Secondary prophylaxis with granulocyte colony-stimulating factor (GCSF) showed a statistically significant improvement in the achievement of adequate relative dose intensity (RDI) in non-intensive chemotherapy regimens, a new study published online ahead of print in the journal Annals of Oncology has shown.1
Because data have suggested that achievement of planned dose intensity may impact survival, researchers sought to compare GCSF with standard management following a first neutropenic event in achieving planned dose intensity.
For the study, researchers enrolled 407 adult patients receiving adjuvant or neoadjuvant chemotherapy for early breast cancer. Most regimens were anthracycline-based, which may have included a sequential taxane and/or were in clinical trials.
Following a first neutropenic event, defined as hospitalization due to neutropenic fever, an ANC < 1.5 x 109/L requiring treatment delay, or dose reduction of ≥15% of planned dose, participants were randomly assigned to receive filgrastim for 7 days or pegfilgrastim as secondary prophylaxis or standard care.
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Results showed that 75% of patients in the GCSF arm achieved 85% planned RDI compared with 50% of patients in the control arm (P<0.0001). Researchers also found that secondary prophylaxis was associated with a reduction in post-randomization neutropenic events, which occurred in 18.2% of the GCSF arm and 65.7% of controls.
“This may have important clinical implications for outcome,” the authors concluded.
- Leonard RCF, Mansi JL, Keerie C, et al. A randomised trial of secondary prophylaxis using granulocyte colony stimulating factor (‘SPROG’ Trial) for maintaining dose-intensity of standard adjuvant chemotherapy for breast cancer – by the Anglo-Celtic Cooperative Group and NCRN [published online ahead of print September 28, 2015]. Ann Oncol. doi: 10.1093/annonc/mdv389.