93230
document
Marginal benefit/disadvantage of granulocyte colony-stimulating factor therapy after autologous blood stem cell transplantation in children : results of a prospective randomized trial . The Japanese Cooperative Study Group of PBSCT . In this prospective trial , a total of 74 children who were scheduled to undergo high-dose chemotherapy followed by autologous peripheral blood stem cell transplantation ( PBSCT ) were prospectively randomized at diagnosis to evaluate the effectiveness of exogenous granulocyte colony-stimulating factor ( G-CSF ) treatment in accelerating hematopoietic recovery after PBSCT . The diagnosis included acute lymphoblastic leukemia ( ALL ) ( n = 27 ) , neuroblastoma ( n = 29 ) , and miscellaneous solid tumors ( n = 18 ) . Eligibility criteria included ( 1 ) primary PBSCT , ( 2 ) chemotherapy-responsive disease , and ( 3 ) collected cell number > 1 x 10 ( 5 ) colony-forming unit-granulocyte-macrophage ( CFU-GM ) /kg and > 1 x 10 ( 6 ) CD34 ( + ) cells/kg patient 's body weight . After applying the above criteria , 11 patients were excluded due to disease progression before PBSCT ( n = 6 ) or a low number of harvested cells ( n = 5 ) , leaving 63 patients for analysis ; 32 patients in the treatment group ( 300 microg/m2 of G-CSF intravenously over 1 hour from day 1 of PBSCT ) and 31 in the control group without treatment . Two distinct disease-oriented high-dose regimens without total body irradiation consisted of the MCVAC regimen using ranimustine ( MCNU , 450 mg/m2 ) , cytosine arabinoside ( 16 g/m2 ) , etoposide ( 1.6 g/m2 ) , and cyclophosphamide ( 100 mg/kg ) for patients with ALL , and the Hi-MEC regimen using melphalan ( 180 mg/m2 ) , etoposide ( 1.6 g/m2 ) , and carboplatinum ( 1.6 g/m2 ) for those with solid tumors . Five patients ( two in the treatment group and three in the control group ) were subsequently removed due to protocol violations . All patients survived PBSCT . The median numbers of transfused mononuclear cells ( MNC ) , CD34 ( + ) cells , and CFU-GM were , respectively , 4.5 ( range , 1 to 19 ) x 10 ( 8 ) /kg , 8.0 ( 1.1 to 25 ) x 10 ( 6 ) /kg , and 3.7 ( 1.2 to 23 ) x 10 ( 5 ) /kg in the treatment group ( n = 30 ) and 2.9 ( 0.8 to 21 ) x 10 ( 8 ) /kg , 6.3 ( 1.1 to 34 ) x 10 ( 6 ) /kg , and 5.5 ( 1.3 to 37 ) x 10 ( 5 ) /kg , respectively , in the control group ( n = 28 ) , with no significant difference . After PBSCT , the time to achieve an absolute neutrophil count ( ANC ) of > 0.5 x 10 ( 9 ) /L in the treatment group was less than that in the control group ( median , 11 v 12 days ; the log-rank test , P =.046 ) , although the last day of red blood cell ( RBC ) transfusion ( day 11 v day 10 ) and the duration of febrile days ( > 38 degrees C ) after PBSCT ( 4 v 4 days ) were identical in both groups . However , platelet recovery to > 20 x 10 ( 9 ) /L was significantly longer in treatment group than control group ( 26 v 16 days ; P =.009 ) and > 50 x 10 ( 9 ) /L tended to take longer in the treatment group ( 29 v 26 days ; P =.126 ) , with significantly more platelet transfusion-dependent days ( 27 v 13 days ; t-test , P =.037 ) . When patients were divided into two different disease cohorts , ALL patients showed no difference in engraftment kinetics between the G-CSF treatment and control groups , while differences were seen in those with solid tumors . We concluded that the marginal clinical benefit of 1 day earlier recovery of granulocytes could be offset by the delayed recovery of platelets . We recommend that the routine application of costly G-CSF therapy in children undergoing PBSCT should be seriously reconsidered .
93231
Intervention_Pharmacological
granulocyte colony-stimulating factor therapy
93232
Intervention_Pharmacological
high-dose chemotherapy
93233
Intervention_Pharmacological
autologous peripheral blood stem cell transplantation
93234
Intervention_Pharmacological
granulocyte colony-stimulating factor
93235
Intervention_Pharmacological
primary PBSCT
93236
Intervention_Pharmacological
PBSCT
93237
Intervention_Pharmacological
G-CSF
93238
Intervention_Pharmacological
PBSCT
93239
Intervention_Control
control group
93240
Intervention_Pharmacological
high-dose regimens without total body irradiation consisted of the MCVAC regimen using ranimustine ( MCNU , 450 mg/m2 ) , cytosine arabinoside ( 16 g/m2 ) , etoposide ( 1.6 g/m2 ) , and cyclophosphamide
93241
Intervention_Pharmacological
Hi-MEC regimen using melphalan
93242
Intervention_Pharmacological
etoposide
93243
Intervention_Pharmacological
carboplatinum
93244
Outcome_Other
benefit/disadvantage
93245
Outcome_Other
effectiveness
93246
Outcome_Physical
hematopoietic recovery
93247
Outcome_Mortality
survived
93248
Outcome_Physical
median numbers of transfused mononuclear cells ( MNC )
93249
Outcome_Physical
CD34
93250
Outcome_Physical
CFU-GM
93251
Outcome_Other
time to achieve an absolute neutrophil count ( ANC ) of > 0.5 x 10 ( 9 ) /L
93252
Outcome_Other
duration of febrile days
93253
Outcome_Other
platelet recovery to > 20 x 10 ( 9 ) /L
93254
Outcome_Other
platelet transfusion-dependent days
93255
Outcome_Physical
engraftment kinetics
93256
Outcome_Physical
recovery of granulocytes
93257
Outcome_Physical
recovery of platelets .
93258
Participant_Age
children
93259
Participant_Sample-size
74
93260
Participant_Age
children
93261
Participant_Condition
high-dose chemotherapy
93262
Participant_Condition
autologous peripheral blood stem cell transplantation ( PBSCT )
93263
Participant_Condition
acute lymphoblastic leukemia
93264
Participant_Sample-size
27
93265
Participant_Condition
neuroblastoma
93266
Participant_Sample-size
29
93267
Participant_Condition
miscellaneous solid tumors
93268
Participant_Sample-size
18
93269
Participant_Condition
primary PBSCT
93270
Participant_Condition
chemotherapy-responsive disease
93271
Participant_Condition
collected cell number > 1 x 10 ( 5 ) colony-forming unit-granulocyte-macrophage ( CFU-GM ) /kg and > 1 x 10 ( 6 ) CD34 ( + ) cells/kg
93272
Participant_Sample-size
11
93273
Participant_Condition
PBSCT
93274
Participant_Sample-size
6
93275
Participant_Sample-size
)
93276
Participant_Sample-size
63
93277
Participant_Sample-size
32
93278
Participant_Sample-size
Five
93279
Participant_Sample-size
two
93280
Participant_Sample-size
three
93281
Participant_Age
children
93282
Participant_Condition
PBSCT