title: A phase I trial of oral metronomic vinorelbine plus capecitabine in patients with metastatic breast cancer.
abstract: OBJECTIVE
  To determine the dose-limiting toxicities (DLTs) and the maximum tolerated doses (MTD) of oral metronomic vinorelbine with capecitabine in patients with metastatic breast cancer (MBC).
  
  
  METHODS
  Escalated doses of oral metronomic vinorelbine (starting dose 30 mg) every other day continuously and capecitabine (starting dose 800 mg/m(2) bid) on days 1-14 every 21 days were administered. DLTs were evaluated during the first cycle.
  
  
  RESULTS
  Thirty-six women were enrolled at eight escalating dose levels. For twenty-four patients, treatment was first line, for eight second line, and for four third line. The DLT level was reached at oral metronomic vinorelbine 70 mg and capecitabine 1,250 mg/m(2), and the recommended MTD doses are vinorelbine 60 mg and capecitabine 1,250 mg/m(2). DLTs were febrile neutropenia grade 3 and 4, diarrhea grade 4, and treatment delays due to unresolved neutropenia. There was no treatment-related death. The main toxicities were grade 2-3 neutropenia in 16.6% of patients each, grade 2-3 anemia 16.5%, grade 2-4 fatigue 27.5%, grade 2-3 nausea/vomiting 11%, and grade 3-4 diarrhea 8.2%. Two complete and 10 partial responses were documented.
  
  
  CONCLUSIONS
  Oral metronomic vinorelbine with capecitabine is a well-tolerated and feasible regimen that merits further evaluation in MBC.
authors: Hellenic Oncology Research Group (HORG), 55 Lomvardou str, 11470 Athens, Greece.
authors: Zacharenia
authors: Z
authors: Saridaki
authors: Nikolaos
authors: N
authors: Malamos
authors: Panagiotis
authors: P
authors: Kourakos
authors: Aristides
authors: A
authors: Polyzos
authors: Alexandros
authors: A
authors: Ardavanis
authors: Nikolaos
authors: N
authors: Androulakis
authors: Kostas
authors: K
authors: Kalbakis
authors: Lambros
authors: L
authors: Vamvakas
authors: Vassilis
authors: V
authors: Georgoulias
authors: Dimitris
authors: D
authors: Mavroudis