FEC mobilized stem cells for high-dose therapy in breast cancer patients. SB6 9401 Study Group

Acta Oncol. 1999;38(2):239-45. doi: 10.1080/028418699431672.

Abstract

The feasibility of mobilizing peripheral blood stem cells (PBSC) using anthracycline containing polychemotherapy and G-CSF on the first 50 patients randomized to the high-dose arm in the adjuvant SBG 9401 is investigated. The patients were treated with standard FEC (5-fluorouracil 600 mg/m2, epirubicin 60 mg/m2, cyclophosphamide 600 mg/m2) for two courses followed by a modified third FEC course with a C dose of 1200 mg/m2 supported with subcutaneous G-CSF (filgrastim) at 5 mg/kg followed by harvest around day 11. The mean yield of CD34+ cells per patient was 10.6x10(6)/kg (range 2.6-29.1). The side effects after the third course were low and only one patient developed an uncomplicated granulopenic fever. Our data indicated a correlation between number of transfused CD34+ cells and days to neutrophil and platelet recovery. In conclusion, the modified FEC regimen followed by G-CSF is a feasible method for PBSC mobilization in the adjuvant setting.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antigens, CD34 / blood
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Breast Neoplasms / drug therapy*
  • Cyclophosphamide / administration & dosage
  • Cyclophosphamide / adverse effects
  • Drug Administration Schedule
  • Epirubicin / administration & dosage
  • Epirubicin / adverse effects
  • Female
  • Filgrastim
  • Fluorouracil / administration & dosage
  • Fluorouracil / adverse effects
  • Granulocyte Colony-Stimulating Factor / administration & dosage*
  • Granulocyte Colony-Stimulating Factor / adverse effects
  • Humans
  • Leukapheresis
  • Recombinant Proteins
  • Stem Cells / immunology*

Substances

  • Antigens, CD34
  • Recombinant Proteins
  • Granulocyte Colony-Stimulating Factor
  • Epirubicin
  • Cyclophosphamide
  • Filgrastim
  • Fluorouracil

Supplementary concepts

  • FEC protocol