Borinstein, S.C., Pollard, J., Winter, L., & Hawkins, D.S. (2009). Pegfilgrastim for prevention of chemotherapy-associated neutropenia in pediatric patients with solid tumors. Pediatric Blood and Cancer, 53, 375–378.

To provide information about organizational experience with use of pegfilgrastim following dose intensive chemotherapy for solid tumors in pediatric patients with cancer.

Medical records of patients receiving myelosuppressive therapy supported with pegfilgrastim were reviewed (cases from 2007–2008). By protocol, pegfilgrastim was given in the outpatient clinic by subcutaneous injection at 0.1 mg/kg to a maximum does of 6 mg 24–48 hours after completion of chemotherapy. Complete blood counts (CBCs) were routinely monitored  every 7–10 days during therapy cycles, then every 2–5 days until neutrophil recovery. Analysis was limited to the first four courses of chemotherapy.

• 47 patients completed 176 courses of chemotherapy.
• Median age was 13 years, with a range of 2 months to 23 years.
• Females made up 53% of the sample; males made up 47%
• Key disease characteristics included Hodgkins disease, rhabdo myosarcoma, neuroblastoma, osteosarcoma, and Ewing sarcoma.
   

• Single site
• Outpatient
• Seattle, WA

• The phase of care was active antitumor treatment.
• The application was for pediatrics.

Retrospective descriptive

• Severe neutropenia was classified as an absolute neutrophil count (ANC) of less than 200 mm³
• Neutrophil recovery was an ANC greater than 200 mm³
• Febrile neutropenia was defined as severe neutropenia with temperature of 38.3ºC or higher with hospitalization and parenteral antibiotic therapy.
   

There were no significant adverse effects observed with pegfilgrastim. Leukocytosis was observed in 73% of patients, with no adverse sequelae. Severe neutropenia occurred in 57% of chemotherapy courses, and febrile neutropenia was seen in 28% of courses. Course delay occurred in 9% of courses, with a mean duration of two days of delay.

 This report provides evidence regarding the safety and efficacy of pegfilgrastim among a pediatric cancer population.

• Risk of bias (no control group) 
• Risk of bias (no blinding)  
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• Key sample group differences that could influence results
• Retrospective study design with associated risk of bias in results. 
• No information is provided regarding any other prophylactic medications for prevention of infection in this population.

Findings suggest that pegfilgrastim is effective and can be safety given to pediatric patients.