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CardioVascular and Interventional Radiology

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Open Access 01-01-2021 | Hepatocellular Carcinoma | Clinical Investigation

Short-term Safety and Quality of Life Outcomes Following Radioembolization in Primary and Secondary Liver Tumours: a Multi-centre Analysis of 200 Patients in France

Authors: Romaric Loffroy, Maxime Ronot, Michel Greget, Antoine Bouvier, Charles Mastier, Christian Sengel, Lambros Tselikas, Dirk Arnold, Geert Maleux, Jean-Pierre Pelage, Olivier Pellerin, Bora Peynircioglu, Bruno Sangro, Niklaus Schaefer, María Urdániz, Nathalie Kaufmann, José Ignacio Bilbao, Thomas Helmberger, Valérie Vilgrain, On behalf of the CIRT-FR Principal Investigators

Published in: CardioVascular and Interventional Radiology | Issue 1/2021

Abstract

Purpose

Radioembolization has emerged as a treatment modality for patients with primary and secondary liver tumours. This observational study CIRT-FR (CIRSE Registry for SIR-Spheres Therapy in France) aims to evaluate real-life clinical practice on all patients treated with transarterial radioembolization (TARE) using SIR-Spheres yttrium-90 resin microspheres in France. In this interim analysis, safety and quality of life data are presented. Final results of the study, including secondary effectiveness outcomes, will be published later. Overall, CIRT-FR is aiming to support French authorities in the decision making on reimbursement considerations for this treatment.

Methods

Data on patients enrolled in CIRT-FR from August 2017 to October 2019 were analysed. The interim analysis describes clinical practice, baseline characteristics, safety (adverse events according to CTCTAE 4.03) and quality of life (according to EORTC QLQ C30 and HCC module) aspects after TARE.

Results

This cohort included 200 patients with hepatocellular carcinoma (114), metastatic colorectal cancer (mCRC; 38) and intrahepatic cholangiocarcinoma (33) amongst others (15). TARE was predominantly assigned as a palliative treatment (79%). 12% of patients experienced at least one adverse event in the 30 days following treatment; 30-day mortality was 1%. Overall, global health score remained stable between baseline (66.7%), treatment (62.5%) and the first follow-up (66.7%).

Conclusion

This interim analysis demonstrates that data regarding safety and quality of life generated by randomised-controlled trials is reflected when assessing the real-world application of TARE.

Trial Registration

Clinical Trials.gov NCT03256994.

Available only for authorised users

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Title: Short-term Safety and Quality of Life Outcomes Following Radioembolization in Primary and Secondary Liver Tumours: a Multi-centre Analysis of 200 Patients in France
Authors: Romaric Loffroy
Maxime Ronot
Michel Greget
Antoine Bouvier
Charles Mastier
Christian Sengel
Lambros Tselikas
Dirk Arnold
Geert Maleux
Jean-Pierre Pelage
Olivier Pellerin
Bora Peynircioglu
Bruno Sangro
Niklaus Schaefer
María Urdániz
Nathalie Kaufmann
José Ignacio Bilbao
Thomas Helmberger
Valérie Vilgrain
On behalf of the CIRT-FR Principal Investigators
Publication date: 01-01-2021
Publisher: Springer US
Keywords: Hepatocellular Carcinoma
Hepatocellular Carcinoma
Published in: CardioVascular and Interventional Radiology / Issue 1/2021
Print ISSN: 0174-1551
Electronic ISSN: 1432-086X
DOI: https://doi.org/10.1007/s00270-020-02643-x

At a glance: The STEP trials

Springer Medicine

Short-term Safety and Quality of Life Outcomes Following Radioembolization in Primary and Secondary Liver Tumours: a Multi-centre Analysis of 200 Patients in France

Abstract

Purpose

Methods

Results

Conclusion

Trial Registration

At a glance: The STEP trials

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

Trial Registration

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