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

Autor: Cirt-Fr Principal Investigators, Jean-Pierre Pelage, Charles Mastier, Valérie Vilgrain, Christian Sengel, Maxime Ronot, Michel Greget, Lambros Tselikas, Bruno Sangro, Bora Peynircioglu, Nathalie Kaufmann, José Ignacio Bilbao, María Urdániz, Thomas Helmberger, Dirk Arnold, Olivier Pellerin, Geert Maleux, Antoine Bouvier, Niklaus Schaefer, Romaric Loffroy
Přispěvatelé: CIRT-FR Principal Investigators, Piana, G., Frandon, J., Tasu, J.P., Kobeiter, H.
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Male
SIR-Spheres
Yttrium-90
Cardiac & Cardiovascular Systems
Tare weight
medicine.medical_treatment
0302 clinical medicine
MICROSPHERES
Quality of life
HEPATOCELLULAR-CARCINOMA
Yttrium Radioisotopes
SIRT
Reimbursement
Incidence
Liver Neoplasms
Radiology
Nuclear Medicine & Medical Imaging
Neoplasms
Second Primary
Embolization
Therapeutic
EORTC
030220 oncology & carcinogenesis
Cohort
030211 gastroenterology & hepatology
Female
TRIAL
France
Cardiology and Cardiovascular Medicine
Life Sciences & Biomedicine
medicine.medical_specialty
Carcinoma
Hepatocellular
Transarterial radioembolization
SIR-spheres
03 medical and health sciences
Carcinoma
Hepatocellular/diagnosis
Carcinoma
Hepatocellular/epidemiology
Carcinoma
Hepatocellular/therapy
Embolization
Therapeutic/methods
France/epidemiology
Humans
Liver Neoplasms/diagnosis
Liver Neoplasms/epidemiology
Liver Neoplasms/therapy
Neoplasms
Second Primary/diagnosis
Neoplasms
Second Primary/epidemiology
Neoplasms
Second Primary/therapy
Quality of Life
Yttrium Radioisotopes/therapeutic use
Interim analysis
Radioembolization
Internal medicine
medicine
Radiology
Nuclear Medicine and imaging
Clinical Investigation
Adverse effect
Science & Technology
INTERNAL RADIATION-THERAPY
business.industry
SORAFENIB
Cardiovascular System & Cardiology
Observational study
business
Zdroj: Cardiovascular and Interventional Radiology
Cardiovascular and interventional radiology, vol. 44, no. 1, pp. 36-49
Popis: 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.
Databáze: OpenAIRE
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