Cioch, M., Jawniak, D., Kotwica, K., Wach, M., Manko, J., Goracy, A., . . . Hus, M. (2014). Biosimilar granulocyte colony-stimulating factor is effective in reducing the duration of neutropenia after autologous peripheral blood stem cell transplantation. Transplantation Proceedings, 46, 2882–2884. 

DOI Link

Study Purpose

To determine the effectiveness of biosimilar granulocyte colony-stimulating factor (G-CSF) as compared to originator G-CSF in reducing the duration of neutropenia following autologous peripheral blood stem cell transplantation (APBSCT).

Intervention Characteristics/Basic Study Process

The study group received biosimilar G-CSF following myeloablative chemotherapy and APBSCT. G-CSF was initiated when the absolute neutrophil count (ANC) dropped below 0.5 and continued until the ANC exceeded 1.5 for three consecutive days. Hematopoietic recovery was compared to the control group, which had received originator G-CSF.

Sample Characteristics

  • N: 46 (23 in prospective cohort)
  • AGE: Study group: 47 (SD = 13); control group: 53.6 (SD = 13)
  • MALES: 52%   
  • FEMALES: 48%
  • KEY DISEASE CHARACTERISTICS: Hematological malignancy (multiple myeloma, Hodgkin’s lymphoma, non-Hodgkin’s lymphoma, and acute myelogenous leukemia)

Setting

  • SITE: Single site    
  • SETTING TYPE: Inpatient    
  • LOCATION: Lublin, Poland

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Prospective observational with historical control comparison

Measurement Instruments/Methods

The primary comparator studied was duration of G-CSF treatment. Adverse events were also compared.

Results

There was no significant difference between the biosimilar and originator G-CSF groups with respect to duration of therapy (p=0.43). The frequency of occurrence of the most common adverse events (neutropenic fever and bone pain) were also comparable.

Conclusions

Biosimilar G-CSF had been previously demonstrated to have similar efficacy and safety as originator G-CSF. This study confirms the value of using biosimilar G-CSF in a post-transplantation setting.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)

 

Nursing Implications

Biosimilar G-CSF therapy has similar efficacy to originator G-CSF in patients with ABPSCT, but with significant cost savings. Because patients and caregivers are typically unable to work during the prolonged transplantation process, financial stressors are a frequent concern. Lowering medical costs helps alleviate financial concerns for patients and insurers.