Badalamenti, G., Incorvaia, L., Provenzano, S., Bronte, G., Leto, G., Fulfaro, F., & Maltese, G. (2013). Lenograstim in preventing chemotherapy-induced febrile neutropenia in patients with soft tissue sarcoma. Anticancer Research, 33, 679–684.

DOI Link

Study Purpose

The purpose of the study was to evaluate incidence of febrile neutropenia and grade 4 neutropenia after receiving lenograstim prophylaxis.

Intervention Characteristics/Basic Study Process

All patients received G-CSF prophylaxis with 263 mcg from days 5–9 in patients receiving three cycles of epirubicin and ifosamide for soft tissue sarcoma. Patients were observed for three cycles. Blood counts were done on days 8,15, and 22.

Sample Characteristics

  • 36 total participants
  • Median age was 53, range was 19–72
  • 48% were male, 52% were female
  • All had soft tissue sarcoma and were receiving chemotherapy regimens associated with a 50% risk of febrile neutropenia 
  • All patients were chemotherapy naive.

Setting

  • Single site
  • Outpatient
  • Italy

Phase of Care and Clinical Applications

Active antitumor treatment

Study Design

Observational

Measurement Instruments/Methods

  • CTCEA [v.4.03]
  • Febrile neutropenia was defined as an absolute neutrophil count of less than 1,000/mm3 and single temperature greater than 38.3ºC.

Results

There were no episodes of febrile neutropenia. Grade 4 neutropenia was seen in 17% of patients—58% on day 8, 29% on day 15, and 13% on day 22.  No treatment delays or dose reductions were required.

Conclusions

G-CSF as given here was effective in preventing the risk of febrile neutropenia and grade 4 neutropenia in patients receiving chemotherapy associated with high risk for these adverse events.

Limitations

  • Small sample (less than100)
  • Risk of bias (no control group) 
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias(sample characteristics)
  • Findings not generalizable
  • Homogenous group of patients receiving the same chemotherapy regimen
  • Findings may not be generalizable to other groups

Nursing Implications

Prophylactic G-CSF reduced risk of febrile neutropenia and grade 4 neutropenia in patients at risk for these problems during chemotherapy for soft tissue sarcoma. The most appropriate timing of prophylactic colony-stimulating factor is not clear. The timing studied here appeared to be effective.