Real World Study of PEG-rhG-CSF in Prevention of Chemotherapy-induced Neutropenia
- Conditions
- Chemotherapy-induced NeutropeniaMyelosuppression
- Interventions
- Registration Number
- NCT03846414
- Lead Sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Brief Summary
The aim of this study is to observe and evaluate the cost-effectiveness,efficacy and safety of PEG-rhG-CSF in preventing chemotherapy-induced neutropenia(CIN) of cancer patients in the real world.1000 patients with non-myeloid malignancy who is planned to receive PEG-rhG-CSF for CIN prevention and 500 patients with non-myeloid malignancy who is planned to receive rhG-CSF for CIN prevention or treatment were prospectively recruited.The primary outcome was cost-effectiveness and second outcome was febrile neutropenia,the incidence and duration of grade IV neutropenia,chemotherapy delay,incidence of reduced dose of chemotherapy and relative dose intensity of chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1500
- Patients' age≥18 years old, male or female
- Diagnosis of non-myeloid malignant solid tumors
- Patients are planned to perform chemotherapy and preventive use the PEG-rhG-CSF or preventive or therapeutic use of rhG-CSF after chemotherapy
- Patients' mental status are well, could understand the study and willing to participate the study, sign the informed consent form
- The investigator believes that patients can benefit from this study
- Patients who have been confirmed to be allergic to Jinyouli® or rhG-CSF or its excipients
- Pregnant or lactating women and women who plan to be pregnant during clinical observation
- Other patients that the doctor believe not suitable for inclusion
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PEG-rhG-CSF group PEG-rhG-CSF This group comprised 1000 patients who received a single subcutaneous injection of PEG-rhG-CSF 24 hours after the end of chemotherapy for each chemotherapy cycle. The dose of PEG-rhG-CSF is determined by the patients' body weight, patients with body weight ≥45 kg is given to PEG-rhG-CSF 6 mg each time, patients\<45 kg is given to PEG-rhG-CSF 3 mg each time.
- Primary Outcome Measures
Name Time Method Cost-Effectiveness through the chemotherapy cycles of PEG-rhG-CSF or rhG-CSF treatment,an average of 3 month Based on the results of the incidence of febrile neutropenia(FN) and the cost perFN in each group, the incremental cost-effectiveness ratio were estimated using the following formula: (CostA-CostB)/(OutcomeA-OutcomeB)
- Secondary Outcome Measures
Name Time Method The incidence of febrile neutropenia From date of randomization until the date of the study completion,an average of 3 month Febrile neutropenia (FN) is defined as oral temperature \>38.3 ℃(under arm temperature \>38.1 ℃) or continuous measurement of oral temperature \>38℃(under arm temperature \>37.8℃) in 2h, and absolute neutrophil count(ANC) \<0.5×10\^9/L, or expected to be \<0.5×10\^9/L
The incidence of grade IV neutropenia From date of randomization until the date of the study completion,an average of 3 month Grade IV neutropenia is defined as the absolute neutrophil count(ANC)\<0.5×10\^9/L
The duration of grade IV neutropenia in every chemotherapy cycle From date of randomization until the date of the study completion,an average of 3 month Defined as days when the ANC\<2.0×10\^9/L occurs to the time when the ANC≥2.0×10\^9/L, take the median
The incidence of the chemotherapy delay From date of randomization until the date of the study completion,an average of 3 month Chemotherapy delay is defined as the delay in starting the next planned chemotherapy for more than 3 days.
The duration of the chemotherapy delay in every chemotherapy cycle From date of randomization until the date of the study completion,an average of 3 month The duration of the chemotherapy delay in every chemotherapy cycle
The incidence of the dose reduction From date of randomization until the date of the study completion,an average of 3 month The incidence of the reduction of planned dose of chemotherapy
Relative chemotherapy dose intensity in every chemotherapy cycle From date of randomization until the date of the study completion,an average of 3 month Relative chemotherapy dose intensity is defined as the actual chemotherapy dose the patient used divided by the planned chemotherapy dose,or the actual chemotherapy time divided by the planned chemotherapy time