Wannesson, L., Luthi, F., Zucca, E., Rosselet-Christ, A., Baglioni, M., Marelli, L., . . . Ketterer, N. (2011). Pegfilgrastim to accelerate neutrophil engraftment following peripheral blood stem cell transplant and reduce the duration of neutropenia, hospitalization, and use of intravenous antibiotics: a phase II study in multiple myeloma and lymphoma and comparison with filgrastim-treated matched controls. Leukemia and Lymphoma, 52, 436–443.

To explore the efficacy of pegfilgrastim to accelerate neutrophil engraftment following stem cell autotransplant.

Patients were given pegfilgrastim 6 mg subcutaneously the day after autologous peripheral stem cell transplant (ASCT). Controls, who were matched for age, gender, disease, high-dose chemotherapy regimen, peripheral blood stem cell dose, and number of prior therapy lines, received filgrastim beginning five to seven days (median = 7) posttransplant. Filgrastim therapy continued daily for 4 to 10 (median = 6.5) doses.

• A total of 80 patients (62.2% male, 38.8% female) who received intervention (pegfilgrastim; N = 40) and matched controls (filgrastim; N = 40) were included.   
• Mean age was 52.8 years (range 21.3–70.6).
• Half of the patients in each group had multiple myeloma (n = 20) and half had lymphoma (n = 20). The lymphoma group was subdivided into Hodgkin lymphoma (pegfilgrastim group [n = 8], filgrastim group [n = 7]) and non-Hodgkin lymphoma (pegfilgrastim group [n = 12], filgrastim group [n = 13]).

• Multi-site  
• Inpatient   
• Switzerland

Patients were undergoing the active treatment phase of care.

This study was a matched control clinical trial.

Time to neutrophil engraftment was defined as the time to the first of three consecutive days of an absolute neutrophil count (ANC) greater than or equal to 0.5x10⁹/L. No specific measurement tools were used other than checking laboratory values.

The pegfilgrastim group had a significantly shorter median time to neutrophil engraftment than the filgrastim group (9.5 versus 11 days, respectively; p < 0.0001), median duration of neutropenia (6 versus 7 days, respectively; p = 0.0001), median duration of intravenous antibiotic therapy (4 versus 6.5 days, respectively; p = 0.0007), and median hospitalization duration (13 versus 14 days, respectively; p=0.0184). The pegfilgrastim and filgrastim groups had a similar median time to platelet engraftment (11.5 versus 11 days, respectively; p=0.42) and median duration of fever (3 versus 3 days, respectively; p=0.35). The two groups required an equal number of red blood cell and platelet transfusions.

Treatment with pegfilgrastim started the day after ASCT results in earlier neutrophil engraftment and reduced neutropenia compared to patients who received filgrastim beginning five to seven days posttransplant. These differences were more pronounced in patients with multiple myeloma than in those with lymphoma, suggesting that interventions may need to be adjusted based on diagnosis.

• Toxicity outcomes were not compared between the pegfilgrastim- and filgrastim-treated groups.
• Small sample (<100)
• Pegfilgrastim was provided free of charge by the manufacturer. There was no cost difference analysis between the pegfilgrastim- and filgrastim-treated populations. 
• No blinding, with associated risk of bias
   

Infection is a potentially life-threatening risk of ASCT. The longer the period of time between chemotherapy-induced pancytopenia and neutrophil engraftment, the greater the risk.  Findings suggest that pegfilgrastim may be more effective with a single injection rather than multi-day injections with filgrastim.