A dose finding study for the combination of epidoxorubicin and vinorelbine, delivered every two weeks with G-CSF support, in advanced breast cancer

The aim of this study was to find the maximum tolerated dose of epidoxorubicin as part of a regimen with vinorelbine at the dose of 25 mg/m ² on days 1 and 5, every 2 weeks in patients with advanced breast cancer. The optimal dose intensity of the two drugs was supported by administration of granulocyte colony stimulating factor (G-CSF) on days 7-12. Patients were treated with epidoxorubicin at three different dose levels (50-65-80 mg/m ² on day 1 of each cycle). No dose limiting toxicity was observed in the first three patients (treated at the dose of 50 mg/m ²). We observed one case of dose limiting toxicity out of the 6 patients treated with 65 mg/m ² and 3/3 cases among patients treated with 80 mg/m ². We conclude that 65 mg/m ² is the maximum tolerated dose of epidoxorubicin in this regimen, which is also able to maintain adequate dose intensities.