TY - JOUR
T1 - The CIREL Cohort
T2 - A Prospective Controlled Registry Studying the Real-Life Use of Irinotecan-Loaded Chemoembolisation in Colorectal Cancer Liver Metastases: Interim Analysis
AU - Pereira, Philippe L.
AU - Iezzi, Roberto
AU - Manfredi, Riccardo
AU - Carchesio, Francesca
AU - Bánsághi, Zoltan
AU - Brountzos, Elias
AU - Spiliopoulos, Stavros
AU - Echevarria-Uraga, Javier J.
AU - Gonçalves, Belarmino
AU - Inchingolo, Riccardo
AU - Nardella, Michele
AU - Pellerin, Olivier
AU - Sousa, Maria
AU - Arnold, Dirk
AU - de Baère, Thierry
AU - Gomez, Fernando
AU - Helmberger, Thomas
AU - Maleux, Geert
AU - Prenen, Hans
AU - Sangro, Bruno
AU - Zeka, Bleranda
AU - Kaufmann, Nathalie
AU - Taieb, Julien
N1 - Publisher Copyright:
© 2020, The Author(s).
PY - 2021/1/1
Y1 - 2021/1/1
N2 - Purpose: 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. Methods: 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. Results: 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. Conclusion: 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. Trial Registration: NCT03086096.
AB - Purpose: 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. Methods: 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. Results: 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. Conclusion: 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. Trial Registration: NCT03086096.
KW - Chemoembolisation
KW - Drug-eluting microspheres
KW - Interim analysis
KW - Irinotecan
KW - TACE
UR - http://www.scopus.com/inward/record.url?scp=85091412268&partnerID=8YFLogxK
U2 - 10.1007/s00270-020-02646-8
DO - 10.1007/s00270-020-02646-8
M3 - Article
C2 - 32974773
AN - SCOPUS:85091412268
SN - 0174-1551
VL - 44
SP - 50
EP - 62
JO - CardioVascular and Interventional Radiology
JF - CardioVascular and Interventional Radiology
IS - 1
ER -