
The incidence of febrile neutropenia (FN) is significantly lesser in children with solid tumours receiving pegylated filgrastim as primary prophylaxis following chemotherapy than in those assigned to filgrastim alone, reports a study. Moreover, no adverse events attributed to the study drug have been observed.
A total of 344 chemotherapy cycles were screened, of which 315 cycles in 61 children were finally included in the analysis. Of these, 160 were randomized to peg-filgrastim and 155 to filgrastim. Eligible patients were predominantly male and had a median age of 3 years.
The incidence of FN was significantly lower in the peg-filgrastim than the filgrastim arm (8 percent vs 18 percent; p=0.01; risk ratio, 0.45, 95 percent confidence interval, 0.24‒0.84).
No significant between-group differences were noted in the duration of absolute neutrophil count (ANC), depth of ANC nadir, and adverse events reported.
Researchers performed this open-label randomized trial in children with solid tumours receiving chemotherapy in which growth factor support was indicated. These patients were screened before chemotherapy and randomly allocated to either the filgrastim arm (5 mgc/kg daily) or peg-filgrastim arm (100 mcg/kg single dose 24-h post-chemotherapy).
The research team followed patients until ANC recovery clinically as well as by thrice weekly complete blood counts. FN incidence was the primary outcome, while 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.