Donkor, K.N., Selim, J.H., Waworuntu, A., & Lewis, K. (2017). Safety and efficacy of pegfilgrastim when given less than 14 days before the next chemotherapy cycle: Review of every 14-day chemotherapy regimen containing 5-FU continuous infusion. Annals of Pharmacotherapy, 51, 840–847.

The purpose of the study was to determine the efficacy and safety of administering pegfilgrastim less than 14 days from the next chemotherapy cycle in patients receiving a regimen containing 5-FU that infuses over at least 46 hours or more.

Authors reviewed the electronic health record for criteria of patients who received chemotherapy containing 5-FU over at least 46 hours. In addition to demographic data, each unique chemotherapy cycle was evaluated, and patients were put into 1 of 4 groups: (a) Cycles of chemotherapy where pegfilgrastim was given less than 14 days from the next chemotherapy cycle; (b) cycles where pegfilgrastim was given more than 14 days from the next chemotherapy cycle;(c) cycles where filgrastim was given instead of pegfilgrastim after chemotherapy; (d) cycles where no colony stimulating factors were given.

• N = 51 patients included in study (translates into 536 chemotherapy cycles containing 5-FU)   
• AGE: 18 years and older
• MALES: 59.5%  
• FEMALES: 40.5%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Diagnosed cancer that requires treatment with chemotherapy treatment that includes 5-FUCI as one of the drugs
• OTHER KEY SAMPLE CHARACTERISTICS: On FUCI for 14-day treatment cycle infused over at least 46 hours

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Loma Linda University Medical Center, Loma Linda, CA

PHASE OF CARE: Active anti-tumor treatment

This was a single-institution retrospective cohort study of patients who received chemotherapy treatment from June 2013 to December 2015.

Counts and percentages were used for data analysis of demographic data as well as generalized linear models to compare mean ANC and WBC counts of the four different groups within the analysis.  A generalized linear model with generalized estimating equations was used to compare mean ANC and WBC with 95% CI limits. Poisson regression models were used to estimate relative risk for neutropenia. All analyses were two sided and conducted at a significance level of 0.05.

The primary study outcome was the number of chemotherapy cycles with neutropenia, febrile neutropenia, and/or hospitalization in cycles where pegfilgrastim was given less than 14 days before the next chemotherapy cycle. The secondary outcome was evaluation of the incidences of neutropenia, mean ANC, and mean WBC for each of the four groups that were evaluated as part of this analysis. 536 total chemotherapy cycles were evaluated based on inclusion criteria. The group that received pegfilgrastim less than 14 days from their chemotherapy cycle did not show evidence of neutropenia or hospitalization as a result of febrile neutropenia. This group demonstrated a mean ANC and WBC count that was statistically significantly higher than the other three research groups as noted above.

Based on the data reviewed, it does not appear as though administering pegfilgrastim less than 14 days before the next chemotherapy cycle causes harm to patient nor increased myeloid toxicity. While this study was small and specific to one site, it may be beneficial for continued research with a larger sample.

• Small sample (< 100)
• Risk of bias (no random assignment)
• Risk of bias (sample characteristics)
• Other limitations/explanation: Single study retrospective review, limited to records available within institution that may not have accounted for care patient’s received elsewhere.

As nurses are the ones to administer pegfilgrastim, it is important for nurses to understand the implications of administration of the drug and how it impacts patient outcomes.