A Randomized Phase 3 Study of Peripheral Blood Progenitor Cell Mobilization With Stem Cell Factor and Filgrastim in High-Risk Breast Cancer Patients
1999; Elsevier BV; Volume: 93; Issue: 8 Linguagem: Inglês
10.1182/blood.v93.8.2491
ISSN1528-0020
AutoresElizabeth J. Shpall, Catherine Wheeler, Stewart A. Turner, Saul Yanovich, Randy A. Brown, Andrew L. Pecora, Thomas C. Shea, Kenneth F. Mangan, Stephanie Williams, C.F. LeMaistre, Gwynn D. Long, Roy B. Jones, Mark M. Davis, Robyn Murphy-Filkins, William Rushton Parker, John A. Glaspy,
Tópico(s)Neuroblastoma Research and Treatments
ResumoThis 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.
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