The CIREL Cohort: A Prospective Controlled Registry Studying the Real-Life Use of Irinotecan-Loaded Chemoembolisation in Colorectal Cancer Liver Metastases: Interim Analysis

• DOI: 10.1007/s00270-020-02646-8
• Publication Date: 2020-09-24T16:02:37Z
• Authors: Philippe L. Pereira; Roberto Iezzi; Riccardo Manfredi; Francesca Carchesio; Zoltan Bánsághi; Elias Brountzos; Stavros Spiliopoulos; Javier J. Echevar...; Belarmino Gonçalves; Riccardo Inchingolo; Michele Nardella; Olivier Pellerin; Maria Sousa; Dirk Arnold; Thierry de Baère; Fernando Gomez; Thomas Helmberger; Geert Maleux; Hans Prenen; Bruno Sangro; Bleranda Zeka; Nathalie Kaufmann; Julien Taieb
• Keywords: Interim analysis; Clinical endpoint; Interim

Abstract Purpose Transarterial chemoembolisation (TACE) using irinotecan-eluting beads is an additional treatment option for colorectal cancer liver metastases (CRLM) patients that are not eligible curative approaches. This interim analysis focuses on feasibility of the planned statistical regarding data distribution and completeness, intention, safety health-related quality life (HRQOL) first 50 prospectively enrolled in CIrse REgistry LifePearl™ microspheres (CIREL), observational multicentre study conducted across Europe. Methods In total, ≥ 18 years diagnosed with CRLM decided to be treated TACE (LP-irinotecan TACE) by a multidisciplinary tumour board. There were no further inclusion or exclusion criteria. The primary endpoint categorisation secondary endpoints presented this safety, considerations HRQOL. Results LP-irinotecan was 42% as salvage therapy, 20% intensification treatment, 16% first-line 14% consolidation 8% combination ablation intent. Grade 3 4 adverse events reported 4% during procedure 10% within 30 days. While 38% worse, 62% stable better global health score, 54% worse score therapy patients. Conclusion confirms prospective study, acceptable toxicity profile. More improved HRQOL than deterioration. Deterioration seen especially Trial Registration NCT03086096.