Lenograstim after autologous peripheral blood progenitor cell transplantation
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Lenograstim after autologous peripheral blood progenitor cell transplantation : results of a double-blind, randomized trial. / Schmitz, N; Ljungman, P; Cordonnier, C; Kempf, C; Linkesch, W; Alegre, A; Solano, C; Simonsson, B; Sonnen, R; Diehl, V; Fischer, T; Caballero, D; Littlewood, T; Noppeney, R; Schafhausen, P; Jost, L; Delabarre, F; Marcus, R.
in: BONE MARROW TRANSPL, Jahrgang 34, Nr. 11, 01.12.2004, S. 955-62.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Lenograstim after autologous peripheral blood progenitor cell transplantation
T2 - results of a double-blind, randomized trial
AU - Schmitz, N
AU - Ljungman, P
AU - Cordonnier, C
AU - Kempf, C
AU - Linkesch, W
AU - Alegre, A
AU - Solano, C
AU - Simonsson, B
AU - Sonnen, R
AU - Diehl, V
AU - Fischer, T
AU - Caballero, D
AU - Littlewood, T
AU - Noppeney, R
AU - Schafhausen, P
AU - Jost, L
AU - Delabarre, F
AU - Marcus, R
PY - 2004/12/1
Y1 - 2004/12/1
N2 - A phase III, randomized, double-blind, placebo-controlled, multi-center trial was conducted in order to compare the incidence of microbiologically defined infections occurring after high-dose chemotherapy (HDT) and ASCT in 98 patients given lenograstim (Granocyte) and 94 patients given placebo after transplantation. Hematopoietic recovery, the use of i.v. antibiotics, the numbers of red blood cell and platelet transfusions, the days spent in hospital, and the days on parenteral nutrition were also compared. The incidence of infections until neutrophil recovery was significantly less in patients who received lenograstim after HDT and ASCT as compared to patients who received placebo (66 of 98 vs 86 of 94 patients, P<0.001). Lenograstim also significantly reduced the use of i.v. antibiotics (P<0.001) and the median duration of i.v. antibiotic treatment (8 days vs 10 days, P=0.04), improved neutrophil recovery (absolute neutrophil count >0.5 x 10(9)/l: 11 days vs 15 days, P<0.001) and reduced the number of days spent in hospital (15 days vs 17 days, P<0.001). The administration of lenograstim after HDT and ASCT significantly reduces the incidence of microbiologically defined infections until neutrophil recovery. It also leads to less use of antibiotics and earlier discharge from hospital.
AB - A phase III, randomized, double-blind, placebo-controlled, multi-center trial was conducted in order to compare the incidence of microbiologically defined infections occurring after high-dose chemotherapy (HDT) and ASCT in 98 patients given lenograstim (Granocyte) and 94 patients given placebo after transplantation. Hematopoietic recovery, the use of i.v. antibiotics, the numbers of red blood cell and platelet transfusions, the days spent in hospital, and the days on parenteral nutrition were also compared. The incidence of infections until neutrophil recovery was significantly less in patients who received lenograstim after HDT and ASCT as compared to patients who received placebo (66 of 98 vs 86 of 94 patients, P<0.001). Lenograstim also significantly reduced the use of i.v. antibiotics (P<0.001) and the median duration of i.v. antibiotic treatment (8 days vs 10 days, P=0.04), improved neutrophil recovery (absolute neutrophil count >0.5 x 10(9)/l: 11 days vs 15 days, P<0.001) and reduced the number of days spent in hospital (15 days vs 17 days, P<0.001). The administration of lenograstim after HDT and ASCT significantly reduces the incidence of microbiologically defined infections until neutrophil recovery. It also leads to less use of antibiotics and earlier discharge from hospital.
KW - Adjuvants, Immunologic
KW - Adolescent
KW - Adult
KW - Aged
KW - Anti-Bacterial Agents
KW - Bacterial Infections
KW - Double-Blind Method
KW - Female
KW - Granulocyte Colony-Stimulating Factor
KW - Hematopoiesis
KW - Humans
KW - Immunosuppression
KW - Incidence
KW - Male
KW - Middle Aged
KW - Multicenter Studies as Topic
KW - Neoplasms
KW - Peripheral Blood Stem Cell Transplantation
KW - Recombinant Proteins
KW - Recovery of Function
KW - Treatment Outcome
U2 - 10.1038/sj.bmt.1704724
DO - 10.1038/sj.bmt.1704724
M3 - SCORING: Journal article
C2 - 15489865
VL - 34
SP - 955
EP - 962
JO - BONE MARROW TRANSPL
JF - BONE MARROW TRANSPL
SN - 0268-3369
IS - 11
ER -