Abstract
This randomized, controlled study compared the ability to mobilize and collect an optimal target yield of 5 × 106 CD34+ cells/kg using stem cell factor (SCF; 20 μg/ kg/day) plus filgrastim (G-CSF; 10 μg/kg/day) vsfilgrastim alone (10 μg/kg/day) in 102 patients diagnosed with non-Hodgkin's lymphoma (NHL) or Hodgkin's disease (HD), who were prospectively defined as being heavily pretreated. Leukapheresis began on day 5 of cytokine administration and continued daily until the target yield was reached, or until a maximum of five leukaphereses had been performed. Compared with the filgrastim-alone group (n = 54), the SCF plus filgrastim group (n = 48) showed an increase in the proportion of patients reaching the target yield within five leukaphereses (44% vs 17%, P = 0.002); reduction in the number of leukaphereses required to reach the target yield (P = 0.003); reduction in the proportion of patients failing to reach a minimum yield of 1 x 106 CD34+ cells/kg to proceed to transplant (16% vs26%, P = NS); increase in the median yield of CD34+ cells per leukapheresis (0.73 × 106/kg vs0.48 × 106/kg, P = 0.04); and an increase in the median total CD34+ cells collected within five leukaphereses (3.6 × 106/kg vs 2.4 × 106/kg, P = 0.05). All patients receiving SCF were premedicated (antihistamines and albuterol), and treatment was generally well tolerated. Five patients experienced severe mast cell-mediated reactions, none of which were life-threatening. In this study of heavily pretreated lymphoma patients, SCF plus filgrastim was more effective than filgrastim alone for mobilizing PBPC for harvesting and transplantation after high-dose chemotherapy. Bone Marrow Transplantation (2000) 26, 471–481.
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Acknowledgements
Administrative costs for the conduct of this study were supported in part by Amgen Inc. The authors would like to thank Carol Cutrone, Beth Kaufman, Cheryl Sickles, Elisa Beck, Carol Rush, Kathy Derr, Sheryl Oliverson, Maureen Hougham, Doshia James, Robin Inabinet, Vicki O'Brien, Julie Morelli, Kristi Snead, Lisa Glenn, Terry Brehm, Kathleen Shannon-Dorcy, Lisa Gaynes, Joya Milano, Jane Quigley, Anne Sharpe, Sara Rasti, Mark Davis, Robyn Murphy-Filkins, Kathy Jelaca-Maxwell, Jerome Hill, Doug Okamoto, Neal Birkett, Hillary O'Kelly, Jody Tyrrell, Erik Olson, Wade Lovelace, and Carol Brannan for their contributions towards this research; and Keith Langley for assistance in preparation of the manuscript.
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Stiff, P., Gingrich, R., Luger, S. et al. A randomized phase 2 study of PBPC mobilization by stem cell factor and filgrastim in heavily pretreated patients with Hodgkin's disease or non-Hodgkin's lymphoma. Bone Marrow Transplant 26, 471–481 (2000). https://doi.org/10.1038/sj.bmt.1702531
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DOI: https://doi.org/10.1038/sj.bmt.1702531
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