ArTisaN
Research type
Research Study
Full title
A Phase II Assessment of the Safety and Efficacy of TheraSphere® Selective Internal Radiation Therapy (SIRT) in the treatment of Metastatic (Liver) Neuroendocrine Tumours (NETs).
IRAS ID
231087
Contact name
R Sharma
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This prospective, open label, single centre Phase 2 study will be performed in patients with inoperable metastatic neuroendocrine liver deposits to test the hypothesis that treatment with Selective Internal Radiation Therapy (Theraspheres) will lead in improved treatment response rates with acceptable toxicity. Secondary aims are the assessment of Progression Free Survival and Quality of Life. Translational end points are the assessment of Radiomics in prediction treatment response.
Lay summary of study results: Study Title: ArTisaN: A Phase II Assessment of the Safety and Efficacy of TheraSphere® Selective Internal Radiation Therapy (SIRT) in the treatment of Metastatic (Liver) Neuroendocrine Tumours (NETs).
This study was sponsored by Imperial College London and was funded by Boston Scientific and The Robert McAlpine Foundation. The study was conducted at Imperial College Healthcare NHS Trust and The London Clinic, starting in February 2019 and ending in August 2023. This study aimed to evaluate the safety and efficacy of Selective Internal Radiation Therapy (SIRT) in patients who were diagnosed with neuroendocrine tumours (NETs) that had spread (or ‘metastasised’), to the liver. SIRT involves an administration of radioactive beads into the liver blood vessels, delivering a high dose of radiation directly to liver tumours. One type of SIRT uses TheraSpheres, which contain radioactive Yttrium-90.In NETs, there were limited studies available in using SIRT for treatment of liver metastases, to effectively guide patient therapy in this cancer type. Surgical treatment of the metastases is an established option, however less than 10% of patients are eligible for this treatment. As the liver is the most common site for metastases, and increases the mortality risk for these patients, researchers are interested in treating liver metastases to improve clinical outcomes.
This study aimed to evaluate the safety and efficacy of using TheraSpheres SIRT in patients with NETs that had metastasised to the liver. It also looked to evaluate how the treatment impacted patients’ survival and quality of life.
Twenty-two patients were treated on the study. During the study, patients received a specialised Single Photon Emission Computed Tomography (SPECT-CT) scan in order to visualise the liver blood vessels, and to ensure it was safe to proceed with the treatment. Within 2 weeks following the scan, they received SIRT treatment. After SIRT administration, patients were followed up at 8 weeks post-treatment, and every 3 months thereafter until their disease progressed.The most frequent adverse reactions related to the study treatment were mild fatigue experienced by 13 (62%) patients, and mild abdominal pain in 9 (43%) patients. 2 (10%) developed a severe radioembolization-induced liver disease (REILD), which resolved without long-term effects with the appropriate treatment. In terms of laboratory toxicities, the most commonly reported event was severe lymphocytopenia (low white blood cell count), experienced by 4 (19%) patients, that resolved without long-term effects. Other side effects reported in a lower percentage of patients included weight loss, nausea, vomiting, flushing and bloating.
The study highlighted a low incidence and severity of treatment-related toxicities. Efficacy of the treatment measured by Overall Response Rate (percentage of patients who demonstrated tumour response) was 45%. Survival was measured using median liver-specific Progression Free Survival (time from treatment until liver disease progresses), Progression Free Survival (time from treatment until disease progresses) and Overall Survival (length of time lived after a treatment), and were 48.1, 13.3 and 49.9 months respectively.
No significant deterioration in quality of life, measured using questionnaires, was observed following SIRT.
This study has helped researchers to demonstrate that SIRT has clinical efficacy and an acceptable safety profile for the management of liver metastases that are secondary to neuroendocrine tumours. It also demonstrated a positive relationship between tumour dose absorbed and the disease response to SIRT.You can find out more information about this study by contacting the Chief Investigator, Prof. Rohini Sharma: r.sharma@imperial.ac.uk
Thank you to all participants in the study
REC name
London - Bloomsbury Research Ethics Committee
REC reference
18/LO/0761
Date of REC Opinion
26 Jun 2018
REC opinion
Further Information Favourable Opinion