Efficacy and Safety of PEG-rhG-CSF in the Prevention of Neutropenia After Chemo in Pts With Gynecological Malignancies

Inclusion Criteria:

• Ages 18-70
• Weight ≥45 kg
• ≤2 lines chemotherapy or postoperative adjuvant chemotherapy patients with cervical cancer, ovarian cancer and endometrial cancer
• Receive paclitaxel combined with platinum three weeks per cycle of chemotherapy
• With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
• Expected survival time of > 3 months

• Main organ functions meet the following criteria:

  1. Hb≥75g/L; WBC≥3.0×109/L; ANC≥1.5×109/L; PLT≥80×109/L;
  2. APTT-ULN≤10s; PT-ULN≤3s; TT-ULN≤3s;
  3. ALT≤2.5×ULN; AST≤2.5×ULN; TBIL≤2.5×ULN;
  4. BUN≤1.5×ULN; Cr≤1.5×ULN; UA≤1.5×ULN；Creatinine clearance≥40mL/min;
  5. without obvious cardiac dysfunction
• Provided consent for participation

Exclusion Criteria:

• With uncontrollable infections or receive systemic antibiotics within 72 hours prior to chemotherapy
• Pregnant or lactating women
• Received bone marrow or hematopoietic stem cell transplantation within the past 3 months
• Concurrent chemoradiotherapy
• Presence of hematological disorders: systemic lupus erythematosus, sjogren's syndrome, rheumatic autoimmune disease, mixed and hoof tissue disease, autoimmune hemolytic anemia, leukopenia , chronic granulocyte leukemia, bone marrow dysplasia syndrome, aplastic anemia, congenital and idiopathic neutropenia, myelodysplastic syndrome, cyclic neutropenia, primary and secondary thrombocytopenic purpura, etc
• Presence of risk of thrombus or high risk of clotting
• Presence of psychosis, neurological disease or brain metastases from tumors
• Presence of uncontrollable complicated disease including symptomatic congestive heart failure, uncontrollable hypertension, unstable angina pectoris, active peptic ulcer, or hemorrhagic disease
• Presence of uncontrollable infectious diseases, active viral hepatitis, tuberculosis, HIV
• Allergic to recombinant human granulocyte stimulating factor or other biological products of E. coli origin
• Received clinical trials within 1 month prior to enrollment