A Randomized Controlled Study Comparing Different Doses of Pegfilgrastim as Support for Adjuvant Chemotherapy for Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- timely recovery of ANC
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
pegfilgrastim 3mg
Pegfilgrastim 3mg per chemotherapy cycle
干预措施: Pegfilgrastim (Drug)
pegfilgrastim 6mg
Pegfilgrastim 6mg per chemotherapy cycle
干预措施: Pegfilgrastim (Drug)
结局指标
主要结局
timely recovery of ANC
时间窗: 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.
次要结局
- grade 4 neutropenia in cycle 1(1 month)
- febrile neutropenia in cycle1(1 month)
- hospitalization due to neutropenia(1 month)
- grade 3/4 neutropenia in cycle 1(1 month)