A randomized study comparing the effect of GM-CSF and G-CSF on immune reconstitution after autologous bone marrow transplantation (original) (raw)

Hematopoietic growth factor after autologous peripheral blood transplantation: comparison of G-CSF and GM-CSF

Bone Marrow Transplantation, 1999

Autologous peripheral blood stem cell (PBSC) transplantation results in rapid hematologic recovery when sufficient numbers of CD34 ؉ cells/kg are infused. Recent studies suggest that filgrastim (G-CSF) administration following transplantation leads to more rapid neutrophil recovery and lower total transplant costs. This study compares the use of G-CSF (5 g/kg/day) with sargramostim (GM-CSF) 500 g/day from day 0 until neutrophil recovery (ANC Ͼ1500/mm 3) in patients with breast cancer or myeloma who had PBSC mobilized with the combination of cyclophosphamide, etoposide, and G-CSF. Twenty patients (13 breast cancer and seven myeloma) received GM-CSF and 26 patients (14 breast cancer and 12 myeloma) received G-CSF. The patients were comparable for age and stage of disease, and received stem cell grafts that were not significantly different (CD34 ؉ ؋10 6 /kg was 12.5 ± 11.1 (mean ± s.d.) for GM-CSF and 19.8 ± 18.5 for G-CSF; P = 0.10). The use of red cells (2.8 vs 2.3 units), and platelet transfusions (2.5 vs 3.1) was similar for the two groups, as was the use of intravenous antibiotics (4.3 vs 4.6 days) and the number of days with temperature Ͼ38.3؇C (2.3 vs 1.8). Platelet recovery was also similar in both groups (platelets Ͼ50 000/mm 3 reached after 11.8 vs 14.9 days). The recovery of neutrophils, however, was faster using G-CSF. ANC Ͼ500/mm 3 and Ͼ1000/mm 3 were reached in the GM-CSF group at 10.5 ؎ 1.5 and 11.0 ؎ 1.7 days, respectively, whereas with G-CSF only 8.8 ؎ 1.2 and 8.9 ؎ 2.2 days were required (P Ͻ 0.001). As a result, patients given G-CSF received fewer injections than the GM-CSF patients (10.9 vs 12.3). Resource utilization immediately attributable to the use of growth factors and the duration of pancytopenia, excluding hospitalization, were similar for the two groups. This study suggests that neutrophil recovery occurs more quickly following autologous PBSC transplant using G-CSF in comparison to GM-CSF, but the difference is not extensive enough to result in lower total cost.

Influence of recombinant human granulocyte colony-stimulating factor (filgrastim) on hematopoietic recovery and outcome following allogeneic bone marrow transplantation (BMT) from volunteer unrelated donors

Bone Marrow Transplantation, 1999

Effects of recombinant human granulocyte colony-stimulating factor (rhG-CSF, filgrastim) on hematopoietic recovery and clinical outcome in patients undergoing allogeneic bone marrow transplantation (BMT) from volunteer unrelated donors (VUD) were analyzed retrospectively. Additionally, the influence of baseline patient and transplant characteristics on hematopoietic recovery was evaluated. From January 1994 to March 1996, 47 consecutive adult patients received VUD-BMT. GVHD prophylaxis was cyclosporin A/short course methotrexate/prednisolone, and in four patients additional ATG. Post-transplantation, cohorts of patients received rhG-CSF (5 g/kg/day) (n ‫؍‬ 22) or no rhG-CSF (n ‫؍‬ 25) in a non-randomized manner. The patient groups with and without rhG-CSF were rather comparable with respect to baseline patient and transplant characteristics. Median time to neutrophil counts (ANC) Ͼ500/l was 14 days with rhG-CSF vs 16 days without rhG-CSF (P ‫؍‬ 0.048), to ANC Ͼ1000/l was 15 vs 18 days (P ‫؍‬ 0.084). Neutrophil recovery was accelerated in patients receiving more than the median MNC dose of 2.54 ؋ 10 8 /kg with a median time to ANC Ͼ1000/l of 13 days vs 19 days (P ‫؍‬ 0.017). RhG-CSF did not influence platelet recovery and incidence of infectious complications. Incidence of acute GVHD II-IV was 50% with rhG-CSF and 28% without rhG-CSF (P ‫؍‬ 0.144), but death before acute GVHD II-IV occurred in 9% of patients with and 20% of patients without rhG-CSF. The median follow-up time was 38 and 36 months in patients with and without rhG-CSF, respectively. Survival at 2 years post-transplant was 39% (95% confidence interval (18%, 60%)) in patients with rhG-CSF and 24% (95% confidence interval (7%, 41%)) in patients without rhG-CSF. Administration of rhG-CSF after VUD-BMT may lead to more rapid neutrophil recovery, but did not influence the incidence of

