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

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 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.

Keywords: Chemoembolisation; Drug-eluting microspheres; Interim analysis; Irinotecan; TACE.

Conflict of interest statement

Pereira reports the receipt of grants from Siemens Healthineers, Terumo, BTG and Biocompatibles, the receipt of honoraria from Terumo, Sirtex, Angiodynamics, Medtronic, Pharmacept and Guerbet, as well as study grants from BMS, MSD, GSK and Terumo and travel support from Bayer. B. Gonçalves reports personal fees from Medtronic, personal fees from Terumo, personal fees from Sirtex, outside the submitted work. T. Helmberger received speaker honoraria from SIRTEX Medical Europe. O. Pellerin has received personal fees from Merit Medical and shareholdings of COGITh-SAS. D. Arnold received consulting fees and speaker honoraria from TERUMO, Boston Scientific, SIRTEX Medical Europe and Biocompatibles. G. Maleux received speaker fees from SIRTEX Medical Europe. B. Sangro has received personal fees from Terumo and BTG, as well as personal fees and a grant from Sirtex Medical. J. Taieb reports receiving honoraria from Merck, Roche, Amgen, Lilly, Sanofi, Samsung, MSD, Servier, Celgene, Pierre Fabre; consulting or advisory Role for Roche, Merck KGaA, Amgen, Lilly, MSD, Servier, Pierre Fabre, Sanofi, Samsung; speakers’ Bureau for Servier, Amgen, Roche, Sanofi, Merck, Lilly, Pierre Fabre. H. Prenen received honoraria and/or travel grants from Roche, Bayer, Amgen, Ipsen, Pfizer, Sanofi, Merck, Terumo and Lilly. R. Iezzi, R. Manfredi, F. Carchesio, Z. Bánsághi, E. Brountzos, S. Spiliopoulos, J. Echevarria-Uraga, R. Inchingolo, M. Nardella, M. Sousa, F. T. Debaere, Gomez, B. Zeka, and N. Kaufmann report no conflict of interest.

Figures

Fig. 1

Procedural medications used during LP-irinotecan TACE treatments. Depicts a heatmap of all medications used during each LP-irinotecan TACE treatment session (n = 127) divided into 4 groups based on similar medications used and a table listing the number of treatment sessions, different sites, as well as country (number of patients) per group. Each row represents one treatment, and each column represents the used class of medication. Coloured fields indicate that during the treatment the respective medication was used. 1 patient (in 2 treatments) where epidural anaesthesia was used in the absence of any other procedural medication is not shown. The heatmap was generated using the R heatmap function with the default clustering algorithm. Dendrograms for the clustering algorithm are not shown

Fig. 2

Health-related quality of life according to EORTC-QLQ 30. Shows HRQOL score of 34 patients collected at baseline (before the first treatment) and at the first follow-up (4–15 weeks later) by analysing global health (a, b), function (c, d) and symptoms (e, f) score according to EORTC-QLQ30 version 3.0. For the global health and the function score, a high score indicates high health and for the symptom scale a low score indicates few symptoms. For general comparisons between baseline and the first follow-up, boxplots were used (a, c, e). The difference between baseline and first follow-up was plotted for individual patients using a waterfall diagram. Cut-offs (dashed line) for clinically significant improvement were set at + 10 for global health, functional score and − 10 for symptom score and at − 10 for global health, functional score and + 10 for symptom score for deterioration. Red bars indicate patients with treatment intention: salvage therapy (see supplementary Table 1)