Real World Study of PEG-rhG-CSF in Prevention of Chemotherapy-induced Neutropenia

Study Overview
=================
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.

Official Title
-----------------
Real World Study of PEGylated Recombinant Human Granulocyte Stimulating Factor(PEG-rhG-CSF) in Prevention of Chemotherapy-induced Neutropenia

Conditions
-----------------
Chemotherapy-induced Neutropenia, Myelosuppression

Intervention / Treatment
-----------------
* Drug: PEG-rhG-CSF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PEG-rhG-CSF group<br>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. | Drug: PEG-rhG-CSF<br>* PEG-rhG-CSF was administered 24 hours after the end of chemotherapy for each chemotherapy cycle.<br>* Other names: Jinyouli;|
| rhG-CSF group<br>This group comprised 500 patients who received rhG-CSF 5 μg/kg/day by subcutaneous injection 24 hours after the end of chemotherapy or the appearance of CIN until the ANC was ≥2.0x109/L for each chemotherapy cycle. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-Effectiveness | 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) | through the chemotherapy cycles of PEG-rhG-CSF or rhG-CSF treatment,an average of 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of febrile neutropenia | 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 | From date of randomization until the date of the study completion,an average of 3 month | 
| The incidence of grade IV neutropenia | Grade IV neutropenia is defined as the absolute neutrophil count(ANC)<0.5×10^9/L | From date of randomization until the date of the study completion,an average of 3 month | 
| The duration of grade IV neutropenia in every chemotherapy cycle | 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 | From date of randomization until the date of the study completion,an average of 3 month | 
| The incidence of the chemotherapy delay | Chemotherapy delay is defined as the delay in starting the next planned chemotherapy for more than 3 days. | 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 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 incidence of the dose reduction | The incidence of the reduction of planned dose of chemotherapy | From date of randomization until the date of the study completion,an average of 3 month | 
| Relative chemotherapy dose intensity in every chemotherapy cycle | 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 | From date of randomization until the date of the study completion,an average of 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PEG-rhG-CSF, Pegfilgrastim