Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy).
Patients were administered pegylated rhG-CSF 150 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy).
Patients were administered rhG-CSF 5 ug/kg daily during chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy) until (1)continuous injection for 14 days (2)two successive ANC counts exceed 5.0×109/L(3)ANC counts exceed 15×109/L at anytime.
307 Hospital Affiliated to Academy Military Medical Science
Beijing, China
Incidence and the duration of grade 3/4 neutropenia in cycle 2 and the time frame of ANC recovery to 2.0×109/L
Proportion and the duration of subjects developing ANC lower than 1.0×109/L
Time frame: 6 weeks
Incidence of the febrile neutropenia in cycle 1 and cycle 2
Rate of ANC\<0.5×109/L and auxiliary temperature\>38.5℃
Time frame: 6 weeks
ANC alteration in cycle 1 and cycle 2
Weekly laboratory ANC value alteration
Time frame: 6 weeks
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