Efficacy and safety of lipegfilgrastim compared with placebo in patients with non-small cell lung cancer receiving chemotherapy: post hoc analysis of elderly versus younger patients

Abstract

Purpose Lipegfilgrastim, a glycoPEGylated recombinant granulocyte colony-stimulating factor (G-CSF), reduces neutropenia duration and febrile neutropenia (FN) incidence in patients with cancer receiving myelosuppressive chemotherapy. A phase 3 trial of lipegfilgrastim was conducted in patients with advanced non-small cell lung cancer (NSCLC) receiving cisplatin/etoposide (which produces mild-to-moderate myelosuppression). Because patients aged >65 years are at higher risk for FN versus younger patients, this post hoc analysis compared outcomes in elderly (>65 years) versus younger participants in this trial. Methods Patients were randomized 2:1 to receive a once-percycle single subcutaneous injection of lipegfilgrastim 6 mg or placebo, with up to 4 cycles of every-3-week cisplatin (day 1) and etoposide (days 1-3). The primary end point was FN incidence during cycle 1. Outcomes were compared across treatment groups and by age groups (≤65 and >65 years). Results For patients aged ≤65 years, FN incidence during cycle 1 was similar in the lipegfilgrastim and placebo groups (3.0 vs 3.2 %, respectively), whereas for elderly patients, there was a reduction in FN incidence with lipegfilgrastim (0 vs 13.3 %, respectively). In both age subgroups, lipegfilgrastim showed a propensity to reduce the incidence and duration of severe neutropenia, time to absolute neutrophil count (ANC) recovery, and depth of ANC nadir. Adverse events were generally similar between groups. Conclusions This analysis suggests that in patients with a higher FN risk, such as the elderly patients of this study, lipegfilgrastim reduces not only the duration of severe neutropenia but also the incidence of FN.

Cost-effectiveness and budgetary impact of lipegfilgrastim for the reduction of chemotherapy-induced neutropenia in Brazil

“…In elderly patients (>65 years), there was a reduction in FN incidence with lipegfilgrastim. Overall, lipegfilgrastim reduced the incidence and duration of SN, time of ANC recovery, and depth of ANC nadir (Volovat et al, 2016). The safety profile of lipegfilgrastim is also similar to that of pegfilgrastim, and bone pain-related symptoms were similar in patients receiving lipegfilgrastim or pegfilgrastim (Bondarenko et al, 2013;Volovat et al, 2016).…”

The prophylactic effects of long-acting granulocyte colony-stimulating factor for febrile neutropenia in newly diagnosed patients with epithelial ovarian cancer: a randomised controlled study

“…The expense of clinical visits, CBC tests and short-acting G-CSF doses saved by the utilisation of long-acting G-CSF will probably compensate for the high cost of the long-acting G-CSF. Other biosimilar pegfilgrastim products have been confirmed to have comparable efficacy and safety profiles to reference pegfilgrastim in a number of studies,9 39–42 and these products would provide more of a selection for patients.…”

PharmaForum Teva

“…Es wird in einer Dosis von 6 mg einmalig pro Chemotherapiezyklus zur Reduktion der Neutropeniedauer und Prophylaxe einer FN eingesetzt. Die Wirksamkeit und Sicherheit des Prä-parats wurde in Studien bei Patienten mit verschiedenen soliden Tumoren gezeigt [5,6]. Als Supportivtherapie war Lipegfilgrastim zur Reduktion schwerer Neutropenien bei der Behandlung von Patientinnen mit Mammakarzinom Pegfilgrastim nicht unterlegen [5].…”

“…Als Supportivtherapie war Lipegfilgrastim zur Reduktion schwerer Neutropenien bei der Behandlung von Patientinnen mit Mammakarzinom Pegfilgrastim nicht unterlegen [5]. Bei älteren Patienten mit nichtkleinzelligem Bronchialkarzinom, die ein erhöhtes Risiko für eine FN haben, verringerte Lipegfilgrastim sowohl die Dauer schwerer Neutropenien als auch die Inzidenz von FN [6].…”