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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
3
|
pubmed:dateCreated |
1997-4-29
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pubmed:abstractText |
In this placebo-controlled randomized trial we evaluated the hematological and clinical effects of r-Hu GM-CSF after high-dose chemotherapy (HDC) followed by GM-CSF-mobilized PBPC transplantation. Fifty patients with poor prognosis malignancies were randomized in a double-blind study to receive either GM-CSF or placebo after HDC followed by PBPC rescue. For all patients, PBPCs were recruited using a combination of VP-16 (300 mg/m2 on days 1 and 2), cytoxan (3 g/m2 on days 3 and 4) and GM-CSF (5 micrograms/kg from day 5). No differences were demonstrated between the two groups in median time to neutrophil or platelet recoveries. There was no significant difference between the GM-CSF group and the placebo group in the median duration of post-transplant hospitalization, in the number of days of antibiotic treatment, in the number of infections and in red blood cell or platelet transfusion requirements. There was a significant difference with an advantage for the placebo group in the mean duration of febrile days (P = 0.01). We conclude that the administration of GM-CSF in patients transplanted with GM-CSF-mobilized PBPC is not associated with a clinical benefit in term of tempo of engraftment, numbers of documented infections, transfusion requirements and mucositis grading.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:month |
Feb
|
pubmed:issn |
0268-3369
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pubmed:author |
pubmed-author:BasileMM,
pubmed-author:BonoJ AJA,
pubmed-author:ChassagneJJ,
pubmed-author:CholletPP,
pubmed-author:ChoufiBB,
pubmed-author:CommunalYY,
pubmed-author:CondatPP,
pubmed-author:FleuryJJ,
pubmed-author:FoxG EGE,
pubmed-author:GlenatCC,
pubmed-author:LegrosMM,
pubmed-author:PlagneRR,
pubmed-author:TavernierFF
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pubmed:issnType |
Print
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pubmed:volume |
19
|
pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
209-13
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pubmed:dateRevised |
2004-11-17
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pubmed:meshHeading |
pubmed-meshheading:9028547-Adult,
pubmed-meshheading:9028547-Cell Differentiation,
pubmed-meshheading:9028547-Female,
pubmed-meshheading:9028547-Granulocyte-Macrophage Colony-Stimulating Factor,
pubmed-meshheading:9028547-Hematopoietic Stem Cell Transplantation,
pubmed-meshheading:9028547-Hematopoietic Stem Cells,
pubmed-meshheading:9028547-Humans,
pubmed-meshheading:9028547-Male,
pubmed-meshheading:9028547-Middle Aged,
pubmed-meshheading:9028547-Neoplasms,
pubmed-meshheading:9028547-Recombinant Proteins,
pubmed-meshheading:9028547-Transplantation, Autologous
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pubmed:year |
1997
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pubmed:articleTitle |
rhGM-CSF vs placebo following rhGM-CSF-mobilized PBPC transplantation: a phase III double-blind randomized trial.
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pubmed:affiliation |
Centre Jean Perrin, Clermont-Ferrand, France.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Randomized Controlled Trial,
Clinical Trial, Phase III
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