Castagna, L., Bramanti, S., Levis, A., Michieli, M. G., Anastasia, A., Mazza, R., . . . Santoro, A. (2010). Pegfilgrastim versus filgrastim after high-dose chemotherapy and autologous peripheral blood stem cell support. Annals of Oncology, 21, 1482–1485.
To demonstrate that one single fixed dose of pegfilgrastim (PEG) was not inferior compared to daily doses of filgrastim after high-dose chemotherapy (HDC) and autologous peripheral stem cell transplant.
Comparisons between two different granulocyte colony-stimulating factors (G-CSFs) (i.e., PEG and filgrastim) were highlighted in this article. The researcher wanted to reveal that PEG is the same high quality as filgrastim after receiving HDC and peripheral blood stem cells starting from day 1. A single fixed dose of PEG was given 24 hours after stem cell infusion. In the control arm, 5 mcg/kg/day of filgrastim was given from day 1 until absolute neutrophil count (ANC) recovered to greater than .5x 109/l. Each setting followed its own supportive care and prophylaxis guidelines; however, all patients received quinolone prophylaxis.
This was an open-label, randomized study with a noninferiority design.
This study illustrated that the use of a single fixed dose of PEG was not inferior to the use of daily filgrastim. There were no significant differences in measured outcomes between the two groups and no differences in treatment side effects.
PEG can be use alternately to filgrastim as it is only given as one single fixed dose of 6 mg as compared to daily doses of filgrastim. Infection-related outcomes studied were not different between these two treatment approaches.
Use of a single dose of PEG rather than daily injections of filgrastim may be a useful alternative for these types of patients in order to avoid multiple injections. Findings of this study were limited by sample size, study design issues, and the fact that other prophylactic treatment was not consistent throughout the sample. Further research in this area will be helpful to confirm differences in the relative equivalency of these two approaches.