Hockings, J.K., Owolabi, D.K., Broyles, J.E., & Wheelis, S.C. (2017). Impact of recommended weight-based dosing of granulocyte-colony stimulating factors in acute leukemia and stem cell transplant patients. Supportive Care in Cancer, 25, 1853-1858.

DOI Link

Study Purpose

To evaluate the effect of recommended weight-based GCSF dosing (under, recommended and over) on duration of neutropenia, compared to under and overweight-based dosing; secondary endpoints were LOS, FN incidence, and mortality between all three dosing groups

Intervention Characteristics/Basic Study Process

Retrospective chart review of 75 patients during 94 admissions for treatment of AML/ALL with induction/consolidation chemotherapy or admitted for a HSCT, admissions divided into weight-based dosing groups of GCSF under 5 mcg/kg; recommended 5 mcg/kg (plus or minus 10%); or over 5 mcg/kg; data collected from initiation of G-CSF to three weeks post: for number of documented doses, ANC nadir, neutropenia duration, time to first fever, and patient disposition at end of study period

Sample Characteristics

  • N = 75 
  • AGE: Mean = 58 years
  • MALES: 40%  
  • FEMALES: 60%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: AML, n = 68 patients; ALL, n = 2 patients; other, n = 5 patients (non-leukemic admitted for HSCT)
  • OTHER KEY SAMPLE CHARACTERISTICS: 68% of patients with overweight BMI, 29% normal BMI, and 3% underweight BMI; reason for admission: 36 patients for induction; 15 for consolidation; 23 for neutropenia; 13 for HSCT; 11 patients had two admissions, 1 patient had three admissions, and 2 patients had four admissions

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Tennessee

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment
  • APPLICATIONS:  Elder care, palliative care 

Study Design

Retrospective chart review: sample collected from database ICD-9-CM codes for acute leukemia or stem cell transplantation for patients admitted from May 2009 through September 2015

Measurement Instruments/Methods

Actual body weight, temperature, neutropenia ANC < 500, nadir ANC; length of neutropenia in number of days; length of stay in number of days; FN incidence (%); mortality incidence (%)

Results

Comparing weight-based dosing of GCSF administered (under 5 mcg/kg; recommended 5 mcg/kg (plus or minus 10%); or more than 5 mcg/kg) during patient admissions for chemotherapy induction/consolidation or HSCT, the study found that recommended dosing for at least three doses leads to lower incidence of febrile neutropenia (p = 0.003); there was no significant differences between the groups for duration of neutropenia, LOS, or mortality rate.

Conclusions

Recommended weight-based dosing of GCSF at 5 mcg/kg of at least three doses showed a reduction in FN incidence for this population of patients

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import      
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias (no appropriate attentional control condition)  
  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results
  • Selective outcomes reporting
  • Key sample group differences that could influence results
  • Findings not generalizable
  • Questionable protocol fidelity
  • Other limitations/explanation: Statistical data selectively reported, Fisher exact test indicates limited data set, number of doses not shown in comparison to the reported outcomes, no data shown on neutropenic nadir; GCSF dosing/outcome data was reported on the same patients with multiple admissions, but treated as separate admission data; no power analysis, no effect size reported, HSCT type not distinguished (allo or auto)

Nursing Implications

This retrospective chart review indicates that recommended GCSF weight-based dosing of at least three doses reduces risk of FN. Larger multi-site randomized controlled trials need to be conducted that will effectively evaluate differences of weight-based dosing on clinical outcomes to determine best practice. Nurses need to remain vigilant and adhere to current recommended GCSF weight-based dosing to reduce incidence of FN and potential infectious risks.