Anthracycline and/or taxane-based (A/T) chemotherapies (CTx) are among the most effective treatments in breast cancer (BC). Many modern A/T regimens used in BC including dose-dense (dd) protocols with treatment intervals of ≤ 2 weeks are associated with a significant incidence of febrile neutropenia (FN) thus forcing a primary prophylaxis using granulocyte colony-stimulating factors (G-CSF). Lipegfilgrastim (LIP) is a glyco-pegylated G-CSF approved to reduce the duration of neutropenia and the incidence of FN. In 2014, a large-scaled non-interventional study (NIS) was initiated to obtain detailed information on the value of LIP in order to prevent both FN and severe neutropenia. Here we report on results from an interim analysis of the NIS NADIR focusing on the subset of pts with BC.
The prospective multicenter NIS NADIR is conducted in 270 outpatient centers and hospitals across Germany aiming to collect data on prophylactic LIP use in 2500 pts with different tumor entities subjected to CTx in the clinical routine. The objective of the study is to assess the effectiveness of LIP by determining the incidence of neutropenia grade 3/4 and FN.
At the time of data cut-off (3/2016), 2422 pts were enrolled by 198 sites. 1556 pts were evaluable; 741 pts were diagnosed with BC, of whom 274 were treated with dd regimens. Mean age was 54.6/ 51.4 years for all BC pts and pts with dd regimens, respectively. In 89.0/ 96.7% of pts, CTx was applied in an adjuvant setting. Overall 96.1% of pts were treated with regimens containing A/T. 94.6/ 96.1% of documented CTx cycles were supported by LIP. Neutropenia grade 3/4 occurred in 29.4/ 33.9% of pts, 2.2/ 1.8% developed FN. Dose reductions were reported in 5.5%/ 4.2% of cycles, in 0.7%/ 0.6% of cases due to CTx-induced neutropenia. For 26.7/ 34.3% of pts, LIP-related adverse events (AE) were reported. The most frequent LIP-related AE was bone pain (11.1/ 18.6%). LIP-related serious adverse events were reported for 2.6/ 3.3% of pts.
LIP was effective and well tolerated in BC pts treated with A/T as well as in the subgroup of pts with dd regimen. The low incidence of neutropenia grade 3/4 and FN was comparable to previous publications.
Clinical trial identification
Study Protocol No.: TV44689-ONC-40004
Legal entity responsible for the study
Ethikkommission der Landesärztekammer Baden-Württemberg
C.M. Kurbacher: Membership on an advisory board / expert reviewer: TEVA GmbH; Remuneration (for membership on an advisory board / expert review): TEVA GmbH; Sponsored research: TEVA GmbH. T. Fietz: Remuneration: TEVA GmbH; Other Financial Relationships: Compensation for travel expenses by TEVA GmbH. All other authors have declared no conflicts of interest.