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document
Use of recombinant human granulocyte colony-stimulating factor to increase chemotherapy dose-intensity : a randomized trial in very high-risk childhood acute lymphoblastic leukemia . PURPOSE To determine whether the use of a recombinant human granulocyte colony-stimulating factor ( [ G-CSF ] lenogastrim ) can increase the chemotherapy dose-intensity ( CDI ) delivered during consolidation chemotherapy of childhood acute lymphoblastic leukemia ( ALL ) . PATIENTS AND METHODS Sixty-seven children with very high-risk ALL were randomized ( slow early response to therapy , 55 patients ; translocation t ( 9 ; 22 ) or t ( 4 ; 11 ) , 12 patients ) . Consolidation consisted of six courses of chemotherapy ; the first , third , and fifth courses were a combination of high-dose cytarabine , etoposide , and dexamethasone ( R3 ) , whereas the second , fourth , and sixth courses included vincristine , prednisone , cyclophosphamide , doxorubicin , and methotrexate ( COPADM ) . G-CSF was given after each course , and the next scheduled course was started as soon as neutrophil count was > 1 x 10 ( 9 ) /L and platelet count was > 100 x 10 ( 9 ) /L . CDI was calculated using the interval from day 1 of the first course to hematologic recovery after the fifth course ( 100 % CDI = 105-day interval ) . RESULTS CDI was significantly increased in the G-CSF group compared with the non-G-CSF group ( mean +/- 95 % confidence interval , 105 +/- 5 % v 91 +/- 4 % ; P < .001 ) . This higher intensity was a result of shorter post-R3 intervals in the G-CSF group , whereas the post-COPADM intervals were not statistically reduced . After the R3 courses , the number of days with fever and intravenous antibiotics and duration of hospitalization were significantly decreased by G-CSF , whereas reductions observed after COPADM were not statistically significant . Duration of granulocytopenia was reduced in the G-CSF group , but thrombocytopenia was prolonged , and the number of platelet transfusions was increased . Finally , the 3-year probability of event-free survival was not different between the two groups . CONCLUSION G-CSF can increase CDI in high-risk childhood ALL . Its effects depend on the chemotherapy regimen given before G-CSF administration . In our study , a higher CDI did not improve disease control .
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Intervention_Physical
recombinant human granulocyte colony-stimulating factor
3170
Intervention_Physical
chemotherapy
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Intervention_Physical
recombinant human granulocyte colony-stimulating factor ( [ G-CSF ] lenogastrim )
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Intervention_Physical
consolidation chemotherapy
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Intervention_Physical
chemotherapy
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Intervention_Pharmacological
high-dose cytarabine
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Intervention_Pharmacological
etoposide
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Intervention_Pharmacological
dexamethasone
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Intervention_Pharmacological
vincristine
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Intervention_Pharmacological
prednisone
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Intervention_Pharmacological
cyclophosphamide
3180
Intervention_Pharmacological
doxorubicin
3181
Intervention_Pharmacological
methotrexate
3182
Intervention_Pharmacological
G-CSF
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Intervention_Pharmacological
G-CSF
3184
Intervention_Pharmacological
non-G-CSF
3185
Intervention_Pharmacological
G-CSF
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Intervention_Pharmacological
post-COPADM
3187
Intervention_Pharmacological
G-CSF
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Intervention_Pharmacological
COPADM
3189
Intervention_Pharmacological
G-CSF
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Intervention_Pharmacological
G-CSF
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Intervention_Pharmacological
G-CSF administration
3192
Outcome_Physical
CDI
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Outcome_Physical
CDI
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Outcome_Physical
post-R3 intervals
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Outcome_Other
number of days with fever and intravenous antibiotics and duration of hospitalization were significantly decreased
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Outcome_Physical
Duration of granulocytopenia
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Outcome_Physical
thrombocytopenia
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Outcome_Mortality
event-free survival
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Participant_Condition
childhood acute lymphoblastic leukemia
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Participant_Age
childhood
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Participant_Condition
acute lymphoblastic leukemia
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Participant_Condition
ALL
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Participant_Sample-size
Sixty-seven
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Participant_Age
children
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Participant_Condition
high-risk childhood ALL