Introduction
tumor, neutropenia, febrile neutropenia, breast cancer, infections, renal or liver dysfunction
TUMOR, NEUTROPENIA, FEBRILE NEUTROPENIA, BREAST CANCER, HIV INFECTION, DISEASE, INFECTIONS, COMPLICATIONS
Chemotherapy‐induced neutropenia can cause complications such as febrile neutropenia (FN) or other infections, which can also be life-threatening. Patients who develop FN often require prolonged hospitalizations and treatment with broad-spectrum antibiotics. The development of FN increases treatment costs and can prompt dose reductions or treatment delays, which may compromise clinical outcomes.Guidelines recommend that risk for FN should be assessed for patients based on disease settings and chemotherapy regimens prior to treatment. Patients with high-risk for FN (> 20%) should receive prophylactic granulocyte colony-stimulating factor (G-CSF) products. Patients with intermediate-risk of FN (10–20%) should further assess the patient-specific risk factors including older age (> 65 years), prior exposure to chemotherapy or radiation therapy, persistent neutropenia, bone marrow involvement by the tumor, poor performance status, recent surgery and/or open wounds, renal or liver dysfunction, and HIV infection. If one or more of the patient-specific risk factors are met, the patient should be treated as high-risk for FN to administer G-CSFs prophylactically [Several G-CSF drugs have been marketed to manage neutropenia for subcutaneous administration including filgrastim [Efbemalenograstim alfa (Ryzneuta™, F-627), is a novel Fc fusion protein, with the construct of G-CSF fused to an immunoglobulin (Ig) G2-Fc fragment via a 16 amino acid peptide linker, with decreased clearance and prolonged half-life of about 46 h. The preliminary potency of management of neutropenia has been demonstrated in the preclinical and phase II clinical studies. In vivo studies have showed that efbemalenograstim alfa may generate faster neutrophil recovery and reduce the severity of cyclophosphamide-induced neutropenia in monkeys when compared to filgrastim or pegfilgrastim [Here we report the results of the first pivotal phase III study of efbemalenograstim alfa (NCT02872103). This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a single fixed dose of efbemalenograstim alfa in reducing the risk for FN in breast cancer patients receiving myelosuppressive chemotherapy.