49Y90 Glass Microsphere Treatment for iCCA: Final Results from the Largest Prospective Real-World Study (PROACTIF)

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Abstract Purpose This study evaluated the effectiveness, safety, and dosimetry of selective internal radiation therapy with Y90 in a real-world clinical setting. Herein, we present the final data for iCCA. Materials and methods All patients treated with yttrium-90 (Y90) glass microspheres (TheraSphere™) across 34 French institutions who agreed to data collection were included. Overall survival (OS) was assessed by Kaplan-Meier analysis. Adverse events (AEs) were assessed using CTCAE v5. Results Among 207 intrahepatic cholangiocarcinoma (iCCA) patients, key baseline and treatment characteristics were: fibrosis/cirrhosis (31.8%), solitary lesion (52.7%), treatment-naïve (52.2%), prior treatment (37.2%; systemic, n = 70; locoregional, n = 7; surgery, n = 10), concomitant treatment (33.8%; mainly gemcitabine and/or cisplatin); multicompartment dosimetry (68.1%), and selective treatment administration (58.9%). Median index lesion (IL) size was 7.0 cm according to RECIST 1.1 and central read. Mean pretreatment absorbed dose to the IL was 357.03 Gy. Median OS was 21.9 months (M). By subgroup, median OS was 23.3M without cirrhosis/fibrosis versus 19.8M with cirrhosis/fibrosis; 23.3M in treatment-naïve patients versus 11.4M in recurrent disease; 21.3M without concomitant treatment versus 21.9M with concomitant treatment; 22.6M in IL tumors ≤7cm versus 23.7M in > 7cm tumors. Patients with surgery had the greatest survival benefit (n = 27; median not reached) compared to patients with subsequent treatment excluding surgery (n = 90; 21.3M), and no subsequent treatment (n = 76; 17.4M). In total, 18 Grade ≥3 AEs and 18 serious AEs were reported. Conclusion This real-world study demonstrates an acceptable safety profile and meaningful survival including patients with cirrhosis and confirms that Y90 should be considered for iCCA patients.

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