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

Abstract

Objectives: This study investigated the efficacy and safety of adding systemic (IV) bevacizumab (Bev) to hepatic arterial infusion (HAI) with floxuridine (FUDR)/dexamethasone (Dex) in unresectable primary liver cancer.

Methods: Patients with unresectable intrahepatic cholangiocarcinoma (ICC) or hepatocellular carcinoma (HCC) were treated with HAI FUDR/Dex plus IV Bev. Results were compared to a recent study of HAI without Bev in a similar patient population.

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%) had stable disease. Median survival was 31.1 months (CI 14.14-33.59), progression-free survival (PFS) 8.45 months (CI 5.53-11.05), and hepatic PFS 11.3 months (CI 7.93-15.69). In the previous trial with HAI alone (no Bev), the response was 50%; median survival, PFS, and hepatic PFS were 29.5, 7.3, and 10.1 months. In the present trial, bilirubin elevation (>2 mg/dl) was seen in 24% of patients and biliary stents were placed in 13.6%, versus 5.8 and 0%, respectively, in the HAI trial without Bev. Due to increased biliary toxicity, the trial was prematurely terminated.

Conclusion: Adding Bev to HAI FUDR/Dex appeared to increase biliary toxicity without clear improvement in outcome (median PFS 8.45 vs. 7.3 months, and median survival 31.1 vs. 29.5 months, for HAI + Bev vs. HAI alone groups, respectively).

Copyright © 2011 S. Karger AG, Basel.

Figures

Fig. 1

Overall survival comparing HAI FUDR/Dex with systemic Bev (broken line) versus HAI FUDR/Dex alone (solid line). Median survival time with Bev = 31.1 months (CI 14.14–33.59). Median survival time without Bev = 28.93 months (CI 21.28–32.75).

Fig. 2

Hepatic PFS comparing HAI FUDR/Dex with systemic Bev (broken line) versus HAI FUDR/Dex alone (solid line). Median hepatic PFS with Bev = 11.28 months (CI 7.93–15.69). Median hepatic PFS without Bev = 10.08 (CI 7.14–12.86).

Fig. 3

PFS comparing HAI FUDR/Dex with systemic Bev (broken line) versus HAI FUDR/Dex alone (solid line). Median PFS with Bev = 8.45 months (CI 5.53–11.05). Median PFS without Bev = 7.27 months (CI 5.30–9.28).

Fig. 4

Maximum reduction from baseline using RESIST (tumor size change ≥30% considered a response).