Details

Autor(en) / Beteiligte

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

Titel

A Randomized Phase 3 Study of Peripheral Blood Progenitor Cell Mobilization With Stem Cell Factor and Filgrastim in High-Risk Breast Cancer Patients

Ist Teil von

• Blood, 1999-04, Vol.93 (8), p.2491-2501

Ort / Verlag

Washington, DC: Elsevier Inc

Erscheinungsjahr

1999

Quelle

MEDLINE

Beschreibungen/Notizen

• This randomized study compared the number of leukaphereses required to collect an optimal target yield of 5 × 106CD34+ 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.