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
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:44 |
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| Enthalten in: |
Cardiovascular and interventional radiology - 44(2021), 1 vom: 25. Jan., Seite 36-49 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Loffroy, Romaric [VerfasserIn] |
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| Links: |
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| Themen: |
Interim analysis |
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| Anmerkungen: |
Date Completed 03.05.2021 Date Revised 03.05.2021 published: Print-Electronic ClinicalTrials.gov: NCT03256994 Citation Status MEDLINE |
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| doi: |
10.1007/s00270-020-02643-x |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM315463791 |
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| 100 | 1 | |a Loffroy, Romaric |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Short-term Safety and Quality of Life Outcomes Following Radioembolization in Primary and Secondary Liver Tumours |b a Multi-centre Analysis of 200 Patients in France |
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| 500 | |a Date Revised 03.05.2021 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03256994 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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%) | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION: Clinical Trials.gov NCT03256994 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Interim analysis | |
| 650 | 4 | |a Radioembolization | |
| 650 | 4 | |a SIR-spheres | |
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| 650 | 4 | |a Transarterial radioembolization | |
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| 700 | 1 | |a Ronot, Maxime |e verfasserin |4 aut | |
| 700 | 1 | |a Greget, Michel |e verfasserin |4 aut | |
| 700 | 1 | |a Bouvier, Antoine |e verfasserin |4 aut | |
| 700 | 1 | |a Mastier, Charles |e verfasserin |4 aut | |
| 700 | 1 | |a Sengel, Christian |e verfasserin |4 aut | |
| 700 | 1 | |a Tselikas, Lambros |e verfasserin |4 aut | |
| 700 | 1 | |a Arnold, Dirk |e verfasserin |4 aut | |
| 700 | 1 | |a Maleux, Geert |e verfasserin |4 aut | |
| 700 | 1 | |a Pelage, Jean-Pierre |e verfasserin |4 aut | |
| 700 | 1 | |a Pellerin, Olivier |e verfasserin |4 aut | |
| 700 | 1 | |a Peynircioglu, Bora |e verfasserin |4 aut | |
| 700 | 1 | |a Sangro, Bruno |e verfasserin |4 aut | |
| 700 | 1 | |a Schaefer, Niklaus |e verfasserin |4 aut | |
| 700 | 1 | |a Urdániz, María |e verfasserin |4 aut | |
| 700 | 1 | |a Kaufmann, Nathalie |e verfasserin |4 aut | |
| 700 | 1 | |a Bilbao, José Ignacio |e verfasserin |4 aut | |
| 700 | 1 | |a Helmberger, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Vilgrain, Valérie |e verfasserin |4 aut | |
| 700 | 0 | |a CIRT-FR Principal Investigators |e verfasserin |4 aut | |
| 700 | 1 | |a Piana, Gilles |e investigator |4 oth | |
| 700 | 1 | |a Frandon, Julien |e investigator |4 oth | |
| 700 | 1 | |a Tasu, Jean-Pierre |e investigator |4 oth | |
| 700 | 1 | |a Kobeiter, Hicham |e investigator |4 oth | |
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