A prospective randomized trial of granulocyte colony-stimulating factor therapy after autologous blood stem cell transplantation in adults

• Published in: Bone marrow transplantation (Basingstoke) Vol. 24; no. 6; pp. 601 - 607
• Main Authors: OJEDA, E, GARCIA-BUSTOS, J, AGUADO, M. J, ARRIETA, R, QUEVEDO, E, JIMENEZ YUSTE, V, CANALES, M, HERNANDEZ-NAVARRO, F
• Format: Journal Article
• Language: English
• Published: Basingstoke Nature Publishing Group 01.09.1999
• Subjects: Adolescent; Adult; Adults; Aged; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Antibiotics; Autografts; Biological and medical sciences; Blood; Body weight; Bone marrow; Bone marrow, stem cells transplantation. Graft versus host reaction; Breast cancer; Breast carcinoma; CD34 antigen; Chemotherapy; Colony-stimulating factor; Costs and Cost Analysis; Cytokines; Female; Fever; Granulocyte colony-stimulating factor; Granulocyte Colony-Stimulating Factor - therapeutic use; Granulocytes; Hematopoiesis; Hematopoietic Stem Cell Transplantation - adverse effects; Hematopoietic stem cells; Hemorrhage; Hemorrhage - etiology; Humans; Infection - etiology; Leukocytes (granulocytic); Lymphoma; Male; Medical sciences; Middle Aged; Non-Hodgkin's lymphoma; Patients; Peripheral blood; Platelets; Prospective Studies; Stem cell transplantation; Stem cells; Transfusion; Transfusions. Complications. Transfusion reactions. Cell and gene therapy; Transplantation; Transplantation, Autologous; Human; Stem cell; Cytokine; Hematopoietic cell; Filgrastim; Blood; Autograft; Granulocyte colony stimulating factor; Randomization; Treatment; Polypeptide; Graft; Adult; Clinical trial; Combined treatment
• ISSN: 0268-3369; 1476-5365
• DOI: 10.1038/sj.bmt.1701972

In order to assess the potential clinical benefit of filgrastim (G-CSF) after peripheral blood stem cell (PBSC) autotransplantation a randomized study was begun in our center in July 1997: 62 patients were involved (30 received filgrastim after PBSC infusion and 32, the control group, received no cytokines). All were adults (median 40 years, range 18-65). Patients with one of three different pathologies were recruited: 28 had advanced breast carcinoma, 23 had lymphomas (12 Hodgkin's disease and 11 non-Hodgkin's lymphoma) and 11 had de novo AML. All of them were transplanted using myeloablative chemotherapy conditioning regimens. G-CSF was administered subcutaneously from day +5 in the treated group at a dose of 5 microg/kg body weight/day. The numbers of CD34+ and mononuclear (MNC) cells infused were similar in each group. Only minor differences regarding the use of G-CSF could be inferred from the analysis of the data. Faster granulocyte engraftment was evident in the treated group (mean of 10 vs 12 days to achieve >0.5 x 109/l granulocytes, P = 0.0008), without differences in incidence and severity of infections, days of fever or duration of antibiotic treatment between groups. There was slightly slower platelet engraftment (mean of 15 days in the group with G-CSF vs 12 days in the other group to achieve >20 x 109/l platelets, P = NS) in this series, but there were no differences in incidence and severity of haemorrhage or platelet transfusion support. Considering the economical costs, the median expenditure per inpatient stay was Eur5961 (range Eur4386-Eur17186) in the G-CSF group compared with Eur5751 (range Eur3676-Eur15640) in the control group (P = 0.47). From our data it could be concluded that for adult patients transplanted with PBSC there is no clear beneficial impact of post-infusion G-CSF administration.