Chemoembolization with Degradable Starch Microspheres for Treatment of Patients with Primary or Recurrent Unresectable, Locally Advanced Intrahepatic Cholangiocarcinoma: A Pilot Study.

To evaluate efficacy and complication rates of TACE with degradable starch microspheres (DSM-TACE) in patients with unresectable intrahepatic cholangiocarcinoma (ICC) with or without prior major liver resection (MLR). This is a retrospective single-center study on 21 patients (age 63 ± 15 years) with either unresectable ICC progressive under systemic chemotherapy or unresectable intrahepatic tumor recurrence after prior MLR. Patients were treated by multi-agent (cisplatin/doxorubicin/mitomycin C) DSM-TACE between August 2012 and July 2016, repeated 3 times at 4-week intervals. Imaging response was evaluated using RECIST 1.1. Overall survival (OS) and complication rates, stratified by history of MLR, were investigated. Patients underwent a total 64 DSM-TACE sessions. Two patients (without MLR) were lost to follow-up after one uneventful DSM-TACE session. One patient underwent living-donor-liver transplantation after one DSM-TACE-session yielding partial remission. Of the remaining 18 patients, imaging response according to RECIST 1.1 was: complete remission in 2/18 (11.1%); PR in 9/18 (50%), and stable disease in 7/18 (38.9%), yielding an objective response rate of 61.1% and a disease control rate of 100%. Median OS of patients with objective response was significantly longer (18.0 months) than that of survival of patients with stable disease (4.8 months) (p = 0.001). Median OS of patients with MLR (12.5 months) was similar to that of patients without MLR (13.2 months). Of 21 patients, 2 (9.5%) developed post-interventional hepatobiliary abscesses, and one of these patients died due to subsequent sepsis. DSM-TACE is an effective treatment for unresectable and otherwise therapy-refractory intrahepatic cholangiocarcinoma, even in those patients with intrahepatic disease recurrence after prior MLR. Level II, therapeutic study.