Efficacy and safety of extimia® (empegfilgrastim): results of a double-blind controlled phase iii study in patients with diagnosis «breast cancer» receiving myelosuppressive chemotherapy

Abstract

Objectives: to compare safety and efficacy of a single dose of empegfilgrastim and daily dosing of filgrastim for prevention of neutropenia in patients receiving AT (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2). Methods. 135 patients with breast cancer were randomly assigned at a ratio of 1:1:1 to receive either single s.c. injection of empegfilgrastim at doses of 6 mg or 7.5 mg, or daily s.c. injections of filgrastim at a dose of 5 mcg/kg (until ANC≥10×109/L), 24 h after chemotherapy. The primary efficacy endpoint was the duration of grade 4 neutropenia (ANC

Keywords

• breast cancer
• chemotherapy
• neutropenia
• filgrastim
• empegfilgrastim
• extimia®