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UFT/leucovorin plus bolus epirubicin and cyclophosphamide in advanced/metastatic breast cancer
R K Gregory1, S R Johnston, I E Smith
1Royal Marsden Hospital, London, United Kingdom.
Abstract:
This article describes the design and early results of an open-label, nonrandomized phase I/II trial of oral UFT plus leucovorin therapy in combination with bolus injections of epirubicin and cyclophosphamide in patients with advanced or metastatic breast cancer. This study was designed as a cohort dose-escalation study with the principal aims being to determine dose-limiting toxicity, overall toxicity, maximum tolerated dose, tumor response, and time to disease progression. Currently there are 22 patients randomized in the study. Overall response rate to date is 56% (66% in the locally advanced group). Based on the preliminary data, the dose-limiting toxicity appears to be neutropenia and the optimum dose of UFT for use in a phase II study appears to be 300 mg/m2.
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