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Efficacy and Safety of Pegylated Filgrastim as Primary Prophylaxis Following Pediatric Dose-intensive Chemotherapy: A
Meena Haldorai1, Jagdish P Meena1, Aditya K Gupta1
1Division of Pediatric Oncology, Department of Pediatrics.
Insights
Pegfilgrastim significantly reduced the incidence of febrile neutropenia (FN) in children undergoing chemotherapy compared to filgrastim. This study provides crucial pediatric data on pegfilgrastim
Area of Science:
- Pediatric Oncology
- Hematology
- Pharmacology
Background:
- Adult studies indicate similar efficacy and safety of pegfilgrastim versus filgrastim for chemotherapy-induced neutropenia.
- Limited large-scale prospective data exists for pegfilgrastim in pediatric populations.
- Chemotherapy-induced neutropenia poses significant risks for pediatric cancer patients.
Purpose of the Study:
- To evaluate the efficacy and safety of pegfilgrastim in pediatric patients receiving chemotherapy.
- To compare the incidence of febrile neutropenia (FN) between pegfilgrastim and filgrastim arms.
- To assess secondary outcomes including neutropenia depth, duration, and recovery time.
Main Methods:
- An open-label, randomized trial involving children with solid tumors requiring growth factor support.
- Patients were randomized to receive either daily filgrastim (5 mcg/kg) or a single dose of pegfilgrastim (100 mcg/kg) 24 hours post-chemotherapy.
- Primary endpoint was the incidence of FN, with secondary endpoints on absolute neutrophil count (ANC) parameters and adverse events.
Main Results:
- 315 chemotherapy cycles in 61 pediatric patients were randomized.
- The incidence of FN was significantly lower in the pegfilgrastim arm (8%) compared to the filgrastim arm (18%) (P=0.01).
- No significant differences were observed in ANC recovery duration, nadir depth, or reported adverse events between the two groups.
Conclusions:
- Pegfilgrastim demonstrated a significantly lower incidence of febrile neutropenia in pediatric cancer patients.
- The study supports the use of pegfilgrastim as an effective and safe option for preventing neutropenia in children.
- No significant adverse events were attributed to the study drug, pegfilgrastim.
Objectives:
Large trials and meta-analyses in adults suggest a similar efficacy and safety of a single dose of peg-filgrastim compared with daily filgrastim in the prevention of chemotherapy-induced neutropenia. However, there is no large prospective data in the pediatric population. This trial was designed to demonstrate the efficacy and safety of peg-filgrastim in children.
Methods:
This was an open-labelled randomized trial. Children with solid tumors receiving chemotherapy in which growth factor support was indicated were screened before chemotherapy and randomized to either the filgrastim arm (5 mcg/kg daily) or peg-filgrastim arm (100 mcg/kg single dose 24 h postchemotherapy). Patients were followed up till absolute neutrophil count (ANC) recovery clinically as well as by thrice weekly complete blood counts. The primary outcome was the incidence of FN, and secondary outcomes included the reduction in the depth of ANC nadir, shortening of the duration of grade-4 neutropenia, reduction in ANC recovery time, and adverse events.
Results:
A total of 344 chemotherapy cycles were screened. After the exclusion of 29 cycles, 315 chemotherapy cycles in 61 patients were randomized to peg-filgrastim (n=160) and filgrastim arm (n=155). The median age of included patients was 3 years (2; 6.5), and males were predominant. The incidence of FN in peg-filgrastim and filgrastim arms was 8% and 18% ( P =0.01) (RR: 0.45; 95% CI: 0.24-0.84). Duration of ANC recovery, depth of ANC nadir, and adverse events reported were not significantly different in both arms.
Conclusions:
The incidence of FN in the peg-filgrastim arm was significantly lesser. No significant adverse events attributable to the study drug were reported.
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