Continuous infusion of hepatic arterial irinotecan in pretreated patients with colorectal cancer metastatic to the liver.

BACKGROUND: Irinotecan is an active drug in colorectal cancer. In patients with liver metastases, hepatic arterial infusion of irinotecan could theoretically result in higher exposure to the drug. In order to determine the efficacy of hepatic arterial irinotecan we conducted a phase II study in pretreated patients with liver metastases of colorectal cancer. PATIENTS AND METHODS: Patients with measurable liver metastases of colorectal cancer with World Health Organization performance status (WHO PS) <2 were treated with a 5-day continuous infusion of hepatic arterial irinotecan every 3 weeks at a dose of 20 mg/m(2)/day. RESULTS: Of the 25 patients included, 22 were evaluable for response. Three of 22 patients (13.6%) had a partial response, nine (40.9%) had stable disease and 10 (45.4%) had progressive disease. No complete responses were observed. Median time to progression was 2.8 (range 1.2-23.8) months. Major toxicities were vomiting and diarrhea. There was no major hematological toxicity. CONCLUSIONS: Five-day continuous hepatic arterial infusion of irinotecan 20 mg/m(2)/day has low activity in patients with liver metastases of colorectal cancer previously treated by chemotherapy.