Safety, Feasibility and Technical Considerations from a Prospective, Observational Study—CIREL: Irinotecan-TACE for CRLM in 152 Patients

CIREL, a prospective, Europe-wide, observational study aimed to assess the real-world feasibility and tolerability of irinotecan-based transarterial chemoembolization (LP-irinotecan TACE) for unresectable colorectal cancer liver metastases with regard to the treatment plan and adverse events (AEs)....

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Main Authors: Thomas Helmberger, Pierleone Lucatelli, Philippe L. Pereira, Aleksandar Gjoreski, Ivona Jovanoska, Zoltan Bansaghi, Stavros Spiliopoulos, Francesca Carchesio, Dirk Arnold, Andreas Baierl, Bleranda Zeka, Nathalie C. Kaufmann, Julien Taieb, Roberto Iezzi
Format: Article
Language:English
Published: MDPI AG 2022-10-01
Series:Journal of Clinical Medicine
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Online Access:https://www.mdpi.com/2077-0383/11/20/6178
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author Thomas Helmberger
Pierleone Lucatelli
Philippe L. Pereira
Aleksandar Gjoreski
Ivona Jovanoska
Zoltan Bansaghi
Stavros Spiliopoulos
Francesca Carchesio
Dirk Arnold
Andreas Baierl
Bleranda Zeka
Nathalie C. Kaufmann
Julien Taieb
Roberto Iezzi
author_facet Thomas Helmberger
Pierleone Lucatelli
Philippe L. Pereira
Aleksandar Gjoreski
Ivona Jovanoska
Zoltan Bansaghi
Stavros Spiliopoulos
Francesca Carchesio
Dirk Arnold
Andreas Baierl
Bleranda Zeka
Nathalie C. Kaufmann
Julien Taieb
Roberto Iezzi
author_sort Thomas Helmberger
collection DOAJ
description CIREL, a prospective, Europe-wide, observational study aimed to assess the real-world feasibility and tolerability of irinotecan-based transarterial chemoembolization (LP-irinotecan TACE) for unresectable colorectal cancer liver metastases with regard to the treatment plan and adverse events (AEs). CIREL enrolled 152 eligible patients (≥18 years) with liver-only or dominant metastases treated with LP-irinotecan TACE following a multidisciplinary tumor board decision. Data were prospectively collected for baseline, the number of planned and performed sessions, and technical information and safety according to CTCAE 4.03/5.0. Results from 351 analyzed treatment sessions showed technical success for 99% of sessions, and 121 patients (79%) completed all planned sessions. Further, 60% of sessions were performed using opioids, 4% intra-arterial anesthetics, and 25% both. Additionally, 60% of patients experienced at least one peri-interventional AE of any grade; 8% of grade 3–4. Occurrence of AEs was related to larger liver-involvement (<i>p</i> < 0.001), bi-lobar disease (<i>p</i> = 0.002), and larger beads (<i>p</i> < 0.001). Using corticosteroids together with antiemetics showed reduced and lower grade vomiting (<i>p</i> = 0.01). LP-irinotecan TACE was tolerated well and had a high proportion of completed treatment plans. This minimally invasive locoregional treatment can be used together with concomitant systemic therapy or ablation.
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spelling doaj.art-c955eddf2b9a4844b268092c75b0e51b2023-12-02T00:34:00ZengMDPI AGJournal of Clinical Medicine2077-03832022-10-011120617810.3390/jcm11206178Safety, Feasibility and Technical Considerations from a Prospective, Observational Study—CIREL: Irinotecan-TACE for CRLM in 152 PatientsThomas Helmberger0Pierleone Lucatelli1Philippe L. Pereira2Aleksandar Gjoreski3Ivona Jovanoska4Zoltan Bansaghi5Stavros Spiliopoulos6Francesca Carchesio7Dirk Arnold8Andreas Baierl9Bleranda Zeka10Nathalie C. Kaufmann11Julien Taieb12Roberto Iezzi13Institut für Radiologie, Neuroradiologie und Minimal-Invasive Therapie, München Klinik Bogenhausen, Englschalkinger Str. 77, 81925 München, GermanyVascular and Interventional Radiology Unit, Department of Radiological Oncological and Anatomopathological Sciences, Sapienza University of Rome, 00161 Roma, ItalySLK-Kliniken Heilbronn GmbH, Zentrum für Radiologie, Minimal-invasive Therapien und Nuklearmedizin, Am Gesundbrunnen 20-26, 74078 Heilbronn, GermanyDiagnostic and Interventional Radiology, General City Hospital “8th September”, 1000 Skopje, North MacedoniaDiagnostic and Interventional Radiology, General City Hospital “8th September”, 1000 