A randomized phase 3 study of peripheral blood progenitor cell mobilization with stem cell factor and Filgrastim in high-risk breast cancer patients

Elizabeth J. Shpall*, Catherine A. Wheeler, Stewart A. Turner, Saul Yanovich, Randy A. Brown, Andrew L. Pecora, Thomas C. Shea, Kenneth F. Mangan, Stephanie F. Williams, C. Fred LeMaistre, Gwynn D. Long, Roy Jones, Mark W. Davis, Robyn Murphy-Filkins, William R.L. Parker, John A. Glaspy

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

88 Scopus citations

Abstract

This randomized study compared the number of leukaphereses required to collect an optimal target yield of 5 x 106 CD34+ peripheral blood progenitor cells/kg, using either stem cell factor (SCF) at 20 μg/kg/d in combination with Filgrastim at 10 μg/kg/d or Filgrastim alone at 10 μg/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 leukaphereses; 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.

Original languageEnglish (US)
Pages (from-to)2491-2501
Number of pages11
JournalBlood
Volume93
Issue number8
StatePublished - Apr 15 1999
Externally publishedYes

ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

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