Lenograstim with or without dexamethasone for neutrophil mobilization in healthy donors: short-term kinetics of white blood cells and effects of granulocyte apheresis.

OBJECTIVES: To determine the optimal time schedule for neutrophil collection after single mobilization with glycosylated recombinant granulocyte colony-stimulating factor (G-CSF, lenograstim) with or without dexamethasone (DXM). DONORS AND METHODS: In this prospective randomized trial, 26 healthy volunteers were randomly assigned to a single subcutaneous dose of lenograstim 6 µg/kg plus 8-mg DXM (G-CSF/DXM, n = 13) or placebo (G-CSF/placebo, n = 13). Hematological and biochemical parameters were analyzed before and 12, 15, 18, 21, 24, 27, 29, 36, 48, 60, 72, and 84 h and 7 and 30 days after mobilization. Six G-CSF/DXM subjects underwent standard neutrophil apheresis (NA) 12 and 36 h after mobilization. RESULTS: Polymorphonuclear neutrophil (PMN) counts 12 and 21 h after mobilization were 22.7 (16.6-32.8) × 10(9) /L and 22.4 (18.6-30.6) × 10(9) /L for G-CSF/placebo versus 33.1 (24.2-44.9) × 10(9) /L and 32.5 (17.4-39.6) × 10(9) /L for G-CSF/DXM. This mobilization plateau was followed by slow normalization at 72-84 h. The six NA subjects had median PMN yields of 62 (47-101) × 10(9) and 39 (23-42) × 10(9) per therapeutic unit. After the first apheresis, PMN counts sharply decreased to 21.1 (14.8-26.3) × 10(9) /L and then temporarily recovered to 25.9 (18.9-36.5) × 10(9) /L (P ≤ 0.001) over the next 8 h. CONCLUSIONS: Single doses of lenograstim with or without DXM induced a PMN plateau that lasted 9 h (12-21 h after mobilization), with PMN counts suitable for neutrophil collection. Lenograstim plus DXM made it possible to perform NA twice, 12 and 36 h after mobilization.