PHASE-II STUDY OF HEPATIC ARTERIAL FLOXURIDINE, LEUCOVORIN, AND DEXAMETHASONE FOR UNRESECTABLE LIVER METASTASES FROM COLORECTAL-CARCINOMA

Purpose: To determine the toxicity, response rate, and survival of a r egimen of hepatic arterial floxuridine (FUDR) with leucovorin (LV) and dexamethasone (Dec) for the treatment of unresectable hepatic metasta ses from colorectal carcinoma. Patients and Methods: Sixty-two patient s with hepatic metastases (33 previously untreated with chemotherapy) were treated with FUDR (0.30 mg/kg/d) and LV (15 mg/m(2)/d) and Dec (2 0 mg total dose) as a 14-day hepatic arterial infusion via an implanta ble pump alternating with 2 weeks of saline. Results: The complete res ponse (CR) plus partial response (PR) rate was 78% in previously untre ated patients, with a median survival duration of 24.8 months; 1- and 2-year survival rates were 91% and 57%, respectively. In the previousl y treated group, the response rate was 52%, with a median survival dur ation of 13.5 months. Only 3% of patients (two of 62) developed biliar y sclerosis; this was significantly lower than the 21% biliary scleros is rate observed in our previous trial of hepatic arterial FUDR and LV without Dec (P = .002). Conclusion: The addition of Dec to hepatic ar terial FUDR and LV reduces biliary toxicity while maintaining an excel lent response rate and survival. We recommend that this treatment be s tudied further. (C) 1994 by American Society of Clinical Oncology.