Biosimilar Filgrastim (Nivestim®) in the Treatment and Prevention of Chemotherapy-Induced Neutropenia: Results of the NEXT Observational Study

Background: This study was a prospective, non-interventional, multicentre study to evaluate the safety and efficacy of Nivestim ® (biosimilar of filgrastim) in chemotherapy-induced febrile neutropenia in real-life setting.Methods: Adult patients undergoing chemotherapy for solid tumor or hematological malignancy treated with prophylactic or curative Nivestim were included.Patients were followed for 1-6 chemotherapy cycles following study inclusion.The primary objective was the assessment of the safety of Nivestim.Results: 2102 patients (mean age, 63.5 years) were analyzed (1579 with solid tumor and 532 with hematological malignancy); 2065 (98.2%) received Nivestim as prophylaxis administered with a median time of two days after onset of chemotherapy.Chemotherapy regimens were associated with a high risk of febrile neutropenia for 19.4%, intermediate risk for 55.6% and low risk for 25.0%.Adverse events were reported for 20.4% (414/2034) of patients: the most common adverse event was muscle and/or bone pain (12.1%).In prophylactic patients, febrile neutropenia was reported in 98 patients (4.9%; 95% CI, 4.06-5.98),occurring at a median time of 14.0 days after the first chemotherapy cycle.Infection occurred in 61 patients (3.1%; 95% CI, 2.39-3.93)after a median time of 23.5 days following onset of chemotherapy.A total of 98 prophylactic patients (4.9%) who presented with febrile neutropenia and/or infection were hospitalized.Conclusions: The safety and efficacy of Nivestim in cancer patients in real-world clinical practice were consistent with the registration studies and in line with reference filgrastim in both the prophylactic and curative settings.