Thiepold, A.L., Lemercier, S., Franz, K., Atta, J., Sulzbacher, A., Steinbach, J.P., & Rieger, J. (2014). Prophylactic use of pegfilgrastim in patients treated with a nitrosourea and teniposide for recurrent glioma. Pharmacotherapy, 34, 633–642. 

To determine whether pegfilgrastim reduces leukopenia and infectious complications in patients with recurrent glioma treated with teniposide and a nitrosourea

Patients received nitrosourea 90 mg/m² on day 1 and teniposide 60 mg/m² on days 1–3 of every cycle. Cycles were given every six weeks until progression. The control group did not receive prophylactic pegfilgrastim, and the intervention group received pegfilgrastim 6 mg subcutaneously 8–24 hours after the third teniposide infusion.

• N = 60
• MEDIAN AGE = 56 years (range = 27–72 years)
• MALES: 55%, FEMALES: 45%
• KEY DISEASE CHARACTERISTICS: Patients with recurrent glioma treated with teniposide and a nitrosourea

• SITE: Single site    
• SETTING TYPE: Multiple settings  
• LOCATION: Germany

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care 

Retrospective review of medical records of patients treated at a neuro-oncology hospital

• Absolute neutrophil count

The expected nadir of teniposide is between days 8–17, and the nadir caused by the nitrosourea is expected after day 35. Therefore, patients may have an early nadir (defined as the period before day 30) and a late nadir (defined as the period from day 30 and beyond). Pegfilgrastim is expected to be active between days 3–11. Pegfilgrastim decreased the number of patients who had grade 3 neutropenia during the early nadir (9% with pegfilgrastim and 31% in the control group, p = 0.04). However, there was no difference in the rate of grade 4 neutropenia during the early nadir. Pegfilgrastim did not prevent any grade of neutropenia in the late nadir. Seven patients (27%) in the control group and six patients (17%) in the pegfilgrastim group were hospitalized because of myelosuppression or infections. There was no difference in the number of days these patients had to be hospitalized or needed intravenous antibiotics during the first two cycles of chemotherapy (p = 0.27 and p = 0.3, respectively).

The prophylactic administration of pegfilgrastim in patients treated with teniposide and nitrosourea for recurrent glioma did not reduce the frequency of grade 4 leukopenia, the need for antibiotics, or the number of days of hospitalization. It did reduce the incidence of grade 3 neutropenia in the nadir that occurred in the first 30 days.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no random assignment)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results

The routine prophylactic administration of pegfilgrastim does not seem to provide a relevant benefit for nitrosourea and teniposide chemotherapy in patients with recurrent glioma other than reduction in the incidence of grade 3 neutropenia during the first 30 days.