Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer

Granulocyte Colony Stimulating Factor for for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer

Long-acting Versus Short-acting Granulocyte Colony Stimulating Factor for the Prevention of Febrile Neutropenia in Epithelial Ovarian Cancer Patients: A Multicenter Phase 3 Randomized Controlled Study

Beijing Hospital, China-Japan Friendship Hospital, Navy General Hospital, Beijing, Seventh Medical Center of PLA Army General Hospital

This study aims to analyze the effects of long-acting versus short-acting granulocyte colony stimulating factor (G-CSF) on the prevention febrile neutropenia (FN) in epithelial ovarian cancer patients. Patients receive platinum-based chemotherapy of 3 to 4 weeks. Patients are randomized into study group and control group. In study group, patients accept long-acting G-CSF 48 hours from the chemotherapy. While the control group accept regular or prophylactic treatment of short-acting G-CSF according to National Comprehensive Cancer Network guidelines. The primary end is the incidence of FN in every course of chemotherapy. The secondary ends include: the incidences of myelosuppression, doses of G-CSF and its expenses, visits to outpatient and emergency clinics, adverse events related to G-CSF, quality of life, and survival outcomes (progression-free survival and overall survival).

Chemotherapy-induced Neutropenia, Febrile Neutropenia, Drug-Induced, Epithelial Ovarian Cancer, Colony Stimulating Factors Adverse Reaction, Granulocyte Colony Stimulating Factor, Cost-effectiveness Analysis, Quality of Life, Progression-free Survival, Overall Survival

Patients in study group accept prophylactic treatment of long-acting granulocyte colony stimulating factor

Patients in control group accept regular or prophylactic treatment of short-acting granulocyte colony stimulating factor according to current guidelines

Patients will accept long-acting granulocyte colony stimulating factor at 48 hour after the chemotherapy

Patients will accept short-acting granulocyte colony stimulating factor followed regular or prophylactic patterns

Doses of long-acting and short-acting granulocyte colony stimulating factor used during each course of chemotherapy

Incidence of adverse events related to granulocyte colony stimulating factor according to Common Terminology Criteria for Adverse Events (CTCAE) v4.03

Inclusion Criteria: With definitive pathological results of epithelial ovarian cancer With an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 Aged 18 or older Receiving 3-4 weeks per cycle of platinum-based chemotherapy with or without debulking surgery Regularly followed up in the study centers Provided consent for participation. Exclusion Criteria: Failure to meet all the inclusion criteria Non-compliance with the study protocols With a history of chemotherapy or pelvic radiotherapy for malignancies Presence of immunosuppressive diseases such as organ transplantation or acquired immune deficiency syndrome Treated with weekly chemotherapy regimens Presence of hematological disorders