Chemotherapy-Induced Neutropenia Febrile Neutropenia
Conditions
Interventions
Experimental group:Single injection of PEG-rhG-CSF
Control group:Injection of rhG-CSF once a day
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Female patients with early-stage breast cancer, aged 18-70 years old, with an expected survival period of more than 12 months; 2.All enrolled patients received first-line chemotherapy with a 4-cycle, 21-day regimen; the chemotherapy dosage and regimen were consistent with the EC- or TC-based 21-day chemotherapy protocols recommended by relevant domestic and international guidelines, including the CSCO Guidelines for Diagnosis and Treatment of Breast Cancer, CACA Guidelines and Standards for Diagnosis and Treatment of Breast Cancer, and NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. 3.Grade 3/4 chemotherapy-induced neutropenia (CIN), possibly complicated with febrile neutropenia (FN), occurred on days 7–11 of the first chemotherapy cycle. 4.The hematopoietic function of the bone marrow was normal before chemotherapy (WBC>3.5×10^9/L, ANC>1.8×10^9/L, RBC>3.5×10^9/L, PLT>100×10^9/L, Hb>9g/dl); 5.Without severe cardiac function and liver or kidney function disorders (two-dimensional echocardiography detected LVEF>55%, ALT and AST=70 points, ECOG<=2 points; 7.Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Prophylactic use of G-CSF drugs before chemotherapy; 2. Body weight 25% of total bone marrow); 5. History of severe cardiovascular and cerebrovascular disease (e.g., unstable angina, chronic heart failure, uncontrolled hypertension, myocardial infarction, or cerebrovascular accident) within 5.6 months; 6. A history of cancer within 6.5 years (except curable basal cell carcinoma and cervical cancer); 7. Patients with uncontrolled lung disease, severe infection, active gastrointestinal ulcer requiring treatment, coagulopathy, severe uncontrolled diabetes mellitus, connective tissue disease or bone marrow suppression, who could not tolerate chemotherapy-related treatment; 8. Peripheral neurotoxicity after chemotherapy was graded >=2 according to CTCAE 5.0. 9. Abnormal coagulation function; 10. Taking glucocorticoids; 11. Known hypersensitivity to G-CSF, anthracyclines, cyclophosphamide, taxanes, trastuzumab, or pertuzumab; twelve Pregnant and lactating women, or women of childbearing age who refuse contraception during and up to 8 weeks after treatment; 13. Mental illness, cognitive impairment, inability to understand the test plan and its side effects, inability to complete the test plan and follow-up workers (systematic review required before trial enrollment); fourteen Having no personal freedom and independent capacity for civil conduct; 15. The investigators considered that the patients had a medical condition or symptoms that were not appropriate for participation in the study, that the study drug might be harmful to the patient's health, or that it might interfere with the judgment of adverse events.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The recovery time of neutropenia after administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence and severity of neutropenia in the second chemotherapy cycle;The quality of life of patients after drug administration was evaluated using the FACT-B scale;Treatment costs;Incidence and severity of adverse reactions after injection of PEG-rhG-CSF/rhG-CSF, including bone pain, arthralgia, muscle pain, etc.; | — |
Countries
China
Contacts
Public ContactWang Jue; Zha Xiaoming
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed