Filgrastim Versus Pegfilgrastim for Neutropenia Prevention in Children with Solid Tumors: A Randomized Trial
Subject Areas : Journal of Chemical Health RisksAziz Eghbali 1 , Maryam Behtash 2 , Roghayyeh Rahimi Afzal 3 , Aygin Eghbali 4 , Bahar Taherkhanchi 5 , Bahador Bagheri 6
1 - Aliasghar Clinical Research Development Center, Iran University of Medical Sciences, Tehran, Iran
2 - Department of Pediatrics, Arak University of Medical Sciences, Arak, Iran
3 - Department of Pediatrics, Arak University of Medical Sciences, Arak, Iran
4 - Aliasghar Clinical Research Development Center, Iran University of Medical Sciences, Tehran, Iran
5 - Department of Pediatrics, Erfan Niyayesh Hospital, Tehran, Iran
6 - Cancer Research Center, Semnan University of Medical Sciences, Semnan, Iran|Department of Pharmacology, Semnan University of Medical Sciences, Semnan, Iran
Keywords: Chemotherapy, Malignancy, Pegfilgrastim, Filgrastim,
Abstract :
Prophylaxis of chemotherapy-induced neutropenia by granulocyte stimulatory factors (GCSFs) has a significant effect on reducing the complications of chemotherapy. The aim of this study was to compare effects of filgrastim and pegfilgrastim (two types of GCSFs) for neutropenia prevention in children with malignancies. This crossover study was carried out in children who were admitted to oncology ward of Amir Kabir Hospital, Arak, Iran. Patients were randomly divided into 3 groups each with 30 participants. Filgrastim (group A), pegfilgrastim (group B) were injected subcutaneously 10 µg/kg/day and 100 µg/kg as a single dose, respectively and patients in group C had no medical treatment. Washout period was 30 days. Cell blood were checked at beginning and at 3, 7, 14 days of the treatment. The mean age in group A was 6.4 ±3.5 years, the group B was 6.4 ± 3.5 and the group C was 6.2 ± 1.8. The mean Absolute Neutrophil Count (ANC) was similar in all three groups prior to chemotherapy. After receiving the last dose of chemotherapy, the mean ANC was not significantly different in 3 groups (p = 0.217), and only 2 cases of mild neutropenia were seen in group B. On the 14th day, the ratio of neutropenia was different in 3 groups, and this difference was significant (p = 0.000) but there was no significant difference between the ratio of neutropenia in group A and group B. (p = 0.524). 20% of cases in group C and then 16.7% in group B were treated due to delayed neutropenia and this difference was significant (p = 0.026). Pegfligrastim was associated with better clinical response and fewer side effects as compared to filgrastim in children with solid tumors. Due to efficacy and acceptable safety profile, pegfligrastim can be a better choice. There was no significant difference between the costs of the three groups (0.064)
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