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Blood, Vol. 93 No. 8 (April 15), 1999:
pp. 2491-2501
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, and
John A. Glaspy
From the Bone Marrow Transplant Programs, University of Colorado
Health Sciences Center, Denver, CO; Beth Israel Hospital/Dana-Farber
Cancer Institute, Boston, MA; Amgen Inc, Thousand Oaks, CA; Medical
College of Virginia Hospitals, Richmond, VA; Washington University
School of Medicine, St Louis, MO; Hackensack University Medical Center,
Hackensack, NJ; UNC Lineburger Cancer Center, Chapel Hill, NC; The
Temple University Cancer Center, Philadelphia, PA; the University of
Chicago Medical Center, Chicago, IL; South Texas Cancer Institute, San
Antonio, TX; Stanford Medical Center, Stanford, CA; and Bowyer Oncology
Center, UCLA School of Medicine, Los Angeles, CA.
This randomized study compared the number of leukaphereses required
to collect an optimal target yield of 5 × 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 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.
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