title: Randomized trial of filgrastim versus chemotherapy and filgrastim mobilization of hematopoietic progenitor cells for rescue in autologous transplantation.
abstract: Peripheral blood cell (PBC) rescue has become the mainstay for autologous transplantation in patients with lymphoma, multiple myeloma, and solid tumors. Different methods of hematopoietic progenitor cell (HPC) mobilization are in use without an established standard. Forty-seven patients with relapsed or refractory lymphoma received salvage chemotherapy and were randomized to have HPC mobilization using filgrastim [granulocyte-colony-stimulating factor (G-CSF)] alone for 4 days at 10 microg/kg per day (arm A) or cyclophosphamide (5 g/m(2)) and G-CSF at 10 microg/kg per day until hematologic recovery (arm B). Engraftment and ease of PBC collection were primary outcomes. All patients underwent the same high-dose chemotherapy followed by reinfusion of PBCs. There were no differences in median time to neutrophil engraftment (11 days in both arms; P =.5) or platelet engraftment (14 days in arm A, 13 days in arm B; P =.35). Combined chemotherapy and G-CSF resulted in higher CD34(+) cell collection than G-CSF alone (median, 7.2 vs 2.5 x 10(6) cells/kg; P =.004), but this did not impact engraftment. No differences were found in other PBC harvest outcomes or resource utilization measures. A high degree of tumor contamination, as studied by consensus CDR3 polymerase chain reaction of the mobilized PBCs, was present in both arms (92% in arm A vs 90% in arm B; P = 1). No differences were found in overall survival or progression-free survival at a median follow-up of 21 months. This randomized trial provides clinical evidence that the use of G-CSF alone is adequate for HPC mobilization, even in heavily pretreated patients with relapsed lymphoma.
authors.affiliation: Division of Hematology-Oncology, Cancer Center and Tupper Research Institute, New England Medical Center, Boston, MA 02111, USA.
authors.forename: U
authors.initials: U
authors.lastname: Narayanasami
authors.forename: R
authors.initials: R
authors.lastname: Kanteti
authors.forename: J
authors.initials: J
authors.lastname: Morelli
authors.forename: A
authors.initials: A
authors.lastname: Klekar
authors.forename: A
authors.initials: A
authors.lastname: Al-Olama
authors.forename: C
authors.initials: C
authors.lastname: Keating
authors.forename: C
authors.initials: C
authors.lastname: O'Connor
authors.forename: E
authors.initials: E
authors.lastname: Berkman
authors.forename: J K
authors.initials: JK
authors.lastname: Erban
authors.forename: K A
authors.initials: KA
authors.lastname: Sprague
authors.forename: K B
authors.initials: KB
authors.lastname: Miller
authors.forename: D P
authors.initials: DP
authors.lastname: Schenkein
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000633:toxicity; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000633:toxicity; D004273:DNA, Neoplasm / Q000032:analysis; D005260:Female; D000069585:Filgrastim; D006085:Graft Survival / Q000187:drug effects; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000633:toxicity; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods / Q000592:standards*; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods* / Q000592:standards; D006801:Humans; D007937:Leukapheresis / Q000592:standards; D008223:Lymphoma / Q000401:mortality / Q000628:therapy; D008297:Male; D008875:Middle Aged; D018365:Neoplasm, Residual / Q000175:diagnosis / Q000235:genetics; D016133:Polymerase Chain Reaction; D011994:Recombinant Proteins; D016879:Salvage Therapy; D016019:Survival Analysis; D014182:Transplantation, Autologous
chemical_list: D000970:Antineoplastic Agents; D004273:DNA, Neoplasm; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D003520:Cyclophosphamide; D000069585:Filgrastim