Randomized T rial o f F ilgrastim, S argramostim, o r Sequential S argramostim a nd F ilgrastim A fter Myelosuppressive C hemotherapy f or t he H arvesting o f Peripheral-Blood S tem C ells

Purpose: The purpose of this study was to compare the effects of filgrastim, sargramostim, or sequential sargramostim and filgrastim on CD34 1 cell yields and morbidity after myelosuppressive mobilization chemotherapy (MC). Patients and Methods: One hundred fifty-six patients were randomized to receive filgrastim (n 5 51), sargramostim (n 5 52), or sargramostim for 5 days followed by filgrastim (n 5 53) after MC with either cyclophosphamide and etoposide (n 5 75) or paclitaxel and cyclophosphamide (n 5 81). Results: Compared with those who received sargramostim, patients who received filgrastim had faster recovery of an absolute neutrophil count of 0.5 3 10 9 /L or greater (a median of 11 v 14 days; P 5 .0001), with fewer patients requiring RBC transfusions (P 5 .008), fewer patients with fever (18% v 52%; P 5 0.001), fewer hospital admissions (20% v 42%; P 5 .013), and less intravenous antibiotic therapy (24% v 69%; P 5 .001). Patients who received filgrastim yielded more CD34 1 cells (median, 7.1 v 2.0 3 10 6 /kg/apheresis; P 5 .0001), and a higher fraction achieved 2.5 3 10 6 (94% v 78%; P 5 .021) and 5 3 10 6 (88% v 53%; P 5 .001) or more CD34 1 cells/kg with fewer aphereses (median, 2 v 3; P 5 .002) and fewer days of growth-factor treatment (median, 12 v 14; P 5 .0001). There were no major differences in outcomes between the filgrastim alone and the sequential regimens. After high-dose chemotherapy, patients who had peripheral-blood stem cells (PBSCs) mobilized with filgrastim or the sequential regimen received higher numbers of CD34 1 cells and had faster platelet recovery (P 5 .015), with fewer patients (P 5 .014) receiving fewer platelet transfusions (P 5 .001) than patients receiving sargramostim-mobilized PBSCs. Conclusion: It was concluded that filgrastim alone or sequential sargramostim and filgrastim were superior to sargramostim alone for the mobilization of CD34 1