Prophylaxis of chemotherapy‐induced neutropenia and febrile neutropenia with lipegfilgrastim in patients with non‐Hodgkin lymphoma (NADIR study)

Abstract

Objective The prospective non‐interventional study (NIS) NADIR was designed to evaluate both effectiveness and safety of prophylactic use of lipegfilgrastim (Lonquex®), a glycopegylated granulocyte colony‐stimulating factor, in cancer patients with different tumor entities undergoing chemotherapy in routine clinical practice. The primary objective was incidence of severe neutropenia, febrile neutropenia (FN), and neutropenia‐associated complications. Method NADIR was a national, multicenter, prospective NIS. Results Here, we present the data on patients with non‐Hodgkin lymphoma (NHL). Final analysis comprised 337 NHL patients having received ≥1 administration of lipegfilgrastim. Primary prophylaxis with lipegfilgrastim was documented in 78.7% of patients with high risk to develop FN. In total, ≥1 severe neutropenia (grade 3/4) was reported in 115 (34.1%) patients and ≥1 event of FN documented in 15 (4.5%) patients. Grade 3/4 infections were reported in 22 (6.5%) patients overall. Most frequently reported adverse events (AEs) related to lipegfilgrastim in total were bone pain (5.4%), leukocytosis (2.1%), back pain (1.8%), platelet count decreased (1.2%), and myalgia (1.2%). Fatal serious AEs were documented in 9 (2.7%) patients; none were attributable to lipegfilgrastim. Conclusion Prophylaxis or therapeutic intention with lipegfilgrastim in NHL patients in routine clinical practice showed similar effectiveness and safety as demonstrated in the pivotal trials.

The reliability of FEbrile Neutropenia after ChEmotherapy (FENCE) scores in predicting granulocyte colony-stimulating factor breakthrough febrile neutropenia among patients with lymphoma undergoing first-cycle chemotherapy: A prospective observational study

“…Specifically, use of the low-risk FENCE score cutoff as a threshold resulted in good discriminatory ability in predicting FN in this study (8,9). The incidence of FN among patients with lymphoma undergoing their first cycle of chemotherapy was consistent with other studies (4,(9)(10)(11)(12)(13). This study included patients with lymphoma, with a median age of 59 years, who received G-CSG prophylaxis.…”

Efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with aggressive B cell non-Hodgkin lymphoma (B-NHL): results of the randomized, open-label, non-inferiority AVOID neutropenia study

“…Results of this study are in line with those of a subanalysis of the prospective, non-interventional NADIR study undertaken to evaluate the effectiveness and safety of lipegfilgrastim in patients with NHL undergoing chemotherapy in routine practice settings [26]. A meta-analysis and indirect treatment comparison of lipegfilgrastim versus pegfilgrastim and filgrastim for the reduction of chemotherapy-induced neutropenia and related events demonstrated significant and clinically meaningful differences in favor of lipegfilgrastim for both time to ANC recovery (which is typically longer than DSN) and risk of severe neutropenia [27].…”

PEG-rhG-CSF Use Reduces Glucose Level Significantly in Cancer Patients Receiving Chemotherapy

“…In a series of clinical trials, its incidence ranged from 25% to 38% in patients receiving pegfilgrastim, when using pegfilgrastim as primary prophylaxis of FN in patients undergoing chemotherapy [13] . Moreover, others include leukocytosis, back pain, anemia and secondary malignancies risk, but no fatal complication was noted [14][15][16] . In fact, all of these adverse events appear to be related, and the toxicities are associated with PEG-rhG-CSF efficacy and with an increased neutrophil count [17] .…”