A Phase III Randomized Equivalence Study of Biosimilar Filgrastim versus Amgen Filgrastim in Patients Receiving Myelosuppressive Chemotherapy for Breast Cancer

摘要: Background: Filgrastim was developed to treat chemotherapy-induced neutropenia. This phase III study designed demonstrate bioequivalence of Amgen filgrastim and a biosimilar by Hospira (Study GCF071; sponsored Hospira). Patients Methods: Breast cancer patients suitable for treatment with doxorubicin docetaxel in the neoadjuvant/adjuvant or first-line metastatic setting were enrolled at 37 European centers. randomized (2:1) receive filgrastim, after end chemotherapy. (5 µg/kg/day) administered under double-blind conditions. Primary endpoint duration severe neutropenia (DSN) cycle 1. Results: 184 95 filgrastim. Mean DSN 1 similar (1.6 days; n = 165) (1.3 85), meeting predefined criteria bioequivalence. Secondary endpoints supporting included mean time absolute neutrophil count recovery incidence febrile The most common treatment-related adverse event grade 1–2 bone pain. Conclusions: are bioequivalent efficacy safety profiles. may be useful prophylaxis complications related caused