Treating primary liver cancer with hepatic arterial infusion of floxuridine and dexamethasone: Does the addition of systemic bevacizumab improve results?

e14658 Background: Unresectable primary liver cancer (UPLC), including intrahepatic cholangiocarcinoma (ICC) and hepatocellular carcinoma (HCC), has poor median survival, typically 10 to 11 months. Hepatic arterial infusion (HAI) has previously shown efficacy, and adding bevacizumab (Bev) may induce changes in the tumor vasculature that improve local delivery of HAI. METHODS Patients with UPLC were treated with HAI of floxuridine (FUDR)/dexamethasone (Dex) administered as 2 week (w) infusion on a 4 w schedule with Bev 5 mg/kg administered IV Q 2w. Response, toxicity and progression-free survival (PFS) were compared to a recent study of HAI without Bev. We hypothesized that adding Bev would result in a 50% improvement in time to progression, which required 48 patients to detect with 90 % power. RESULTS Twenty-two patients (18 ICC/4 HCC) were treated with HAI FUDR/Dex plus Bev; 7 (31.8%) had partial response and 15 (68.2%) stable disease. Median survival, PFS, and hepatic progression free survival (HPFS) were 31.1, 8.5, and 11.3 months, respectively. In the previous trial (n=34; 26 ICC, 8 HCC) using HAI without Bev, response was 50% and median survivals as listed below. Adding Bev to HAI led to increase in serum bilirubin elevation (>2 mg/dl) in 24% of patients and biliary stent placement in 13.6%, compared to 5.8% and 0% in the first study without Bev. The present study was terminated early due to biliary toxicity. CONCLUSIONS This trial was closed prematurely due to increased biliary toxicity without apparent improvement in outcome (median survival 31.1 and 29.5 months for HAI + Bev versus HAI alone groups). [Table: see text].