Randomized phase II trial of adjuvant hepatic arterial infusion and systemic chemotherapy with or without bevacizumab in patients with resected hepatic metastases from colorectal cancer.

ABSTRACT:

Purpose

Add systemic bevacizumab (Bev) to adjuvant hepatic arterial infusion (HAI) plus systemic therapy after liver resection to increase recurrence-free survival (RFS).

Patients and methods

Patients were randomly assigned to HAI plus systemic therapy with or without Bev. If 1-year RFS of ≥ 80% was obtained in Bev arm, then the regimen would be studied further. HAI with fluorodeoxyuridine plus dexamethasone was given on days 1 to 14 of a 5-week cycle. Systemic therapy and Bev 5 mg/kg was delivered on days 15 and 29: oxaliplatin 85 mg/m², leucovorin 400 mg/m², and fluorouracil 2,000 mg/m² infusion for 2 days (if patients received prior oxaliplatin, then irinotecan 150 mg/m² was used). RFS and survival were estimated by using the Kaplan-Meier method and compared by using the

SUBMITTER: Kemeny NE 

PROVIDER: S-EPMC3646323 | biostudies-literature | 2011 Mar

REPOSITORIES: biostudies-literature