LAUSR

Background Gemcitabine, a chemotherapy for hepatic metastasis with pancreatic cancer (PC) or intrahepatic cholangiocarcinoma (ICC) origin, may radiosensitize the targeted tumor cells for yttrium-90 radioembolization (90Y-RE). This clinical trial was designed to investigate the effects of a combination of 90Y-RE and gemcitabine in hepatic metastasis of PC or ICC origin. Methods Fourteen patients who had histopathologic diagnosis of unresectable hepatic metastasis of PC or ICC origin were enrolled into the open-label phase Ib clinical trial. Induction dose of gemcitabine on day 1 was followed by 90Y-RE on day 2 with predetermined doses of gemcitabine to follow till week 12. Maximal tolerated dose (MTD) of gemcitabine in combination with 90Y-RE, associated toxicities and hepatic progression free survival (HPFS) were assessed. The tumor response rate was evaluated using both RECIST and PERCIST criteria. Results Eight patients met the study criteria; three with PC and five with ICC. The mean age of the patients was 69.4 years. Seven out of 8 patients tolerated predetermined gemcitabine regime (dose level 1 at 400 mg/m2 and dose level 2 at 600 mg/m2). All of the patients developed grade 1 toxicities. Three patients (37.5%) had grade 2 hepatobiliary toxicity and one patient (12.5%) had grade 3 hepatobiliary toxicity, who was hospitalized for a short-term. The median HPFS was 8.7 months for all patients. The objective response rate was 62%. Conclusions A combination of 90Y-RE and gemcitabine at 600 mg/m2 is a safe and potential treatment option for hepatic metastasis of pancreaticobiliary origin.