Short-term Safety and Quality of Life Outcomes Following Radioembolization in Primary and Secondary Liver Tumours: a Mul

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CLINICAL INVESTIGATION

INTERVENTIONAL ONCOLOGY

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 • Marı´a Urda´niz15 • Nathalie Kaufmann15 • Jose´ Ignacio Bilbao16 • Thomas Helmberger17 • Vale´rie Vilgrain2 • On behalf of the CIRTFR Principal Investigators Received: 16 July 2020 / Accepted: 2 September 2020 Ó The Author(s) 2020

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

Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00270-020-02643-x) contains supplementary material, which is available to authorized users. & Nathalie Kaufmann [email protected] 1

Department of Vascular and Interventional Radiology, Image-Guided Therapy Center, CHU Dijon Bourgogne, Franc¸ois-Mitterrand University Hospital, 14 Rue Gaffarel, 21000 Dijon, France

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

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Interventional Radiology, De´partement d’anesthe´sie Chirurgie et Interventionel (DACI), Gustave Roussy, Universite´ Paris-Saclay, Villejuif, France

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Oncology and Hematology, Asklepios Tumorzentrum Hamburg, AK Altona, Paul-Ehrlich-Str. 1, 22763 Hamburg, Germany

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Department of Radiology, Universite´ de Paris, Hoˆpital Beaujon APHP, and CRI, INSERM 1149, Paris, France

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Radiology, Universitair Ziekenhuis Leuven, Herestraat 49, 3000 Leuven, Belgium

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Service d’Imagerie interventionnelle, Hoˆpitaux Universitaires de Strasbourg, 1 Avenue Moliere, 67000 Strasbo