Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
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Comparison of filgrastim and lenograstim in pediatric solid tumors.

PURPOSE: Chemotherapy-induced febrile neutropenia (FEN), which causes treatment delays or chemotherapy dose reductions, is a serious side effect of cancer treatment. In Turkey, recombinant G-CSF (rG-CSF) has been used since 2000 to control neutropenia. The purpose of this prospective randomized study is to compare the effectiveness, toxicities and the cost of these two drugs in children.

METHODS: Between April and December 2008, 29 patients were administered 40 courses of chemotherapy in each arm. A randomized crossover study was designed. All patients were administered rG-CSF 24 hours after the last day of chemotherapy as a secondary prophylaxis. Complete blood counts as well as peripheral blood progenitor (CD34+) cell levels were measured before G-CSF treatment and on the fifth and the seventh day of treatment.

RESULTS: The median duration of neutropenia, FEN, the length of hospitalization, the incidence of FEN, and documented infection was not different between the two rG-CSF treatment groups. Erythrocyte and platelet transfusion rates were also similar. After 7 days, the mean leukocyte (WBC [white blood cell]) and neutrophil count (ANC [absolute neutrophil count]), hemoglobin and platelet levels were not significantly different. However, the CD34+ cell level was significantly higher in the lenograstim group. Lenograstim was also more expensive than filgrastim. No serious side effects were reported for either rG-CSF treatment.

CONCLUSIONS: There is no difference following the administration of either lenograstim or filgrastim for the duration of neutropenia, FEN or hospitalization for pediatric cancer patients. For stem cell mobilization, lenograstim was superior to filgrastim.

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