Skopje, North MacedoniaMedical Imaging Center, Semmelweis University, 1082 Budapest, HungaryInterventional Radiology Unit, 2nd Department of Radiology, School of Medicine, National and Kapodistrian University of Athens, Rimini 1, 124 62 Athens, GreeceDipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, UOC di Radiologia Diagnostica ed Interventistica Generale, Fondazione Policlinico Universitario “A. Gemelli” IRCCS, 00168 Rome, ItalyAsklepios Tumorzentrum Hamburg, AK Altona, 22763 Hamburg, GermanyDepartment of Statistics and Operations Research, University of Vienna, 1010 Vienna, AustriaClinical Research Department, Cardiovascular and Interventional Radiological Society of Europe, Neutorgasse 9, 1010 Vienna, AustriaClinical Research Department, Cardiovascular and Interventional Radiological Society of Europe, Neutorgasse 9, 1010 Vienna, AustriaAssistance Publique Hôpitaux de Paris, Service d’Hepatogastroentérologie et d’Oncologie Digestive, Hôpital Européen Georges Pompidou, Université Paris Descartes, Sorbonne Paris-Cité, 75015 Paris, FranceDipartimento di Diagnostica per Immagini, Radioterapia Oncologica ed Ematologia, UOC di Radiologia Diagnostica ed Interventistica Generale, Fondazione Policlinico Universitario “A. Gemelli” IRCCS, 00168 Rome, ItalyCIREL, a prospective, Europe-wide, observational study aimed to assess the real-world feasibility and tolerability of irinotecan-based transarterial chemoembolization (LP-irinotecan TACE) for unresectable colorectal cancer liver metastases with regard to the treatment plan and adverse events (AEs). CIREL enrolled 152 eligible patients (≥18 years) with liver-only or dominant metastases treated with LP-irinotecan TACE following a multidisciplinary tumor board decision. Data were prospectively collected for baseline, the number of planned and performed sessions, and technical information and safety according to CTCAE 4.03/5.0. Results from 351 analyzed treatment sessions showed technical success for 99% of sessions, and 121 patients (79%) completed all planned sessions. Further, 60% of sessions were performed using opioids, 4% intra-arterial anesthetics, and 25% both. Additionally, 60% of patients experienced at least one peri-interventional AE of any grade; 8% of grade 3–4. Occurrence of AEs was related to larger liver-involvement (<i>p</i> < 0.001), bi-lobar disease (<i>p</i> = 0.002), and larger beads (<i>p</i> < 0.001). Using corticosteroids together with antiemetics showed reduced and lower grade vomiting (<i>p</i> = 0.01). LP-irinotecan TACE was tolerated well and had a high proportion of completed treatment plans. This minimally invasive locoregional treatment can be used together with concomitant systemic therapy or ablation.https://www.mdpi.com/2077-0383/11/20/6178CRLMmCRCTACEDEBIRIirinotecan
spellingShingle Thomas Helmberger
Pierleone Lucatelli
Philippe L. Pereira
Aleksandar Gjoreski
Ivona Jovanoska
Zoltan Bansaghi
Stavros Spiliopoulos
Francesca Carchesio
Dirk Arnold
Andreas Baierl
Bleranda Zeka
Nathalie C. Kaufmann
Julien Taieb
Roberto Iezzi
Safety, Feasibility and Technical Considerations from a Prospective, Observational Study—CIREL: Irinotecan-TACE for CRLM in 152 Patients
Journal of Clinical Medicine
CRLM
mCRC
TACE
DEBIRI
irinotecan
title Safety, Feasibility and Technical Considerations from a Prospective, Observational Study—CIREL: Irinotecan-TACE for CRLM in 152 Patients
title_full Safety, Feasibility and Technical Considerations from a Prospective, Observational Study—CIREL: Irinotecan-TACE for CRLM in 152 Patients
title_fullStr Safety, Feasibility and Technical Considerations from a Prospective, Observational Study—CIREL: Irinotecan-TACE for CRLM in 152 Patients
title_full_unstemmed Safety, Feasibility and Technical Considerations from a Prospective, Observational Study—CIREL: Irinotecan-TACE for CRLM in 152 Patients
title_short Safety, Feasibility and Technical Considerations from a Prospective, Observational Study—CIREL: Irinotecan-TACE for CRLM in 152 Patients
title_sort safety feasibility and technical considerations from a prospective observational study cirel irinotecan tace for crlm in 152 patients
topic CRLM
mCRC
TACE
DEBIRI
irinotecan
url https://www.mdpi.com/2077-0383/11/20/6178
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