Changes in immunological recovery in patients who received post-transplant G-CSF or GM-CSF after autologous peripheral blood stem cell transplantation (PBSCT)

Haematologia, 2002

In this prospective study, the effects of granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony-stimulating factor (GM-CSF) on immunological reconstitution after autologous peripheral blood stem cell transplantation (PBSCT) were investigated for 6 months. Thirty-ve patients received G-CSF 5 ¹g/ kg per day and 26 patients received GM-CSF SC 5 ¹g/ kg per day from day 1 to leukocyte engraftment (>1000 per mm 3). Peripheral blood samples were obtained on 14, 28, 100, and 180 days after transplantation for immunological evaluation. CD3C, CD4C, CD8C, CD19C, and CD56C cells were analysed by ow cytometry. Immunoglobulin levels (IgG, IgA, and IgM) and complement levels (C3c and C4) were measured by nephelometry. Both G-CSF and GM-CSF groups were comparable with respect to age, sex, the period from diagnosis to transplantation, total nucleated cells infused, the number of CD34C cells, conditioning regimens (TBI and non-TBI), and post-transplant infection. CD3C and CD8C cells on day 14 following autologous PBSCT C G-CSF were signi cantly higher than following autologous PBSCT C GM-CSF (p D 0:008 and p D 0:021, respectively). The number of CD4 cells and the CD4 / CD8 ratio were not different at several time points between the two groups. CD19C, CD56C cells and immunoglobulin levels showed a faster recovery pattern in the autologous PBSCT C G-CSF group. The effect of G-CSF on immune reconstitution after autologous PBSCT is more prominent than that of GM-CSF. The possible role of haematopoietic growth factor on immune recovery and its clinical importance should be investigated in further studies.

Impact of posttransplantation G-CSF on outcomes of allogeneic hematopoietic stem cell transplantation

Blood, 2006

3150 articles) Clinical Trials and Observations (1630 articles) Transplantation Articles on similar topics can be found in the following Blood collections http://bloodjournal.hematologylibrary.org/site/misc/rights.xhtml#repub\_requests Information about reproducing this article in parts or in its entirety may be found online at: http://bloodjournal.hematologylibrary.org/site/misc/rights.xhtml#reprints Information about ordering reprints may be found online at: http://bloodjournal.hematologylibrary.org/site/subscriptions/index.xhtml Information about subscriptions and ASH membership may be found online at: Granulocyte colony-stimulating factor (G-CSF) is often administered after hematopoietic-cell transplantation (HCT) to accelerate neutrophil recovery, but it is unclear what impact G-CSF has on long-term transplantation outcomes. We analyzed within the database of the Center for International Blood and Marrow Transplant Research the impact of giving posttransplantation G-CSF on the outcomes of allogeneic HCT for acute myelogenous leukemia and chronic myelogenous leukemia in 2719 patients who underwent transplantation between 1995 and 2000. These included 1435 recipients of HLAidentical sibling bone marrow (BM), 609 recipients of HLA-identical peripheral-blood stem cells (PBSCs), and 675 recipients of unrelated donor BM transplants. Outcomes were compared between patients receiving or not receiving G-CSF within 7 days of HCT according to graft type. Median follow-up was more than 30 months (range, 2-87 months). G-CSF shortened the posttransplantation neutropenic period, but did not affect days ؉30 and ؉100 treatment-related mortality (TRM). Probabilities of acute and chronic graft-versus-host disease (GVHD), leukemia-free survival (LFS), and overall survival were similar whether or not G-CSF was given. Multivariate analyses confirmed that giving G-CSF did not affect the risk of GVHD, TRM, LFS, or survival. In conclusion, results of this study found no long-term benefit or disadvantage of giving G-CSF after transplantation to promote hematopoietic recovery. (Blood. 2006;107:1712-1716)

