Neutropenia
Conditions
Brief summary
Pegfilgrastim is a long-acting recombinant human granulocyte-colony stimulating factor as support for chemotherapy, which can be used conveniently. According to the package inserts in America, Europe, and China, the recommended dose for pegfilgrastim is 6mg per cycle, while it is recommended at a dose of 3.6mg in Japan. It is still unclear whether pegfilgrastim 3mg can produce similar efficacy with pegfilgrastim 6mg. In this trial, the investigators prospectively compared the efficacy and safety of pegfilgrastim 3mg with 6mg in patients with breast cancer receiving AC regimen, a commonly used regimen in adjuvant chemotherapy for breast cancer.
Detailed description
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.
Interventions
DRUGPegfilgrastim
Pegfilgrastim 3mg per chemotherapy cycle
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| timely recovery of ANC | 1 month | The proportion of patients with absolute neutrophil count (ANC) ≥2.0×10\^9/L before the second chemotherapy cycle. Blood routine test was used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| febrile neutropenia in cycle1 | 1 month | the incidence of neutropenia with fever in cycle 1. Blood test was used and body temperature was taken. |
| grade 3/4 neutropenia in cycle 1 | 1 month | the incidence of absolute neutrophil count (ANC) \<1.0×10\^9/L before the second chemotherapy cycle. Blood routine test was used. |
| grade 4 neutropenia in cycle 1 | 1 month | the incidence of absolute neutrophil count (ANC) \<0.5×10\^9/L before the second chemotherapy cycle. Blood routine test was used. |
| hospitalization due to neutropenia | 1 month | the incidence of unplanned hospitalization due to neutropenia |
Other
| Measure | Time frame | Description |
|---|---|---|
| adverse events | 1 month | the profile and incidence of adverse events. Symptoms and signs were observed; blood routine test and blood biochemistry tests were performed. |
Countries
China
Outcome results
None listed