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
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| Názov: | 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 |
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| Autori: | 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, Gilles Piana, Julien Frandon, Jean-Pierre Tasu, Hicham Kobeiter |
| Prispievatelia: | Repositorio de Navarra, CIRT-FR Principal Investigators, Piana, G., Frandon, J., Tasu, J.P., Kobeiter, H., PORCHEROT, Ivan |
| Zdroj: | Cardiovasc Intervent Radiol Dadun. Depósito Académico Digital de la Universidad de Navarra Universidad de Navarra Cardiovascular and interventional radiology, vol. 44, no. 1, pp. 36-49 |
| Informácie o vydavateľovi: | Springer Science and Business Media LLC, 2020. |
| Rok vydania: | 2020 |
| Predmety: | Male, 0301 basic medicine, Yttrium-90, Cardiac & Cardiovascular Systems, Carcinoma, Hepatocellular, Transarterial radioembolization, SIR-spheres, 03 medical and health sciences, MICROSPHERES, 0302 clinical medicine, Carcinoma, Hepatocellular/diagnosis, Carcinoma, Hepatocellular/epidemiology, Carcinoma, Hepatocellular/therapy, Embolization, Therapeutic/methods, Female, France/epidemiology, Humans, Incidence, 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, SIRT, HEPATOCELLULAR-CARCINOMA, Yttrium Radioisotopes, Clinical Investigation, 1102 Cardiorespiratory Medicine and Haematology, Science & Technology, [PHYS.PHYS.PHYS-BIO-PH] Physics [physics]/Physics [physics]/Biological Physics [physics.bio-ph], INTERNAL RADIATION-THERAPY, Radiology, Nuclear Medicine & Medical Imaging, Liver Neoplasms, CIRT-FR Principal Investigators, Neoplasms, Second Primary, Embolization, Therapeutic, 3. Good health, SORAFENIB, EORTC, Nuclear Medicine & Medical Imaging, Cardiovascular System & Cardiology, TRIAL, France, 3201 Cardiovascular medicine and haematology, Life Sciences & Biomedicine |
| 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. |
| Druh dokumentu: | Article Other literature type |
| Popis súboru: | application/pdf |
| Jazyk: | English |
| ISSN: | 1432-086X 0174-1551 |
| DOI: | 10.1007/s00270-020-02643-x |
| Prístupová URL adresa: | https://link.springer.com/content/pdf/10.1007/s00270-020-02643-x.pdf https://pubmed.ncbi.nlm.nih.gov/32975600 https://hdl.handle.net/10171/115046 https://pubmed.ncbi.nlm.nih.gov/32975600/ https://link.springer.com/article/10.1007/s00270-020-02643-x https://link.springer.com/content/pdf/10.1007/s00270-020-02643-x.pdf https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7728633 https://europepmc.org/article/PMC/PMC7728633 https://serval.unil.ch/resource/serval:BIB_8216514E3692.P001/REF.pdf http://nbn-resolving.org/urn/resolver.pl?urn=urn:nbn:ch:serval-BIB_8216514E36921 https://serval.unil.ch/notice/serval:BIB_8216514E3692 |
| Rights: | CC BY |
| Prístupové číslo: | edsair.doi.dedup.....71ee18c72cc9ba56091bfd26a6c6d85f |
| Databáza: | OpenAIRE |
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Nájsť tento článok vo Web of Science | Abstrakt: | 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. |
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| ISSN: | 1432086X 01741551 |
| DOI: | 10.1007/s00270-020-02643-x |