Lenograstim after autologous peripheral blood progenitor cell transplantation

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 -