Clinical Application of Trans-Arterial Radioembolization in Hepatic Malignancies in Europe: First Results from the Prospective Multicentre Observational Study CIRSE Registry for SIR-Spheres Therapy (CIRT).
- Helmberger T Department of Radiology, Neuroradiology and Minimal-Invasive Therapy, Klinikum Bogenhausen, Englschalkinger Str. 77, 81925, Munich, Germany.
- Golfieri R Radiology Unit, Department of Experimental, Diagnostic and Speciality Medicine, Sant'Orsola Hospital, University of Bologna, Via Bagni di Mario 15, 40136, Bologna, Italy.
- Pech M Department of Radiology and Nuclear Medicine, University of Magdeburg, Leipziger Strasse 44, 39120, Magdeburg, Germany.
- Pfammatter T Institut für Diagnostische und Interventionelle Radiologie, Universitätsspital Zürich, Rämistrasse 100, 8091, Zürich, Switzerland.
- Arnold D Oncology and Hematology, Asklepios Tumorzentrum Hamburg, AK Altona, Paul-Ehrlich-Str. 1, 22763, Hamburg, Germany.
- Cianni R Department of Interventional Radiology, S. Camillo Hospital, Circonvallazione Gianicolense, 85, 00149, Rome, Italy.
- Maleux G Radiology, Universitair Ziekenhuis Leuven, Herestraat 49, 3000, Leuven, Belgium.
- Munneke G Interventional Oncology, University College London Hospitals NHS Foundation Trust, 250 Euston Road, NW1 2PG, London, UK.
- Pellerin O Interventional Radiology Department, Hôpital Européen Georges Pompidou, 20 rue Leblanc, 75015, Paris, France.
- Peynircioglu B Department of Radiology, School of Medicine, Hacettepe University, Sihhiye Campus, 06100, Ankara, Turkey.
- Sangro B Liver Unit, Clínica Universidad de Navarra, IDISNA and CIBEREHD, Avda. Pio XII 36, 31008, Pamplona, Spain.
- Schaefer N Service de médecine nucléaire et imagerie moléculaire, Inselspital Hospital Lausanne, Rue du Bugnon 46, 1011, Lausanne, Switzerland.
- de Jong N Clinical Research Department, Cardiovascular and Interventional Radiological Society of Europe, Neutorgasse 9, 1010, Vienna, Austria. dejong@cirse.org.
- Bilbao JI Interventional Radiology, Clínica Universidad de Navarra, Avenida Pio XII, No 36, 31008, Pamplona, Spain.
- 2020-09-22
Published in:
- Cardiovascular and interventional radiology. - 2020
Hepatocellular carcinoma
Liver
Metastasis
Observational study
Radioisotope brachytherapy
Registries
Therapeutic embolization
Trans-arterial radioembolization
Yttrium-90
English
PURPOSE
To address the lack of prospective data on the real-life clinical application of trans-arterial radioembolization (TARE) in Europe, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) initiated the prospective observational study CIRSE Registry for SIR-Spheres® Therapy (CIRT).
MATERIALS AND METHODS
Patients were enrolled from 1 January 2015 till 31 December 2017. Eligible patients were adult patients treated with TARE with Y90 resin microspheres for primary or metastatic liver tumours. Patients were followed up for 24 months after treatment, whereas data on the clinical context of TARE, overall survival (OS) and safety were collected.
RESULTS
Totally, 1027 patients were analysed. 68.2% of the intention of treatment was palliative. Up to half of the patients received systemic therapy and/or locoregional treatments prior to TARE (53.1%; 38.3%). Median overall survival (OS) was reported per cohort and was 16.5 months (95% confidence interval (CI) 14.2-19.3) for hepatocellular carcinoma, 14.6 months (95% CI 10.9-17.9) for intrahepatic cholangiocarcinoma. For liver metastases, median OS for colorectal cancer was 9.8 months (95% CI 8.3-12.9), 5.6 months for pancreatic cancer (95% CI 4.1-6.6), 10.6 months (95% CI 7.3-14.4) for breast cancer, 14.6 months (95% CI 7.3-21.4) for melanoma and 33.1 months (95% CI 22.1-nr) for neuroendocrine tumours. Statistically significant prognostic factors in terms of OS include the presence of ascites, cirrhosis, extra-hepatic disease, patient performance status (Eastern Cooperative Oncology Group), number of chemotherapy lines prior to TARE and tumour burden. Thirty-day mortality rate was 1.0%. 2.5% experienced adverse events grade 3 or 4 within 30 days after TARE.
CONCLUSION
In the real-life clinical setting, TARE is largely considered to be a part of a palliative treatment strategy across indications and provides an excellent safety profile.
LEVEL OF EVIDENCE
Level 3.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02305459.
To address the lack of prospective data on the real-life clinical application of trans-arterial radioembolization (TARE) in Europe, the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) initiated the prospective observational study CIRSE Registry for SIR-Spheres® Therapy (CIRT).
MATERIALS AND METHODS
Patients were enrolled from 1 January 2015 till 31 December 2017. Eligible patients were adult patients treated with TARE with Y90 resin microspheres for primary or metastatic liver tumours. Patients were followed up for 24 months after treatment, whereas data on the clinical context of TARE, overall survival (OS) and safety were collected.
RESULTS
Totally, 1027 patients were analysed. 68.2% of the intention of treatment was palliative. Up to half of the patients received systemic therapy and/or locoregional treatments prior to TARE (53.1%; 38.3%). Median overall survival (OS) was reported per cohort and was 16.5 months (95% confidence interval (CI) 14.2-19.3) for hepatocellular carcinoma, 14.6 months (95% CI 10.9-17.9) for intrahepatic cholangiocarcinoma. For liver metastases, median OS for colorectal cancer was 9.8 months (95% CI 8.3-12.9), 5.6 months for pancreatic cancer (95% CI 4.1-6.6), 10.6 months (95% CI 7.3-14.4) for breast cancer, 14.6 months (95% CI 7.3-21.4) for melanoma and 33.1 months (95% CI 22.1-nr) for neuroendocrine tumours. Statistically significant prognostic factors in terms of OS include the presence of ascites, cirrhosis, extra-hepatic disease, patient performance status (Eastern Cooperative Oncology Group), number of chemotherapy lines prior to TARE and tumour burden. Thirty-day mortality rate was 1.0%. 2.5% experienced adverse events grade 3 or 4 within 30 days after TARE.
CONCLUSION
In the real-life clinical setting, TARE is largely considered to be a part of a palliative treatment strategy across indications and provides an excellent safety profile.
LEVEL OF EVIDENCE
Level 3.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02305459.
- Language
-
- English
- Open access status
- hybrid
- Identifiers
-
- DOI 10.1007/s00270-020-02642-y
- PMID 32959085
- Persistent URL
- https://sonar.ch/global/documents/46838
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