Comparative study of 06 mg versus 03 mg of peg gcsf in patient receiving adjuvant and/or neoadjuvant dose-dense adriamycin and cyclophosphamide (AC) or epirubicin and cyclophosphamide (EC) in breast cancer treatment protocols
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 382
- 试验地点
- 1
- 主要终点
- Incidence of chemotherapy induced grade IV neutropenia in both arms
研究概览
简要总结
The use of pegfilgrastim, a long-acting granulocyte-colony stimulating factor (G-CSF), has improved the management of chemotherapy-induced neutropenia. Neutropenia is one of the most common adverse effects of chemotherapy and can result in serious infections, hospitalisations, and dose reductions, which can compromise the effectiveness of chemotherapy. Pegylated filgrastim is a modified form of G-CSF that has a longer half-life and can reduce the frequency of dosing compared to non-pegylated formulations. Several studies have compared the efficacy and safety of low-dose 3 mg pegfilgrastim (Peg-3) with the standard 6 mg dose (Peg-6) in patients receiving chemotherapy. This was based on the comparable pharmacokinetics of 60mcg/kg and 100mcg/kg doses. Overall, these studies have shown that Peg-3 is non-inferior to Peg-6 in terms of its ability to reduce the duration and severity of chemotherapy-induced neutropenia, the incidence of febrile neutropenia, and the need for dose reductions or delays. One randomised, double-blind, phase III study compared the efficacy and safety of Peg-3 with Peg-6 in patients with breast cancer receiving docetaxel and cyclophosphamide chemotherapy. The study found no significant difference between the two groups in terms of the incidence of febrile neutropenia, the duration of severe neutropenia, or the need for dose reduction or delays. Other studies have reported similar findings, showing no significant differences in efficacy between Peg-3 and Peg-6 in various chemotherapy regimens, including those for colorectal cancer, lung cancer, and urothelial carcinoma. In terms of safety, both Peg-3 and Peg-6 have been well-tolerated, with similar rates of adverse events reported in clinical trials. In conclusion, the use of low-dose 3 mg pegfilgrastim is a viable and effective option for the prevention of chemotherapy-induced neutropenia. The available literature suggests that Peg-3 is non-inferior to Peg-6 in terms of its ability to reduce the duration and severity of neutropenia, the incidence of febrile neutropenia, and the need for dose reductions or delays. As such, Peg-3 may offer some advantages over Peg-6, including reduced cost and potentially lower risk of adverse events. Further studies are needed to confirm these findings and determine the optimal dosing strategy for pegfilgrastim in different patient populations. The use of low-dose Peg GCSF has not been well studied thoroughly in India.. In this study, we are comparing 3 mg Peg GCSF vs 6 mg in carcinoma breast patients receiving AC/EC in neoadjuvant/adjuvant setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female aged 18–65 years, pathohistological and clinical diagnosis of stage II or III primary invasive breast carcinoma, Eastern Cooperative Oncology Group performance status ≤2, Baseline normal CBC biochemistry and left ventricular ejection fraction more than 50 %.
排除标准
- •female aged less than 18 years and more than 65 years and patients who had a history of radiation therapy before chemotherapy, a history of stem cell or bone marrow transplantation, or comorbid malignancies other than breast cancer.
结局指标
主要结局
Incidence of chemotherapy induced grade IV neutropenia in both arms
时间窗: Complete blood counts will be done at baseline and after 01 week in first cycle. Complete blood counts will be done on day of each chemotherapy cycle at baseline from cycle 02 onwards that is every 02 weekly. total duration will be 02 months for each patient.
次要结局
- Incidence of Febrile neutropenia in both arms(Incidence of Febrile neutropenia in both arms during dose dense chemotherapy)
- Need of additional dose of GCSF(Need of additional dose of GCSF during dose dense chemotherapy)
- Delay in the subsequent cycle of chemotherapy that is defined by more than 3 days delay in next cycle(Delay in the subsequent cycle of chemotherapy that is defined by more than 3 days delay in next cycle during dose dense chemotherapy)
- Comparison of adverse events profiles of both arms(Comparison of adverse events profiles of both arms during dose dense chemotherapy)
研究者
Dharmendra Singh
Army hospital research and referral