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Abstract Details
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
Romaric Loffroy1, Maxime Ronot2, Michel Greget3, Antoine Bouvier4, Charles Mastier5, Christian Sengel6, Lambros Tselikas7, Dirk Arnold8, Geert Maleux9, Jean-Pierre Pelage10, Olivier Pellerin11, Bora Peynircioglu12, Bruno Sangro13, Niklaus Schaefer14, María Urdániz15, Nathalie Kaufmann16, José Ignacio Bilbao17, Thomas Helmberger18, Valérie Vilgrain2, CIRT-FR Principal Investigators
1Department of Vascular and Interventional Radiology, Image-Guided Therapy Center, CHU Dijon Bourgogne, François-Mitterrand University Hospital, 14 Rue Gaffarel, 21000, Dijon, France.
2Department of Radiology, Université de Paris, Hôpital Beaujon APHP, and CRI, INSERM 1149, Paris, France.
3Service d'Imagerie interventionnelle, Hôpitaux Universitaires de Strasbourg, 1 Avenue Moliere, 67000, Strasbourg, France.
4Department of Radiology, Angers University Hospital, 4 Rue Larrey, 49933, Angers, France.
5Interventional Radiology, Centre Léon Bérard, 28 Prom. Léa Et Napoléon Bullukian, 69008, Lyon, France.
6Interventional Radiology, Centre Hospitalier Universitaire de Grenoble, Boulevard de la Chantourne, 38100, Grenoble, France.
7Interventional Radiology, Département d'anesthésie Chirurgie et Interventionel (DACI), Gustave Roussy, Université Paris-Saclay, Villejuif, France.
8Oncology and Hematology, Asklepios Tumorzentrum Hamburg, AK Altona, Paul-Ehrlich-Str. 1, 22763, Hamburg, Germany.
10Department of Diagnostic Imaging and Interventional Radiology, Caen University and Medical Center, avenue de la Cote de Nacre, 14033, Caen, France.
11Interventional Radiology Department, Hôpital Européen Georges Pompidou, 20 rue Leblanc, 75015, Paris, France.
12Department of Radiology, School of Medicine, Hacettepe University, Sihhiye Campus, 06100, Ankara, Turkey.
13Clínica Universidad de Navarra, IDISNA and CIBEREHD, Liver Unit, Avda. Pio XII 36, 31008, Pamplona, Spain.
14Service de médecine nucléaire Et Imagerie moléculaire, Centre Hospitalier Universitaire de Lausanne, Rue du Bugnon 46, CH-1011, Lausanne, Switzerland.
15Clinical Research Department, Cardiovascular and Interventional Radiological Society of Europe, Neutorgasse 9, 1010, Vienna, Austria.
16Clinical Research Department, Cardiovascular and Interventional Radiological Society of Europe, Neutorgasse 9, 1010, Vienna, Austria. kaufmann@cirse.org.
17Interventional Radiology, Clínica Universidad de Navarra, Avenida Pio XII, no 36, 31008, Pamplona, Spain.
18Department of Radiology, Neuroradiology and Minimal-Invasive Therapy, Klinikum Bogenhausen, Englschalkinger Str. 77, 81925, Munich, Germany.
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.