Researchers involved in an international multicenter randomized trial have reported that single-dose Neulasta® (pegfilgrastim) is as effective as multiple-dose Neupogen® (filagrastim) for support of children receiving intensive chemotherapy for previously treated sarcoma. The details of this study were published in the March 10, 2010 issue of the Journal of Clinical Oncology.[1]

Pegylation is a technique that allows for the slow delivery of biologic agents, cutting down the need for daily dosing. It has been used successfully to develop Aranesp® (darbepoetin alfa), which is a long-acting form of recombinant human erythropoietin. Aranesp can be given weekly or at longer intervals. The same technology has been used to develop Neulasta, a long-acting form of Neupogen.

Previous studies have shown that a single dose of Neulasta is equivalent to multiple doses of Neupogen in patients given dose-intensive chemotherapy. Most of these studies have been performed in adults with malignant disease; there have been very few studies in children. Researchers from the Fred Hutchinson Cancer Research Center have recently reported that Neulasta was well tolerated and effective in children with solid tumors. This study included patients who weighed less than 45 kg. There have also been two recent studies showing that single-dose Neulasta can effectively mobilize peripheral blood stem cells in children receiving autologous transplantation. Researchers from the National Cancer Institute have recently reported that single-dose Neulasta is well tolerated and may be as effective as daily Neupogen in children and young adults with sarcomas receiving dose-intensive chemotherapy.

The current study randomly allocated 44 children, adolescents, or young adults to receive single-dose Neulasta or multiple-dose Neupogen on a 6:1 ratio. Chemotherapy consisted of two cycles of high dose vincristine, doxorubicin, and cyclophosphamide and two cycles of ifosfamide and etoposide. All efficacy endpoints were similar between the two arms of this study. These authors concluded: “A single dose of pegfilgrastim at 100 ug/kg administered once per chemotherapy cycle is comparable to daily injection of filgrastim at 5ug/kg for pediatric sarcoma patients receiving myelosuppressive chemotherapy.”

Comments: These data confirm that Neulasta is as well tolerated and effective in children with malignancy as in adults.

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