摘要：

Purpose The purpose of this study was to assess hepatic arterial infusion (HAI) of oxaliplatin combined with intravenous 5-fluorouracil (5-FU) and l-leucovorin (l-LV) in colorectal cancer (CRC) patients with systemic chemotherapy failure in a phase I/II trial. Methods CRC patients with unresectable liver metastases following standard systemic chemotherapy failure were eligible. A catheter-port system for HAI was placed using interventional radiology. In phase I, escalating doses of oxaliplatin for levels 1 and 2 were set at 50 and 100?mg/m_(2), respectively, and were combined with fixed doses of intravenous 5-FU (200?mg/m_(2)bolus and 2400?mg/m_(2)/46-h continuous infusion) and l-LV (200?mg/m_(2)). The dose-limiting toxicity (DLT) was assessed, and the recommended dose (RD) was estimated. In phase II, patients receiving RD were included to assess the 6-month survival rate (the expected rate 80%), overall survival time, tumor response, and toxicity. Results In phase I, none of the six enrolled patients exhibited DLT. RD for oxaliplatin by HAI was estimated as 100?mg/m_(2). In phase II, seven additional patients were enrolled. In patients receiving RD ( n ?=?10), the disease control rates for total lesions and liver lesions were 30 and 70%, respectively. The 6-month survival rate and the overall survival time were 53.3% and 6.9?months, respectively. There were no adverse reactions equivalent to DLT in any of the patients. Conclusions The estimated RD for oxaliplatin by HAI in combination with intravenous 5-FU and l-LV was 100?mg/m_(2). This combination therapy was feasible and safe, but the expected efficacy was not achieved.

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