The purpose of this study is to try to find a better injection regimen (including time and dose) of PEG-rhG-CSF, which is supposed to better prevent bone marrow suppression and/or FN in breast cancer patients who receive chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 7 after chemotherapy. If FN occurs in the experimental group and the control group, reduce the dose of chemotherapy in the next course of treatment, timely change the chemotherapy regimen, and closely monitor to ensure patient safety. Record the results of routine blood follow-up and temperature curves of patients at different time periods. If WBC \>= 15 x 10\^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.
patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 3 after chemotherapy. If FN occurs in the experimental group and the control group, reduce the dose of chemotherapy in the next course of treatment, timely change the chemotherapy regimen, and closely monitor to ensure patient safety. Record the results of routine blood follow-up and temperature curves of patients at different time periods. If WBC \>= 15 x 10\^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
the rates of grade III/IV neutropenia during the first and second chemotherapy cycle
grade III or IV neutropenia (ANC \< 1x 10\^9/L or 0.5 x 10\^9/L)
Time frame: up to 9 weeks
the rates of FN during the first and second chemotherapy cycle
the occurrent rate of FN(FN:Body temperature ≥38.3°C or ≥38.0°C continued for 1 h, with neutrophil count \<500/mcl or neutrophil count \<1000/mcl, but expected to drop to \<500/ mcl after 48 hours .)
Time frame: up to 9 weeks
Proportion of patients with down-regulated dosage of PEG-rhG-CSF from 6mg to 3mg
If WBC \>= 10 x 10\^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle
Time frame: up to 9 weeks
Adverse reactions after injection of PEG-rhG-CSF during first and second chemotherapy cycle
Adverse reactions
Time frame: up to 9 weeks
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