Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
Link, H; Boogaerts, MA; Carella, AM; Ferrant, A; Gadner, H; Gorin, NC; Harabacz, I; Harousseau, JL; Hervé, P; Holldack, J; Linkesch, W; et al..
A controlled trial of recombinant human granulocyte-macrophage colony-stimulating factor after total body irradiation, high-dose chemotherapy, and autologous bone marrow transplantation for acute lymphoblastic leukemia or malignant lymphoma.
BLOOD. 1992; 80(9): 2188-2195.
Doi: 10.1182/blood.V80.9.2188.2188
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- Co-Autor*innen der Med Uni Graz
- Linkesch Werner
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- Abstract:
- Infections during granulocytopenia are major complications of autologous bone marrow transplantation (ABMT). Since recombinant human granulocyte-macrophage colony-stimulating factor (rhuGM-CSF) has proved to accelerate bone marrow recovery after cytostatic chemotherapy, we studied its effects on hematopoietic regeneration and on infectious complications after total body irradiation (TBI) and high-dose chemotherapy followed by ABMT. Eighty-one patients with acute lymphoblastic leukemia (ALL) in complete remission (CR) or with non-Hodgkin's lymphoma (NHL) in CR or partial remission were randomized in a double-blind, placebo-controlled trial. They received either rhuGM-CSF 250 micrograms/m2 (Escherichia coli-derived) daily by continuous infusion after ABMT, or placebo. Treatment was continued until the neutrophil counts reached greater than 500/microL for 1 week. The maximum treatment duration was 30 days. Thirty-nine patients in the rhuGM-CSF group and 40 patients in the placebo group were evaluable. The median time needed to reach a neutrophil count of 500/microL was 15 days with rhuGM-CSF and 28 days with placebo (P = .0001). Bacterial infections occurred in 14 (35.9%) of the patients with rhuGM-CSF and in 25 (62.5%) of the patients given the placebo (P = .024). Nine of the 14 bacterial infections in the rhuGM-CSF group and 20 of the 25 infections in the placebo group were diagnosed within the first 10 days after ABMT. Capillary leakage and a reversible fluid retention were seen in five of the rhuGM-CSF-treated patients. Patients treated with rhuGM-CSF had lower serum protein and albumin levels than patients in the placebo group. There was no statistically relevant difference in overall survival between the two groups (P = .47). Relapse occurred in 14 (34%) patients with rhuGM-CSF and in 18 (45%) patients with placebo. We conclude that continuous infusion of rhuGM-CSF after ABMT accelerates the regeneration of granulocytes and reduces the number of bacterial infections.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult -
- Antineoplastic Agents - therapeutic use
- Bacterial Infections - etiology
- Blood Transfusion - etiology
- Bone Marrow Purging - etiology
- Bone Marrow Transplantation - etiology
- Combined Modality Therapy - adverse effects
- Double-Blind Method - adverse effects
- Female - adverse effects
- Granulocyte-Macrophage Colony-Stimulating Factor - therapeutic use
- Humans - therapeutic use
- Leukemia, Lymphocytic, Acute - blood
- Leukocyte Count - blood
- Lymphoma, Non-Hodgkin - blood
- Male - blood
- Multivariate Analysis - blood
- Patient Isolation - blood
- Probability - blood
- Prognosis - blood
- Recombinant Proteins - therapeutic use
- Survival Analysis - therapeutic use
- Time Factors - therapeutic use
- Transplantation, Autologous - therapeutic use
- Whole-Body Irradiation - therapeutic use