The CIREL Cohort: A Prospective Controlled Registry Studying the Real-Life Use of Irinotecan-Loaded Chemoembolisation in Colorectal Cancer Liver Metastases: Interim Analysis.
Chemoembolisation
Drug-eluting microspheres
Interim analysis
Irinotecan
TACE
Journal
Cardiovascular and interventional radiology
ISSN: 1432-086X
Titre abrégé: Cardiovasc Intervent Radiol
Pays: United States
ID NLM: 8003538
Informations de publication
Date de publication:
Jan 2021
Jan 2021
Historique:
received:
07
07
2020
accepted:
05
09
2020
pubmed:
26
9
2020
medline:
4
5
2021
entrez:
25
9
2020
Statut:
ppublish
Résumé
Transarterial chemoembolisation (TACE) using irinotecan-eluting beads is an additional treatment option for colorectal cancer liver metastases (CRLM) patients that are not eligible for curative treatment approaches. This interim analysis focuses on feasibility of the planned statistical analysis regarding data distribution and completeness, treatment intention, safety and health-related quality of life (HRQOL) of the first 50 patients prospectively enrolled in the CIrse REgistry for LifePearl™ microspheres (CIREL), an observational multicentre study conducted across Europe. In total, 50 patients ≥ 18 years diagnosed with CRLM and decided to be treated with irinotecan-eluting LifePearl™ microspheres TACE (LP-irinotecan TACE) by a multidisciplinary tumour board. There were no further inclusion or exclusion criteria. The primary endpoint is the categorisation of treatment intention, and secondary endpoints presented in this interim analysis are safety, treatment considerations and HRQOL. LP-irinotecan TACE was conducted in 42% of patients as salvage therapy, 20% as an intensification treatment, 16% as a first-line treatment, 14% a consolidation treatment and 8% combination treatment with ablation with curative intent. Grade 3 and 4 adverse events were reported by 4% of patients during procedure and by 10% within 30 days. While 38% reported a worse, 62% reported a stable or better global health score, and 54% of patients with worse global health score were treated as salvage therapy patients. This interim analysis confirms in a prospective analysis the feasibility of the study, with an acceptable toxicity profile. More patients reported a stable or improved HRQOL than deterioration. Deterioration of HRQOL was seen especially in salvage therapy patients. NCT03086096.
Identifiants
pubmed: 32974773
doi: 10.1007/s00270-020-02646-8
pii: 10.1007/s00270-020-02646-8
pmc: PMC7728640
doi:
Substances chimiques
Topoisomerase I Inhibitors
0
Irinotecan
7673326042
Banques de données
ClinicalTrials.gov
['NCT03086096']
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
50-62Subventions
Organisme : Terumo Europe NV
ID : unrestriced educational grant
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