Background/aims: Hepatic arterial infusion (HAI) chemotherapy has a number of limitations, including a low rate of complete response and frequent extrahepatic recurrence, in colorectal cancer (CRC) patients with unresectable hepatic metastases. A clinical trial was planned to assess the safety and efficacy of combination chemotherapy of HAI and oral administration of UFT and leucovorin (UZEL) in CRC patients with unresectable liver metastases.
Methodology: Sixteen CRC patients with unresectable liver metastases were treated with concurrent HAI and systemic oral UFT/UZEL. Eligible patients were previously untreated (except for adjuvant therapy) CRC patients with unresectable liver metastases, with WHO performance statuses of 0 to 2. On an outpatient basis, the patients received a treatment regimen consisting of 5-fluorouracil at 1000 mg/m2 and l-Leucovorin at 50 mg/m2 for 5 hours on days 1, 8, 15, and 22 by hepatic arterial infusion plus oral UFT (300 mg/m2) and UZEL (75 mg/body) on days 2-7, 9-14, and 23-28 followed by withdrawal for one week. The cycles were repeated every 5 weeks until disease progression.
Results: A total of 103 cycles of HAI with the UFT/UZEL regimen were administered (median, 5 cycles; range, 6 to 9 cycles). The response rate was 87.5% (14 partial responses and 2 stable diseases). The median progression-free survival rate was 9.2 months, and the median survival time was 22 months. No treatment-related grade 3 or 4 adverse events were observed.
Conclusions: This novel locoregional HAI with an oral UFT/UZEL systemic chemotherapeutic regimen is feasible in an outpatient setting and should be considered as first-line chemotherapy for CRC patients with unresectable liver metastases.