A randomized, non-inferiority study comparing efficacy and safety of a single dose of pegfilgrastim versus daily filgrastim in pediatric patients after autologous peripheral blood stem cell transplant.

A randomized, non-inferiority study comparing efficacy and safety of a single dose of pegfilgrastim versus daily filgrastim in pediatric patients after autologous peripheral blood stem cell transplant.

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PurposeTo assess the non-inferiority of pegfilgrastim versus filgrastim in speeding the recovery of polymorphonuclear Canine - Toys - Birthday cells (PMN) in pediatric patients who underwent autologous peripheral blood stem cell transplant (PBSCT).MethodsThe sample size of this randomized, multicenter, phase III study, was calculated assuming that a single dose of pegfilgrastim of 100 ug/kg was not inferior to 9 doses of filgrastim of 5 ug/kg/day.Randomization was performed by a computer-generated list and stored by sequentially numbered sealed envelopes.ResultsSixty-one patients, with a median age of 11.5 years, were recruited: 29 in the filgrastim arm and 32 in the pegfilgrastim arm.

Twenty percent were affected by lymphoma/leukaemia and eighty percent by solid tumors.The mean time to PMN engraftment was 10.48 days (standard deviation [SD] 1.57) and 10.44 days (SD 2.

44) in the filgrastim and pegfilgrastim arms, respectively.Having fixed a non-inferiority margin Delta of 3, the primary endpoint of non-inferiority was reached.No differences were observed for other secondary endpoints: platelet engraftment, mean time to platelet recovery (28 days vs.33 days), fever of unknown origin (79% vs.78%), proven infection (34% vs.

28%), mucositis (76% vs.59%).After a median follow-up of 2.3 years (95% C.I.

: 1.5, 3.3), 20 deaths were observed due to disease progression.ConclusionsWe conclude that pegfilgrastim was not inferior to daily filgrastim in pediatric patients who Socks Kids underwent PBSCT.EU CLINICAL TRIAL REGISTER NUMBER: 2007-001430-14.