TY - JOUR T1 - A Dose Escalation Study of Leucovorin (LV) and 48-hour Continuous Infusion of 5-Fluorouracil in Combination with Cyclophosphamide and Vinorelbine in Pretreated Patients with Metastatic Breast Cancer JF - Anticancer Research JO - Anticancer Res SP - 4217 LP - 4222 VL - 24 IS - 6 AU - CHARALAMBOS KOUROUSSIS AU - KONSTANTINOS KALBAKIS AU - NIKOLAOS ANDROULAKIS AU - SOPHIA AGELAKI AU - LAMBROS VAMVAKAS AU - KONSTANTINOS MALAS AU - JOHN SOUGLAKOS AU - NIKOLAOS VARDAKIS AU - VASSILIS GEORGOULIAS Y1 - 2004/11/01 UR - http://ar.iiarjournals.org/content/24/6/4217.abstract N2 - Purpose: To determine the maximum tolerated doses (MTD) and dose-limiting toxicities (DLTs) of vinorelbine (VNR) with fixed doses of cyclophosphamide (CPM) and 5-fluorouracil/leucovorin (5-FU/LV) in patients with metastatic breast cancer (MBC) pretreated with anthracyclines and taxanes. Patients and Methods: Eighteen patients with MBC pretreated with anthracyclines and taxanes were enrolled. VNR was administered as a 10-min intravenous infusion (i.v.) on day 1 at escalated doses with CPM 300 mg/m2 i.v. bolus and LV 500 mg/m2 as a 2-hour i.v. infusion, followed by 5-FU 1500mg/m2 as a 22-hour continuous infusion (c.i.) for two consecutive days. Treatment was repeated every two weeks. Results: At the dose of VNR 22.5mg/m2 without rhG-CSF and 25mg/m2 with rhG-CSF support, the DLT had been reached. Grade 3 or 4 neutropenia occurred in six (33%) patients and in fourteen (27%) cycles with no episode of febrile neutropenia. One (5.5%) patient developed grade 4 thrombocytopenia. Grade 3 neurotoxicity occurred in two patients and grade 2 and 3 asthenia in five (28%). Conclusion: The recommended doses for phase II studies are 20mg/m2 for VNR (22.5mg/m2 with rhG-CSF support) and 300mg/m2 for CPM on day 1, with 500mg/m2 for LV and 1500mg/m2 for 5-FU on days 1 and 2. Copyright© 2004 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved ER -