Original article Dose-finding study of paclitaxel and cyclophosphamide in advanced breast cancer

Background: The toxicity profile of prolonged infusions of paclitaxel in combination with cyclophosphamide in metastat-ic breast cancer has already been defined. The objective of this dose-finding study was to determine the maximum tolerable doses (MTDs) of shorter (three-hour) infusions of paclitaxel in combination with i.v. bolus cyclophosphamide in patients who had previously received a maximum of one chemotherapy for advanced breast carcinoma. The MTD of the same regimen with granulocyte colony-stimulating factor (G-CSF) support was then established. Patients and methods: Eighty women with metastatic breast cancer received a total of 352 fully evaluable courses of ther-apy. The starting doses were paclitaxel 135 mg/m2 and cyclo-phosphamide 750 mg/m2 given every three weeks. At least three patients were treated at each dose level and if there wer