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

J Chemother. 1998 Aug;10(4):326-30. doi: 10.1179/joc.1998.10.4.326.

Abstract

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/m2 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/m2 on day 1 of each cycle). No dose limiting toxicity was observed in the first three patients (treated at the dose of 50 mg/m2). We observed one case of dose limiting toxicity out of the 6 patients treated with 65 mg/m2 and 3/3 cases among patients treated with 80 mg/m2. We conclude that 65 mg/m2 is the maximum tolerated dose of epidoxorubicin in this regimen, which is also able to maintain adequate dose intensities.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Breast Neoplasms / drug therapy*
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Epirubicin / administration & dosage
  • Epirubicin / adverse effects
  • Female
  • Granulocyte Colony-Stimulating Factor / therapeutic use*
  • Humans
  • Middle Aged
  • Vinblastine / administration & dosage
  • Vinblastine / adverse effects
  • Vinblastine / analogs & derivatives
  • Vinorelbine

Substances

  • Granulocyte Colony-Stimulating Factor
  • Epirubicin
  • Vinblastine
  • Vinorelbine