Paksu, M.S., Paksu, S., Akbalik, M., Ozyurek, E., Duru, F., Albayrak, D., & Fisgin, T. (2012). Comparison of the approaches to non-febrile neutropenia developing in children with acute lymphoblastic leukemia. Fundamental and Clinical Pharmacology, 26, 418–423.

The purpose of this study was to investigate of the influences of high-dose (20 mg/kg per day) methyl prednisolone (HDMP) and granulocyte–colony-stimulating factor (G-CSF) in shortening the duration of chemotherapy-induced neutropenia encountered in children with ALL receiving maintenance therapy.

Comparison of HDMP (oral), G-CSF (subcutaneous), or no treatment following neutropenic events in children with acute lymphoblastic leukemia (ALL) receiving St Jude XIII maintenance protocol (details of the protocol not provided with the exception of vepeside-cyclosphosphamide noted as part of the protocol). The protocol for administration of HDMP or G-CSF included an absolute neutrophil count (ANC) below the required level to administer chemotherapy (more than 1,500/mm³ for patients receiving high-dose methotrexate and more than 1,000/mm³ for patients receiving drugs other than methotrexate). The goal was to increase neutrophil count by day 2 or day 4 so that the chemotherapy could continue to be administered. Non-febrile neutropenia was defined as having an ANC below the accepted level for chemotherapy administration with the absence of a fever or laboratory signs of infection.

• 29 participants took part
• The mean age of participants was 7.9 years, with a range of 2.8–17.6.
• Males outnumbered females 52% to 48%, respectively.
• ALL was the key diagnosis characteristic

A single-site outpatient location (Ondokuz Mayis University, Samsun, Turkey)

• The phase of care was active antitumor treatment
• Application was for pediatrics

Retrospective

Statistical analyses included comparisons between no treatment, G-CSF, and HDMP with number of neutropenic events. Chi-square or Fisher’s exact chi-square tests were used for frequency differences, normally distributed variables were evaluated with analysis of variance (ANOVA) and non-normally distributed variables were evaluated with the Kruskal-Wallis test. The Mann-Whitney U test with Bonferroni correction was used for group differences.

There were 64 non-febrile neutropenic events among 29 patients. Second day and overall success rates (not defined) were higher for G-CSF and HDMP groups compared to no treatment for a neutropenic event. No differences were found between G-CSF and HDMP. Second day and overall neutrophil counts were higher in the G-CSF group.

HDMP was equal to G-CSF for successful outcome of shortening the course of delayed treatment due to neutropenia. The researchers noted HDMP is less expensive than G-CSF and may be a good option for the treatment of neutropenia in children with ALL.

• Small sample (less than 30 participants)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Both HDMP and G-CSF were noted as tolerable, but side effects were not discussed.

Use of HDMP or G-CSF can limit treatment delays due to neutropenia. Understanding the differences between HDMP and G-CSF (higher neutrophil count return with G-CSF) and similarities (same outcome goal reached of shortening treatment delay) is important to discuss regarding treatment decision-making. HDMP may be more cost-effective.