Randomized trial of filgrastim, sargramostim, or sequential sargramostim and filgrastim after myelosuppressive chemotherapy for the harvesting of peripheral-blood stem cells

Purpose: The purpose of this study wets to compare the effects of filgrasti m, sargramostim, or sequential sargramostim and filgrastim on CD34(+) cell yields and morbidity alter myelosuppressive mobilization chemotherapy (MC). Patients and Methods: One hundred fifty-six patients were randomized to rec eive filgrastim (n = 51), sargramostim (n = 52), or sargramostim for 5 days followed by filgrastim (n = 53) after MC with either cyclophosphamide and etoposide (n = 75) or paclitaxel and cyclophosphamide (n = 81). Results: Compared with those who received sargramostim, patients who receiv ed filgrastim had faster recovery of an absolute neutrophil count of 0.5 x 10(9)/L or greater (a median of 11 v 14 days; P = .0001), with fewer patien ts requiring RBC transfusions (P = .008), fewer patients with fever (18% v 52%; P = 0.001), fewer hospital admissions (20% v 42%; P = .013), and less intravenous antibiotic therapy (24% v 69%; P = .001). patients who received filgrastim yielded more CD34(+) cells (median, 7.1 v 2.0 x 10(6)/kg/aphere sis; P = .0001), and a higher fraction achieved 2.5 x 10(6) (94% v 78%; P = .021) and 5 x 10(6) (88% v 53%; P = .001) or more CD34(+) cells/kg with fe wer aphereses (median, 2 v 3; P = .002) and fewer days of growth-factor tre atment (median, 12 v 14; P = .0001). There were no major differences in out comes between the filgrastim alone and the sequential regimens. After high- dose chemotherapy, patients who had peripheral-blood stem cells (PBSCs) mob ilized with filgrastim or the sequential regimen received higher numbers of CD34+ cells and had faster platelet recovery (P = .015), with fewer patien ts (P = .014) receiving fewer platelet transfusions (P = .001) than patient s receiving sargramostim-mobilized PBSCs. Conclusion: It was concluded that filgrastim alone or sequential sargramost im and filgrastim were superior to sargramostim alone for the mobilization of CD34(+) cells and reduction of toxicities after MC. (C) 2000 by American Society of Clinical Oncology.