Rifkin, R., Spitzer, G., Orloff, G., Mandanas, R., McGaughey, D., Zhan, F., . . . Beveridge, R. (2010). Pegfilgrastim appears equivalent to daily dosing of filgrastim to treat neutropenia after autologous peripheral blood stem cell transplantation in patients with non-Hodgkin lymphoma. Clinical Lymphoma, Myeloma & Leukemia, 10, 186–191.

To compare time to absolute neutrophil count (ANC) recovery for patients treated with filgrastim versus pegfilgrastim.  

Patients were randomized to Arm A, pegfilgrastim 6 mg subcutaneously on day 1 after autologous peripheral blood stem cell transplant (PBSCT), or Arm B, weight-based dose of filgrastim subcutaneously from day 1 until either the third consecutive day of ANC greater than 5,000/mm³ or one day of ANC greater than 10,000/mm³ after PBSCT.  Duration of treatment was not to be more than 21 days.

• Ninety-two patients (64% male, 36% female) with non-Hodgkin lymphoma (NHL) were included.
• Age range was 23.4 to 73 years.
• Patients had previously undergone PBSCT.

Multi-site

Patients were undergoing the active treatment phase of care.

This was a randomized, phase II study.

• Until engraftment:  brief daily history, physical examination, and laboratory work
• After engraftment as clinically indicated:  daily history, physical examination, weekly Eastern Cooperative Oncology Group Performance Status (ECOG PS), complete blood count (CBC) at least 3 times a week, and comprehensive metabolic panel at least twice a week
• Test hypotheses:  H0 (MEANarm A - MEANarmB >2 days) versus H1 (MEANarm A - MEANarmB  <2 days), where MEANarm A represents the mean time to ANC recovery in patients treated with pegfilgrastim and MEANarmB represents the mean time to ANC recovery in patients treated with filgrastim.
• Equivalence of pegfilgrastim to filgrastim would be accepted if time to recovery with pegfilgrastim was different by less than 2 days when compared to filgrastim.
• Similar methods were used for secondary objectives. Febrile neutropenia, intravenous (IV) antibiotics, positive blood cultures, and red blood cell transfusion.  
   

• Forty-eight patients in arm A and 44 patients in arm B completed treatment.
• Mean ANC recovery time was 9.3 days for pegfilgrastim (Arm A) compared to 9.8 days for filgrastim (Arm B), resulting in statistically significant finding (p < 0.01).

In the posttransplant setting, pegfilgrastim is preferred over filgrastim based on faster neutrophil recovery, less patient discomfort, and comparable cost.

Small sample size

Pegfilgrastim is favored over filgrastim in patiens undergong NHL posttransplantation due to faster ANC recovery with less patient discomfort at cost that is comparable.