Milano-Bausset, E., Gaudart, J., Rome, A., Coze, C., Gentet, J.C., Padovani, L., . . . André, N. (2009). Retrospective comparison of neutropenia in children witih Ewing sarcoma treated with chemotherapy and granulocyte colony-stimulating factor (G-CSF) or pegylated G-CSF. Clinical Therapeutics, 31, 2388–2395.

DOI Link

Study Purpose

The purpose of the study was to compare efficacy of pegfilgrastim and filgrastim administered after chemotherapy in children with Ewing sarcoma. 

Intervention Characteristics/Basic Study Process

All patients received both types of G-CSF in different treatment courses of chemotherapy, which consisted of vincristine, ifosfamide, doxorubicin, and etoposide (VIDE); vincristine, atinomycin D, and ifosfamide (VAI); or vincristine, atcinomycin D, and cyclophosphade (VAC). A single injection of pegfilgrastim 100 mcg/kg subcutaneously or a daily injection of filgrastim 5–10 mcg/kg subcutaneously was administered 48–72 hours after the completion of chemotherapy. Twenty children were included. A total of 178 chemotherapy courses were administered and evaluated, including 134 courses with pegfilgrastim and 44 courses with filgrastim.

Sample Characteristics

  • 20 participants
  • Median age was 12.8 years, with a range of 9–17 years.
  • Females made up 65% of the sample; males made up 35%.
  • Participants had  Ewings sarcoma
  • Participants' weight range was 28–90 kg  with median weight of 45.2 kg.
     

Setting

Single-site location in Marseille, France
 

Phase of Care and Clinical Applications

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

Study Design

Retrospective chart review

Measurement Instruments/Methods

  • Proportion of chemotherapy courses with grade 4 neutropenia    
  • Duration of grade 4 neutropenia
  • Proportion with severe neutropenia
  • Proportion with febrile neutropenia
  • Duration of antibiotic treatment
  • Duration of hospitalization
  • Percentage of patients receiving transfusion
     

Results

Considering all types of chemotherapy combined, those courses in which pegfilgrastim was used were associated with a significantly lower incidence versus severe neutropenia (0.21 versus 0.85; p = 0.034), a shorter duration of severe neutropenia (0.49 versus 2.36 days; p = 0.01), and a shorter duration of antibiotic treatment (1.07 versus 4.22 days; p = 0.03) compared with courses with filgrastim. No statistically significant differences were observed for the proportion of febrile neutropenia, duration of hospitalization, or transfusions.

Conclusions

Using pegfilgrastim after chemotherapy courses was associated with significantly reduced frequency and shorter duration of severe neutropenia compared with those courses followed by filgrastim.

Limitations

  •  Small sample (less than 30 participants)
  •  Administration of G-CSF was not randomized.

Nursing Implications

Randomized, controlled trials are needed to confirm the results.