title: Randomized trial of autologous filgrastim-primed bone marrow transplantation versus filgrastim-mobilized peripheral blood stem cell transplantation in lymphoma patients.
abstract: Although a large amount of data is available on the effects of filgrastim (granulocyte colony-stimulating factor [G-CSF]) on the mobilization of stem cells in the circulation, data concerning its effects on bone marrow (BM) harvesting is scarce and controversial. We have designed a randomized trial comparing filgrastim-mobilized peripheral blood stem cell (PBSC) transplantation with filgrastim-primed autologous bone marrow transplantation (ABMT). Fifty-five patients affected by non-Hodgkin's (n = 38) or Hodgkin's (n = 17) lymphoma, selected for autologous transplantation over a 12-month period in a single institution, were randomized 2:1 to undergo BM or PB harvest/collection after priming for 3 days with filgrastim, 16 microg/kg body weight daily subcutaneously. BM priming with G-CSF allowed the harvest of a significantly higher number of mononuclear cells (MNC) (0.53 x 10(8)/kg, range, 0.32 to 1.40), as compared with a historical control of unprimed BM harvests (0.43 x 10(8) MNC/kg, range, 0.15 to 0.72, P = .001). After high-dose ablative therapy, median time to neutrophil recovery above 0.5 x 10(9)/L was 12 days for BM and 11 days for PB (P = .219); median time to platelet recovery above 20 x 10(9)/L was 13 days for BM and 11 days for PB (P = .242). The same number of red blood cells, platelet transfusions, and posttransplant G-CSF doses were required in the two groups of patients. Less patients (50% v 70%) became febrile in the group transplanted with mobilized PB, but days of fever/patient and days on antibiotics were overlapping. The median time spent in the hospital after reinfusion was 16.5 and 15.5 days after primed BM and primed PB, respectively (P = .134). These data suggest that in patients with lymphoma submitted to autologous transplantation, the reinfusion of filgrastim-primed BM or filgrastim-mobilized PB leads to similar results, with an advantage of only 1 day in the neutrophil recovery and 1 day on the time spent in the hospital in favor of primed PB. Either option can be chosen on the basis of the availability of a surgery room or cell separator facilities and considering the patients' characteristics and wishes.
authors.affiliation: Department of Bone Marrow Transplantation, University Hospital, Udine, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Damiani
authors.forename: R
authors.initials: R
authors.lastname: Fanin
authors.forename: F
authors.initials: F
authors.lastname: Silvestri
authors.forename: S
authors.initials: S
authors.lastname: Grimaz
authors.forename: L
authors.initials: L
authors.lastname: Infanti
authors.forename: A
authors.initials: A
authors.lastname: Geromin
authors.forename: M
authors.initials: M
authors.lastname: Cerno
authors.forename: M
authors.initials: M
authors.lastname: Michieli
authors.forename: C
authors.initials: C
authors.lastname: Rinaldi
authors.forename: C
authors.initials: C
authors.lastname: Savignano
authors.forename: G
authors.initials: G
authors.lastname: Trani
authors.forename: M
authors.initials: M
authors.lastname: Fiacchini
authors.forename: M
authors.initials: M
authors.lastname: Baccarani
mesh_terms: D016026:Bone Marrow Transplantation; D002469:Cell Separation; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D018380:Hematopoietic Stem Cell Transplantation; D006689:Hodgkin Disease / Q000628:therapy*; D006801:Humans; D007279:Injections, Subcutaneous; D008228:Lymphoma, Non-Hodgkin / Q000628:therapy*; D011994:Recombinant Proteins; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim