93064
document
Recombinant human granulocyte and granulocyte-macrophage colony-stimulating factor ( G-CSF and GM-CSF ) administered following cytotoxic chemotherapy have a similar ability to mobilize peripheral blood stem cells . The availability of hematopoietic growth factors has greatly facilitated the mobilization and collection of peripheral blood stem cells ( PBSC ) . It was the aim of this double-blind study to compare the PBSC-mobilizing efficacy of recombinant human G-CSF and GM-CSF when administered post-chemotherapy . Twenty-six patients with relapsed Hodgkin 's disease were included in the study . Their median age was 31 years ( range , 22-59 ) and 14 patients were males and 12 were females . Patients were pretreated with a median of eight cycles of cytotoxic chemotherapy , while 18 patients had undergone extended field irradiation . The patients received dexamethasone 24 mg days 1-7 , melphalan 30 mg/m2 day 3 , BCNU 60 mg/m2 day 3 , etoposide 75 mg/m2 days 4-7 , Ara-C 100 mg/m2 twice daily days 4-7 ( Dexa-BEAM ) . Twelve patients were randomized to receive 5/microg/kg/day G-CSF and 14 patients to receive 5 microg/kg/day GM-CSF , both administered subcutaneously starting on day 1 after the end of Dexa-BEAM . Primary endpoints of the study were the number of CD34+ cells harvested per kg body weight on the occasion of six consecutive leukaphereses and the time needed for hematological reconstitution following autografting . Twenty-one patients completed PBSC collection , and six patients of the G-CSF group and nine of the GM-CSF group were autografted . No difference was observed with respect to the median yield of CFU-GM and CD34+ cells : 32.5 x 10 ( 4 ) /kg vs 31.3 x 10 ( 4 ) /kg CFU-GM , and 7.6 x 10 ( 6 ) /kg vs 5.6 x 10 ( 6 ) /kg CD34+ cells , for G-CSF and GM-CSF , respectively ( U test , P= 0.837 and 0.696 ) . High-dose chemotherapy consisted of cyclophosphamide 1.7 g/m2 days 1-4 , BCNU 150 mg/m2 days 1-4 , etoposide 400 mg/m2 days 1-4 . All patients transplanted with more than 5 x 10 ( 6 ) CD34+ cells/kg had a rapid platelet recovery ( 20 x 10 ( 9 ) /l ) between 6 and 11 days and neutrophil recovery ( 0.5 x 10 ( 9 ) /1 ) between 9 and 16 days , while patients transplanted with less than 5 x 10 ( 6 ) /kg had a delayed reconstitution , regardless of the kind of growth factor used for PBSC mobilization . In conclusion , our data indicate that in patients with Hodgkin 's disease G-CSF and GM-CSF given after salvage chemotherapy appear to be not different in their ability to mobilize PBSC resulting in a similar time needed for hematological reconstitution when autografted following high-dose therapy .
93065
Intervention_Pharmacological
Recombinant human granulocyte and granulocyte-macrophage colony-stimulating factor ( G-CSF and GM-CSF )
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Intervention_Pharmacological
cytotoxic chemotherapy
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Intervention_Pharmacological
recombinant human G-CSF
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Intervention_Pharmacological
GM-CSF
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Intervention_Pharmacological
post-chemotherapy
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Intervention_Pharmacological
cytotoxic chemotherapy
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Intervention_Pharmacological
dexamethasone 24 mg days 1-7 , melphalan 30 mg/m2 day 3 , BCNU 60 mg/m2 day 3 , etoposide 75 mg/m2 days 4-7 , Ara-C 100 mg/m2 twice daily days 4-7 ( Dexa-BEAM )
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Intervention_Pharmacological
receive 5/microg/kg/day G-CSF
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Intervention_Pharmacological
5 microg/kg/day GM-CSF
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Intervention_Pharmacological
Dexa-BEAM
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Intervention_Pharmacological
G-CSF
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Intervention_Pharmacological
GM-CSF
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Intervention_Pharmacological
cyclophosphamide
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Intervention_Pharmacological
BCNU
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Intervention_Pharmacological
etoposide
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Outcome_Physical
mobilization and collection of peripheral blood stem cells ( PBSC )
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Outcome_Other
number of CD34+ cells harvested per kg body weight on the occasion of six consecutive leukaphereses
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Outcome_Other
time needed for hematological reconstitution following autografting
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Outcome_Other
median yield of CFU-GM and CD34+ cells
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Outcome_Other
G-CSF
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Outcome_Physical
and
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Outcome_Other
GM-CSF
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Outcome_Physical
platelet recovery
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Outcome_Physical
neutrophil recovery
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Outcome_Other
ability to mobilize
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Outcome_Physical
PBSC
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Outcome_Other
time needed for hematological reconstitution
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Participant_Sample-size
Twenty-six
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Participant_Condition
relapsed Hodgkin 's disease
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Participant_Age
31
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Participant_Sex
14
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Participant_Sex
males
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Participant_Sex
12
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Participant_Sex
females
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Participant_Sample-size
18
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Participant_Condition
Hodgkin 's disease