo)在CE 标记范围内不推荐用于治疗成人不可切除的晚期HCC。
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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