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.
Study Type
OBSERVATIONAL
Enrollment
1,500
PEG-rhG-CSF was administered 24 hours after the end of chemotherapy for each chemotherapy cycle.
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)
Time frame: through the chemotherapy cycles of PEG-rhG-CSF or rhG-CSF treatment,an average of 3 month
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From date of randomization until the date of the study completion,an average of 3 month
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