Aarts, M.J., Peters, F.P., Mandigers, C.M., Dercksen, M.W., Stouthard, J.M., Nortier, H.J., . . .  Mattijssen, V. (2013). Primary granulocyte colony-stimulating factor prophylaxis during the first two cycles only or throughout all chemotherapy cycles in patients with breast cancer at risk for febrile neutropenia. Journal of Clinical Oncology, 31, 4290–4296. 

DOI Link

Study Purpose

To evaluate whether neutropenia prophylaxis could be limited to the first two cycles of chemotherapy only, based on the observation that patient risk for febrile neutropenia (FN) is highest in the first two cycles

Intervention Characteristics/Basic Study Process

Patients receiving chemotherapy every three weeks with regimens associated with more than a 20% risk of FN were randomly assigned to receive a granulocyte–colony-stimulating factor (G-CSF) throughout all chemotherapy cycles (standard arm) or during the first two cycles only. Pegfilgrastim (6 mg) was given 24–30 hours after chemotherapy administration. Participating sites were stratified according to whether they used prophylactic antibiotics.

Sample Characteristics

  • N = 167   
  • MEDIAN AGE = 50 years
  • FEMALES: 100%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: All had breast cancer. The majority were receiving TAC (docetaxel, doxorubicin, and cyclophosphamide) chemotherapy.
 

 

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Netherlands

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Randomized, parallel-group, noninferiority trial

Measurement Instruments/Methods

  • Blood cell counts

Results

The incidence of FN was 10% with standard treatment and 36% in the experimental arm. Grade 3–4 neutropenia occurred in 6% of the standard arm versus 51% of the experimental arm, and confirmed infection occurred more often in the experimental arm. The study was closed prematurely because of an unacceptablely high rate of FN.

Conclusions

The findings showed that the incidence of FN was higher among patients who did not receive G-CSF during each cycle of chemotherapy.

Limitations

  • Risk of bias (no blinding)

 

Nursing Implications

The findings showed that patients who did not receive recommended CSF prophylaxis during each cycle of chemotherapy had significantly higher rates of FN. These results showed that the provision of prophylaxis according to recommended guidelines is important for FN prevention.