Table 5

Recent clinical trials of prophylactic G-CSF in patients with AML

CSF, dose, schedule, and routeAdult/pediatric (median age, y)No. patientsAmelioration of depth and/or duration of neutropenia*Decrease in neutropenic feverDecrease in documented infectionsDecrease in antibiotic usageDecrease in hospitalizationsImprovement in rate of complete remissionImprovement in disease-free survivalReference
Lenograstim, 150 μg/m2/d, intravenously, start d 1 of chemotherapy or d 1 after completion of chemotherapy Adult (68) 722† P < .001; 25 vs 20 days (no G-CSF vs G-CSF after chemotherapy) — — — P < .001; 29.7 vs 27.2 (no G-CSF vs G-CSF after chemotherapy) P = .009; 48.6% vs 58.3% (no G-CSF vs G-CSF with chemotherapy) NS Amadori et al16  
Filgrastim, 5 μg/kg/d, subcutaneously or intravenously, start d 2 after completion of chemotherapy Pediatric (7.6) 512 P = .003 and P < .001; 42 vs 38 d for cycle 1, 51 vs 44 d for cycle 2 NS NS — P < .001; 69 vs 63 d (overall results for 2 cycles) NS NS Alonzo et al30  
Filgrastim, 200 μg/m2/d intravenously, start d 3 after completion of chemotherapy Adult (49) 270† P < .001; 18 vs 12 d NS NS NS — NS NS Usuki et al15  
Lenograstim, 293 μg/d, subcutaneously, start d 8 after completion of chemotherapy Adult (66) 226† — — — — — NS NS Goldstone et al14  
Filgrastim, 5 μg/kg/d, subcutaneously, start d 1 after completion of chemotherapy Adult (46) 194† P < .001; 19 vs 12 d for cycle 1, 28 vs 20 d for cycle 2  NS P = .02 and P = .04; 15 vs 13 d for cycle 1, 22 vs 15d for cycle 2 P < .001; 27 vs 24 d for cycle 1, 34 vs 29 d for cycle 2 — NS Harrouseau et al31  
Filgrastim, 400 μg/m2/d, intravenously, start d 4 after completion of chemotherapy Adult (68) 234† P = .014; 24 vs 21 d NS NS NS NS NS NS Godwin et al12  
Filgrastim, 5 μg/kg/d, subcutaneously, start d 1 after completion of chemotherapy Adult (54) 521† P < .001; 25 vs 20 d NS NS P < .001; 18.5 vs 15 d P < .001; 25 vs 20 d NS NS Heil et al11  
Lenograstim, 5 μg/kg/d, intravenously, start d 2 after completion of chemotherapy Adult (71) 173† P < .001; 27 vs 21 d‡ — NS — — P = .002; 47% vs 70% NS Dombret et al10  
Filgrastim, 200 μg/m2/d, intravenously, start d 2 before start of chemotherapy Adult (45) 58† P < .001; 29 vs 24 d — NS — — NS NS Ohno et al9  
CSF, dose, schedule, and routeAdult/pediatric (median age, y)No. patientsAmelioration of depth and/or duration of neutropenia*Decrease in neutropenic feverDecrease in documented infectionsDecrease in antibiotic usageDecrease in hospitalizationsImprovement in rate of complete remissionImprovement in disease-free survivalReference
Lenograstim, 150 μg/m2/d, intravenously, start d 1 of chemotherapy or d 1 after completion of chemotherapy Adult (68) 722† P < .001; 25 vs 20 days (no G-CSF vs G-CSF after chemotherapy) — — — P < .001; 29.7 vs 27.2 (no G-CSF vs G-CSF after chemotherapy) P = .009; 48.6% vs 58.3% (no G-CSF vs G-CSF with chemotherapy) NS Amadori et al16  
Filgrastim, 5 μg/kg/d, subcutaneously or intravenously, start d 2 after completion of chemotherapy Pediatric (7.6) 512 P = .003 and P < .001; 42 vs 38 d for cycle 1, 51 vs 44 d for cycle 2 NS NS — P < .001; 69 vs 63 d (overall results for 2 cycles) NS NS Alonzo et al30  
Filgrastim, 200 μg/m2/d intravenously, start d 3 after completion of chemotherapy Adult (49) 270† P < .001; 18 vs 12 d NS NS NS — NS NS Usuki et al15  
Lenograstim, 293 μg/d, subcutaneously, start d 8 after completion of chemotherapy Adult (66) 226† — — — — — NS NS Goldstone et al14  
Filgrastim, 5 μg/kg/d, subcutaneously, start d 1 after completion of chemotherapy Adult (46) 194† P < .001; 19 vs 12 d for cycle 1, 28 vs 20 d for cycle 2  NS P = .02 and P = .04; 15 vs 13 d for cycle 1, 22 vs 15d for cycle 2 P < .001; 27 vs 24 d for cycle 1, 34 vs 29 d for cycle 2 — NS Harrouseau et al31  
Filgrastim, 400 μg/m2/d, intravenously, start d 4 after completion of chemotherapy Adult (68) 234† P = .014; 24 vs 21 d NS NS NS NS NS NS Godwin et al12  
Filgrastim, 5 μg/kg/d, subcutaneously, start d 1 after completion of chemotherapy Adult (54) 521† P < .001; 25 vs 20 d NS NS P < .001; 18.5 vs 15 d P < .001; 25 vs 20 d NS NS Heil et al11  
Lenograstim, 5 μg/kg/d, intravenously, start d 2 after completion of chemotherapy Adult (71) 173† P < .001; 27 vs 21 d‡ — NS — — P = .002; 47% vs 70% NS Dombret et al10  
Filgrastim, 200 μg/m2/d, intravenously, start d 2 before start of chemotherapy Adult (45) 58† P < .001; 29 vs 24 d — NS — — NS NS Ohno et al9  

NS indicates not significant; —, no analysis of this endpoint performed in the study.

*

Neutropenia is defined as 500 neutrophils/μL except otherwise specified.

*

Design of the study includes randomization with a control group.

*

Neutropenia defined as ANC below 1.0 × 109/L.

View Large
Close Modal
This Feature Is Available To Subscribers Only

or Create an Account

Close Modal
Close Modal