Lenograstim after autologous peripheral blood progenitor cell transplantation: results of a double-blind, randomized trial.
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.
Department of Hematology, AK St. Georg, Hamburg, Germany. norbert.schmitz@ak-stgeorg.lbk-hh.de
N
N
Schmitz
P
P
Ljungman
C
C
Cordonnier
C
C
Kempf
W
W
Linkesch
A
A
Alegre
C
C
Solano
B
B
Simonsson
R
R
Sonnen
V
V
Diehl
T
T
Fischer
D
D
Caballero
T
T
Littlewood
R
R
Noppeney
P
P
Schafhausen
L
L
Jost
F
F
Delabarre
R
R
Marcus
D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D001424:Bacterial Infections / Q000209:etiology / Q000517:prevention & control; D004311:Double-Blind Method; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects; D006410:Hematopoiesis / Q000187:drug effects; D006801:Humans; D007165:Immunosuppression Therapy / Q000009:adverse effects; D015994:Incidence; D000078224:Lenograstim; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009369:Neoplasms / Q000503:physiopathology / Q000628:therapy; D036102:Peripheral Blood Stem Cell Transplantation; D011994:Recombinant Proteins / Q000008:administration & dosage* / Q000009:adverse effects; D020127:Recovery of Function / Q000187:drug effects; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D000900:Anti-Bacterial Agents; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000078224:Lenograstim