Randomized trial of autologous filgrastim-primed bone marrow transplantation versus filgrastim-mobilized peripheral blood stem cell transplantation in lymphoma patients

• Published in: Blood Vol. 90; no. 1; pp. 36 - 42
• Main Authors: DAMIANI, D, FANIN, R, TRANI, G, FIACCHINI, M, BACCARANI, M, SILVESTRI, F, GRIMAZ, S, INFANTI, L, GEROMIN, A, CERNO, M, MICHIELI, M, RINALDI, C, SAVIGNANO, C
• Format: Journal Article
• Language: English
• Published: Washington, DC The Americain Society of Hematology 01.07.1997
• Subjects: Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; Bone Marrow Transplantation; Bone marrow, stem cells transplantation. Graft versus host reaction; Cell Separation; Filgrastim; Granulocyte Colony-Stimulating Factor - administration & dosage; Hematologic and hematopoietic diseases; Hematopoietic Stem Cell Transplantation; Hodgkin Disease - therapy; Humans; Injections, Subcutaneous; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis; Lymphoma, Non-Hodgkin - therapy; Medical sciences; Recombinant Proteins; Transfusions. Complications. Transfusion reactions. Cell and gene therapy; Transplantation, Autologous; Treatment Outcome; Human; Transfusion; Stem cell; Cytokine; Hematopoietic cell; Hodgkin disease; Malignant hemopathy; Non Hodgkin lymphoma; Filgrastim; Blood; Mobilization; Autograft; Granulocyte colony stimulating factor; Treatment; Lymphoproliferative syndrome; Bone marrow; Graft; Clinical trial; Comparative study
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.v90.1.36

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.