Late G-CSF after allogeneic bone marrow or peripheral blood stem cell transplantation: a prospective controlled trial

Bone Marrow Transplantation, 2002

Granulocyte colony-stimulating factor (G-CSF) is widely used to accelerate neutrophil recovery after allogeneic BMT or PBSC transplantation. The optimal time to start G-CSF treatment is not known. Forty-two patients undergoing allogeneic BMT or PBSC transplantation for hematological malignancies received G-CSF either on day 6 or on day 9 post transplant. The time to hematological recovery was monitored and the two groups were compared with respect to peritransplant morbidity and mortality. Recovery of the neutrophil counts to Ͼ0.1 ؋ 10 9 /l, Ͼ 0.5 ؋ 10 9 /l and Ͼ1.0 ؋ 10 9 /l were not significantly different in either group. There was no difference in recovery of red blood cell and platelet counts and no difference between the two groups with respect to the number of febrile days or number of days on antibiotic treatment. Documented bacterial, viral or fungal infections did not occur more often when G-CSF treatment was started on day 9. Delaying treatment with G-CSF resulted in a significant reduction in the length of treatment from 13 to 10 days (23.1% reduction). Reducing the length of the treatment by 3 days lowered the costs by 395.40 Euro per patient. Delaying G-CSF treatment and starting on day 9 after BMT or PBSC transplantation is safe and results in a clear economic benefit.

The role of granulocyte colony-stimulating factor (G-CSF) in the post-transplant period

Bone Marrow Transplantation, 2002

The administration of G-CSF post transplant has been shown to accelerate the time to neutrophil engraftment. However, this does not necessarily translate into a meaningful clinical benefit to the patient. This randomized study was designed to determine the role of G-CSF following transplantation in patients with breast cancer (BC). A total of 241 evaluable patients with BC were included. There were 200 patients with high-risk BC, and 41 had disseminated BC in complete remission. All patients received conventional dose chemotherapy prior to transplantation. Patients were mobilized with G-CSF, received the STAMP V regimen, were transplanted with у2.5 ؋ 10 6 of CD34 ؉ cells/kg and were then randomized to receive 5 g/kg of G-CSF starting on the day of infusion (arm A), five days later (arm B), or no G-CSF (arm C). The need for transfusion support, infectious complications and length of hospitalization were the variables chosen to demonstrate clinical benefit. Patients receiving G-CSF reached 500 and 1000 neutrophils significantly faster (P ‫؍‬ 0.001) than patients with no G-CSF. This translated into a significantly (P Ͻ 0.05) shorter hospitalization time for patients receiving G-CSF. Arm C was closed and, after recruiting 110 patients in arm A, and 106 in arm B, the significant difference in neutrophil recovery persisted with no difference in the time of hospitalization between arms A and B. Therefore, G-CSF significantly accelerates the time to neutrophil engraftment. This translates into a shorter time of hospitalization. There is no difference in this variable regarding the time of administering the G-CSF: day 0 vs day ؉5. Therefore, G-CSF on day ؉5 should be the standard in this setting.