Transarterial chemoembolisation with irinotecan (irinotecan-TACE) as salvage or post-inductive therapy for colorectal cancer liver metastases: effectiveness results from the CIREL study

Background: A pan-European, prospective, observational study on the use of irinotecan-eluting transarterial chemoembolisation (irinotecan-TACE) was conducted to evaluate effectiveness outcomes in salvage and post-inductive/consolidation therapy settings of colorectal cancer liver metastases (CRLMs). Materials and methods: One hundred and fifty-two patients were consecutively enrolled between February 2018 and August 2020. All patients received irinotecan-TACE for CRLMs. Response data were assessed by a central independent image review panel according to RECIST v1.1. Prognostic factors for overall survival (OS), hepatic progression-free survival (HPFS), and progression-free survival (PFS) were calculated using multivariable Cox regression. Health-related quality of life (HRQoL) at the first follow-up was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Results: One hundred and fifty-two (median age 66 years, 61% male) patients were prospectively enrolled. Overall, the median OS was 14.5 months [95% confidence interval (CI) 11.6-17.0 months]. The median OS (95% CI) of irinotecan-TACE as salvage therapy was 9.9 months (7.4-12.8 months) and the median PFS was 3.8 months (2.9-4.7 months). The median OS for post-inductive/consolidation therapy when used with systemic therapy or thermal ablation was 19.1 months (16.2-24.2 months), the median PFS was 6.0 months (4.5-8.7 months), and the median HPFS was 8.7 months (6.9-10.6 months).Following a multivariable analysis, negative prognostic factors for OS were Eastern Cooperative Oncology Group performance status ≥2 [hazard ratio (HR) 4.3], >50 mm lesion size (HR 2.1), progressive extrahepatic disease (HR 2.0), ≥2 prior systemic therapy lines (HR 2.4), >50% liver involvement (HR 8.5), and treatment plan not completed (HR 2.0). For PFS, progressive disease outside the liver (HR 1.8) and liver involvement of 25%-50% (HR 2.0) or >50% (HR 3.4) were identified as negative prognostic factors. HRQoL was generally stable or improved overall. Conclusions: The results from the largest, pan-European, real-life study on irinotecan-TACE for CRLMs show a comparably long median OS when used as salvage therapy and promising HPFS when used with systemic therapy or thermal ablation as post-inductive/consolidation therapy. With its potential to maintain HRQoL, irinotecan-TACE could be further integrated into systemic treatment pathways.