• Radioembolization with holmium-166 microspheres was efficacious; in 73% of the patients the target lesions showed disease control after 3 months.
• Most common adverse events were transient abdominal pain and nausea (18% and 8%).
• Holmium-166 microspheres could be quantified with high accuracy and precision using SPECT.
Single-arm, single-center phase II efficacy trial.
38 Patients with unresectable liver metastases of any primary origin, who were unable to undergo systemic treatment were eligible. The main primary malignancies were colorectal (61%), breast (11%), cholangiocarcinoma (11%), neuroendocrine tumor (5%) and uveal melanoma (5%).
Single radioembolization with Holmium-166 polylactic microspheres, administered via the hepatic artery. The projected average absorbed dose was 60 Gy to the liver (equal to 3.8 GBq/kg liver tissue).
Study results have been published in PhD thesis of J.F. Prince; ISBN 978-90-393-6489-5; 2016.
Publication in peer-reviewed journal is expected soon.
ClinicalTrials.gov Identifier: NCT01612325
• Holmium-166 radioembolization is considered feasible and safe.
• Toxicity after holmium-166 radioembolization was mainly conﬁned to symptoms associated with post-embolisation syndrome; including fatigue, nausea, vomiting, abdominal pain, fever, and anorexia.
• The Maximum Tolerated Radiation Dose was identified to be an aimed whole liver average absorbed dose of 60 Gy.
• The distribution of holmium-166 microspheres can be visualized in vivo by both single-photon-emission CT (SPECT) and MRI, possibly enabling individualized and improved patient treatment in the future.
Single-arm, single-center phase I dose-escalation trial.
15 Patients with unresectable, chemo refractory liver metastases were treated in cohorts of 3 patients. The primary tumour types were ocular melanoma (6/15), colorectal carcinoma (6/15), cholangiocarcinoma involvement (2/15), and breast carcinoma (1/15).
Single radioembolization with holmium-166 polylactic microspheres, administered by infusion in the liver artery using an arterial catheter in the femoral artery. Aimed whole-liver absorbed doses for consecutive dose cohorts were 20 Gy (n=6), 40 Gy (n=3), 60 Gy (n=3), and 80 Gy (n=3).
Smits et al, Journal of Experimental & Clinical Cancer Research 2010, 29:70
Smits et al, Lancet Oncol. 2012, Oct;13(10):1025-34
ClinicalTrials.gov Identifier: NCT01031784
25 Patients with unresectable, chemorefractory, liver-dominant colorectal liver metastases will be included in this study.
ClinicalTrials.gov Identifier: NCT02208804
48 Patients with gastroenteropancreatic neuroendocrine tumours (NET) will be included in this study.
ClinicalTrials.gov Identifier: NCT02067988
Feasibility of holmium-166 microspheres for selective intratumoral treatment in head and neck cancer: biodistribution and safety in patients with malignancy of the tongue (HIT)
20 Patients with T1-2 squamous cell carcinoma of the tongue, who are eligible for local surgery, will be included in this study.
ClinicalTrials.gov Identifier: NCT02975739
QuiremSpheres® and Q-Suite™ are not available for sale in all countries. This information is provided only in respect to markets where QuiremSpheres® and Q-Suite™ are approved or cleared. QuiremSpheres® and Q-Suite™ s not FDA cleared in the US for sale.