Use of lipegfilgrastim in clinical practice for the prophylaxis of chemotherapy-induced neutropenia: interim results of pan-European non-interventional study

Background

Lipegfilgrastim (Lonquex®) is a long-acting glycopegylated G-CSF that was proven to be non-inferior with regards to duration of severe neutropenia compared with pegfilgrastim in breast cancer patients. The objective of this study was to evaluate effectiveness of lipegfilgrastim in everyday clinical practice in adult patients with different tumor types who are treated with cytotoxic chemotherapy.

Methods

This is a prospective non-interventional study. Patients with different tumor types treated with cytotoxic chemotherapy (CT), who received lipegfilgrastim in primary (PP) or secondary prophylaxis (SP) are included in this study. CT dose modifications and neutropenic and neutropenia-related events are recorded and analyzed. Evaluation of effectiveness following the first lipegfilgrastim-supported treatment cycle is presented here.

Results

At the time of analysis (March 2016), a total of 621 patients have been included. Mean age of included patients was 59.2 ± 13.2 and 67.6% were female. Most patients had breast cancer (39.8%) and lymphoma (24.0%). Exposure to lipegfilgrastim has been documented for 507 patients. Data on CT dose modifications and neutropenic events following the first lipegfilgrastim-supported cycle were available for 409 and 448 patients, respectively. CT dose omissions were observed in 0.3% patients when lipegfilgrastim was applied in PP. No omissions were observed when it was applied in SP. CT dose delays were observed in 10.3% (PP) and 15.0% (SP) of patients and CT dose reductions in 5.2% (PP) and 7.5% (SP) of patients. Febrile neutropenia was recorded in 1.4% (PP) and 1.2% (SP) of patients, whereas severe neutropenia was recorded in 1.9% (PP) and 4.7% (SP) of patients. A total of 89 (17.6%) patients exposed to lipegfilgrastim reported at least one adverse drug reaction (ADR). The most common ADRs were myalgia, bone pain, and headache. Serious ADRs were reported by 25 (4.9 %) patients.

Conclusions

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

N/A

Legal entity responsible for the study

Teva Pharmaceuticals

Funding

Teva Pharmaceuticals

Disclosure

E. Petru: Honoraria from Teva, Roche, Amgen, Sandoz. All other authors have declared no conflicts of interest.