Main Findings HEPAR 2 study:
- Radioembolization with 166Ho 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%).
- 166Ho microspheres could be quantified with high accuracy and precision using SPECT
Patient population
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%).
Treatment
Single radioembolization with 166Ho 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).
Results
Response 3 months after 166Ho radioembolization
| Category of response | Target lesions | Liver specific |
| Complete response | - | - |
| Partial response | 5 (14%) | 5 (14%) |
| Stable disease | 22 (59%) | 13 (35%) |
| Progressive disease * | 10 (27%) | 19 (51%) |
| Total | 37 (100%) | 37 (100%) |
Number of patients (percentage of total).
* Not evaluable and/or missing patients classified as progressive disease
References:
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
