Lipegfilgrastim (Lonquex®) is a long-acting glycopegylated G-CSF, which was proven to be non-inferior to pegfilgrastim in breast cancer patients. The objectives of this study were to evaluate effectiveness and safety of lipegfilgrastim in everyday clinical practice in adult patients with different tumor types, who are treated with cytotoxic chemotherapy.
Patients with different tumor types treated with cytotoxic chemotherapy, who received lipegfilgrastim in primary (PP) or secondary prophylaxis (SP) were included in this prospective non-interventional study. Evaluation of chemotherapy (CT) and biological therapy (BT) dose modifications as well as neutropenic events following the first lipegfilgrastim supported treatment cycle is presented here.
A total of 1,313 patients were included in the safety set. Mean age of included patients was 58.4±13.3 and 70.2% were female. The majority of patients had breast cancer (46.7%) and lymphoma (26.4%). A total of 895 (68.2%) patients received lipegfilgrastim in PP starting from CT cycle 1 and 192 (14.6%) patients received it in SP for the first time. They were included in the effectiveness analysis. In the first cycle febrile neutropenia (FN) was reported in 1.8% of patients receiving lipegfilgrastim in PP and in 1.0% of patients receiving lipegfilgrastim in SP. Grade 3/4 neutropenia was reported in 7.5% (PP) and 6.7% (SP) of patients. CT and/or BT was delayed, reduced or omitted in 20.1% of patients receiving lipegfilgrastim in PP and in 28.1% of patients receiving it in SP. This was associated with FN and grade 3/4 neutropenia in only 1.0% and 2.2% of these patients in case of PP and 2.1% and 5.5% in case of SP. A total of 284 (21.6%) patients reported at least one adverse drug reaction (ADR) throughout the study. The most common ADRs were bone pain (5.86%), myalgia (3.43%) and back pain (1.83%). Serious ADRs were reported by 42 (3.2 %) of patients.
Lipegfilgrastim is effective and well tolerated in the real world setting administered either in PP or SP. Both effectiveness and safety data obtained in this study are in line with published data for lipegfilgrastim.
Clinical trial identification
Legal entity responsible for the study
G. Steger, P. Pichler, M. Airoldi, P. Mazza, C. Fontaine, J. Timmer Bonte, J.A. Walewski, J. Katolicka, M. Mikulova: Investigator in Teva sponsored study. M. Gasparic: Employee: Teva Pharmaceuticals Europe B.V.