Kahl, C., Sayer, H. G., Hinke, A., Freund, M., & Casper, J. (2012). Early versus late administration of pegfilgrastim after high-dose chemotherapy and autologous hematopoietic stem cell transplantation. Journal of Cancer Research and Clinical Oncology, 138, 513–517.

To evaluate the optimal application time for pegfilgrastim in autologous hematopoietic stem cell transplant (AHSCT) recipients.

Within two institutions, patients were assigned to either receive pefilgrastim 6 mg subcutaneously on day 1 (Peg1) or pegfilgrastim 6 mg subcutaneously on day 4 (Peg4). Primary study endpoint was time between transplant and neutrophil recovery to greater than 500/µl.  A difference of less than 1 day was not considered clinically significant.

• Fifty-three patients (45.3% male, 54.7% female) were included.      
• Mean age was 56.5 years (range 25–69).
• The most common diagnosis was multiple myeloma.  
• Most patients received high-dose melphalan.

• Multi-site  
• Inpatient

Patients were undergoing the active antitumor treatment phase of care.  

This was an open-label, phase II study.

• Neutrophil engraftment >500 µl
• Granulocyte greater than1,000 µl
• Platelet recovery greater than 20,00 and greater than 50,000 Gpt/l
• Incidence and duration of neutropenic fever
• Incidence and duration of intravenous (IV) antibiotics
• Transfusion requirement

Both groups had a median of 10 days to neutrophil engraftment >500 µl and granulocyte engraftment greater than 1,000 µl, with no difference between groups.  There were no differences between groups in time to platelet engraftment, incidence of febrile neutropenia, incidence or duration of IV antibiotics, or transfusion requirements.

 Early administration of pegfilgrastim demonstrated no benefit versus administration on day 4 after AHSCT. No clear recommendation can be made with respect to an optimal time for pegfilgrastim use.

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

The study findings suggest that early and late administration of pegfilgrastim are equally effective in terms of time to neutrophil, granulocyte, and platelet recovery after AHSCT, need for IV antibiotics, transfusion, and incidence of febrile neutropenia.