title: A randomized phase 3 study of peripheral blood progenitor cell mobilization with stem cell factor and filgrastim in high-risk breast cancer patients.
abstract: This randomized study compared the number of leukaphereses required to collect an optimal target yield of 5 x 10(6) CD34(+) peripheral blood progenitor cells/kg, using either stem cell factor (SCF) at 20 micrograms/kg/d in combination with Filgrastim at 10 micrograms/kg/d or Filgrastim alone at 10 micrograms/kg/d, from 203 patients with high-risk stage II, III, or IV breast cancer. Leukapheresis began on day 5 of cytokine administration and continued daily until the target yield of CD34(+) cells had been reached or a maximum of 5 leukaphereses performed. By day 5 of leukapheresis, 63% of the patients treated with SCF plus Filgrastim (n = 100) compared with 47% of those receiving Filgrastim alone (n = 103) reached the CD34(+) cell target yield. There was a clinically and statistically significant reduction (P <.05) in the number of leukaphereses required to reach the target yield for the patients receiving SCF plus Filgrastim (median, 4 leukaphereses) compared with patients receiving Filgrastim alone (median, 6 or more leukapherses; ie, <50% of patients reached the target in 5 leukaphereses). All patients receiving SCF were premedicated with antihistamines, albuterol, and pseudoephedrine. Treatment was safe, generally well tolerated, and not associated with life-threatening or fatal toxicity. In conclusion, SCF plus Filgrastim is a more effective peripheral blood progenitor cell (PBPC)-mobilization regimen than Filgrastim alone. In addition to the potential for reduced leukapheresis-related morbidity and costs, SCF offers additional options for obtaining cells for further graft manipulation.
authors: Bone Marrow Transplant Programs, University of Colorado Health Sciences Center, Denver, CO, USA.
authors: E J
authors: EJ
authors: Shpall
authors: C A
authors: CA
authors: Wheeler
authors: S A
authors: SA
authors: Turner
authors: S
authors: S
authors: Yanovich
authors: R A
authors: RA
authors: Brown
authors: A L
authors: AL
authors: Pecora
authors: T C
authors: TC
authors: Shea
authors: K F
authors: KF
authors: Mangan
authors: S F
authors: SF
authors: Williams
authors: C F
authors: CF
authors: LeMaistre
authors: G D
authors: GD
authors: Long
authors: R
authors: R
authors: Jones
authors: M W
authors: MW
authors: Davis
authors: R
authors: R
authors: Murphy-Filkins
authors: W R
authors: WR
authors: Parker
authors: J A
authors: JA
authors: Glaspy
mesh_terms: D000328:Adult; D015703:Antigens, CD / Q000097:blood; D018952:Antigens, CD34 / Q000097:blood; D001943:Breast Neoplasms / Q000097:blood / Q000473:pathology / Q000628:therapy*; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods*; D018380:Hematopoietic Stem Cell Transplantation; D006412:Hematopoietic Stem Cells / Q000187:drug effects / Q000473:pathology / Q000502:physiology; D006801:Humans; D007937:Leukapheresis; D008875:Middle Aged; D009367:Neoplasm Staging; D011994:Recombinant Proteins; D019089:Stem Cell Factor / Q000627:therapeutic use*
chemical_list: D015703:Antigens, CD; D018952:Antigens, CD34; D011994:Recombinant Proteins; D019089:Stem Cell Factor; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim