Reduced Dose of Pegfilgrastim as Support for Chemotherapy for Breast Cancer

All patients received AC regimen (epirubicin or pirarubincin in combination with cyclophosphamide) intravenously. Epirubicin 90mg/m^2 (or pirarubicin 60mg/m^2) and cyclophosphamide 600mg/m^2 were administered on day 1 of the chemotherapy cycle. AC regimen was administered bi-weekly or 3-weekly.

Eligible patients were randomly assigned to 3mg arm (the study arm) and 6mg arm (the control arm) in a 1:1 ratio, stratified according to body weight (≤60kg or >60kg). Patients in the study arm and the control arm received a subcutaneous injection of 3mg PEG-rhG-CSF and 6mg, respectively, forty-eight hours after completing chemotherapy infusion.

Inclusion criteria

• female aged 18-69 years
• diagnosed pathologically as early breast cancer
• with indication for adjuvant chemotherapy and suitable for AC regimen (epirubicin and cyclophosphamide, or pirarubicin and cyclophosphamide, planned chemotherapy with taxanes after AC regimen were allowed)
• received no prior chemotherapy (chemotherapy naïve)
• have Karnofsky performance status ≥ 80,
• baseline hemoglobin ≥90g/L, white blood cell count ≥4.0X10^9/L,ANC≥2.0X10^9/L, platelet count ≥100X10^9
• adequate cardiac, hepatic and renal function

Exclusion criteria

• enrolled onto or had not yet completed other investigational drug trials
• allergic to any component of PEG-rhG-CSF injection, or other biological products derived from genetically engineering Escherichia coli;
• pregnant or lactating women;
• previous large volume radiotherapy, or prior bone marrow or stem-cell transplantation