Treatment of Unresectable Cholangiocarcinoma Using Yttrium-90 Microspheres Results From a Pilot Study

BACKGROUND. The objective of this report was to present data from an open-label cohort study in which patients with intrahepatic cholangiocarcinoma (ICC) underwent radioembolization with yttrium-90 (Y-90) microspheres. METHODS. Twenty-four patients with histologically proven ICC were treated. The planned target dose was 120 Gray. Patients were stratified according to Eastern Cooperation Oncology Group (ECOG) performance status, tumor morphology (infiltrative vs peripheral), tumor distribution (solitary vs multifocal), and the presence or absence of portal vein thrombosis (PVT). Before and after the procedure, the following variables were assessed: 1) biochemical and clinical toxicity, 2) imaging (computed tomography/magnetic resonance imaging) response according to World Health Organization and European Association for the Study of Liver Disease (EASL) criteria, and 3) median survival after the first treatment using Kaplan-Meier methodology. RESULTS. in total, 48 Y-90 treatments were administered to hepatic segments or lobes. Fatigue and transient abdominal pain were reported in 18 patients (75%) and 10 patients (42%), respectively. One patient (4%) developed grade 3 bilirubin toxicity. One patient (4%) developed a treatment-related gastroduodenal ulcer. On imaging follow-up of 22 patients, tumors demonstrated a partial response in 6 patients (27%), stable disease in 15 patients (68%), and progressive disease in 1 patient (5%). By using EASL guidelines, 17 patients (77%) showed >50% tumor necrosis on imaging follow-up. Two patients (9%) demonstrated 100% tumor necrosis. The median overall survival for the entire cohort (n = 24) was 14.9 months. The median survival for patients with an ECOG performance status of 0, 1, and 2 was 31.8 months, 6.1 months, and I month, respectively (P < .0001); the median survival for patients without and with PVT was 31.8 months and 5.7 months, respectively (P = .0003); and the median survival for patients with peripheral versus periductal-infiltrative tumors was 31.8 months and 5.7 months, respectively (P = .0005). CONCLUSIONS. Radioembolization with Y-90 may be a therapeutic option for the treatment of unresectable ICC. Cancer 2008;113:2119-28. (C) 2008 American Cancer Society.