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Terumo Europe is delighted to share that a positive guidance has been published by NICE stating that Selective Internal Radiation Therapy (SIRT) is now recommended to be used for the treatment of neuroendocrine tumors with liver metastasis (NELM).

This is a key milestone as it expands the existing treatment options (surgery, percutaneous ablation, systemic therapies, peptide receptor radionuclide therapy (PRRT) & other intra-arterial therapies) for the treatment of patients with NELM.  

The NICE guidance describes SIRT as a tool to reduce tumor size within the liver, slow local tumor growth or control a collection of symptoms caused by some neuroendocrine tumors that release hormones. SIRT can be preceded or followed by other treatments such as PRRT and it can be repeated over time. The committee stated that SIRT is likely to be better tolerated than other intra-arterial therapies, because SIRT relies on radiation rather than an embolic effect to kill the tumor cells. 
This guidance is part of NICE's interventional procedure program which considers whether interventional procedures (e.g. SIRT) are safe and work well enough for wider use in the NHS. A comprehensive review of the literature and consultations with clinical experts and patient representatives informed the decision of the Committee. 

This is a positive endorsement for the safety and efficacy of SIRT and a complement to the 2020 ESMO guidelines for Gastro-entero-pancreatic Neuroendocrine Neoplasms in which loco-regional therapies (including SIRT) have been recommended for tumor shrinkage and for symptoms control in patients with NELM suffering from carcinoid syndrome (flushing and/or diarrhea). The European Neuroendocrine Tumor Society (ENETS) guidance (2022) also mentions that SIRT can be considered as a therapeutic option for patients with NELM with carcinoid syndrome2.  

The positive impact on the quality of life of the NELM patient has been described in the NICE report. It was reported from a patient that nearly two months after the treatment, the tiredness subsided and he began to enjoy normal activities and hobbies again, slowly returning to his old self.  
QuiremScoutTM (Holmium-166 microspheres) & QuiremSpheresTM (Holmium-166 microspheres) as components of the Holmium Platform can be used for an individualized treatment approach (work-up and therapy) of patients with NELM.  

Two publications by Braat3 & C. Ebbers4 et. al. (2020 & 2022) concerning the HEPAR PLuS study, concluded that QuiremSpheresTM microspheres are effective with an acceptable safety profile after initial peptide receptor radionuclide therapy (PRRT) for patients with bulky NELM.   
Another recent publication by RamdHani5 et al. (2024) demonstrated a clear dose-response relationship in patients with NELM treated by QuiremSpheresTM. More specifically, achieving a tumor dose ≥ 120 Gy provides the highest likelihood (90%) for obtaining a response based on a retrospective analysis of QuiremSpheresTM use in real-world practice.

Dr Kibriya (King’s College hospital in London) is very enthusiastic about this guidance:  
"SIRT provides a minimally invasive treatment option for patients with metastatic neuroendocrine tumors (mNETs) of the liver, offering precise targeting of tumour cells while sparing healthy tissue. This approach has demonstrated significant tumour response rates and prolonged progression-free survival, leading to improved outcomes and quality of life for individuals with mNETs. Additionally, SIRT can be combined with other therapies, enhancing its effectiveness in managing advanced diseases and providing hope for patients facing this challenging condition. This specific NICE guidance can help us to receive UK reimbursement soon and therefore get wider access of this treatment modality for our patients”.

NICE Guidance is accessible here.

*1 Reference: Pavel M, Öberg K, Falconi M, Krenning EP, Sundin A, Perren A, Berruti A; ESMO Guidelines Committee. Electronic address: [email protected]. Gastroenteropancreatic neuroendocrine neoplasms: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020 Jul;31(7):844-860. doi: 10.1016/j.annonc.2020.03.304. Epub 2020 Apr 6. PMID: 32272208.
*2 Reference: Grozinsky-Glasberg S, Davar J, Hofland J, Dobson R, Prasad V, Pascher A, Denecke T, Tesselaar MET, Panzuto F, Albåge A, Connolly HM, Obadia JF, Riechelmann R, Toumpanakis C. European Neuroendocrine Tumor Society (ENETS) 2022 Guidance Paper for Carcinoid Syndrome and Carcinoid Heart Disease. J Neuroendocrinol. 2022 Jul;34(7):e13146. doi: 10.1111/jne.13146. Epub 2022 May 25. PMID: 35613326; PMCID: PMC9539661.
*3 Reference: Braat AJAT, Bruijnen RCG, van Rooij R, Braat MNGJA, Wessels FJ, van Leeuwaarde RS, van Treijen MJC, de Herder WW, Hofland J, Tesselaar MET, de Jong HWAM, Lam MGEH. Additional holmium-166 radioembolisation after lutetium-177-dotatate in patients with neuroendocrine tumour liver metastases (HEPAR PLuS): a single-centre, single-arm, open-label, phase 2 study. Lancet Oncol. 2020 Apr;21(4):561-570. doi: 10.1016/S1470-2045(20)30027-9. Epub 2020 Feb 26. PMID: 32112737.
*4 Reference: Ebbers SC, Brabander T, Tesselaar MET, Hofland J, Braat MNGJA, Wessels FJ, Barentsz MW, Lam MGEH, Braat AJAT. Inflammatory markers and long term hematotoxicity of holmium-166-radioembolization in liver-dominant metastatic neuroendocrine tumors after initial peptide receptor radionuclide therapy. EJNMMI Res. 2022 Feb 2;12(1):7. doi: 10.1186/s13550-022-00880-4. PMID: 35107642; PMCID: PMC8811020.  
*5 Reference: Ramdhani K, Beijer-Verduin J, Ebbers SC, van Rooij R, Smits MLJ, Bruijnen RCG, de Jong HWAM, Lam MGEH, Braat AJAT. Dose-effect relationships in neuroendocrine tumour liver metastases treated with [166Ho]-radioembolization. Eur J Nucl Med Mol Imaging. 2024 Feb 19. doi: 10.1007/s00259-024-06645-6. Epub ahead of print. PMID: 38369678.

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