Efficacy, Safety and Cost-effectiveness of PEG-rhG-CSF for Primary Prophylaxis Versus Secondary Prophylaxis of Chemotherapy Induced Neutropenia in Patients Receiving Chemotherapy With High-risk FN: a Real World Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Incidence of FN rate
研究概览
简要总结
This trial is a multicenter, non-interventional, registered real-world clinical study. Based on available evidence and recommendations of guidelines, tumor patients with high risk of FN and eligible for all enrollment criteria were recruited into primary prophylaxis of PEG-rhG-CSF or secondary prophylaxis of PEG-rhG-CSF according to the real-world clinical pathway without randomization. All patients need to receive at least 2 cycles of PEG-rhG-CSF prophylaxis. Researchers will record the incidence of FN, RDI, FN-related hospitalization, antibiotic use, direct medical care and indirect medical care cost under the real clinical conditions, and assess the efficacy, safety and cost-effectiveness of PEG-rhG-CSF primary prophylaxis versus secondary prophylaxis through sub-group analysis and exploratory research.
详细描述
Patients with cancer planning for chemotherapy assessed with high risk of febrile neutropenia (FN) according to NCCN and ASCO guidelines are recruited, receiving primary or secondary prophylaxis of PEG-rhG-CSF according to real-world clinical pathway in local cancer center for at least 4 cycles of chemotherapy. The primary outcome is the incidence of FN rate and proportion of patients completing chemotherapy on schedule, the second outcomes are the incidence of 3-4 grade of neutropenia, FN-related hospitalization and antibiotic use, incidence of reduction and delay of chemotherapy dose, safety and pharmacoeconomics of PEG-rhG-CSF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Before the start of the study, all patients have been fully understood the research and the must sign the informed consent
- •Aged 13 years or older
- •accept at least 4 cycles of chemotherapy
- •ECOG PS 0-2
- •expected survival time ≥ 3 months
- •with -high risk of FN according to researchers
排除标准
- •accepted stem cell or bone marrow transplant
- •undergoing any other clinical trial
- •uncontrolled infection, temperature≥38℃
- •per-week scheme chemotherapy
- •severe and uncontrolled diabetes
- •People with allergic diseases or allergies, or who are allergic to this or other genetically engineered Escherichia coli-derived biological products
- •Suspected or confirmed drug use, drug abuse, alcoholics
- •Severe mental or neurological disorders affecting informed consent and/or adverse effect presentation or observation
- •Severe heart, kidney, liver and other important organs chronic diseases
- •Pregnancy or lactation in women or women with gestation detection positive before the first time using drug
- •Patients who have fertility but are unwilling to receive contraception or partners are not willing to accept contraceptives
- •The investigator believes that the patient's condition is not suitable for this clinical study.
研究组 & 干预措施
PEG-rhG-CSF primary prophylaxis
Patients receiving chemotherapy who have a overall FN risk >=20% receive PEG-rhG-CSF for primary prophylaxis
干预措施: PEG-rhG-CSF (Drug)
PEG-rhG-CSF secondary prophylaxis
Patients receiving chemotherapy who had FN or dose-limited neutropenia receive PEG-rhG-CSF for secondary prophylaxis
干预措施: PEG-rhG-CSF (Drug)
结局指标
主要结局
Incidence of FN rate
时间窗: through study completion, an average of 2 year
FN was defined as fever \>=38.3°C orally (\>=38.0°C for a duration over 2h) or axillary temperature \>=38.1°C (\>=37.8°C for a duration over 2h) and ANC \< 0.5 X 10\*9/L
Proportion of patients completing chemotherapy on schedule
时间窗: through study completion, an average of 2 year
proportion of patients completing chemotherapy on schedule
次要结局
- Incidence of 3-4 grade of neutropenia(through study completion, an average of 2 year)
- FN-related hospitalization and antibiotic use(through study completion, an average of 2 year)
研究者
Yue-Yin Pan
Chief Physician
Anhui Provincial Hospital