ECIO 2024 Book of Abstracts

Purpose: PROACTIF is a post-approval study evaluating the effectiveness, quality-of-life, safety, and dosimetry of transarterial radioembolization (TARE) with yttrium-90 (Y-90) glass microspheres in the treatment of primary and metastatic liver tumors, including intrahepatic cholangiocarcinoma* (ICC), in a real-world clinical setting.Materials and methods: This prospective registry includes patients who were not opposed to data collection, treated with standard of care Y-90 across 35 French institutions.Data was extracted 01DEC2023.Duration of follow-up and overall survival (OS) were assessed by reverse and Kaplan-Meier analysis, respectively.Toxicity was assessed using CTCAE v5.Results: Among patients with unresectable ICC (N=168) 52.4% were female; median age was 69 years; 57.1% were ECOG 0; 31.5% had associated liver fibrosis/cirrhosis; the mean index lesion was 70.7mm.Prior to Y-90 treatment, 48.8% were treatment naïve and 37.5% had previous treatment (systemic, n=56; locoregional, n=6; liver surgery, n=10).Personalized treatments comprised of multicompartment dosimetry (63.1%); ultraselective or selective treatment (53.6%); and repeat treatments: two (23.2%) or three (1.2%).Median followup was 18.2 months [95% CI: 14.6-19.6].Median OS was 18.1 months [16.3-23.9].Adverse events (AEs) were experienced by 14 patients (n=19; 12 device/procedure related) and 13 had serious AEs (n=17; 10 device/procedure related; 4 hepatobiliary related).Conclusion: This ad hoc analysis demonstrates that TARE is frequently used in appropriately selected ICC patients.Patients received personalized treatment (multicompartment dosimetry, repeat treatments), resulting in long survival and low AEs.Final results for this study are expected in 2025.PI-1789608-AA *The use of TheraSphere for ICC is outside the labeled indication.