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Comparison of the effects of two different doses of Filgrastim in febrile neutropenia management in childhood malignancy: A randomized clinical trial

Background: Febrile neutropenia (FN) is most often caused due to chemotherapy. Solid or certain lymphoproliferative malignancies can increase the duration of hospitalization and other complications in cancer patients. Filgrastim is used in childhood FN management. This study aimed to compare the effect of two different doses of Filgrastim on hematological and paraclinical factors in hospitalized febrile neutropenic patients with cancer.  
Materials and methods: In this randomized clinical trial, 60 febrile neutropenic patients with cancer complying with the inclusion criteria were assigned to both groups A and B. Thirty patients in group A received Filgrastim 5μg/kg/day whereas 30 others in group B received Filgrastim 15μg/kg/day. Hematological factors, physical examination findings, antibiotic administration period, and type of malignancy were then recorded. Complete blood count with differential (CBC diff) was also tested. Lung infiltration was examined by chest X-ray (CXR), and the spleen and abdomen were monitored by ultrasound. 
Results: The mean age of patients was 6 ± 3 years old. The most prevalent malignancies included acute lymphoblastic leukemia (ALL) (35.0%), neuroblastoma (18.3%), osteosarcoma (11.7%), acute myeloid leukemia (AML) (8.3%), and Rhabdomyosarcoma (8.3%). The frequency distribution of malignancies significantly differed between the two groups (P= .01). Changes in hematological factors, including white blood cells (WBC), mature neutrophil cells, and absolute neutrophil count (ANC) in group A, appeared lower than those in the other group. However, none of the studied factors, including hematological factors, physical examination findings, and antibiotic administration period, were found to differ significantly between the two groups (P> 0.05). 
Conclusion: Much as a higher dose of Filgrastim seems to bear a better effect on ANC, no significant difference was identified between the two groups. Further studies should be designed with a larger population to address the issue. 