Effectiveness of filgrastim and polyethylene glycol-filgrastim in the treatment of postchemotherapy neutropenia in children: Phase I clinical trial

Abstract

Abstract Background: One of the most common side effects of chemotherapy in cancer patients is neutropenia that can result in hospitalization. The purpose of this study was to evaluate the efficacy and tolerability of polyethylene glycol (PEG)-filgrastim compared with filgrastim in the recovery of neutropenia. Methods: This study was a Phase I clinical trial conducted among patients with acute lymphoblastic leukemia aged <16 years who were referred to the Ali Asghar Hospital, Tehran, Iran, from April 2012 until October 2013. Eleven patients were selected, and filgrastim and PEG-filgrastim were injected subcutaneously at a dose of 5–10 μg/kg/day for 7 days and 100 μg/kg as a single dose, respectively. Absolute neutrophil count (ANC) was checked 7 days after the last injection in the two groups. Results: The mean age of the patients was 8.82 ± 4.36 years (3–15 years). Six boys (54.5%) and five girls (45.5%) participated in the study. ANC increase among patients treated with PEG-filgrastim or filgrastim was analyzed separately, and the results showed statistically significant differences between the study groups (P = 0.038). Conclusions: According to the findings, it can be concluded that the PEG-filgrastim is better than filgrastim alone to improve neutropenia induced by chemotherapy in patients with acute lymphoblastic leukemia.