Prophylactic low-dose G-CSF in patients with breast cancer experiencing grade 4 neutropenia during their previous (neo-) adjuvant (F)EC-chemotherapy cycle: Results of a pilot study

Abstract

Grade 4 neutropenia is associated with an increased risk of infections. Low-dose lenograstim at 13 million units per day is commonly used in children undergoing cytotoxic chemotherapy. The present pilot study investigated the effect of prophylactic low-dose lenograstim (13 million units of lenograstim, GranozyteR, Sanofi-Aventis Pharma) in 20 patients with breast cancer who received (neo) adjuvant (F)EC (5-fluorouracil-epirubicin-cyclophosphamide) chemotherapy on days 3 to 10 of the chemotherapy cycle. All of them had experienced nadirs of absolute neutrophil counts (ANC) < 500/mm³ and white blood cells (WBC) < 1,000/mm³ during the preceding identical (F)EC chemotherapy cycle, respecttively. The primary endpoint of this study was the number of cycles with recurrent grade 4 neutropenia.

White blood cells, neutrophil granulocytes, hemoglobin, and platelets were recorded on days 1, 8, 15, and 22 of each cycle. Neutrophil counts and white blood cells remained stable over time (p > .05). Grade 4 neutropenia occurred in 4% of lenograstim-supported cycles only. Antibiotics were necessary in 4% of cycles only. Grade 1 or 2 bone pain was recorded in 14%. In conclusion, an economic regimen of  prophylactic low-dose lenograstim, administered at 13 million units per day over 8 days, has been demonstrated to maintain neutrophil levels above the critical level and thus to prevent grade 4 neutropenia. Trials comparing this regimen with pegylated G-CSF seem warranted.