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Radiopharmaceuticals for Radionuclide Therapy
Published in Michael Ljungberg, Handbook of Nuclear Medicine and Molecular Imaging for Physicists, 2022
Meltem Ocak, Emre Demirci, Jessie R. Nedrow, Rebecca Krimins
Selective Internal Radiation (SIR)-Spheres are biocompatible resin micropolymers ranging in size between 20–60 µM, averaging 32 ± 10 µM, with Yttrium-90 permanently embedded. Gray and colleagues demonstrated in early studies that patients with liver metastases from primary tumours of the large bowel had a high rate of tumour regression following SIR therapy [28]. A Phase III study further investigated the potential of SIR-Spheres in combination with chemotherapy administered via the hepatic artery to provide increased benefit to patients with liver metastases from primary adenocarcinoma of the large bowel. Phase III demonstrated significant improvement tumour area and volumes, carcino-embryonic antigen (CEA), and median time to disease progress in patients receiving SIR-Spheres and intra-arterial chemotherapy as compared to chemotherapy alone with limited toxicity and low impact on patients’ quality of life [29]. The SIRvsNIB (NCT01135056) clinical study found HCC patients treated with yttrium-90 resin microspheres did not see an improvement in overall survival as compared to patients treated with sorafenib, a multi-kinase inhibitor; however, SIR-Spheres–treated patients did have fewer adverse effects [30]. As subsequent therapy, SIR-Spheres have demonstrated positive clinical benefits; however, Phase 3 trials investigating SIR-Spheres in combination with chemotherapy as a first-line therapy in metastatic colorectal cancer with liver metastases did not improve overall survival or adverse effects [31].
Medical management of neuroendocrine gastroenteropancreatic tumors
Published in Demetrius Pertsemlidis, William B. Inabnet III, Michel Gagner, Endocrine Surgery, 2017
Liver-directed intra-arterial therapies available in the treatment of unresectable liver metastases include transarterial embolization (TAE), transarterial chemoembolization (TACE), and selective internal radiotherapy (SIRT) with yttrium 90 microspheres. For TAE or TACE, symptomatic responses have been reported in 53%–100% of patients (up to 55 months) and tumor reduction in about 35%–74%, with a progression-free survival (PFS) of about 18–20 months and 5-year survival of 40%–80% [7–10]. Yttrium 90 radioembolization has been shown to be an effective treatment for hepatic metastases and is well tolerated [11–13]. It involves injection of embolic resin spheres (SIR-spheres, Sirtex Medical Ltd.) or glass spheres (TheraSphere, BTG Inc.). Microspheres loaded with beta-emitting radioisotope yttrium 90 are injected into the tumor hepatic arterial supply. In a recent meta-analysis of 12 relevant studies, radiographic response rates according to Response Evaluation Criteria in Solid Tumors (RECIST) range from 12% to 80%. Disease-controlled rates, defined as complete response or partial response plus stable disease, range from 62% to 100%. An administered radioactivity median of 1.7 GBq (range 1.2–3.4 GBq) did not correlate with either the response or control rate. The median overall survival rate ranges from 14 up to 70 months, with a median of 28.5 months. The response rate correlated with the median survival (p = 0.008) [14]. It has been suggested that many factors, including prior surgery, size of target lesions, performance status, baseline chemistry value, Ki-67 index, presence of extrahepatic disease, and inability to deliver a specified dose, influence patient outcomes for treatment of hepatic metastases with yttrium 90 radioembolization [14].
Yttrium-90 for colorectal liver metastasis - the promising role of radiation segmentectomy as an alternative local cure
Published in International Journal of Hyperthermia, 2022
Pouya Entezari, Ahmed Gabr, Riad Salem, Robert J. Lewandowski
There are two Y90 radioembolization devices that have been studied for patients with CRLM: resin (SIR-Spheres®, Sirtex Medical Ltd., North Sydney, Australia) and glass (TheraSphere®, Boston Scientific, Natick, Massachusetts). Per the U.S Food and Drug Administration (FDA), SIR-Spheres is indicated for the treatment of unresectable metastatic liver tumors from primary CRC with adjuvant intra-hepatic artery chemotherapy of floxuridine. Meanwhile, TheraSphere is approved by FDA for local tumor control of solitary tumors (1-8 cm in diameter), in patients with unresectable HCC, Child-Pugh Score A cirrhosis, well-compensated liver function, no macrovascular invasion, and good performance status. To this date, a direct prospective comparison of resin and glass microspheres has not been conducted in metastatic CRC. However, several studies employing these devices have yielded comparable survival outcomes [20,21].
A systematic literature review and network meta-analysis of first-line treatments for unresectable hepatocellular carcinoma based on data from randomized controlled trials
Published in Expert Review of Anticancer Therapy, 2021
Richard F. Pollock, Victoria K. Brennan, Suki Shergill, Fabien Colaone
In 2019, the National Institute for Health and Care Excellence (NICE) commenced a multiple technology appraisal (MTA) of SIRT in the treatment of patients with unresectable early-, intermediate-, or advanced-stage HCC. The MTA covers three SIRT technologies: Yttrium-90 (Y-90) resin microspheres (SIR-Spheres; Sirtex Medical), Y-90 glass microspheres (TheraSphere; Boston Scientific), and Holmium-166 Poly(L-lactic acid) microspheres (QuiremSpheres; Terumo Europe NV). There are fundamental differences in the radioisotopes and microsphere substrates employed in the three SIRT technologies that manifest as different half-lives, embolic material density, radioactivity per microsphere, and a number of microspheres infused. QuiremSpheres uses a different radioisotope, whose effectiveness and safety in the treatment of HCC have not been demonstrated. Despite SIR-Spheres and TheraSphere using the same radioactive isotope (Y-90), higher amounts of injected radioactivity and radiation doses are recommended to achieve tumor response with TheraSphere compared to SIR-Spheres, suggesting different toxicity profiles, as higher injected radioactivity and radiation doses to the non-tumoral liver cells are associated with increased risks of liver complications [12–14]. Equal efficacy and safety can therefore not be assumed between the different SIRT technologies.
A cost-utility analysis of SIR-Spheres Y-90 resin microspheres versus best supportive care in the treatment of unresectable metastatic colorectal cancer refractory to chemotherapy in the UK
Published in Journal of Medical Economics, 2020
V. K. Brennan, F. Colaone, S. Shergill, R. F. Pollock
For patients refractory to third-line therapy or ineligible for current third-line treatments, no other systemic therapy options are currently available and disease management may therefore be restricted to best supportive care (BSC), which is associated with median survival of 4–6 months.20 However, in patients with liver-only or liver-dominant metastases, selective internal radiation therapy (SIRT) with SIR-Spheres Y-90 resin microspheres represents another potential treatment option. SIRT is recommended in the European Society for Medical Oncology (ESMO) 2016 Guidelines for patients who are refractory or intolerant to chemotherapy (category B recommendation for SIR-Spheres Y-90 resin microspheres) and in the National Comprehensive Cancer Network (NCCN) Guidelines v2.2018 (category 2A recommendation for “arterially directed catheter therapy, and in particular yttrium-90 microsphere selective internal radiation”) in this indication.21,22 In the UK, the National Institute for Health and Care Excellence (NICE) 2020 interventional procedures guidance on the use of SIRT in patients with mCRC recommended that SIRT could be used in patients who cannot tolerate chemotherapy or have liver metastases refractory to chemotherapy, with special arrangements for clinical governance, consent, and audit or research.23