Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
Geissler, K; Koller, E; Hubmann, E; Niederwieser, D; Hinterberger, W; Geissler, D; Kyrle, P; Knöbl, P; Pabinger, I; Thalhammer, R; Schwarzinger, I; Mannhalter, C; Jaeger, U; Heinz, R; Linkesch, W; Lechner, K.
Granulocyte colony-stimulating factor as an adjunct to induction chemotherapy for adult acute lymphoblastic leukemia--a randomized phase-III study.
BLOOD. 1997; 90(2): 590-596.
Doi: 10.1182/blood.V90.2.590.590_590_596
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- Co-Autor*innen der Med Uni Graz
- Linkesch Werner
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- Abstract:
- Because of the recommendation to avoid the concomitant administration of growth factors and chemotherapy, there is only limited information on colony-stimulating factor (CSF) therapy in acute lymphoblastic leukemia (ALL) induction protocols, in which cytotoxic drugs are administered in divided doses over a prolonged period of time, thus requiring a simultaneous administration of growth factors and chemotherapy. We conducted a prospective, randomized, controlled study to determine the safety and efficacy of granulocyte colony-stimulating factor (G-CSF; filgrastim) as an adjunct to phase I of induction chemotherapy for adult ALL. Patients (n = 53) were randomized to receive no growth factor or G-CSF (5 microg/kg/d subcutaneously) starting on day 2 of chemotherapy consisting of daunorubicin (45 mg/m2) and vincristine (1.5 mg/m2) on days 1, 8, 15, and 22; L-asparaginase (2500 U/m2) on days 1 through 14; and prednisone (60 mg/m2) on days 1 through 28. A total of 25 patients in the G-CSF group and 26 patients in the control arm fulfilled the inclusion criteria of the study. G-CSF markedly ameliorated neutropenia because the median proportion of days with neutropenia less than 1,000/microL was 29% in the G-CSF group as compared with 84% in the control arm (P < .00005). The median time to reach absolute neutrophil counts (ANC) > or = 1,000/microL was 16 days in G-CSF patients and 26 days in controls (P < .001). More importantly, G-CSF significantly reduced the incidence of febrile neutropenia (12% v 42% in controls, P < .05) and documented infections (40% v 77%, P < .05). No significant differences were found with regard to requirements for red blood cell transfusions and platelet concentrates. A total of 24 of 25 (96%) patients in the G-CSF group and 20 of 25 (80%) evaluable control patients had complete remission after phase I of induction therapy. We conclude that G-CSF can be safely administered as an adjunct to induction therapy of ALL and is clinically beneficial by ameliorating neutropenia and reducing infectious complications.
- Find related publications in this database (using NLM MeSH Indexing)
- Adolescent -
- Adult -
- Aged -
- Antineoplastic Combined Chemotherapy Protocols - adverse effects
- Asparaginase - administration and dosage
- Blood Transfusion - administration and dosage
- Daunorubicin - administration and dosage
- Erythrocyte Count - administration and dosage
- Female - administration and dosage
- Granulocyte Colony-Stimulating Factor - adverse effects
- Humans - adverse effects
- Immunophenotyping - adverse effects
- Leukemia, Lymphocytic, Acute, L1 - drug therapy
- Male - drug therapy
- Middle Aged - drug therapy
- Neutropenia - chemically induced
- Neutrophils - chemically induced
- Platelet Count - chemically induced
- Prednisone - administration and dosage
- Remission Induction - administration and dosage
- Survival Rate - administration and dosage
- Vincristine - administration and dosage