An open-label, randomized study comparing lipegfilgrastim with filgrastim in pediatric patients receiving chemotherapy for Ewing sarcoma or rhabdomyosarcoma.

This study compared efficacy and safety of lipegfilgrastim with filgrastim in pediatric patients. Children and adolescents receiving chemotherapy (4 cycles) for Ewing sarcoma or rhabdomyosarcoma were randomized 1:1 to lipegfilgrastim (100 µg/kg) once per cycle or filgrastim (5 µg/kg), once daily for ≥ 5 days for up to 14 days or until absolute neutrophil count (ANC) recovery. In 39 evaluable patients, no meaningful difference was observed between lipegfilgrastim and filgrastim treatment groups in duration of severe neutropenia (DSN; mean [standard deviation]) in cycle 1 (2.7 [2.25] vs. 2.5 [2.09] days); least squares mean treatment difference (lipegfilgrastim minus filgrastim) 1.0 day (95% CI: -0.21,2.26) or cycles 2-4, duration of very severe neutropenia in cycles 1-4, incidence of severe neutropenia (85% vs. 84%) or very severe neutropenia (70% vs. 68%). The incidence of febrile neutropenia was numerically lower with lipegfilgrastim (35%) vs. filgrastim (42%). Mean area under the curve of ANC until day 15 in cycle 1 was numerically higher with lipegfilgrastim vs. filgrastim (105 × 10