Li, Y., Klippel, Z., Shih, X., Wang, H., Reiner, M., & Page, J.H. (2016). Trajectory of absolute neutrophil counts in patients treated with pegfilgrastim on the day of chemotherapy versus the day after chemotherapy. Cancer Chemotherapy and Pharmacology, 77, 703–712. 

DOI Link

Study Purpose

To compare absolute neutrophil count (ANC) and febrile neutropenia (FN) in patients who receive pegfilgrastim on the same day of chemotherapy versus the next day

Intervention Characteristics/Basic Study Process

Data from a prior randomized, controlled trial was pooled for analysis. The trajectory of ANC and incidence of FN and related events were analyzed.

Sample Characteristics

  • N = 192   
  • MEAN AGE = 58.9 years (SD = 12.7)
  • MALES: 32.3%, FEMALES: 67.7%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Multiple tumor types—most were breast, lung, and non-Hodgkin lymphoma
  • OTHER KEY SAMPLE CHARACTERISTICS: Sixty-two percent were at intermediate FN risk, and 38% were at high risk.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Not specified    
  • LOCATION: United States

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Secondary analysis of four phase-II, randomized, controlled trials

Measurement Instruments/Methods

  • Grade 3–4 FN defined at body temperature greater than or equal to 38.2 degrees Celsius, infection-related hospitalization, or infection related adverse event occurring within one day of grade 3–4 neutropenia
  • Common Terminology Criteria for Adverse Events (CTCAE) for neutropenia grade

Results

ANC at nadir was significantly lower in those who received same-day pegfilgrastim (p = 0.003). Time to nadir was slightly lower in those with same-day pegfilgrastim (p = 0.019). ANC at nadir was much lower among those who got same-day treatment (0.27 compared to 0.74 x 109/l, p < 0.001).  Risk of grade 4 neutropenia was higher among those who got same-day treatment (odds ratio [OR] = 0.23, 95% CI [0.1, 0.49]). No significant difference existed between groups in incidence of FN as defined for this pooled analysis; however, the actual incidence was lower among those who received next-day treatment. ANC recovery was faster in those who received next-day pegfilgrastim.

Conclusions

Patients who received pegfilgrastim the day after chemotherapy had less severe ANC suppression and more rapid ANC recovery. No clear differences in incidence of FN were reported.

Limitations

Initial trials were not designed to capture the incidence of FN and infections, so pooled analysis capability was limited.

Nursing Implications

This study adds to the body of evidence supporting the administration of pegfilgrastim as recommended, one to three days after chemotherapy.